Posts Tagged ‘Patent Law’

Shire v. Amneal Pharma – Adjusting the Rearview Mirror

Wednesday, September 30th, 2015

iStock_000023270394_SmallWhile the IP law world is being rocked by new developments in biosimilars, patent-eligible subject matter and IPR’s, it is almost refreshing to see a decision upholding the validity of claims to a “small molecule” drug based on application of the principles of obviousness–particularly the no-no of hindsight reconstruction. Shire LLC v. Amneal Pharmaceuticals, LLC, Appeal no. 2014-1736 et al. (Fed. Cir., September 24, 2015). (A copy of this decision can be found at the end of this post.)

This was a straightforward Hatch-Waxman infringement suit, during which Shire had to defend the validity of four patents covering a derivative of “speed,” L-lysine-d-amphetamine (“LDX”) dimesylate, marketed as Vyvanse® to treat autism. Defendants needed to convince the court that it would be obvious to both make the L-lysine derivative of d-amphetamine and then to make the dimesylate salt.


PTO Announces Requirements for Expedited Appeals for Small Entities

Wednesday, September 16th, 2015

gavel3For some years, I have complained that the lack of a timely appeal process to the Board (“PTAB”) effectively removes the appeal process as a prosecution tool. The average pendency of an appeal to the Board from a rejection arising in Group 1600 is presently 32.5 months. That is a long time for a small entity like a University or a start-up to go without a patent. I personally do not feel that the pre-appeal conference helps much, since the brief is reviewed by the Examiner and two other PTO personnel, with no opportunity for the attorney or the applicant(s) to participate. As a result, the backlog at the USPTO is, as Donald Trump would say, “HUGE.”  (more…)

Sandoz Launches First Biosimilar Drug in U.S.

Friday, September 4th, 2015

AiStock_000013653107_Small new chapter in the generics/innovator wars began Thursday as Sandoz, Novartis’ generics division launched its Neupogen biosimilar, Zarxio, in the U.S. at about a 15-30% discount from the price of Neupogen. While biosimilars have been marketed in Europe since 2006, Congress established the regulatory framework for biosimilar drugs in the US in 2010, with the passage of “Obamacare.” Neupogen has been on the market for more than 20 years.


Another Claim Bites the Dust left by Teva v. Sandoz

Thursday, September 3rd, 2015

iStock_000022074976_SmallAlthough the jury found the claims valid, and the Fed. Cir. affirmed, this decision, which found that the claims were not insolubly ambiguous, was revisited by the Fed. Cir. While there are pages on issue preclusion, in the end, the Fed. Cir. took the appeal and reversed its original position. Here there were four possible methods to measure the parameter “stretch hardening” of the claimed polymer, and the specification did not identify which one was used. Following Teva, in which three methods of measuring molecular weight led to the Supreme Court’s imposition of the “reasonable certainty” standard for determining if a claim satisfied s.112, the Fed. Cir. had little choice but to invalidate the claims that recited this parameter. I have always resisted the mantra that would require lots of definitions of claim elements, but the writing is on the wall, and this new “easy-to-use” mode of claim invalidation will only gain momentum.

Dow v Nova