Regeneron, Genentech go head-to-head - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Regeneron, Genentech go head-to-head - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "

Bayer and Regeneron have initiated a head-to-head Phase III study of the VEGF Trap-Eye versus Genentech's Lucentis. Both therapies treat age-related macular degeneration, or Wet AMD. The companies expect to enroll 1,200 subjects at 200 sites. The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year, compared to Lucentis patients. VEGF Trap-Eye can be taken less frequently than Lucentis, which Bayer and Regeneron hope will give it an edge in the market. Lucentis has already been through another head-to-head trial with Visudyne and came out on top.

- check out this release

Related Articles:
Regeneron wins rich pact for VEGF trap. Report
Doctors balancing effects, costs of Lucentis and Avastin. Report
Lucentis beats Visudyne in trial. Report


Patent Law Blog (Patently-O): Summary Judgment of Non-Infringement: Downward Force <> Upward Force

Patent Law Blog (Patently-O): Summary Judgment of Non-Infringement: Downward Force <> Upward Force: "

SafeTCare’s patent covers a bariatric hospital bed designed for obese patients. On summary judgment, the district court found that the Tele-Made beds do not infringe. Other defendants and counterclaims are still pending.

Jurisdiction: On appeal, the CAFC sua sponte questioned jurisdiction. Because the judgment was not complete as to all parties and the judge had not issued a Rule 54(b) order of appealability (See Bashman), the CAFC did not have jurisdiction at the time of oral arguments. However, the CAFC allowed the parties time to ask for such an order from the district court before dismissing the appeal. (This pragmatism is perhaps due to Judge Robinson’s place on the panel).

LEVER_SMUpward Force: SafeTCare’s patent requires a plurality of motors exerting a pushing or upward force on the bed. Tele-Made’s motors are essentially attached to one end of a lever, and by pulling down, cause an upward force on the other end of the lever. However, because SafeTCare’s specification implied a direct link between the motor and the bed, the levered approach was non-infringing. Prosecution history estoppel blocks DOE coverage.

Non-infringement affirmed."

MaRS Blog - Innovation and Commercialization in Canada � Blog Archive � Today’s Pick: Cleantech VC in China

MaRS Blog - Innovation and Commercialization in Canada � Blog Archive � Today’s Pick: Cleantech VC in China: "Environmental Finance highlights a report from the Cleantech Network on the growing appeal of Chinese cleantech companies. Venture capitalists poured $420 million into Chinese cleantech technologies in 2006, with 70% of investment funds going to solar power. Cleantech investments already represent nearly 20% of total VC investment in China ($2.2 billion in 2006), and investment is expected to grow, reaching $720 million by 2008.

Download: China Cleantech Venture Capital Investment Report"

Is Pursuing a Career in Patent Law the Right Move for You? - Arabia on Line

Is Pursuing a Career in Patent Law the Right Move for You? - Arabia on Line: "

What's It All About?
The field of patent law is wide open to Biologists, Chemists, Engineers, Computer Scientists, and many other science and technology professionals. And it's true; individuals with the proper science or engineering degree need only pass the Patent Bar to become registered Patent Agents.

Upon becoming a Patent Agent, you may gain employment writing and prosecuting patent applications at law firms, technology transfer offices, biotech or engineering corporations, and government institutes.

From there, you may decide whether or not to go on to law school and become a Patent Attorney. In addition to writing and prosecuting patents, a Patent Attorney can also litigate in patent infringement cases.

The Perfect Skill Set
Patent law is the perfect field for many creative and talented individuals since it requires so many qualities to be successful.

There is definitely a people-oriented side to a career in patent law. This is especially true when you consider the "isolated lab environment" most scientists and engineers are used to. Contrast this with the fact that an inventor's hopes and dreams will be riding on the invention and that you will be there every step of the way to help them achieve their goals. Obviously, a great deal of interviewing and excellent communication is required in order to adequately learn what was invented and write a patent application.

Which brings us to the next point; patent practitioners must also have excellent writing skills. Drafting a quality patent application is tedious work that requires the absolute best in written communication.

In addition, a strong background in either science or technology is a must. You will have to understand exactly what has been invented in order to write a quality patent application.

Lastly, as a Patent Practitioner, you should possess a thirst for never-ending knowledge. You will be right on the cutting edge of research and development. You will constantly be exposed to new and exciting discoveries virtually before anyone else!

The Dollars and Cents
It's the million dollar question. What might you expect to make as a professional in the field of patent law? Well, the pay scale varies from $45,000 up to $250,000+ for Patent Practitioners and is determined by many factors (yes I realize that's quite a span).

First, as we've already eluded, if you are a scientist or engineer without a law degree you will be classified as a Patent Agent after you pass the Patent Bar Exam. If you have a law degree and are already considered an attorney, you will be classified as a Patent Attorney upon passing the exam. As a Patent Attorney with the same level of experience as a Patent Agent, you will typically earn the higher income because in addition to writing and prosecuting patents, you may also help protect patents in a court of law.

Second, your degree level will help determine your pay. If you have a Bachelor's degree in your particular area of expertise, you will typically make less than someone with a Master's or a PhD.

Third, your experience level will make a difference. Your previous positions will count when factoring your salary. The number of years you have worked as an engineer or scientist will make a difference. The more experience you have, usually the more valuable you will be perceived by the company. The longer you have worked in the field of patent law, the higher your pay will be as well.

Lastly, where you seek employment makes a difference in your pay. Law firms typically pay the most, whereas a Technology Transfer department at a University will usually pay the least. Furthermore, the state and city you apply for work in will also play a factor.

Hot Commodity
Businesses in the science and technology sectors regard patents as their lifeline. Therefore, gaining status as a registered Patent Practitioner can open many career doors for you.

Since the fields of research and intellectual property are so intertwined, imagine the new career opportunities you would be presented with if you were trained in both areas. Furthermore, as a scientist or engineer, most of the qualifications necessary to achieve registration as a Patent Practitioner have usually already been met. It is likely that your only requirement may be to pass the Patent Bar Exam. It is a difficult hurdle, but in comparison to the time and money you already spent to become a scientist or an engineer, the time and money necessary to pass the Patent Bar Exam is reasonable.

In today's unpredictable job market, expanding your skills makes sense, especially when this can be accomplished for a relatively low expense and little time. Compared to getting a degree, setting aside even a full year (although it can be completed in much less time) to learn about the patent prosecution process and take the Patent Bar Exam is very reasonable. Especially when you further consider the fact that it will open an entirely new career door for you. Whether you wish for a complete job change or the desire to become more marketable for technology based companies, gaining skills is always a smart move to make.

Please review www.PatentBarStudy.com to learn more about the Patent Bar Exam and how you can jump-start your career as a Patent Practitioner.

Lisa Parmley
Intellectual Properties Enterprises, Inc

: "n th" As India continues to become more relevant in a global world, hoping to leapfrog into a developed nation through its brainpower and service capabilities, the importance of intellectual property and its protection will come even more sharply into the foreground.

At present, one of the grey areas clouding corporate investment decisions in the Indian economy is the concern over our compliance with internationally accepted intellectual property standards.

A recent Business Week article explained that part of the trouble with India is its deficit of traditional infrastructures such as highways, reliable power and clean water. Yet, there is another infrastructure that India needs to be focusing on strongly, in order to propel its economy forward much faster — one that consists of protection for innovation.

This protection must be delivered in a manner that is perceived by corporates to be credible, transparent and based on principles of commitment and unimpeachable integrity. Inevitably, this intangible infrastructure is one of the basic building blocks of our fast-emerging knowledge economy.

Against this background, corporate India is closely watching the Novartis Pharmaceuticals case in the Madras High Court. Novartis has claimed that section 3(d) of the Indian Patents Act — amended in 2005, which defines exactly what a new invention should consist of — is not in compliance with the WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and is therefore unconstitutional and in breach of international trade law.

It has claimed that this section creates additional hurdles, is outside the normal patentability criteria, and goes beyond the framework of international agreements for pharmaceutical patents.

This case has evoked strong emotions from health activists and NGOs who feel that if the section was indeed struck down or amended significantly by the high court, patents would be granted far more widely in India, heavily restricting the production of affordable medicines that has become crucial to the treatment of diseases across the developing world.

At the heart of the matter is the way the court will interpret the challenge to the legislation. However, it is clear that significant events hang in balance, depending on which way this judgement will go. Investors, both foreign and domestic, will use it to benchmark the long-term potential of the Indian pharma market.

It is worthwhile to note that this market is increasingly going to see not only greater interest from foreign players but also a fight for dominance by Indian players who have exponentially increased their R&D spends to morph from being great chemical synthesisers into innovators of repute.

At stake is the balancing of a long-term sustainable investment in healthcare infrastructure — along with encouragement and nurturing of domestic scientific talent (the third largest in the world) — with making medicines more affordable.

This balancing is excruciatingly difficult and will have to be achieved objectively, realising that the pharmaceutical industry itself is highly competitive, not only nationally but also internationally. As Asia becomes a global hub for investment, particularly for the pharmaceutical industry, India must compete with key players in the region — many of whom are more willing to adopt internationally acceptable intellectual-property standards.

A case in point is Singapore, which is striving to successfully transition to developed-country status and has taken certain steps concerning patent law that appeal to foreign investors. Recognising the importance of IPRs, the Intellectual Property Office of Singapore has implemented various initiatives, such as making Singaporeans ‘IP ready’ by educating school children about IP, and teaching businesses how to use the IP system to be more competitive.

If India has to contend to be a viable investment option within Asia, we must ensure we maintain our competitive edge over other countries in the region.

The current boost to FDI in India is only the trickle at the beginning of what could be a flood, which could help us to bridge the “prosperity gap” and herald more inclusive growth for our people. Without strong intellectual property protection, there is a disincentive for corporates to invest in a sustainable manner in developing innovative IP, which could, in the medium to long term, hamper our ability to harness opportunities for growth.

Strong intellectual property laws and a fair and credible implementation that gives investors the opportunity to be rewarded for their innovations and to recoup the value of their investments are necessary building blocks for spurring even more investment in IP innovation.

The resultant increase in economic activity could provide a chance to many of our less fortunate brethren to escape the shackles of poverty and deprivation.

Economic theory holds out, since time immemorial, the direct correlation of risk and reward and a climate conducive to innovation and entrepreneurship is a sine qua non to long-term economic prosperity.

(The author is sector leader, Pharmaceuticals, KPMG)

Biotechnology Clusters in North America

Biotechnology Clusters in North America: "The following is a list of the top biotechnology hubs in North America. Each cluster is an active site of R&D, job and investment opportunities in the life sciences or agricultural biotech. The clusters are not listed in any particular order.

For a map of worldwide hubs, including these centers, check out the Global Biotechnology Clusters map at University of Minnesota's MBBNet."

Biotechnology Hubs in North America

Biotechnology Hubs in North America: "Although the order of the top biotech hubs in NA might vary slightly depending if they are ranked based on revenue, employment opportunities, number of companies, or other criteria, in general, Toronto and Montreal, Canada, are two of the top centers"

Technology Review: Making Gasoline from Bacteria

Technology Review: Making Gasoline from Bacteria: " into producing hydrocarbons that could be processed into fuels like those made from petroleum.

LS9, a company based in San Carlos, CA, and founded by geneticist George Church, of Harvard Medical School, and plant biologist Chris Somerville, of Stanford University, had previously said that it was working on what it calls "renewable petroleum." But at a Society for Industrial Microbiology conference on Monday, the company began speaking more openly about what it has accomplished: it has genetically engineered various bacteria, including E. coli, to custom-produce hydrocarbon chains.

To do this, the company is employing tools from the field of synthetic biology to modify the genetic pathways that bacteria, plants, and animals use to make fatty acids, one of the main ways that organisms store energy. Fatty acids are chains of carbon and hydrogen atoms strung together in a particular arrangement, with a carboxylic acid group made of carbon, hydrogen, and oxygen attached at one end. Take away the acid, and you're left with a hydrocarbon that can be made into fuel.

"I am very impressed with what they're doing," says James Collins, codirector of the Center for Advanced Biotechnology at Boston University. He calls the company's use of synthetic biology and systems biology to engineer hydrocarbon-producing bacteria "cutting edge."

In some cases, LS9's researchers used standard recombinant DNA techniques to insert genes into the microbes. In other cases, they redesigned known genes with a computer and synthesized them. The resulting modified bacteria make and excrete hydrocarbon molecules that are the length and molecular structure the company desires.

Stephen del Cardayre, a biochemist and LS9's vice president for research and development, says the company can make hundreds of different hydrocarbon molecules. The process can yield crude oil without the contaminating sulfur that much petroleum out of the ground contains. The crude, in turn, would go to a standard refinery to be processed into automotive fuel, jet fuel, diesel fuel, or any other petroleum product that someone wanted to make.

Next year LS9 will build a pilot plant in California to test and perfect the process, and the company hopes to be selling improved biodiesel and providing synthetic biocrudes to refineries for further processing within three to five years. (See "Building Better Biofuels.")

But LS9 isn't the only company in this game. Amyris Biotechnologies, of Emeryville, CA, is also using genes from plants and animals to make microbes produce designer fuels. Neil Renninger, senior vice president of development and one of the company's cofounders, says that Amyris has also created bacteria capable of supplying renewable hydrocarbon-based fuels. The main difference between the companies, Renninger says, is that while LS9 is working on a biocrude that would be processed in a refinery, Amyris is working on directly producing fuels that would need little or no further processing."

Patent Prospector: Drama?

Patent Prospector: Drama?: "Guardian Media unleashed a rash of declaratory judgment suits related to its patents for parental content control for TV programs; from Sony, Mitsubishi, JVC, Matsushita, and Thomson. After consolidation, Guardian got the district court to dismiss for lack of controversy. The appeals court disagreed, finding all the ingredients for an adjudicatable dispute.

Sony Electronics & Mitsubishi Digital Electronics America & Thomson & Victor Company of Japan & Matsushita Electric Industrial v. Guardian Media Technologies (CAFC 2006-1363)

Background on the patents -

The [4,930,160] ’160 patent generally relates to methods and apparatuses for blocking the viewing of certain television programs. Similar to the ’160 patent, the [4,930,158] ’158 patent relates to methods and apparatuses for blocking the playing of certain programs recorded on a videotape or other medium. The patents describe a system in which users can selectively block the viewing or playing of programs that have particular program classification codes. Such a system can be used, for example, by parents wishing to prevent their children from viewing television programs designated unsuitable for children. Both patents were issued on May 29, 1990, both list Peter S. Vogel as the inventor, and both were assigned to Guardian in November 2003.

Guardian Media had pursued Sony with letters asserting infringement, and claim charts, for five years. Other companies garnered similar attentions. The reply had been the declaratory judgment motions, and requests for reexaminations for both patents in fall of 2005, which were granted.

The CAFC summarizes the situation: Sony et al said it had "reasonable apprehension that Guardian would file an infringement suit;" Guardian's notion that "an actual controversy (and thus jurisdiction) arises only after an express or implicit threat of litigation." -

The main question we must answer in this case is whether the facts show that there is an “actual controversy” between Guardian and each of the appellants within the meaning of the Declaratory Judgment Act, 28 U.S.C. § 2201(a). Because the relevant facts are undisputed, we review de novo the district court’s decision to dismiss the consolidated cases for lack of an actual controversy. SanDisk Corp v. STMicroelectronics, Inc., 480 F.3d 1372, 1377 (Fed. Cir. 2007); Arrowhead Indus. Water, Inc. v. Ecolochem, Inc., 846 F.2d 731, 735 (Fed. Cir. 1988).

Sony, Matsushita, JVC, and Mitsubishi (collectively, “appellants”) argue that the district court erroneously required each appellant to establish that it faced an express or implicit threat of immediate litigation. Appellants argue that the 1999 letters from Vogel, the previous owner of the ’158 and ’160 patents, amount to “express charge[s] of infringement,” which should be imputed to Guardian for purposes of determining whether there is an actual controversy. Citing Arrowhead, 846 F.2d at 736, appellants maintain that an express charge of infringement alone is sufficient to establish an actual controversy under the correct legal standard.

In addition, each of the appellants also argues that (while not required) it has demonstrated that the totality of the circumstances gave rise to a reasonable apprehension that Guardian would file an infringement suit against it. For example, Sony argues that the letters sent by Guardian in 2004 and 2005—including the detailed charts comparing certain claims of the ’158 and ’160 patents to representative Sony products—establish that Guardian “had reached a studied and considered determination” that Sony was infringing. Id. at 738. According to Sony, these letters thus demonstrate that Sony’s apprehension of suit was reasonable. Sony and the other appellants also point out that the negotiations between appellants and Guardian, to the extent any occurred, had ended by the time these suits were filed.

Guardian, on the other hand, argues that the district court properly dismissed each of the appellants’ complaints for lack of an actual controversy. According to Guardian, an actual controversy (and thus jurisdiction) arises only after an express or implicit threat of litigation by the patentee. Guardian points out that it never expressly threatened any of the appellants with an infringement suit.

The legal backdrop; most notably, that the Supreme Court refused to articulate a bright-line standard to adjudge controversy -

The Declaratory Judgment Act provides that, “[i]n a case of actual controversy within its jurisdiction . . . any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought.” 28 U.S.C. § 2201(a). The phrase “case of actual controversy” “refers to the type of ‘Cases’ and ‘Controversies’ that are justiciable under Article III.” MedImmune, 127 S. Ct. at 771; Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240 (1937).

The Supreme Court has not articulated a bright-line rule for distinguishing those cases that satisfy the actual controversy requirement from those that do not. Indeed, it has stated that “[t]he difference between an abstract question and a ‘controversy’ contemplated by the Declaratory Judgment Act is necessarily one of degree, and it would be difficult, if it would be possible, to fashion a precise test for determining in every case whether there is such a controversy.” Md. Cas. Co. v. Pac. Coal & Oil Co., 312 U.S. 270, 273 (1941). Instead of fashioning a precise test, the Supreme Court has required only that the dispute be “‘definite and concrete, touching the legal relations of parties having adverse legal interests’; and that it be ‘real and substantial’ and ‘admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.’” MedImmune, 127 S. Ct. at 771 (quoting Aetna, 300 U.S. at 240-41). “Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” Md. Cas., 312 U.S. at 273.

The CAFC had developed a clear standard, which the Supreme Court abrogated in MedImmune.

As a result, our post-MedImmune decisions, while not attempting to define the outer boundaries of declaratory judgment jurisdiction, have made clear that a declaratory judgment plaintiff does not need to establish a reasonable apprehension of a lawsuit in order to establish that there is an actual controversy between the parties. SanDisk, 480 F.3d at 1380-81; Teva, 482 F.3d at 1339.

[T]he Declaratory Judgment Act was intended to fix the problem that arises when the other side does not sue. See Minn. Mining & Mfg. Co. v. Norton Co., 929 F.2d 670, 673 (Fed. Cir. 1991) (“In promulgating the Declaratory Judgment Act, Congress intended to prevent avoidable damages from being incurred by a person uncertain of his rights and threatened with damage by delayed adjudication.”); Goodyear Tire & Rubber Co. v. Releasomers, Inc., 824 F.2d 953, 956 (Fed. Cir. 1987) (“[T]he purpose of the Declaratory Judgment Act . . . in patent cases is to provide the allegedly infringing party relief from uncertainty and delay regarding its legal rights.”)

The appeals court had no doubt of Sony's reasonable apprehension.

Applying the standard articulated by the Supreme Court, we think it is clear that, at the time that Sony filed its complaint, an actual controversy had arisen between Sony and Guardian within the meaning of the Declaratory Judgment Act. The dispute is, without a doubt, “definite and concrete, touching the legal relations of parties having adverse legal interests.” Aetna, 300 U.S. at 240-41.

Prior to Sony filing its complaint, the parties had taken adverse positions regarding whether Sony’s sale of products possessing parental rating control technology infringed any valid claims of the ’158 and ’160 patents.

In the words of the Supreme Court, the parties’ dispute “is manifestly susceptible of judicial determination. It calls, not for an advisory opinion upon a hypothetical basis, but for an adjudication of present right upon established facts.” Id. at 242.

Being a patient negotiator doesn't let a patent owner keep pounding regardless of what the other party wants, which most often is getting on with business, and quick resolution if so required.

In so holding, we reject Guardian’s suggestion that there can be no jurisdiction in the courts because it was at all times willing to negotiate a “business resolution” to the dispute. In SanDisk, we recognized that a patentee’s apparent continued willingness to engage in licensing negotiations does not prevent a plaintiff from maintaining a declaratory judgment suit. 480 F.3d at 1382. Accordingly, even if the parties’ interactions in this case could be characterized as “negotiations,” Sony was within its rights to terminate them when it determined that further negotiations would be unproductive. Id. Although Guardian may have wanted to negotiate with Sony, Sony was not required to negotiate with Guardian.

In short, because Guardian asserts that it is owed royalties based on specific past and ongoing activities by Sony, and because Sony contends that it has a right to engage in those activities without a license, there is an actual controversy between the parties within the meaning of the Declaratory Judgment Act. See id. at 1381 (“[At least] where a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party, and where that party contends that it has the right to engage in the accused activity without license, an Article III case or controversy will arise and the party need not risk a suit for infringement by engaging in the identified activity before seeking a declaration of its legal rights.”). The district court, therefore, erred in dismissing Sony’s complaint for lack of subject matter jurisdiction.

As went Sony, so the others.

Vacated and remanded.


Sunshine helps in the fight against breast cancer - Times Online

Sunshine helps in the fight against breast cancer - Times Online: "

Women who stay out of the sun are increasing their risk of developing breast cancer, a new study suggests.

The safe-tanning messages that are drummed into women each year may help to reduce their risk of skin cancer – but at the cost of increasing their risk of breast cancer.

The majority of vitamin D comes from exposure of the skin to sunlight but many women – exposed less in winter and reluctant to bare themselves in summer because of the dangers – are deficient.

There has been anecdotal evidence to suggest that breast cancer is less common among women who live closer to the Equator, where the sunshine is stronger.

However a new study provides evidence that the lower the levels of vitamin D in a woman’s blood-stream, the greater the risk of her developing breast cancer if she has passed the menopause.

Of more than 1,000 women who took part in a trial, those who were given both calcium and vitamin D supplements had less than half the chance of developing breast cancer than those given a placebo (13 cases among 446 women compared with 20 cases among 288 women.

A team from Creighton University in Omaha, Nebraska, enrolled 1,179 women all 55 or older, who had no history of cancer. The women were divided randomly into groups and given either supplements of calcium alone, calcium plus vitamin D, or a placebo for four years.

The researchers were interested primarily in the risk of the women suffering from osteoporosis, but they also looked at cancer risks.

The team, whose study was published in the American Journal of Clinical Nutrition, found that calcium alone also had a protective effect against cancer but it was not as strong.

When the researchers repeated the analysis for those women who were free of cancer after the first year of the study, the results were even more striking. By doing this, the team excluded any cases that would have been present, but undetected, before the trial began.

In this second analysis, the risks were reduced by more than three quarters.

“Our findings of decreased all-cancer risk with improved vitamin D status are consistent with a large and still growing body of epidemiologic and observational data showing that cancer risk, cancer mortality, or both are inversely associated with solar exposure, vitamin D status, or both,” the researchers said.

The findings underscored the value of achieving and maintaining a high concentration of the vitamin, they added.

The Creighton University study follows one published in May in Archives of Internal Medicine that reached similar conclusions.

This earlier one used data from the Nurses’ Study at Harvard, which followed more than 30,000 women for up to 15 years. Their dietary intake of both calcium and vitamin D was calculated from dietary questionnaires. The team, from Brigham and Women’s Hospital and Harvard Medical School, found that high levels of the two nutrients were linked with a 40 per cent lower risk of breast cancer in younger women.

The difference was more marked for aggressive cancers. But this study, unlike the Creighton trial, did not find a link among older women.

“Findings from this study suggest that higher intakes of calcium and vitamin D may be associated with a lower risk of developing premenopausal breast cancer,” the authors concluded.

Vitamin D is present in foods including milk, eggs, oily fish, green vegetables and fortified margarines. But a significant part of the vitamin D need is manufactured in the skin by exposure to sunlight.

Earlier studies have linked high levels of vitamin D to reduced risks of other cancers, including of the colon and prostate. But the advice of Cancer Research UK has long been that the risk of skin cancer from overexposure to the sun exceeds benefits achieved through higher vitamin D status.

Not all experts agree. Cedric Garland, of the University of California at San Diego, claimed in the British Medical Journalin 2003 that sun avoidance would increase the risk of cancers overall, especially among those who live at latitudes as far north as Britain.

He recommended 10-15 minutes a day of sun exposure, without sunscreen, to allow adequate synthesis of vitamin D. But this alone is not enough, he suggested, because vitamin D is not stored for long in the body and there is not enough sun during the winter to synthesise it.

He therefore recommended the use of supplements, as in the new trial, to boost levels. But the risks from overdosing are such that these must be taken with caution."


Patent Docs: Somerset Pharmaceuticals, Inc. v. Dudas (Fed. Cir. 2007)

Patent Docs: Somerset Pharmaceuticals, Inc. v. Dudas (Fed. Cir. 2007): " In a nonprecedential opinion, the Federal Circuit affirmed the District Court of Delaware's denial of Somerset's request for preliminary injunction to compel the Director of the USPTO to grant an interim patent term extension. Somerset is the owner of U.S. Patent No. RE34,579 ("Method of treating depression," issued April 5, 1994), which is set to expire on August 18, 2007. Somerset sought an extension in term of the '579 patent after receiving FDA approval to market Emsam®, a transdermal patch containing selgline; the '579 patent covers methods of treating depression using Somerset's patch.

I2_t_2 On April 27, 2006, pursuant to 35 U.S.C. § 156(d)(1), which authorizes an applicant to file for an extension of patent term based on regulatory delay, Somerset filed an application for term extension with the USPTO. On February 21, 2007, Somerset filed a request for interim extension under § 156(e)(2), which authorizes the Director, where a patent is set to expire before a certificate of extension can be either granted or denied, to extend the term of a patent for up to one year until such a decision is made, provided that the patent is eligible for extension.

Dudas_1000 On May 22, 2007, with no decision from the USPTO in hand, Somerset filed suit in the District Court of Delaware to compel the Director to act on - and grant - its request for interim extension. Somerset also moved for a preliminary injunction for the same relief. The District Court denied the preliminary injunction on June 29, 2007. Somerset appealed to the CAFC, moving for, and receiving, an expedited briefing schedule. The motion for expedited briefing was granted on July 12, and on that same day the Director denied Somerset's application for interim extension as well as its original application for term extension under § 156(d)(1).

In view of the USPTO's decision, Sommerset withdrew the portion of its appeal directed at compelling the Director to act on its request for interim extension, and as such, the CAFC dismissed that portion of the appeal as moot. Sommerset nevertheless maintained the appeal insofar as it sought injunctive relief to compel the Director to grant the interim extension.

The CAFC affirmed the lower court's denial of preliminary injunction on the basis that Somerset could not show a reasonable likelihood of success. The statute authorizing the Director to grant an interim extension, noted the CAFC, only did so in situations where a certificate of extension could not be granted or denied prior to expiration of the patent at issue. Because the USPTO had already denied Somerset's original application for extension, the Director had no authority to grant an interim extension, and Somerset therefore had no reasonable likelihood of success on the merits. The CAFC did add in a footnote, however, that nothing in their opinion was intended to address the merits of the Director's decision to deny a term extension.

Somerset Pharmaceuticals, Inc. v. Dudas (Fed. Cir. 2007)
Nonprecedential disposition
Panel: Chief Judge Michel and Circuit Judges Prost and Moore
Opinion by Circuit Judge Moore

Additional information regarding this case can be found at Orange Book Blog ."

Our Opinion: 3 schools tops in biotechnology | www.tucsoncitizen.com �

Our Opinion: 3 schools tops in biotechnology | www.tucsoncitizen.com �: "Three Tucson high schools are on the biotechnology cutting edge - something that will pay dividends for students.
Palo Verde, Pueblo and Tucson high magnet schools - all in the Tucson Unified School District - were recognized for their biotechnology programs.
The three schools were among nine in Arizona featured in 'Building the Bioscience Pipeline,' a report by the Flinn Foundation and the Salt River Project.
The report found that few Arizona schools address the need for qualified laboratory scientists. It also determined that a 'generation of biology students lack employable laboratory skills.'
It is good to know that three local schools are giving students a leg up in a field that will be rapidly growing and critically important locally, regionally and nationally."

Free Article - WSJ.com

Free Article - WSJ.com: "Three months after the Supreme Court handed down what many called a landmark patent decision, judges have begun to rule in favor of companies defending themselves against infringement lawsuits -- in one case dismissing a suit and in another ordering a review.

Last week, a federal judge in San Francisco who previously had allowed a patent-infringement lawsuit to proceed against RealNetworks Inc. changed course and dismissed the case, citing the Supreme Court's April ruling in KSR v. Teleflex. The case is believed to be the first in which a trial-court judge has reversed his ..."

Mice engineer to be schizophrenic - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Mice engineer to be schizophrenic - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "Scientists at Johns Hopkins have genetically engineered mice to carry a human gene that triggers schizophrenia, an advance that will help researchers search for new methods to control the disease. Researchers currently rely on mice that are given doses of powerful drugs such as PCP to induce schizophrenia. The gene was found in a Scottish family prone to the disease. By inserting the mutant gene into mouse DNA, the researchers were able to create mice with the type of brain abnormalities associated with schizophrenia. According to the National Institutes of Mental Health, schizophrenia affects about one percent of the population.

'Before, we would inject a rodent with a drug and say it's a schizophrenic mouse, but it did not reflect the underlying cause of the disease,' said Hopkins scientist Dr. Akira Sawa."

ImmunoGen, Inc. Initiates Phase II Clinical Trial of HuC242-DM4

ImmunoGen, Inc. Initiates Phase II Clinical Trial of HuC242-DM4: "CAMBRIDGE, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops novel targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP) technology, announced today that the Company has initiated a Phase II clinical study that evaluates its huC242-DM4 compound for the treatment of stomach (gastric) cancer. Patient dosing in this study began earlier this week. Stomach cancer is one of the most common cancers on a global basis, and is one of the leading causes of cancer deaths."

ImmunoGen surges on milestone trial achievement - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

ImmunoGen surges on milestone trial achievement - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Shares of ImmunoGen took off yesterday after the biotech announced that Genentech's launch of a mid-stage cancer trial for trastuzumab-DM1 would trigger a $5 million milestone payment. The drug, which is being developed to treat a certain kind of breast cancer, is a combination of ImmunoGen's cell-killing agent and an antibody from Genentech. Analysts called the start of the Phase II trial as a significant validation of ImmunoGen's technology. Genentech has a pact to use ImmunoGen's technology in its drug discovery work."

Pharmacyclics shares plunge after Xcytrin flunks Phase III - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Pharmacyclics shares plunge after Xcytrin flunks Phase III - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Shares of Pharmacyclics cratered this morning after the company reported that Xcytrin failed a late-stage trial designed to slow the spread of non-small cell lung cancer to the brain. Its stock plunged 61 percent in early trading. Patients receiving Xcytrin with radiation therapy lived an average of 15.4 months compared to 10 months for patients receiving radiation alone. But those results were not considered statistically significant. Pharmacyclics said that it would continue to study the drug for lung cancer and will discuss the future of Xcytrin with the FDA."

Industry exec says FDA approval process too strict - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Industry exec says FDA approval process too strict - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Citing the recent decision by GPC Biotech to withdraw its application for satraplatin, Pharmacyclics CEO Richard Miller says that the FDA is making it too tough to gain approvals for new cancer therapies and other drugs that fight life-threatening illnesses. Writing in The Wall Street Journal, Miller maintains that satraplatin is just the latest in a series of cases where the FDA has been making life too difficult for developers. Only one therapy achieved accelerated approval last year and none have made it through that process so far this year. He calls on the agency to revise its approach to drugs that can save the lives of patients who have exhausted other possible treatments."

PRESS RELEASE: SurModics Acquires Brookwood Pharmaceuticals - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

PRESS RELEASE: SurModics Acquires Brookwood Pharmaceuticals - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "

EDEN PRAIRIE, Minn. -- Aug 1, 2007 - SurModics, Inc., a leading provider of surface modification and drug delivery technologies to the healthcare industry, announced today that it has acquired Brookwood Pharmaceuticals, Inc., a leading provider of drug delivery technology primarily to the pharmaceutical industry, from Southern Research Institute for $40 million in cash at closing and up to an additional $22 million in cash upon the successful achievement of specified milestones.

Brookwood Pharmaceuticals is a drug delivery company that provides its proprietary polymer based technologies to companies developing improved pharmaceutical products. The company has particular strength in proprietary injectable microparticles and implant technology, both of which are based on biodegradable polymers, to provide sustained drug delivery. Currently, Brookwood has nearly 30 customer paid development projects in progress with top pharmaceutical, biotechnology and medical device clients as well as smaller public and private companies. These customer projects target a number of key clinical indications in the diabetes, oncology, ophthalmology, cardiovascular, orthopedics, central nervous system (CNS) and alcoholism markets, in addition to other fields. Similar to SurModics, Brookwood's business model includes revenue from research and development fees, polymer sales, and royalty and milestone generating licenses.

"We are very excited to welcome the employees of Brookwood Pharmaceuticals to SurModics," said Bruce Barclay, President and CEO. "We expect the combination of our two businesses to further strengthen SurModics' position as a leading company in polymer based drug delivery. Our collective technology will allow us to offer both site specific and systemic drug release capabilities to a broader range of customers in several large markets, some of which we do not participate in today. The combination of broader technology platforms and an expanded customer base will help to fulfill several of our strategic objectives, including further diversification of our business."

Anticipated Acquisition Benefits

Broader Technology Offerings to Customers

-- Deepens SurModics' capabilities in drug delivery to include both systemic and site specific drug release

-- Adds new proprietary polymer platform technologies

Revenue, Market and Customer Diversification

-- Broadens the range of markets SurModics participates in to include diabetes, oncology, ophthalmology, orthopedics and alcoholism, among others

-- Expands SurModics' customer base to incorporate many new pharmaceutical, biotech and medical device companies

-- Enhances SurModics' pipeline of potential revenue generating opportunities

-- Diversifies SurModics' revenue base

Improved Capabilities

-- Enhances product manufacturing capabilities, an element of SurModics' "climbing the value chain" strategy

-- Bolsters SurModics' capabilities to support key projects with Merck and other important customers

-- Strengthens SurModics' technical and business management teams

"The combination of our two companies is compelling given the similarity of our business models, focus on innovative drug delivery technologies and talented teams," added Barclay. "We have learned about the significant opportunities available in the pharmaceutical industry from our work in ophthalmology, and the addition of pharmaceutical expertise allows us to better participate in this industry. Brookwood's pharmaceutical manufacturing capabilities will be of great benefit to us as we work with Merck to commercialize products related to our recently announced joint development programs. Together, we expect to be able to accelerate many elements of our seven point strategic growth plan which we expect to drive strong financial results going forward. It is expected that each company's existing technology platforms will help the other drive new business with their existing customers. For example, by combining SurModics' proprietary, internally developed Eureka(TM) biodegradable polymer family with Brookwood's proprietary drug delivery platforms and capabilities, we believe a compelling novel technology can be offered that is well suited for systemic drug release products. Finally, given the similarity of our business models, both of which involve partnering with companies developing new products in the healthcare industry, we believe the fit is excellent for both companies."

"We are thrilled to combine our growing business with SurModics," said Arthur J. Tipton, Ph.D., President and CEO of Brookwood. "Since we formed Brookwood, our primary focus has been to combine strong technologies and the skills of a talented staff to develop improved drug delivery products. We are enthusiastic about this combination because it allows the combined entity to offer clients an expanded set of technologies and capabilities, and creates further opportunities to develop novel products. We believe our technology portfolios and technical capabilities are highly complementary and look forward to incorporating additional technologies in customer projects for both groups. Further, while most current Brookwood customers are in the pharmaceutical industry, we are increasingly asked to provide assistance to medical device companies for coating of drug delivery implants. We believe SurModics and its portfolio of technologies will enhance Brookwood's ability to make our customers successful."

New Business Unit

Brookwood Pharmaceuticals is a private company located in Birmingham, Alabama, that was formed in 2005 as a spinoff from Southern Research Institute. It will operate as a distinct business unit of SurModics. Dr. Art Tipton will lead the team as Vice President of SurModics and President of Brookwood Pharmaceuticals, Inc. Brookwood's headquarters and operations will remain in Birmingham.

An important piece of Brookwood's business has been to supply biodegradable polymers through its subsidiary, Lakeshore Biomaterials. This business will continue to be an important focus, and will also remain in Birmingham as we seek to meet the needs of current and future customers with an uninterrupted supply of materials.

"We have been very impressed by the success Art and the entire team at Brookwood have achieved in such a short history as an independent company," said John A. Secrist, III, Ph.D., President and CEO of Southern Research Institute, Brookwood's parent. "While we will miss having Brookwood as part of our extended organization, we are convinced that the combined companies will be much more successful than they would be apart. Furthermore, the Birmingham community has benefited from Brookwood's growth and presence, and we are very pleased that SurModics has decided to retain Brookwood in Birmingham."


SurModics paid $40 million in cash at closing and may pay up to an additional $22 million in cash upon the successful achievement of certain revenue targets and development, regulatory and other milestones associated with customer projects. Brookwood generated $12.7 million of revenue and strong year-over-year growth in calendar year 2006, with the majority coming from research and development fees. Furthermore, Brookwood is profitable and cash flow positive. The acquisition is expected to be neutral to modestly accretive to SurModics' fiscal 2008 earnings and significantly accretive thereafter.

Goldman, Sachs & Co. served as financial advisor to SurModics in this transaction, and Southern Research Institute was represented by Stonecroft Capital, LLC.

Live Webcast

SurModics will host a webcast at 8:30 a.m. ET (7:30 a.m. CT) today to discuss the acquisition of Brookwood Pharmaceuticals. Bruce Barclay, Dr. Art Tipton, and Phil Ankeny, Senior Vice President and Chief Financial Officer, will be speaking on the call. To access the webcast, go to the investor relations portion of the company's web site, www.surmodics.com, and click on the webcast icon. If you wish to participate in the conference call, dial 800-218-9073. A replay of the conference call will be available by dialing 800-405-2236 and entering conference call ID 11094661. The audio replay will be available beginning at 9:30 a.m. CT on Wednesday, August 1, until 9:30 p.m. CT on Wednesday, August 8.

About SurModics, Inc.

SurModics, Inc. is a leading provider of surface modification and drug delivery technologies to the healthcare industry. SurModics partners with the world's foremost medical device, pharmaceutical and life science companies to bring innovation together for better patient outcomes. Recent collaborative efforts include the implementation of SurModics' Bravo(TM) drug delivery polymer matrix as a key component of the first-to-market drug-eluting coronary stent. SurModics is also active in the ophthalmology market with a sustained drug delivery system that is currently in human trials for treatment of retinal disease. A significant portion of SurModics' revenue is generated by royalties earned from the sale of our customers' commercial products. SurModics is headquartered in Eden Prairie, MN. More information about the company can be found at www.surmodics.com. The content of SurModics' web site is not part of this release or part of any filings the company makes with the SEC.

Safe Harbor for Forward Looking Statements

This announcement contains forward looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations, are forward looking statements. These forward looking statements cover, among other things, the future prospects of SurModics. Forward looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the following: (1) costs or difficulties relating to the integration of the Brookwood Pharmaceuticals and SurModics businesses may be greater than expected and may adversely affect our results of operations and financial condition; (2) the expected benefits of the transaction, including revenue growth, increased profitability and shareholder returns, may take longer than anticipated to achieve or may not be achieved in their entirety or at all; (3) the transaction will expand the operations of SurModics and the markets in which SurModics participates, and such operations and markets may be subject to unique risks and difficulties with which we have not previously dealt; (4) developments in the regulatory environment, as well as market and economic conditions, may adversely affect the business and profitability of SurModics; and (5) other factors identified under "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2006, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our web site at www.surmodics.com and at the SEC web site at www.sec.gov. Forward looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.'"


PDL Shareholder Battle: Round 3

PDL Shareholder Battle: Round 3: "Hedge fund Third Point and its intriguing leader, Daniel Loeb, yesterday continued their war of words directed at the management of Motley Fool Rule Breakers pick PDL BioPharma (Nasdaq: PDLI).

Third Point is the largest shareholder of PDL stock, controlling 16% of shares. Loeb and Third Point have been lobbying for seats on the board of directors and the replacement of PDL CEO Mark McDade since March because of their perception that he has "destroy(ed) shareholder value."

This latest attack by Third Point (launched via an SEC filing seen here) lays out its case in more detail. Among new things, Third Point is accusing McDade of not notifying the rest of PDL's board of directors about acquisition discussions he held with a "large pharmaceutical company" and of promoting people to PDL management positions based on "favoritism" and "personal relationships" rather than for performance-related reasons.

Not being privy to all the details behind or veracity of Third Point's claims, I can't say whether McDade deserves to be ousted for these new issues. Some Fools make the case that he deserves more of a chance.

Just by listening to last quarter's conference call and how PDL's management made a much greater effort to explain its extravagant $100 million headquarters shift and the delays with lead drug Nuvion, it's clear that the increased oversight and criticisms by Third Point are having an effect on management's actions (which may be all that is needed to fix things in the future at PDL).

Being a former shareholder who sold his PDL shares after becoming disenchanted with the repeated delays with its drug pipeline and profligate spending, I like seeing Third Point's attempts to bring PDL's management to task for past actions if the current board of directors is not willing to do it.

Getting rid of McDade and his management team wouldn't necessarily solve such PDL problems as its slow pace of enrolling the Nuvion clinical studies and getting an Ularitide partnership deal completed on good terms. If Third Point wants to get more shareholders on its side, it needs to better outline who it would put in charge of PDL and be more specific about what changes it would make to rectify the issues plaguing the company.

One thing everyone including potential acquirers, Third Point, and the current management team seems to agree on is that shares of the drugmaker are undervalued at these levels. The trick will be to figure out how to best unlock that value and who will be leading the company to do it."

California Stem Cell Report: CIRM Directors to Address Business IP and Lab Grants

California Stem Cell Report: CIRM Directors to Address Business IP and Lab Grants: "Directors of the California stem cell agency meet next Wednesday with a $220 million matter foremost in their minds, but other issues, such as intellectual property rules for grants to businesses, also are up for action.

Criteria and procedures for the $220 million lab grant RFA – the largest single grant effort by CIRM – are likely to dominate the discussion. The meeting is expected to be the last stop before grant applications are sought. California stem cell Chairman Robert Klein is talking about approving the first stage of the grants in January(see item below).

Proposed payback requirements for businesses that receive grants from CIRM, which are part of the IP regulations, are up for possible action. The agenda is vague, but if I were a business interested in having a voice on what could be a multimillion dollar matter, I would want to be present for the Wednesday meeting in San Francisco.

The agenda also includes a proposal for pre-approval of certain Japanese stem cell lines in CIRM-funded research and changes aimed at making it easier to do research in California on reprogramming of somatic cells.

One cryptic agenda item lists consideration of an unspecified proposal from the California State University system. No details were available on the agenda at the time of this writing, but we are attempting to find out more."

ImmunoGen Initiates Phase II Clinical Trial of HuC242-DM4

ImmunoGen Initiates Phase II Clinical Trial of HuC242-DM4: "ImmunoGen announced that it initiated a Phase II clinical study that evaluates its huC242-DM4 compound for the treatment of stomach (gastric) cancer.

According to ImmunoGen, this single-agent Phase II study is designed to assess the activity — as measured by objective responses — and tolerability of huC242-DM4 for the treatment of stomach cancer.

To qualify for enrollment, patients must have metastatic or locally-advanced gastric or gastroesophageal cancer and have failed front-line chemotherapy.
Patients receive 168 mg/m2 of huC242-DM4, administered once every three weeks, the company said. The trial is expected to include up to approximately 40 response-evaluable patients and will be conducted at multiple centers in the U.S., the company added."

Incomprehension, Out For A Stroll. In the Pipeline:

Incomprehension, Out For A Stroll. In the Pipeline:: "

Here's a little night-time journey through Genentech's Vacaville manufacturing site, through the eyes of someone who has no idea of what he's seeing. The problem is, he doesn't know that - he and his friend think that they have it all figured out:

"On the one hand this place makes drugs that save people's lives -- treatments for cancers and cystic fibrosis and asthma," she told me. "Heading out," I told her, as the construction worker walked across the campus towards the gate.

"And yet, on the other hand, this place is pure evil." We walked past large vats labeled "Poison" and huge machines that looked like they could crush us. Smoke belched from the top of the building and we could see more buildings and a parking lot in the distance.

"Companies like this are made up of dozens of people, each of whom, individually, are the sweetest guys. Nice, friendly people who just care about doing well at their work." As we approached the buildings, we saw that even now -- 2AM -- the place was alive. New cars were pulling into the lot and men and women were walking from building to building. The yellowed light on their white lab coats gave the whole thing a sinister air.

"And yet, together, they manage to pull off the most incomprehensible evils. . ."

Well, incomprehensible to Aaron Swartz and his friend, anyway. The essay is written as a feeble imitation of Hunter Thompson's "Fear and Loathing in Las Vegas

Swartz presents himself through the whole piece as a passive, puzzled observer. It all just seems too much for him - equipment he doesn't recognize, people doing things he doesn't understand for reasons that he can't quite work out. The Genentech scientist in the piece comes across as a much more human figure, although there's some attempt to make him a figure of fun. Which reminds me - if anyone out there works at the Vacaville site, or knows someone who does, I'd be interested in hearing from anyone who witnessed this tiny adventure from another perspective).

Aaron Swartz, by the way, was one of the early people behind the social media site Reddit, which is intermittently interesting. These days, though, it's more often a swamp of delusional conspiracy groupthink. If it were your only news source, you'd likely be convinced that (among many other unusual things) storm troopers were sweeping the streets, rounding up supporters of Ron Paul. Or, perhaps, that Genentech was run by creatures out of H. P. Lovecraft."

FDA Law Blog: Big Steps Ahead for the Nanotech Industry

FDA Law Blog: Big Steps Ahead for the Nanotech Industry: "

Last week, FDA announced the publication of a report by the Agency’s Nanotechnology Task Force (“NTF”) that recommends that FDA develop guidance and take other steps to address regulatory and scientific issues related to nanotechnology. Nanotechnology is an emerging field of applied science and technology covering a broad range of topics in which the primary unifying theme is the control of matter on a scale 1/100,000th the thicknes of a sheet of paper (or one billionth of a meter). FDA announced the creation of the NTF in August 2006 and charged it with “determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.” In October 2006, the NTF held a public meeting to discuss some of the issues discussed in its report.

The NTF report acknowledges that although products incorporating nanotechnology pose regulatory challenges similar to those posed by other FDA-regulated products using new technologies:

[t]hese challenges may be magnified both because nanotechnology can be used in, or to make, any FDA-regulated product, and because, at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated products might change repeatedly as size enters into or varies within the nanoscale range. In addition, the emerging and uncertain nature of the science and potential for rapid development of applications for FDA-regulated products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway.

As such, the NTF report recommends that FDA take several actions. First, with respect to scientific issues, the NTF “recommends strengthening FDA’s promotion of, and participation in, research and other efforts to increase scientific understanding, to facilitate assessment of data needs for regulated products,” for example, by “[a]ssessing data on general particle interactions with biological systems and on specific particles of concern to FDA,” and “[c]ollecting/collating/interpreting scientific information, including use of data calls for specific product review categories.” Second, with respect to regulatory policy issues, the NTF recommends that FDA:

[i]ssue guidance to sponsors regarding identification of the particle size for:

    • Products subject to premarket authorization, including OTC drugs (when a new monograph or amendment to a monograph is being proposed), and food and color additives (in petitions to approve new additives or to amend existing approvals); and
    • Products not subject to premarket authorization but for which the sponsor is required to provide notice (such as dietary supplements containing certain new dietary ingredients), or may choose to provide notice (such as a GRAS notification).

In addition, although several comments were submitted to the FDA docket established for the October 2006 NTF meeting urging the disclosure (in labeling) of the presence of nanoscale materials in FDA-regulated products, the NTF recommends otherwise:

Because the current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials, the [NTF] does not believe there is a basis for saying that, as a general matter, a product containing nanoscale materials must be labeled as such.

In May 2006, prior to the creation of the NTF, the International Center for Technology Assessment (“CTA”) submitted a citizen petition to FDA requesting that the Agency create a new regulatory framework to address nanoscale particles --one that treats all nanoparticles as new substances subject to nano-specific paradigms of health and safety testing, and labeling requirements. In addition, CTA requests, among other things, a product recall and development moratorium for sunscreens and cosmetics using nanoscale materials. Although FDA has not substantively responded to the petition, clearly the NTF report is urging a more tempered FDA approach to nanotech products at this time."

Orange Book Blog: Federal Circuit Affirms Denial of Somerset Pharma's Interim Patent Term Extension on Depression Patch

Orange Book Blog: Federal Circuit Affirms Denial of Somerset Pharma's Interim Patent Term Extension on Depression Patch: "

Somerset Pharmaceuticals v. Dudas, No. 2007-1447 (Fed. Cir. 2007)

The Federal Circuit decided an odd case yesterday respecting Somerset Pharmaceuticals' application for an interim patent term extension for U.S. Reissue Patent No. RE 34,579. The '579 patent covers a method of treating depression using Emsam, a transdermal patch that includes selegiline as the active ingredient.

35 USC 156(e)(1) provides for a patent term extension to compensate for delays in FDA regulatory review of a new drug application. 35 USC 156(e)(2) provides for an interim patent term extension if the patent "would expire before a certificate of extension is issued or denied under paragraph (1)."

Somerset's '579 patent is set to expire on August 18, 2007. In April 2006, Somerset filed a request for patent term extension under Section 156(e)(1) on the '579 patent. In February of this year, the Patent and Trademark Office had still not ruled on Somerset's request, and therefore Somerset filed a request for an interim patent term extension under Section 156(e)(2).

Shortly thereafter, Somerset filed suit against Mr. Dudas, the director of the PTO, seeking to compel the PTO to rule on its request for an interim patent term extension. Somerset also filed a motion for preliminary injunction at the same time. The district court denied Somerset's motion in June, and Somerset promptly appealed to the Federal Circuit. Meanwhile, on July 12, the PTO denied both Somerset's application for a patent term extension under Section 156(e)(1) and its application an interim extension under Section 156(e)(2).

In yesterday's decision, the Federal Circuit dismissed as moot Somerset's request to compel the PTO to act on its request for an interim patent term extension. Moreover, the Federal Circuit affirmed the district court's denial of Somerset's motion for a preliminary injunction to compel the PTO to grant Somerset's request for an interim patent term extension, finding that because the PTO denied Somerset's application for a patent term extension under Section 156(e)(1), the PTO has no statutory authority to issue an interim extension.

The Federal Circuit stated expressly that yesterday's opinion does not address any claim that Somerset may have on the underlying merits of the PTO's July 12, 2007 denial of its request for a patent term extension under Section 156(e)(1). Presumably, Somerset is appealing that decision separately."

The Fire of Genius � DC Drug Price Law Struck Down (Again)

The Fire of Genius � DC Drug Price Law Struck Down (Again): "The Federal Circuit has, today, affirmed the D.C. District Court decision striking down D.C.’s Prescription Drug Excessive Pricing Act of 2005. The case is Biotechnology Industry Org._v_D.C., No. 06-1593 (Fed. Cir. Aug. 1, 2007). The Federal Circuit held that federal patent law preempts the D.C. drug price law. Pages 1-14 of the slip opinion are taken up with the background of the case, as well as an analysis of subject matter jurisdiction and standing. The preemption analysis begins on page 15, and the heart of it occurs in the opinion’s final two pages."

Biotech Blog � Carnival of Biotechnology

Biotech Blog � Carnival of Biotechnology: "Industry Trends
Singapore-based ES Cell International, the company that was poised to lead in stem cell therapeutics, has abandoned its plans for stem cell therapies. Sometimes its hard for a company to live up to the high expectations they engender in their quest for financing.

In other news, Signals Magazine reports that funding is on track for a record year.

Drug Pricing
Pharmalot has an update on the ongoing saga of international price controls. The New Zealand government’s drug buying agency has expressed their frustration at not reaching an agreement over pricing for cardiovascular drug Betaloc, accusing AstraZeneca of gambling with patients lives. Not exactly ‘building a golden bridge‘.

The Wall St. Journal has an interesting report on the efficacy of diabetes drugs: “Old, cheap diabetes drugs are as good as or better than newer, more expensive drugs at lowering blood sugar.

The New York Times has an article on on how a lack of FDA guidance is impeding innovation in biotech foods.

According to the Wall St. Journal, Japan’s drug development industry is facing a crisis: “Domestic drug makers are having trouble competing overseas and the world’s drug makers are passing over Japan when introducing new products.”


The Volokh Conspiracy - Sowood Capital Latest Casualty of Credit Market Turbulence:

The Volokh Conspiracy - Sowood Capital Latest Casualty of Credit Market Turbulence:: "The hedge fund, run by the former manager of Harvard's endowment, is liquidating after losing 57% of its value. Fortunately for Harvard, it had 'only' 500 million dollars invested in this fund. This follows the high-profile collapse of two Bear Stearns credit market hedge funds, victims of the subprime debacle.

Well, Harvard can't say it wasn't warned. I posted on Feb. 27th: '[I]f I had my money in a hedge fund that even provided a hint that it invested in mortgage-backed securities, I'd be pulling my money out pronto. Remember Long Term Capital Management? These folks aren't as smart as those folks.' [Concession: I can't tell from news reports what percentage of Sowoods' funds were in mortgage-backed securities, as opposed to other debt instrument.]

Note: Despite the allure of wishful thinking, even though I'm a homeowner now, I don't think the housing bubble has finished deflating."


Army aims to turn soldiers into 'terminators' by 2020-India-The Times of India

Army aims to turn soldiers into 'terminators' by 2020-India-The Times of India: " NEW DELHI: Arnold Schwarzeneggers they may not be, but the aim certainly is to make them ‘‘terminators’’. The Army wants to transform its 3.5 lakh infantry soldiers into high-tech, self-contained killing machines by 2020.

The Army’s futuristic modernisation programme for foot-soldiers, the F-INSAS (future infantry soldier as a system), in the pipeline for the past three years, as reported earlier by TOI , has finally taken concrete shape now.

The infantry commanders’ conference chaired by General J J Singh, which kicked off at Mhow on Monday, discussed in detail the F-INSAS project, akin to US Army’s ‘‘land warrior’’ and ‘‘objective force warrior’’ programmes.

F-INSAS basically aims at ‘‘converting an infantryman into a fully-networked all-terrain, all-weather, weapons platform with enhanced lethality, survivability, sustainability, mobility and situational awareness’’ for the digitised battlefield of the future.

Sources said the Army will approach the government with the ‘‘firm’’ F-INSAS project, along with the ‘‘costing’’, before the end of this year since it wants ‘‘systems development and integration by 2010’’.

‘‘The aim is to equip up to 10 infantry battalions (each with 800-1,000 soldiers) by 2010-2015 for F-INSAS user trials. By 2020, the project will be fielded for the entire infantry, which with 359 battalions is the largest arm of the 1.13-million strong Army,’’ said a source.

Though F-INSAS will primarily be developed through a military-DRDO-indigenous industry partnership, senior officers like Gen Singh have visited countries like US, Israel and France for a first-hand look at the programmes they have undertaken for their infantry soldiers.

In the coming years, Indian infantry soldiers will progressively get equipment like light-weight integrated ballistic helmets with ‘‘heads-up display’’ and miniaturised communication systems; portable visual, chemical and biological sensors; hand-held computer displays, GPS and video links; ‘‘smart’’ vests with sensors to monitor vital body signs; and of course lethal firepower with laser-guided modular weapon systems.

There are plans to also equip each infantry section of 10-12 soldiers with a ‘‘robotic mule’’, which apart from helping them carry additional load will also be mounted with remotely-activated weapon systems for concentrated firepower.

‘‘F-INSAS aims at integrating cutting-edge composite material sciences, information technology, nanotechnology and biotechnology as well as robotics to make a soldier into a versatile and potent sensor and shooter platform in a fully-networked battlefield environment,’’ said a senior officer.

All this, of course, will take a lot of doing. But the defence ministry, led by A K Antony, has assured the Army of full support for its around 600 modernisation schemes, worth about Rs 70,000 crore in the 11th Plan (2007-2012) period. The infantry, consequently, will be one of the major thrust areas.

MidwestBusiness.com: Midwest Business & Technology News

MidwestBusiness.com: Midwest Business & Technology News: "Anxious to find out how the Midwest has been faring on the VC funding front, I went to a focused source on both the Midwest and the life sciences sector: BioEnterprise. This organization is based in Cleveland and is dedicated to the growth of bioscience companies.

BioEnterprise has gone to great effort to compile data and track Midwest health care-related VC trends from a variety of sources. Its definition of the Midwest is a little more liberal than I would use and includes western Pennsylvania, Kentucky, Kansas and West Virginia. Even if we were to leave out these four states, the results would be very impressive.

According to BioEnterprise President Baiju Shah, the Midwest (as defined above) reported a record $742 million in VC funding in 64 companies (or an average funding of $11.6 million per company) for the first half of 2007. This level of funding compares with $286.6 million raised in 2006 or a spectacular growth of 159 percent.

As the average funding per company during the first part of 2006 was only $5.8 million, the level of funding per company in 2007 was also substantially higher.

This trend augurs well for the Midwest. Like the PricewaterhouseCoopers MoneyTree report, BioEnterprise breaks this funding into three areas: biopharmaceuticals (drugs), medical devices and health care software and service companies.

The lion�s share of funding (62 percent or $462 million) went into biopharmaceuticals. About 20 percent (or $148 million) of the funding went to medical devices and the remaining 18 percent (or $132 million) went into the health care software and services companies.

The breakdown of life sciences VC funding by state is always of interest. The dark horse (Ohio) led the way with $244.3 million for the period followed by strong results from Minnesota ($126 million) and Indiana ($117.8 million).

While these results are surprisingly good and demonstrated a lot of investor interest in Midwest companies, not all the news was good.

Illinois ranked No. 6 for the period with $42.5 million, which was less than half of what was raised in 2006 during the first six months. Furthermore, three states (Iowa, Kansas and West Virginia) showed $0 invested in their companies during the first six months. Let�s take a look at the funding by state in greater detail:

Another important perspective on these VC results for the first half is the number of deals completed and average funding size for each deal. Let�s take yet another look:

Ohio took first prize once again.

Not only did it have the most amount of VC funding but it had the most number of deals and a phenomenal growth in deal amount versus 2006. Indiana showed the highest amount of average funding per deal and an equally monumental growth over deal size from 2006.

Western Pennsylvania, Wisconsin and Indiana have averaged about a deal per month in 2007 and are ahead of their deal flow from 2006 in numbers of deals and amount of money per deal. Illinois has definitely dropped in the number of deals done in 2007.

Finally, let�s take a look at the leading deals completed in the first half of 2007:

Considering that none of these companies are publicly traded and for some this was their first round of funding, these results represented outstanding levels of funding for Midwest companies. This is an encouraging trend.

Furthermore, there was investment into Midwest companies by major east and west coast VCs such as Polaris Ventures, Burrill & Co., MPM, NEA, Orbimed, Perseus-Soros Funds, Thomas Weisel Healthcare Ventures, Interest Partners and Domain Partners. These are premier names in the VC world that are heretofore rarely seen in the Midwest.

Even some of the Big Pharma venture funds participated such as the Johnson & Johnson. This is finally some recognition.

Tough IPO Market Continues

The above trend is even more notable when you take into account the dearth of IPOs during 2007.

In the whole U.S., there were only 11 life sciences IPOs during the first half of 2007. They raised $933.3 million (or about $85 million per company). Four IPOs in the biotech space raised $224 million (or $56 million a piece). I don�t think any of these IPOs took place in the Midwest, which makes the above level of funding even more extraordinary.

While it�s only the halfway point in 2007, these stellar VC results demonstrate that great science in the Midwest is getting both recognized and funded on a national level. See you soon!


Lilly Bucks Trend in Biotech Pursuit - WSJ.com

Lilly Bucks Trend in Biotech Pursuit - WSJ.com: "
As Competitors Buy Way In,
Signs Point to Payoff
From In-House Program
July 31, 2007; Page A10

Like almost every other old-line drug maker, Eli Lilly & Co. wants to get deeper into the lucrative game of selling expensive biotechnology medicines.

But unlike its competitors, Lilly isn't buying its way into biotechnology with large acquisitions. Instead, it has been trying to build a biotech-drug pipeline from within. The take-it-slow, in-house approach shows signs of paying off. But the company has yet to prove to many investors and others in the industry that it has become a major presence in biotech.

This year, half of Lilly's drugs entering human testing will be biotech drugs, up from less than 10% in 2001, the company said, though it won't disclose specifics. By 2011, Lilly has promised Wall Street that it will bring to market one new biotech product each year -- an ambitious target for a company that has invented only a handful of such products in its 130-year history. Lilly says it has invested $2.5 billion in its biotech drive in the past three years.

[Stronger Dose?]

Venturing deeper into biotechnology carries risks. Biotech drugs -- large molecules made from living cells -- are more complicated to make than drugs made from traditional chemical compounds, known as small-molecule drugs. As a result, they can cost several hundred million dollars more to bring to market and require dedicated manufacturing lines.

That is also why they are so lucrative: their complexity has so far shielded them from generic competition and lets manufacturers charge higher prices, though that could change as Congress debates whether to create a way for the Food and Drug Administration to approve cheaper copies of biotech drugs. One plus is that their potential to hit disease targets more precisely often allows them to make it through labs more quickly and with fewer side effects.

Lilly, based in Indianapolis, made insulin out of pig tissue starting in 1923 and licensed the technology to make the first biotech drug, human insulin, from Genentech in 1982. But Lilly fell behind that biotech pioneer and until earlier this decade, its forays into biotechnology were haphazard. Five years ago, after the loss of marketing exclusivity on its best-selling antidepressant Prozac sent its stock tumbling, it deepened its commitment to the field. In its only major acquisition, in 2004 it bought Applied Molecular Evolution Inc., a company that makes technology to improve protein design, for $400 million. By contrast, AstraZeneca PLC, of London, just paid $15.6 billion for biotech company MedImmune Inc.

So far, the biotech push hasn't reversed Lilly's stock-market fortunes. Of the major drug companies, its share price declined the most last year, falling by 7.9%. The company has been beset by lawsuits that have tarnished the reputation of its best-selling schizophrenia drug Zyprexa, and pipeline hopefuls have stumbled. Zyprexa loses patent protection in 2011, and shortly thereafter Lilly stands to lose exclusivity on many other top drugs. Lilly's second-quarter profit, released last week, dropped 19% to $663.6 million from $822 million in the year-earlier period, largely because of acquisition-related charges. Revenue rose 20% to $4.63 billion from $3.87 billion.

Lilly spent an analyst meeting in December trying to get investors to buy into its biotech transformation. Most attendees, though, focused on its main blockbuster hopeful in late-stage human testing, a chemical compound to prevent blood clots called prasugrel.

"Lilly is the No. 5 biotech company [by sales], but it doesn't show up on people's lists," says John Lechleiter, Lilly's president and chief operating officer.

Barbara Ryan, an analyst who covers Lilly at Deutsche Bank AG, says "there's no magic wand that gets waved when a company is admitted to the biotech club. If more of Lilly's revenues were from biologics, then the market would view their earnings persistency as greater."

Aside from its large financial investment, part of which went to pay for a $560 million new biotech complex in Indianapolis, Lilly has had to meld two different scientific cultures: chemistry and biology. Biologists and chemists tend to take different approaches to developing products. Some old-line drug companies making the shift to biotechnology through acquisitions have kept their biologists separate from their chemists for fear of stifling the former's creativity and entrepreneurial spirit.

Lilly wanted the two sides to work together, thinking they could benefit from a joint approach to scientific challenges. "To differentiate ourselves, we need to integrate," says Sidney Taurel, Lilly's chief executive.

William Chin, vice president of discovery research, who runs Lilly's scientists on a day-to-day basis, says tensions can arise between the two groups over turf. "We're talking about biology and chemistry, two disciplines with their own history and world, so there's a natural pride and envy -- a Yankees and Red Sox sort of thing." He says several senior scientists probably wished the new biotech team would "go away."

To get the two groups to cooperate, Lilly created clusters of senior scientists with small- and large-molecule backgrounds, called "drug hunting" teams, and made them work together based on disease specialties. Lilly also changed its rewards system to praise scientists for cooperating, giving cash awards to groups that effectively "synergized," says Dr. Chin. It recently honored one group for working together on a new protein for diabetes by letting it present at an internal Lilly meeting called the "Grand Rounds."

One early skeptic of the strategy was Steven Paul, Lilly's chief of research and development. A psychiatrist by training, Dr. Paul admits he wasn't very interested in biotech drugs at first because the large, complex molecules can't usually pass through the blood-brain barrier. As a small-molecule researcher, his bias was toward drugs like Prozac, which helped define Lilly as a premier neuroscience center in the 1980s.

"Three or four years ago, I was getting depressed," says Dr. Paul, adding that he asked himself: "Do we have enough science to come up with the next generation" of neurological drugs?

But Dr. Paul's own lab surprisingly came up with a biotech drug for Alzheimer's that is thought to work by attaching to and clearing out disease-causing plaque. It is now one Lilly's of most advanced biotech projects, in the second of three phases of human testing, and has helped make Dr. Paul one of the biggest proponents of the company's biotech strategy.