Posts Tagged ‘ip’

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.


25 Critical Patentability & Validity Developments

Monday, September 28th, 2015

bookThe Chisum Patent Academy is pleased to announce the September 2015 publication by Wolters Kluwer Law & Business of the annual Update for Volume I (Patentability and Validity) of the practitioner treatise, Mueller on Patent Law, authored by our co-founder, Janice M. Mueller

The two-volume Mueller on Patent Law treatise was first published in 2012. Volume I addresses patentability, validity, and prosecution procedures; Volume II covers patent infringement, USPTO post-issuance procedures, design patents, and international patenting issues. For detailed tables of contents for both volumes, click here.


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.