Posts Tagged ‘Federal Circuit’

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.


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

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.”


Eisenberg Analyzes the 101 Exception for Patents Claiming Diagnostic

Tuesday, August 4th, 2015

iStock_000011677313_SmallPatentlyO recently posted a nearly final draft of a paper writer by Professor Rebecca Eisenberg that will be published in the Journal of Science and Technology Law (note to author – fix fn 23). (A copy can be found at the end of this post.) She and I have been on the opposite side of issues such as patents for genes at various times, but she nails the purposeful and logically unsupportable rationales of the Fed. Cir. and the Supreme Court that she believes have already ended patent-eligibility for claims directed to diagnostic methods. While I have argued that, even post-Ambry and Ariosa, there should be room for focused claims to diagnostic methods based on the discovery of naturally-occurring correlations, this paper suggests that “It ain’t over ’til it’s over” is hopelessly optimistic.

In some of my earliest posts, pre-Myriad and pre-Prometheus (“Mayo”), I argued that the Metabolites Labs. dissent by Justices Breyer, Stevens and Souter conflated the in vivo existence of cobalamin and homocysteine in the blood with the human act of correlating an elevated level of one with a deficiency of the other. On April 27, 2009, I wrote:

 “Justice Breyer, I respectfully submit that nature may contain [the basis for] correlations but it does not analyze, much less correlate, anything. Nature doesn’t care if your homocysteine level is low or high and what consequences may befall you if it is too high or low. Just as nature doesn’t care what your PSA level is, even though it is certainly a natural phenomenon that men have PSA in their blood. But a claim: ‘Human blood containing PSA’ does not anticipate a claim to a method of detecting prostate cancer by assaying blood for PSA and correlating an elevated PSA level to the presence of prostate cancer. Good thing those patents have expired; they yielded workable life-saving test before they expired.”