Posts Tagged ‘biotechnology law’

USPTO TRIPs over Myriad-Mayo guidance

Thursday, July 31st, 2014

Timothy W. Roberts, Chartered Patent Attorney; MA (Oxon); LL.D (honoris causa, Sheffield University)

Paul G. Cole,  Chartered Patent Attorney;  MA (Oxon); LLM, NottinghamTrent; Visiting Professor, Bournemouth University

The above UK-based European Practitioners have today filed comments at the USPTO arguing that the USPTO’s Myriad-Mayo Guidance is inconsistent with the provisions of Article 27 of the TRIPs Agreement.

They argue that the ruling of Justice Thomas in Myriad is TRIPs-compliant only on the narrow holding that mere isolation of a DNA sequence unaccompanied by new, improved or extended utility does not give rise to eligibility. Any broader interpretation of the ruling e.g. to exclude natural products selected or isolated by the hand of man and possessing new or improved utility would be inconsistent with the express provisions of the Agreement. It will be recollected that Justice Ginsburg during oral argument in Myriad was concerned that the US was at risk of adopting a rule quite different from that of other industrialised nations and would be placing itself in an isolated position. Only the suggested interpretation, they argue,  would avoid those concerns, and they submit that the Court had these considerations in mind when it handed down its limited and cautious opinion in Myriad.

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FDA Accepts First Biosimilar Application for Review

Monday, July 28th, 2014

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years ago, the FDA was authorized to permit generic biologicals in a section of “Obamacare” (the Affordable Care Act), but final rules have not yet been promulgated. Since Neupogen is not “under patent” or NCE exclusivity in the U.S. this can roughly be analogized to a Para. III ANDA filing. With many other applications in progress, we will have to see how rough this gets.

Read more here.

Myriad Guidance Comments

Thursday, July 10th, 2014

The USPTO is now publishing comments

http://www.uspto.gov/patents/law/comments/myriad-mayo_guidance_comments.jsp

 

Abbvie V. Janssen Biotech –Written Description Requirement Road Map

Monday, July 7th, 2014

The recent decision in Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir. , July 1, 2014) deserves more attention than it has received. (A copy of the decision is available at the end of this post.) The appeal was by Abbvie from a District Court decision entering a judgment of invalidity of Abbvie’s patents on fully humanized antibodies (Abs) to IL-12. Although Abbvie won an interference involving its U.S. Patent No. 6,914,128, a jury found both patents invalid inter alia as failing the written description requirement (“WDR”) of s.112, para. 1.

The “modern” WDR as created in UC v. Lilly and applied in decisions such as U. of Rochester v. Searle and Ariad v. Lilly has been a potent patent-killer, particularly when functional claims are asserted. That is just what Abbvie attempted, e.g.:

Claim 29. A neutralizing isolated human antibody…that binds to human IL-12 and disassociates from human IL-12 with a koff rate constant of 1×10(-2)s(-1) or less, as determined by surface plasmon resonance. See slip. op p.7.

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