9.13.2007

PLI - Patent Blog

PLI - Patent Blog: "

Yesterday the United States Court of Appeals for the Federal Circuit did something rather curious. The Court reissued an opinion as precedential that was originally published on July 11, 2007 as non-precedential. In Daiichi Sankyo Co., LTD. v. Apotex, Inc., Apotex, Inc. appealed the judgment of the United States District Court for the District of New Jersey that Apotex infringed U.S. Pat. No. 5,401,741 and that the ’741 patent is not invalid or unenforceable. The Federal Circuit determined that the invention of the ’741 patent would have been obvious in view of the prior art and reversed. What is a little curious is why this has suddenly become a precedential opinion.

The Federal Circuit started off this obviousness determination by explaining the familiar four-part test for obviousness, which includes:

(1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness.

For years this obviousness test has bothered me because the Federal Circuit has made objective evidence of nonobviousness required for every obviousness determination despite the fact that in Graham v. John Deere the Supreme Court specifically explained that such evidence "may" be helpful. How the permissive "may" has been turned into a mandatory "shall" never quite set well with me, but it is not the first time that the Federal Circuit has overruled the Supreme Court so what the heck, right?

After setting forth the obviousness factors, which are certainly not worthy of being a precedential opinion, the Court explained that they were going to focus their inquiry on the second factor, the level of ordinary skill in the prior art. This then lead the court to once again state the well established law relative to determining the level of ordinary skill, which include but are not limited to:

(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field."

The Federal Circuit then went on to determine that the inventors of the ’741 patent were specialists in drug and ear treatments—not general practitioners or pediatricians. At the time of the invention, Inventor Sato was a university professor specializing in otorhinolaryngology; Inventor Handa was a clinical development department manager at Daiichi, where he was involved with new drug development and clinical trials; and Inventor Kitahara was a research scientist at Daiichi engaged in the research and development of antibiotics. Therefore, the Federal Circuit concluded that the level of ordinary skill in the art was that of a person engaged in developing pharmaceutical formulations and treatment methods for the ear or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.

Having made this determination relative to exactly what the level of skill in the art was, the Federal Circuit had little difficulty concluding that the claims had to fall because they were obvious. This was an easy conclusion given that there was a reference explaining that a ciprofloxacin compound would be effective and that it was well known that ofloxacin (the compound used in the claims) was a substitute for ciprofloxacin.

So why did the Federal Circuit make this a precedential opinion? Perhaps it was because the district court followed recent Federal Circuit precedent and, nevertheless, still managed to get it wrong in the eyes of the Federal Circuit.

Specifically, the district court concluded that the ordinary person skilled in the art pertaining to the ’741 patent "would have a medical degree, experience treating patients with ear infections, and knowledge of the pharmacology and use of antibiotics. This person would be . . . a pediatrician or general practitioner..." In reaching this determination the district court relied on Merck & Co. v. Teva Pharm. USA, Inc., 347 F.3d 1367 (Fed. Cir. 2003), a case in which the invention related to a method of treating, as did the invention in this case. Nevertheless, the Federal Circuit pointed out that even though the affirmed that in the Merck/Teva case where they affirmed that the the person having ordinary skill in the relevant art was a person having a medical degree, experience treating patients, and knowledge of the pharmacology and usage of biphosponates, the level of skill in the art was not disputed by the parties and, thus, the Federal Circuit simply accepted the district court’s finding.

So you are not convinced that is enough? Me either. So essentially what we have here is another situation where there is going to be Federal Circuit precedent going both ways. Sometimes when the invention relates to a method of treating the person of skill in the art will be a medical practitioner, and sometimes it will be a research scientist. I suppose that it will all depend upon who the inventors are, which as Dennis Crouch from Patently-O puts it means that in this case the invention was obvious because the inventors were experts. I'm not sure I would go that far, but if this case does stand for that proposition god help us all!

For additional information on this case I suggest the Orange Book Blog, which provided a summary of the original non-precedential opinion.

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