Tag Archives: Lead Compound

Federal Circuit Affirms PTAB Lead Compound Analysis Upholding Vimpat Lacosamide Patent

The Federal Circuit decision in Mylan Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc., highlights the difficulty of challenging a patent directed to a new chemical entity. The court affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that upheld the validity of RCT’s Vimpat lacosamide patent, which is approved for the treatment … Continue reading this entry

A Fresh Look At The Lead Compound Analysis

I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the claims against an obviousness challenge, including a factor that doesn’t always get much attention.… Continue reading this entry

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court explained that a novel product with unexpected advantageous properties is not obvious just because the process by which it was made might have … Continue reading this entry

Federal Circuit Upholds Lyrica Patents

In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer’s Lyrica® product. According to the court’s rules, the non-precedential designation of Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. means that the panel determined that it did not add significantly to … Continue reading this entry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

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