BIO Calls For 14 Years of Data Exclusivity in Any Follow-On Biologics Legislation

BIO Calls For 14 Years of Data Exclusivity in Any Follow-On Biologics Legislation: "WASHINGTON--(BUSINESS WIRE)--Any legislation creating a regulatory pathway for follow-on biologics should provide 14 years of data exclusivity for the pioneering product, the Biotechnology Industry Organization (BIO) said in a paper released today. BIO defines data exclusivity as the time period after approval of the innovator’s product during which the Food and Drug Administration may not approve a follow-on biologic (FOB) product relying to any degree on the safety and effectiveness of the innovator product.

“Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a sufficient period of time in order to secure the necessary resources from venture capitalists and other funding sources. Such certainty can most predictably be provided through lengthy data exclusivity,” said BIO President and CEO Jim Greenwood. “This is because, due to the very nature of an FOBs regime, the patent system may not provide innovator biologics with effective protection against follow-on manufacturers prematurely entering the market."

Patent ruling could hurt biotechs North County Times - North San Diego and Southwest Riverside County News - NCTimes.com - Californian.com

Patent ruling could hurt biotechs North County Times - North San Diego and Southwest Riverside County News - NCTimes.com - Californian.com: "San Diego County's large biotechnology industry is likely to be a net loser following the Supreme Court's patent ruling Monday, said John Benassi, a San Diego intellectual property attorney who works with life science companies. The ruling makes it easier to challenge a patent on the grounds that the idea was obvious or showed no real innovation."

Orange Book Blog: Pharma News Briefs

Orange Book Blog: Pharma News Briefs: "Pharma News Briefs

* AP published this report on yesterday's House hearing on 'reverse payment' settlements.
* AP also recently published this article on follow-on biologics legislation, entitled 'Time is Running Out for Generic Biotech.'
* Antitrust Review recently posted an update on the FTC's authorized generics study.
* FDA Law Blog has a new post today on the most recent developments in the generic Norvasc litigation.
* FDA Law Blog also posted last week on a Medicis challenge to FDA's policy regarding exclusivity for 'old' antibiotics.
* Patent Docs has two interesting recent posts--here and here--on applying TRIPS to patented drugs in developing countries.
* Patently-O has a new post today by Cal Crary, a pharma litigation analyst: 'Impact of KSR v. Teleflex on the Pharmaceutical Industry.'
* PhRMA put out this press release on the U.S. Trade Representative's annual report on IP rights; see also this related post on Pharmalot.
* Pharmalot also recently had this interesting post on India's generic drug companies."

Human Genome Research Reveals Diabetes Loci

Human Genome Research Reveals Diabetes Loci: "Scientists from several research teams have used our rapidly expanding knowledge of the human genome to locate several new genes that appear to be clearly involved in the risk of developing Type 2 diabetes. Project leaders from University of Michigan, Harvard, MIT, and deCODE Genetics Inc. were part of an enormous project in which the entire genome of about 50,000 people was studied for links between genetic factors and the incidence of diabetes. Several genes, at least three of them not previously identified, stood out as risk indicators for the disease. Several published online reports can be found in Nature Genetics and Science dated April 26, 2007. The project also included groups across the USA, and in Sweden, Finland and the UK."

Orange Book Blog: House Energy and Commerce Committee to Hold Hearings on Follow-on Biologics and Reverse Payments

Orange Book Blog: House Energy and Commerce Committee to Hold Hearings on Follow-on Biologics and Reverse Payments: "On Wednesday, May 2nd, two subcommittees of the House Committee on Energy and Commerce will hold hearings of importance to pharmaceutical companies: first, on legislation to establish an abbreviated pathway for FDA approval of follow-on biologics; second, on a pending bill to ban 'reverse payment' settlements of Hatch-Waxman litigation.

At 10 a.m. ET, the Subcommittee on Health will hold a hearing entitled 'Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States.' Persons scheduled to appear include Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer of the FDA, as well as executives from Insmed, Genentech, GPhA, and others.

At 3 p.m. ET, the Subcommittee on Commerce, Trade, and Consumer Protection will hold a hearing entitled 'Protecting Consumer Access to Generic Drugs Act of 2007.' Persons scheduled to appear include Jon Leibowitz, Commissioner of the FTC, as well as Prof. Scott Hemphill, law professor at Columbia, Dr. Barry Sherman, CEO of Apotex, and others."

FuturePundit: $10 Device Synthesizes DNA

FuturePundit: $10 Device Synthesizes DNA: "Polymerase chain reactions (PCRs) are widely used to synthesize DNA as part of DNA sequencing work. Dr. Victor Ugaz at Texas A&M University has found a way to speed up the PCR DNA copying process at very low cost.

A pocket-sized device that runs on two AA batteries and copies DNA as accurately as expensive lab equipment has been developed by researchers in the US.

The device has no moving parts and costs just $10 to make. It runs polymerase chain reactions (PCRs), to generate billions of identical copies of a DNA strand, in as little as 20 minutes. This is much faster than the machines currently in use, which take several hours.

The development of cheap miniature devices is the future of biotechnology and is going to do to biotechnology what miniaturization has done to computer technology. Therefore we should expect a huge accelerate of the rate at which biological science advances and the development of very cheap methods of repair of aged bodies."

Patent Docs: The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries

Patent Docs: The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries: "In just the latest in a series of developments unwelcomed by Western drug companies, Brasil has threatened to distribute a generic version of Merck & Co.'s anti-AIDS drug efavirenz (Stocrin�). This action is consistent with earlier steps taken by Brasil, as well as Thailand, that thwart the intentions of the provisions of the TRIPS agreement regarding intellectual property protection, while paradoxically being in full compliance with WTO policies and practices."

Health Blog : Court Nixes Ban on Sale of Doctor Data

Health Blog : Court Nixes Ban on Sale of Doctor Data: "A federal judge has overturned a New Hampshire law that barred the sale of data that tell the drug industry and its sales representatives which doctors are prescribing which drugs. Yesterday’s ruling found that the law violated the First Amendment’s protection of free speech."

Pentagon to Merge Next-Gen Binoculars With Soldiers' Brains -

Pentagon to Merge Next-Gen Binoculars With Soldiers' Brains -: "U.S. Special Forces may soon have a strange and powerful new weapon in their arsenal: a pair of high-tech binoculars 10 times more powerful than anything available today, augmented by an alerting system that literally taps the wearer's prefrontal cortex to warn of furtive threats detected by the soldier's subconscious.

In a new effort dubbed 'Luke's Binoculars' -- after the high-tech binoculars Luke Skywalker uses in Star Wars -- the Defense Advanced Research Projects Agency is setting out to create its own version of this science-fiction hardware. And while the Pentagon's R&D arm often focuses on technologies 20 years out, this new effort is dramatically different -- Darpa says it expects to have prototypes in the hands of soldiers in three years."

RNAi Therapeutics: RNAi Therapeutics Companies

RNAi Therapeutics: RNAi Therapeutics Companies: "There are a few dozen companies now, small and large alike, that have started developing drugs based on RNAi. While most of them are in the pre-clinical stages, in 2004 Acuity Pharmaceuticals (soon to be known as Opko) was the first to start phase I trials for age-related macular degeneration (AMD). Since then 5 more programs have entered the clinic: 2 additional ones for AMD (Sirna Therapeutics, acquired by Merck in 2006 for the handsome sum of $1.1 billion; and Quark Biotech), and one each in RSV (Alnylam Pharmaceuticals), diabetic macular edema (Acuity), and acute kidney injury (Quark Biotech). "

Health Blog : FDA Science Under the Microscope

Health Blog : FDA Science Under the Microscope: "A Nobel laureate and a former Merck CEO are among the scientists from industry and academia set to review the state of science at the FDA.

In an agency-wide email distributed late last week and obtained by the WSJ’s Anna Wilde Mathews, FDA Commissioner Andrew von Eschenbach wrote that the group will determine “where there are gaps and unnecessary redundancies across the agency’s scientific work.” The outside experts will also evaluate how well the agency’s scientific capabilities are keeping up with emerging fields.

Gail Cassell, Eli Lilly’s vice president for scientific affairs, is chairing the group. In an interview this morning, she gave us a few clues as to what the they’ll be looking at:"

Press Release: Pfizer Wins Celebrex Patent Decision in Canadian Court - FierceBiotech

Press Release: Pfizer Wins Celebrex Patent Decision in Canadian Court - FierceBiotech: "NEW YORK--(BUSINESS WIRE)--Pfizer Inc reported today that the Federal Court of Appeal of Canada has reversed a lower court ruling that would have permitted generic manufacturer Novopharm to launch a competitor product to Celebrex. The appellate court issued an order prohibiting regulatory approval of Novopharm's product in Canada until Celebrex's compound patent expires in November 2014."

ScienceDaily: Moderate Coffee Drinking Reduces Many Risks, Panel Says

ScienceDaily: Moderate Coffee Drinking Reduces Many Risks, Panel Says: "Coffee is among the most widely consumed beverages in the world, and Dr. Coughlin says that the preponderance of scientific evidence - some by the panelists - suggests that moderate coffee consumption (3-5 cups per day) may be associated with reduced risk of certain disease conditions, such as Parkinson's disease. Some research in neuropharamacology suggests that one cup of coffee can halve the risk of Parkinson's disease. Other studies have found it reduces the risk of Alzheimer's disease, kidney stones, gallstones, depression and even suicide."

Decode heart attack drug clears first test hurdle | Health | Reuters

Decode heart attack drug clears first test hurdle | Health | Reuters: "LONDON, May 1 (Reuters) - Icelandic biotech company Decode Genetics Inc. (DCGN.O: Quote, Profile, Research said on Tuesday its DG051 experimental drug for preventing heart attacks had produced positive results in initial Phase I clinical tests."

Biogenerics bill could squeeze biotechs, if it passes - Apr. 30, 2007

Biogenerics bill could squeeze biotechs, if it passes - Apr. 30, 2007: "NEW YORK (CNNMoney.com) -- Lawmakers are pushing forward with legislation that could help create generic competition for Big Biotech, drastically lowering the costs of expensive biotech drugs and changing the landscape in the pharmaceutical industry forever.

The Senate is expected to vote Wednesday on a bill that would extend the 15-year-old process of requiring drug companies to pay fees to the Food and Drug Administration to help fund the drug review process. Advocates say the law has helped streamline the review process so that it takes months instead of years to get lifesaving drugs approved for the market.
More drug news

On the same day the Senate is voting, members of the House Energy and Commerce Committee are holding a hearing on a bill that would create a way for the FDA to review generic biotech drugs. Right now, there's nothing on generic biotech drugs in the Senate bill, and there's no guarantee that the bill will be modified."

ScienceDaily: Chinese compound fights kidney cysts

ScienceDaily: Chinese compound fights kidney cysts: "NEW HAVEN, Conn., April 30 (UPI) -- A U.S. scientist, using a compound from a centuries-old Chinese traditional medicine, has prevented formation of kidney-destroying cysts in a mouse model.

Yale University researcher Craig Crews said his findings hold hope for what would be the first treatment, other than kidney transplant or frequent dialysis, for one of the most lethal of kidney diseases worldwide."

Positive Phase III data inspires $133M Eurand IPO - FierceBiotech

Positive Phase III data inspires $133M Eurand IPO - FierceBiotech: "Eurand has filed for an IPO of seven million shares designed to raise up to $133 million. The drug developer, which has operations in Europe as well as the U.S., plans to sell its shares for $17 to $19 each. The offering is following closely on the heels of an announcement in early April that its lead therapy delivered positive results in two late-stage studies. "

Green tea compound may be a therapy for people with rheumatoid arthritis

Green tea compound may be a therapy for people with rheumatoid arthritis: "ANN ARBOR, Mich. -- A new study from the University of Michigan Health System suggests that a compound in green tea may provide therapeutic benefits to people with rheumatoid arthritis.

The study, presented April 29 at the Experimental Biology 2007 in Washington, D.C., looks at a potent anti-inflammatory compound derived from green tea. Researchers found that the compound -- called epigallocatechin-3-gallate (EGCG) -- inhibited the production of several molecules in the immune system that contribute to inflammation and joint damage in people with rheumatoid arthritis.

The compound from green tea also was found to suppress the inflammatory products in the connective tissue of people with rheumatoid arthritis."

BBC NEWS | Health | Scientists 'reverse' memory loss

BBC NEWS | Health | Scientists 'reverse' memory loss: "Scientists found mice with a similar condition to Alzheimer's were able to regain memories of tasks they had previously been taught.

A team at the Massachusetts Institute of Technology found two methods - brain stimulation and drugs - both worked.

Their findings were published in British journal Nature."

Scientists Identify 7 New Diabetes Genes - New York Times

Scientists Identify 7 New Diabetes Genes - New York Times: "Researchers said yesterday that they had identified seven new genes connected to the most common form of diabetes — the latest result of an intensifying race between university researchers and private companies to find genes linked to a range of diseases.

The findings, presented in three reports by university scientists and one by a private company, offer novel insights into the biology of a disease that affects 170 million people worldwide.

And the sudden spate of new results mark an acceleration, and perhaps a turning point, in the ability to find disease genes, the long-promised payoff from the human genome project that began in 1989."

Minuscule Molecules Pack A Powerful Punch In Immune Defence

Minuscule Molecules Pack A Powerful Punch In Immune Defence: "Scientists have shown that a tiny microRNA molecule called miR-155, plays a critical role in immune defence and may be a lynchpin in the immune system. The findings reported today in Science reveal that mice lacking the bic/miR-155 gene, one of the world's first microRNA 'knockout' mice, have compromised immune systems and are less able to resist infection and mount an immune response to bacteria like Salmonella typhimurium, a leading cause of human gastroenteritis. They also develop symptoms similar to those of human autoimmune disorders."

MicroRNA Can Suppress Tumors

MicroRNA Can Suppress Tumors: "In the May 1 issue of Genes & Development, UVa researchers Drs. Yong Sun Lee and Anindya Dutta have shown that microRNAs can suppress the overexpression of a gene called HMGA2. This gene is related to creation of fatty tissue and certain tumors, as well as diet-induced obesity."

Bill would support stem cell research

Bill would support stem cell research: "Oregon would join a half-dozen states in helping fund stem cell research under a bill set for debate next week in the state House of Representatives."

ScienceDaily: Adult Stem/progenitor Cells Repair Of Damaged Brain, Pancreas, Kidney Cells Newly Understood

ScienceDaily: Adult Stem/progenitor Cells Repair Of Damaged Brain, Pancreas, Kidney Cells Newly Understood: "Dr. Prockop described two series of experiments. In the first studies, human stem/progenitor cells were injected into the hippocampal region of the brain in immunodeficient mice. The human stem/progenitor cells increased the growth and differentiation of stem cells normally found in the brains of mice and other animals. In the second studies, when human stem/progenitor cells were intravenously infused into mice that had been made to have a disease similar to human diabetes, the stem/progenitor cells traveled to and engrafted themselves in the pancreas. There, they increased the growth of the stem cells normally found in the pancreas, producing more islet cells, thus increasing the mice's production of insulin, and lowering blood sugar. With some tissue damage, the administered cells are able to do their repair activities in as little as a day and largely disappear."

WHEN SMELL CELLS FAIL THEY CALL IN STEM CELL RESERVES

WHEN SMELL CELLS FAIL THEY CALL IN STEM CELL RESERVES: "Hopkins researchers have identified a backup supply of stem cells that can repair the most severe damage to the nerves responsible for our sense of smell. These reservists normally lie around and do nothing, but when neighboring cells die, the scientists say, the stem cells jump into action. A report on the discovery will appear online next week in Nature Neuroscience."

Cape Argus: Horses lead race for viable stem-cell therapy

Cape Argus: Horses lead race for viable stem-cell therapy: "Professor Roger Smith examines a small vial of straw-coloured liquid containing millions of stem cells before filling his syringe.

His 'patient' - a nine-year-old thoroughbred bay gelding - stands sedated but still conscious while Smith guides the needle into a damaged tendon on its foreleg.

An ultrasound monitor tracks the stem cells bubbling through the tissue and in a few minutes it is all over. The leg is bandaged and the horse led back to stables.

Stem cell therapy may be controversial in human medicine, but in the world of horse racing it is becoming the odds-on favourite for tackling tendon damage, which accounts for one in three race-course injuries.

Soon the same technology could be applied to humans."

Nanomaterials used to fix neuron damage - FierceBioReseacher

Nanomaterials used to fix neuron damage - FierceBioReseacher: "Northwestern University researcher Samuel Stupp has presented the results of a study in which he injected nanomaterials into the severed spinal cords of mice, allowing them to walk again after several weeks of therapy. The nanomaterials he used were designed to self-assemble into nanofibers which repaired damaged neurons. The research offers new insights into the near-term research potential of nanotechnology and offers hope for patients with Alzheimer's and Parkinson's who suffer from severe neuron damage."

Drug switches on fat-burning gene in mice - FierceBioReseacher

Drug switches on fat-burning gene in mice - FierceBioReseacher: "Ronald M. Evans, an investigator at The Salk Institute in San Diego, has developed a drug that switches on the PPAR-d gene in mice, protecting them against weight gain from high-calorie and high-fat diets. The drug--which mimics fat--triggers their metabolisms and generates a physical response similar to exercising. After treatment, the mice had lower levels of fatty acids, triglyceride and sugar levels. These mice also exhibited much greater stamina, allowing them to exercise twice as long as normal. "

Researchers study the possible use of carboranes

Researchers study the possible use of carboranes: "Researchers in the International Institute of Nano and Molecular Medicine at the University of Missouri-Columbia are studying the possible use of carboranes, which are clusters of boron and carbon atoms, to prevent such side effects. These boron-rich clusters are substituted for carbon-based benzene rings commonly found in pharmaceuticals of all types, including COX inhibitors, which give unwanted side effects."

EETimes.com - Report: China seeks 'indigenous innovation'

EETimes.com - Report: China seeks 'indigenous innovation': "Nevertheless, AeA concludes that China will seek to use the R&D push to end its dependence on foreign technology to foster 'indigenous innnovation.' Nanotechnology and biotechnology are expected to be key focus areas, the industry group said."

News: Alethia and Emerillon to Tackle Bone Diseases. Genetic Engineering News - Biotechnology from Bench to Business

News: Alethia and Emerillon to Tackle Bone Diseases. Genetic Engineering News - Biotechnology from Bench to Business: "According to the deal, Emerillon will provide a list of genetic loci that are associated with an osteoporotic phenotype in mice. In return, Alethia will generate bone-specific cDNA libraries to help identify these genes. It also will conduct cell-based validation studies to determine the functional relevance of the genes provided."

Promote the Progress� ::: J. Matthew Buchanan's Patent Blog ::: KSR v. Teleflex - get back to where you once belonged

Promote the Progress� ::: J. Matthew Buchanan's Patent Blog ::: KSR v. Teleflex - get back to where you once belonged: "My review of the KSR v. Teleflex opinion is now available on FedCirc.us. I've reproduced the summary below.

In KSR v. Teleflex, a unanimous Supreme Court reminded the Court of Appeals for the Federal Circuit that Graham v. John Deere controls the obviousness inquiry and warned that a rigid application of the teaching / suggestion / motivation test as a litmus test for obviousness is inconsistent with the Graham framework. Stopping short of rejecting the TSM test outright, the Supreme Court slapped the test into submission, leaving it gutless and wanting for a purpose. Simply put, the TSM shortcut for an obviousness analysis is no longer available."

Biotech Establishes New Record for Market Cap in April

Biotech Establishes New Record for Market Cap in April: "SAN FRANCISCO, May 1 /PRNewswire/ -- It wasn't only the Dow Jones Industrial Average that established a new record in April, breaking through the 13,000 barrier: the collective market cap of the 360 public biotech listed on the Nasdaq and Amex, and monitored by Burrill & Company, soared above $500 billion for the first time in its history. The new mark was set April 17 and since that date it went on to close the month at $507 billion. 'The biotech industry has been growing steadily since its last 'down cycle' ended in 2003,' said G. Steven Burrill CEO, Burrill & Company, a San Francisco based global leader in life sciences whose principal activities are in Venture Capital, Merchant Banking and Media. 'The growth is even more remarkable when you take into account the fact that we have seen several leading biotechnology companies, with multibillion dollar market caps, being acquired by big pharma and their market cap value removed from the industry's collective total."

CyDex Licenses Captisol(R) to Proteolix, Inc. for Promising Oncology Compound

CyDex Licenses Captisol(R) to Proteolix, Inc. for Promising Oncology Compound: "LENEXA, Kan.--(BUSINESS WIRE)--CyDex, Inc., a specialty pharmaceutical company developing improved products through innovative drug delivery, today announced an agreement licensing its Captisol� enabling technology to Proteolix, Inc. for use with a proteasome inhibitor that has shown promise in treating certain cancers such as multiple myeloma and mantle cell lymphoma."

Dendreon: Provenge's Shortcomings Have the Shorts Coming - Seeking Alpha

Dendreon: Provenge's Shortcomings Have the Shorts Coming - Seeking Alpha: "Ishmiel Kapur submits: Perhaps one of the fastest stocks being shorted this past week and this coming week will be the one and only Dendreon Corporation (DNDN). That's right, this was the one that soared a few hundred percent a few weeks back as FDA advisors recommended the approval of their prostate cancer drug. You see how I emphasized 'recommended'? That's because the actual FDA regulators haven't actually given the final approval. And now there have been plenty of signs pointing to the possibility that they'll get a big red stamp on their application papers stating either rejected, turned-down, or even dismissed."

Stem Cell Bill Supporters Try Again

Stem Cell Bill Supporters Try Again: "In April 2007, the US Senate voted, once again, to lift restrictions on embryonic stem cell research . The bill, passed on April 11th, is the second attempt by supporters to allow federal funding for research such as regenerative medicine and therapeutic cloning using embryonic stem cell lines created after August 9, 2001. President Bush, however, has made it very clear that he intends to veto the bill, for a second time. A two-thirds majority vote is needed by the House of Representatives to override the president's veto, and it doesn't look like there are enough supporters for the stem cell bill to survive."

Patent ruling could hurt biotechs - North County Times - North San Diego and Southwest Riverside County News - NCTimes.com - Californian.com

Patent ruling could hurt biotechs - North County Times - North San Diego and Southwest Riverside County News - NCTimes.com - Californian.com: "San Diego County's large biotechnology industry is likely to be a net loser following the Supreme Court's patent ruling Monday, said John Benassi, a San Diego intellectual property attorney who works with life science companies. The ruling makes it easier to challenge a patent on the grounds that the idea was obvious or showed no real innovation."

Press Release: Zorro-LNA stops genetic disorders in their tracks - FierceBioReseacher

Press Release: Zorro-LNA stops genetic disorders in their tracks - FierceBioReseacher: "A study to appear in the June 2007 issue of The FASEB Journal describes a new agent, called 'Zorro-LNA,' which has the potential to stop genetic disorders in their tracks.

In the study, researchers from the Karolinska Institute in Stockholm, Sweden, describe how they developed Zorro-LNA to bind with both strands of a gene's DNA simultaneously, effectively disabling that gene. This development has clinical implications for virtually every human condition caused by or worsened by dominant defective genes. Examples include: Huntington's disease, familial high cholesterol, polycystic kidney disease, some instances of glaucoma and colorectal cancer, and neurofibromatosis, among others."

Aastrom Initiates Adult Stem Cell Clinical Trial for Peripheral Arterial Disease - PipelineReview.com | Business Intelligence Center

Aastrom Initiates Adult Stem Cell Clinical Trial for Peripheral Arterial Disease - PipelineReview.com | Business Intelligence Center: "ANN ARBOR, MI, USA | Apr 30, 2007 | Aastrom Biosciences, Inc. (Nasdaq:ASTM), a regenerative medicine company, today announced that it has initiated its U.S. Phase IIb prospective, controlled, randomized, double-blind, multi-center clinical trial to treat patients suffering from peripheral arterial disease (PAD). The Company will use its Tissue Repair Cell (TRC)-based product to treat critical limb ischemia (CLI) in this patient population. Approximately 10 million people in the U.S. suffer from PAD; of this group, 900,000 suffer from the most severe form, CLI, which leads to 100,000 amputations per year."

AGIPNEWS4346 BIO Reacts to Supreme Court Ruling on Obviousness ag-ip-news.com (Intellectual Property News Agency)

AGIPNEWS4346 BIO Reacts to Supreme Court Ruling on Obviousness ag-ip-news.com (Intellectual Property News Agency): "“Our decision to file a brief in this case had less to do with the specific facts of this case than with the general principle that courts have to proceed carefully in declaring patents obvious based on prior art.”

“Upon first blush, the Supreme Court appears to agree that courts need to apply a careful and deliberate analysis to the question of obviousness, focusing on the predictability of the results of the invention. The impact of the decision on the biotechnology sector will be determined by how the opinion is applied by lower court judges and Patent and Trademark Office examiners.”"

Patent Docs: KSR Int'l Co. v. Teleflex Inc. (2007)

Patent Docs: KSR Int'l Co. v. Teleflex Inc. (2007): "It is important to note that while the Court rejected the Federal Circuit's 'rigid' application of the TSM test in the present case, the Court did not discount that the test might serve as a useful analytical device in the context of a proper obviousness analysis. In fact, the Supreme Court observed that when the Federal Circuit's predecessor first established the TSM test, it had 'captured a helpful insight,' and further, that '[t]here is no necessary inconsistency between the idea underlying the TSM test and the Graham analysis.' The Court concluded, however that '[h]elpful insights . . . need not become rigid and mandatory formulas; and when it is so applied, the TSM test is incompatible with our precedents.'"

Patently-O: Patent Law Blog: Sarnoff Discusses KSR v. Teleflex

Patently-O: Patent Law Blog: Sarnoff Discusses KSR v. Teleflex: " By Professor Joshua Sarnoff, Assistant Director of the Glushko-Samuelson Intellectual Property Law Clinic and a Practitioner-in-Residence at the Washington College of Law, American University. Professor Sarnoff filed an amicus brief in support of Petitioner KSR.

In its unanimous decision in KSR Int’l. Co v. Teleflex Inc., No. 04-1350 (April 30, 2007), the Supreme Court expressly overruled the Court of Appeals for the Federal Circuit’s “teaching-suggestion-motivation” (“TSM”) test for finding a claimed invention obvious and reaffirmed the Court’s precedents (in light of the 1952 enactment of Section 103 and its holding in Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)) regarding the obviousness of patents “based on the combination of elements found in the prior art” where there the combination “does no more than yield predictable results.” "

FuturePundit: 60% Cancer Drop From Vitamin D Supplements

FuturePundit: 60% Cancer Drop From Vitamin D Supplements: "As regular readers know, I've been after you for years to raise your body vitamin D levels. If you haven't gotten off your duff yet to do anything about it how about this as something to get you going? A study coming out in June will report a more than halving of the incidence of cancer by taking vitamin D supplements."

BBC NEWS | UK | Scotland | Tayside and Central | Cancer fighting gene identified

BBC NEWS | UK | Scotland | Tayside and Central | Cancer fighting gene identified: "Researchers have found that people who carry a variant of a specific gene are less likely to develop lung cancer.

The study also revealed that the variant gene can act faster and more effectively to break down a potentially cancer-causing protein."

High Court Eases Current Patent Standard | World Latest | Guardian Unlimited

High Court Eases Current Patent Standard | World Latest | Guardian Unlimited: "Until now, a challenger seeking to invalidate a patent must be able to show that all parts of a claimed invention were known previously. In addition, the challenger must show that there is a prior ``teaching, suggestion or motivation'' to combine these prior technologies to produce the invention. Patent examiners use the same test at the front end of the process when companies are seeking patent protection for their claimed inventions.

In the past two decades, patent applications have more than tripled to more than 440,000 a year. The government approves more than half of the patents sought. Washington attorney Robert Greene Sterne, representing Teleflex, said obtaining a patent will undoubtedly become harder, cost more to pursue and take more time to reach a final decision."

Final Vectibix(TM) Positive Pivotal Phase 3 Trial Results In Metastatic Colorectal Cancer Patients Published

Final Vectibix(TM) Positive Pivotal Phase 3 Trial Results In Metastatic Colorectal Cancer Patients Published: "THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Amgen (NASDAQ:AMGN), today announced final results from a pivotal Phase 3 trial which showed that Vectibix™ (panitumumab), a fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFr), prolonged progression-free survival (PFS) compared to best supportive care (BSC) in metastatic colorectal cancer patients who had failed fluoropyrimidine, irinotecan, and oxaliplatin containing chemotherapy regimens. The results were published in the May issue of the Journal of Clinical Oncology."

Scoop: Boston beckons for kiwi biotech firms

Scoop: Boston beckons for kiwi biotech firms: "Thirty five New Zealand biotech companies and organisations will be showcased at the international biotechnology conference Bio 2007 in Boston, Economic Development Minister Trevor Mallard said today."

Webcast Alert: Supreme Court KSR v. Teleflex Decision: Teleflex Counsel Press Briefing Quotes and Full Audio Available Now

Webcast Alert: Supreme Court KSR v. Teleflex Decision: Teleflex Counsel Press Briefing Quotes and Full Audio Available Now: "WASHINGTON, April 30 /PRNewswire-USNewswire/ -- The attorneys who argued for Teleflex in KSR International Co. v. Teleflex Inc. held a press briefing earlier today. Widely viewed as the most important patent case in 40 years, it addresses the fundamental question of when an invention is 'obvious' and therefore not patentable, a question that may affect the viability of millions of patents valued at many tens of billions of"

Court Cases Threaten Weaker Patents - Forbes.com

Court Cases Threaten Weaker Patents - Forbes.com: "The Supreme Court on Monday delivered two decisions that experts say weaken the value of patents, fueling criticism that technological innovation, particularly in the biotech and pharmaceutical sectors, could be hindered.

In the more important of the two cases, the court made it simpler for companies to challenge patents on the grounds that they cover products that are obvious combinations of existing technologies. Under U.S. law, an invention must be new, useful and not obvious in order to merit a patent. The case involved Canada-based KSR International Inc. and Teleflex Inc., based in Limerick, Penn.

In the second case, the court curtailed the reach of U.S. patent laws overseas, ruling in favor of Microsoft Corp. in its dispute with AT&T Inc. over Microsoft's sale of Windows software outside the United States that allegedly infringed AT&T's patents. The decision will likely reduce damage awards in patent cases by excluding patent infringement overseas from consideration."

Patently-O: Patent Law Blog: KSR v. Teleflex: Supreme Court on Obviousness

Patently-O: Patent Law Blog: KSR v. Teleflex: Supreme Court on Obviousness: "Patent Value: In the short-term, this case reduces the average value of patent holdings. Courts should find it easier to invalidate patents based on expert testimony and the jury's concept of obviousness. The story also becomes more important -- and attorneys who can tell an 'invention story' will be in demand. During prosecution, inventors and experts should get their pens ready to sign declarations of patentability."

Patent Prospector: Obviousness Redux

Patent Prospector: Obviousness Redux: "April 30, 2007
Obviousness Redux

In its landmark decision of KSR v. Teleflex, reversing the appeals court, the Supreme Court has broadened the interpretive scope of 35 U.S.C. � 103(a), the obviousness clause. Patentable subject matter is thus constricted. In the large, in light of the ruling, a known combination of elements are only patentable if their combined functionality yields the unexpected. What was once impermissible hindsight is now permissible."

Health Blog : Supremes' Decision Leaves Pharma Patents Vulnerable

Health Blog : Supremes' Decision Leaves Pharma Patents Vulnerable: "April 30, 2007, 6:11 pm
Supremes’ Decision Leaves Pharma Patents Vulnerable
Posted by Jacob Goldstein

The Supreme Court today “unanimously reversed a lower appeals court test for when a patent is too obvious to warrant protection under federal law,” Dow Jones’s Mark Anderson reports. The ruling could make it harder for drug makers to defend the type of patents that protect extended-release formulations of brand-name drugs.

“It’s the patent case that the entire patent bar has been waiting for all year,” Aaron Barkoff, a patent attorney at McDonnell Boehnen Hulbert & Berghoff and the author of a blog on patents in the drug industry told the Health Blog. “Patents on pharmaceutical formulations might be harder to obtain or to defend in light of today’s decision. Today’s decision seems to have raised the bar for patentability.”"

Wisconsin Stem Cell Patent Foundation's Managing Director Should Quit Patent Office Post to Avoid Conflict of Interest, Consumer Advocates Say

Wisconsin Stem Cell Patent Foundation's Managing Director Should Quit Patent Office Post to Avoid Conflict of Interest, Consumer Advocates Say: "SANTA MONICA, Calif., April 30 /PRNewswire-USNewswire/ -- Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation (WARF), should resign from the U.S. Patent Public Advisory Committee to avoid a conflict of interest while key stem cell patents are being considered for rejection, consumer advocates said today. The U.S. Patent Office is re-examining three patents held by WARF on human embryonic stem cells after a challenge filed last summer by the Foundation for Taxpayer and Consumer Rights (FTCR) and the Public Patent Foundation (PUBPAT)."

Opinion | Lawmakers Have Proposed 'Witch's Brew' of Biotech Bills, Op-Ed States - Kaisernetwork.org

Opinion | Lawmakers Have Proposed 'Witch's Brew' of Biotech Bills, Op-Ed States - Kaisernetwork.org: " Lawmakers in recent months 'have stirred up a witch's brew of initiatives that is cause for some concern -- not only for the biotech industry, but for all Americans,' James Mullen, president and CEO of Biogen and chair of the Biotechnology Industry Organization, writes in a Wall Street Journal opinion piece. 'What will the next 30 years mean for our industry and the patients we serve?' Mullen writes, adding, 'The answer will depend in large measure on what happens in Washington over the next two years.' "

The upstart revolution in biotech - FierceBiotech

The upstart revolution in biotech - FierceBiotech: "It struck me that this year there's a distinct abundance of promising companies being bankrolled by some very eager venture capital groups. It's a thoroughly non-scientific approach to trend-spotting, but for me it underscores just how strong the drug development field is right now. A good business plan, experienced management and a couple of intelligent licensing deals can propel a company into clinical development in relatively short order. "

Sangamo, Genentech in Development Pact - Forbes.com

Sangamo, Genentech in Development Pact - Forbes.com: "Sangamo BioSciences Inc., a developer of gene-based therapies, said Monday it entered an agreement to provide Genentech Inc. with technology to make protein drugs.

Financial terms were not disclosed.

Under the agreement, Sangamo will provide Genentech (nyse: DNA - news - people ) with its zinc finger DNA-binding protein technology and make enzymes for Genentech to evaluate for drug development."

Cloned cows a no-show at next week's BIO - FierceBiotech

Cloned cows a no-show at next week's BIO - FierceBiotech: "Every annual meeting of BIO is attended by some protests, and this year's upcoming gathering in Boston is no exception. Boston police asked Iowa-based TransOva to scrap plans to bring in two cloned cows to the meeting next week, out of fear that the bovine imports would trigger animal rights protests. (There was also a little problem with the exhibition hall's rules on live animal appearances.) It's doubtful that official appeasement can keep all the protesters away, though. American animal rights groups may not use the radical tactics on display in the UK, but they can be loud."

BBC NEWS | Technology | Mouse brain simulated on computer

BBC NEWS | Technology | Mouse brain simulated on computer: "US researchers have simulated half a virtual mouse brain on a supercomputer.

The scientists ran a 'cortical simulator' that was as big and as complex as half of a mouse brain on the BlueGene L supercomputer."

Press Release: Sangamo BioSciences Announces Research and License Agreement With Genentech for ZFP Technology - FierceBiotech

Press Release: Sangamo BioSciences Announces Research and License Agreement With Genentech for ZFP Technology - FierceBiotech: "RICHMOND, Calif., April 30, 2007 -- Sangamo BioSciences, Inc. today announced that it had entered into a Research and License Agreement with Genentech, Inc. Under this agreement, Sangamo will provide Genentech with access to Sangamo's proprietary zinc finger DNA-binding protein (ZFP) technology and will design and engineer ZFP nucleases (ZFN(TM)) for Genentech to evaluate and potentially use to generate cell lines with novel characteristics for protein pharmaceutical production purposes. Financial terms of the agreement were not disclosed."

People's Daily Online -- Germplasm bank of wild species established in southwest China

People's Daily Online -- Germplasm bank of wild species established in southwest China: "A comprehensive research and preservation facility for the germplasm of rare and endangered plants, wild animal species and microorganisms was completed on Sunday in southwest China's Yunnan Province."

New BioTrends Report Highlights the Growing Use of Biologics among Dermatologists and Rheumatologists in the US

New BioTrends Report Highlights the Growing Use of Biologics among Dermatologists and Rheumatologists in the US: "KING OF PRUSSIA, Pa., April 30 /PRNewswire/ -- The introduction of biologic agents has expanded therapeutic options for patients with Psoriasis, Psoriatic Arthritis (PsA), Rheumatoid Arthritis (RA), and many other immunologic conditions."

The Buffalo News: Business

The Buffalo News: Business: "That concept might be a little difficult for someone outside the scientific world to grasp, but CH3 BioSystems says it will provide high-performance ingredients for the discovery of protein methylation pathways in cells and tissues.

Lukasiewicz offers an analogy to explain. Imagine a dark corridor with many doors. In the past, scientists would find some of those doors on occasion or by accident, and knew there were others. CH3 BioSystems’ work is designed to illuminate those doors and give scientists the tools to unlock them, to help diagnose and discover answers about different diseases."

PRMinds - Malaysia Endeavors to Outsource Biotech Services from US

PRMinds - Malaysia Endeavors to Outsource Biotech Services from US: "The dynamically growing US biotech market can emerge as an outsourcing hub. Malaysia, to make its mark on the global biotech market, is looking to attract biotech exports from US. "

Omrix’s Biosurgical Patches Help Stop The Bleeding - Seeking Alpha

Omrix’s Biosurgical Patches Help Stop The Bleeding - Seeking Alpha: "Brian Orelli submits: Now I’m no surgeon, but I can guess that during surgery, there’s a lot of blood (actually, come to think of it, that’s part of the reason that I’m not an MD). Generally speaking, bleeding isn’t a good thing; Omrix’s (OMRI) biosurgical products and pipeline are designed to stop the bleeding (herein referred to by its clinical name, hemostasis)."

Patently-O: Patent Law Blog: 2007 Patent Reform: Proposed Amendments on Damages

Patently-O: Patent Law Blog: 2007 Patent Reform: Proposed Amendments on Damages: "2007 Patent Reform: Proposed Amendments on Damages

By Professor Amy Landers

The proposed 2007 Patent Reform Act (the “Leahy-Berman bill”)[1] details modifications to 35 USC � 284 that will most certainly reduce many patent infringement damages awards. Three portions of the Leahy-Berman bill concern monetary compensation: First, the bill seeks to limit reasonable royalty damages to the inventive aspects of the claim. Second, the bill restricts the use of the entire market value rule. Third, the bill expressly confirms a fact finder’s ability to rely on certain types of evidence to measure compensatory harm.[2]"

FuturePundit: Conjugated Linoleic Acid Boosts Inflammation Markers

FuturePundit: Conjugated Linoleic Acid Boosts Inflammation Markers: "Things that boost the level of inflammation in human bodies generally accelerate aging and are to be avoided. With that in mind, the popular use of conjugated linoleic acid (CLA) to take off fat might be a bad idea. In a controlled trial CLA lowered the good HDL cholesterol but boosted some markers for inflammation such as C-Reactive Protein (CRP)."

Press Release: Inspire Pharmaceuticals Announces FDA Approval Of AzaSite - FierceBiotech

Press Release: Inspire Pharmaceuticals Announces FDA Approval Of AzaSite - FierceBiotech: "DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved AzaSite(TM) (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis. Inspire anticipates launching AzaSite in the latter part of the third quarter of 2007 and expects to generate $30 - $45 million in sales in the 2008 calendar year based on current manufacturing and commercial plans."

Pro-Pharmaceuticals and Digna Biotech Sign Agreement to Apply DAVANAT(R) with Novel Drugs to treat Hepatitis C

Pro-Pharmaceuticals and Digna Biotech Sign Agreement to Apply DAVANAT(R) with Novel Drugs to treat Hepatitis C: "NEWTON, Mass.--(BUSINESS WIRE)--Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of first-in-class carbohydrate therapeutics, today announced it has signed an agreement with Digna Biotech SL of Pamplona, Spain to investigate the application of the Company’s carbohydrate technology platform in combination with Digna’s novel drugs to improve treatment of chronic Hepatitis C infections. "

Health Blog : Drugs In Works for Advanced Prostate Cancer

Health Blog : Drugs In Works for Advanced Prostate Cancer: "Several experimental drugs may soon be able to help patients with prostate cancer whose disease doesn’t respond to hormone therapy. That lack of response marks the last, deadly stage of the disease. Only one drug, Sanofi-Aventis’s Taxotere, is approved for men in this stage, and median survival for patients on the drug is only 19 months. Cowen and Company has a report out today on some possible new drugs to treat this condition. Here are the key points."

Clinical outsourcing more common in early stages

Clinical outsourcing more common in early stages: "30/04/2007 - Clinical trial sponsors are outsourcing the majority of clinical work in Phase I and gradually bringing functions back in-house as compounds move through the development stages.

Survey data gathered by Cutting Edge information shows that on average, 54.6 per cent of clinical trial staff allocation is outsourced by sponsors in Phase I, dropping slightly to 47.3 per cent in Phase II."

Press Release: Insmed Incorporated Says IPLEX Shows Positive Results in Mid-Stage Trial - FierceBiotech

Press Release: Insmed Incorporated Says IPLEX Shows Positive Results in Mid-Stage Trial - FierceBiotech: "RICHMOND, Va. -- Insmed Inc., today announced positive results from a Phase II investigator-sponsored clinical study of the company's drug IPLEX(TM) in HIV-infected patients affected with HIV-associated Adipose Redistribution Syndrome (HARS)."

PRESS RELEASE Generex Biotechnology to Ring NASDAQ Closing Bell on May 2nd

PRESS RELEASE Generex Biotechnology to Ring NASDAQ Closing Bell on May 2nd: "Generex Biotechnology Corporation (NASDAQ: GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that Anna Gluskin, its Chairman and Chief Executive Officer, will ring the ceremonial NASDAQ Stock Market Closing Bell on Wednesday, May 2, 2007 at 4:00 p.m. (Eastern), at the NASDAQ MarketSite at 4 Times Square (43rd and Broadway) in New York City."

News: Oncolytics Biotech Completes Initial Scale-Up of Manufacturing Process for Reolysin. Genetic Engineering News - Biotechnology from Bench to Busi

News: Oncolytics Biotech Completes Initial Scale-Up of Manufacturing Process for Reolysin. Genetic Engineering News - Biotechnology from Bench to Business: "Oncolytics Biotech reports the successful initial scale-up of the manufacturing process for its anticancer candidate. Reolysin is a formulation of the human reovirus and is in clinical trials for treating Ras-activated tumor cells and some cellular proliferative disorders."

Technology Review: Faster-Healing Artificial Skin

Technology Review: Faster-Healing Artificial Skin: "Artificial skin that slowly releases a stem-cell-attracting protein could improve the healing process for patients with severe burns and for diabetics with foot ulcers. Preliminary studies combining a commonly used skin substitute with a growth factor have demonstrated faster healing in mice. The animals even appear to have regenerated new tissue, rather than scar tissue."

bioethics.com � Blog Archive � Doctors study surgery through body’s existing openings

bioethics.com � Blog Archive � Doctors study surgery through body’s existing openings: "A 4-year-old boy lay on an operating table here a few weeks ago with a tumor that had eaten into his brain and the base of his skull. Standard surgery would involve cutting open his face, leaving an ugly scar and hindering his facial growth as he matured. "

News: BIO White Paper Addresses the Challenges of Creating Any Pathway for Follow-On Biologics. Genetic Engineering News - Biotechnology from Bench to

News: BIO White Paper Addresses the Challenges of Creating Any Pathway for Follow-On Biologics. Genetic Engineering News - Biotechnology from Bench to Business: "The paper details the legal and regulatory implications of the many important differences between biologics and traditional 'small molecule' drugs. Biologics have very different physical structures and characteristics from small molecule drugs as they are generally large complex molecules produced using living organisms in an intricate manufacturing process. Since traditional drugs and their generic counterparts can typically be shown in a lab to have identical chemical structures, the law and regulations provide a straightforward and safe pathway for the approval of generic versions of drugs. In contrast, a follow-on version of a biologic cannot be a physical duplicate of the innovator version--it can only be comparable or similar. Because of the differences in the complexity of the molecules and the importance of the manufacturing processes used to create biologics, the core scientific principles that allow the Hatch-Waxman Act to provide safe and effective generic small molecule drugs do not apply to biologics."