Posts Tagged ‘biotechnology news’

Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

Thursday, October 8th, 2015

nobelIn re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that methods of isolating cffDNA were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different” structure requirement for patent eligibility that the PTO had proposed abandoning in December 2004:

“[According to Chakrabarty], discoveries that possess ‘markedly different characteristics from any found in nature,’ are eligible for patent protection. In contrast, any existing organism or new discovered plant found in the wild is not patentable.”

In Ariosa, Judges Renya, Linn and Wallach turned a method of isolation of cffDNA into a “natural product”:

“The method therefore begins and ends with a natural phenomenon. Thus the claims are directed to matter that is naturally occurring….Because the claims at issue are directed to naturally occurring  phenomena, …the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”


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.


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.


Fed. Cir. Rules Requirements for Direct Infringement by Multiple Parties

Friday, August 14th, 2015

CAFC Decides Akamai v Limelight–Holds For Infringement By Limelight–Defines Criteria For Directing And Controlling Customers’ Performance

iStock_000005967663_SmallIn Akami Technologies v. Limelight Networks, App. No. 2009-1372, -1380, -1416, -1417 (Fed. Cir., August 13, 2015), the court, sitting en banc after a remand from the S. Ct., set out the requirements for direct infringement involving acts by two or more parties under s. 271(a). The unanimous ruling held that an entity is responsible for others’ performance of method steps (1) where that entity directs or controls the acts of another, or (2) where the actors form a joint enterprise. (A copy of this decision is found at the end of this post.)

The court explained:

“… we have held that an actor is liable for infringement under s. 271(a) if it acts through an agent … or contracts with another to perform one or more steps of a claimed method. See BMC, 498 F.3d at 1380-81. We conclude, on the facts of this case, that liability….can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance…. In those instances, the third party’s actions are attributed to the alleged infringer such that the alleged infringer becomes the single actor chargeable with direct infringement.”