In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim because it recites a non-obvious result. Some of the court’s reasoning in this opinion is troubling, and the non-obvious result may be difficult to extrapolate to other cases, but this case illustrates the value of including a variety of claims that focus on different aspects of the same invention.Continue reading this entry
In Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court and held that Bayer’s patent covering its Yaz® birth control pill product is invalid as obvious. The court found a strong prima facie case of obviousness, and rejected each of Bayer’s arguments relating to secondary indicia of non-obviousness.
In Pozen, Inc. v. Par Pharmaceutical Inc., the Federal Circuit upheld the district court’s determination that the patents at issue were not invalid as obvious and were infringed by the subject Abbreviated New Drug Applications (ANDAs). Comparing this case to In re Droge, I cannot help but wonder how much the procedural posture impacted the Federal Circuit’s decisions. While the court reached opposite determinations as to obviousness, in each case it affirmed the decision on appeal. Continue reading this entry
In In re Droge, the Federal Circuit upheld the decision of the USPTO Board of Patent Appeals and Interferences that found that claims directed to recombinant biotechnology methods were obvious. At 8 pages, the decision is one of the shortest precedential opinions that I’ve read, and illustrates the difficulty of overturning a Board decision of obviousness. Continue reading this entry
In Alcon Research, Ltd. v. Apotex Inc., the Federal Circuit held that most claims of Alcon’s patent were obvious in view of prior art that suggested the use of the recited active agent to treat the recited condition, but not by the recited mechanism of action, because the prior art used a concentration of active agent that overlapped with the concentration recited in several dependent claims. Two claims that recited a specific concentration outside the range disclosed in the prior art and used in Alcon’s commercial product were upheld, due in part to the evidence of commercial success.
In Mintz v. Diets & Watson, Inc., the Federal Circuit vacated the district court’s determination that the claims at issue were obvious. In so doing, the court discussed several steps in an obviousness analysis that can guard against the improper use of hindsight. The court’s emphasis on the importance of objective evidence of non-obviousness is a reminder of the potential value of developing a strong factual record to support patentability.
In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a “lead compound” approach to the obviousness determinations. This case reaffirms the applicability of the “lead compound” analytical framework, and highlights subtle differences in its application to questions of obviousness and obviousness-type double patenting. Continue reading this entry
In Celsis In Vitro, Inc. v. Cellzdirect, Inc., the Federal Circuit upheld the district court’s grant of a preliminary injunction based on a finding that Celsis had shown a likelihood of success against an obviousness challenge. While the opinion of the court (authored by Chief Judge Rader and joined by Judge Prost) did not strike me as unusual, Judge Gajarsa’s dissent certainly got my attention.Continue reading this entry
The Federal Circuit decision in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc. is interesting in several respects. In this article, I look at the court’s decision to permit unexpected results discovered after the patent applications at issue were filed to support non-obviousness.
The recent Federal Circuit decision in In re Huai-Hung Kao addressed obviousness rejections in three separate patent applications assigned to Endo Pharmaceuticals, Inc. The court affirmed the Board’s rejections in two of the applications, but vacated and remanded in the other application. This article looks at the court’s finding in that application that the rejection was “based . . . on factual findings lacking in substantial evidence,” and also discusses the court’s commentary on the “nexus” requirement for secondary evidence of non-obviousness, including unexpected results and commercial success.
The Federal Circuit’s recent decision in Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd. is a nice example of a thorough analysis of the patentability of a new chemical entity by the "lead compound" approach to obviousness. The case emphasizes the perspective of the "medicinal chemist of ordinary skill" and illustrates how evidence on multiple aspects of non-obviousness can insulate a patent from obviousness challenges.
On September 1, 2010 the USPTO issued an update to the Obviousness Examination Guidelines that were promulgated after the Supreme Court’s 2007 KSR decision. The new Guidelines are intended to supplement, not replace, the 2007 Guidelines, and extract teaching points from Federal Circuit decisions addressing obviousness in the wake of KSR. I was surprised by the number of pharmaceutical cases discussed in the Guidelines—out of 24 decisions, 13 relate to chemical, biotech or pharmaceutical inventions.