Posts Tagged ‘ip’

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.

Q. Todd Dickinson Resigns as Executive Director of AIPLA

Monday, July 14th, 2014

After six years as AIPLA Executive Director, Q. Todd Dickinson has announced that he will step down. While he was an effective leader at AIPLA, Todd (the “Q” doesn’t stand for anything) made his mark as the first effective Director of the USPTO in some time, and many thought he would be a good choice to lead the Office a second time when Obama took office.

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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