Tag Archives: Obviousness

Federal Circuit Finds Taclonex Patent Not Obvious, Reverses USPTO Decision

In Leo Pharmaceutical Products, Ltd. v. Rae, the Federal Circuit issued a rare decision reversing an obviousness determination by the USPTO Patent Trial and Appeal Board (PTAB). The patent at issue was a Taclonex® patent, and the court found both that the prior art did not render the claimed combination formulations obvious and that the … Continue reading this entry

Federal Circuit Invalidates Prandin Patent Claim As Obvious

In its third look at the Novo Nordisk A/S patent related to Prandin®, in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories Ltd., the Federal Circuit affirmed the district court’s finding that claim 4 of U.S. Patent No. 6,677,358 is invalid as obvious, but reversed the district court’s finding that the patent is unenforceable due to … Continue reading this entry

Federal Circuit Upholds One Claim Covering Combigan

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 … Continue reading this entry

Federal Circuit Finds Yaz Patent Obvious

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.… Continue reading this entry

Federal Circuit Reviews Safeguards Against Hindsight

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 … Continue reading this entry

The "Lead Compound" Approach To Obviousness And Obviousness-Type Double Patenting

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 … Continue reading this entry

Federal Circuits Finds Broad Range Anticipates Narrower Range

In ClearValue, Inc. v. Pearl River Polymers, Inc., the Federal Circuit found that a jury verdict of validity was not supported by substantial evidence, and so reversed the district court’s decision denying Pearl River’s motion for judgment as a matter of law (JMOL). This case is interesting because it explains when a broad range may … Continue reading this entry

Judge Gajarsa Questions The Patentability of Celsis Multi-Cryopreserved Hepatocytes

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 … Continue reading this entry

Federal Circuit Permits Post-Filing Date Unexpected Results To Support Non-Obviousness

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.… Continue reading this entry

Federal Circuit Overturns Obviousness Rejection Based On Non-Analogous Art

In In re Klein, the Federal Circuit reversed an obviousness rejection because the cited references were found to be non-analogous art. This case is an important reminder that questioning the relevance of the cited references can be an important first step to overcoming an obviousness rejection.… Continue reading this entry

Federal Circuit Finds Low-Dose Product Claims Obvious Over Medical Reference Book

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit affirmed the district court’s finding that product claims reciting a specific dose of temazepam were obvious in view of an entry in a medical reference book. Although Tyco tried to overcome the disclosure with evidence of unexpected results and commercial success, its … Continue reading this entry

Federal Circuit Reverses Rejection Based On Board Conjecture

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 … Continue reading this entry

Patentability Versus Freedom To Operate

The difference between patentability and freedom to operate took the forefront in Siemens Medical Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc.  The Federal Circuit upheld the district court’s denial of JMOL after a jury found that Saint-Gobain was liable for infringing Siemens’ patent under the doctrine of equivalents, even though Saint-Gobain’s product was … Continue reading this entry

Tidbits from Tokai

The Federal Circuit decision in Tokai Corp. v. Easton Enterprises, Inc. touches on several “hot” issues in patent law. While the case involved a mechanical invention, the principles are applicable across the board, and may arise in the context of pharmaceutical and biotech patent challenges. The Patents At Issue The patents at issue (U.S. 5,697, 775; … Continue reading this entry

An Ounce of Prevention Can Be Patentable Over A Pound of Cure

In In re Glatt Air Techniques, Inc., the Federal Circuit reversed a decision of the U.S. Board of Patent Appeals and Interferences that held a claim obvious. The decision is remarkable in that it overturned the Board under the deferential "substantial evidence" standard, and found that the USPTO had not even established a prima facie case of obviousness. The court also criticized the Board for dismissing the applicant's evidence of commercial success because it only related to one embodiment of the claims. … Continue reading this entry

The Medicinal Chemist

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 … Continue reading this entry

Pharma Cases Dominate New USPTO Obviousness Examination Guidelines

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 … Continue reading this entry