Posts Tagged ‘biotechnology law’

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

Friday, July 8th, 2016

Tfda officehe FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this post.) The strategies involve the generation of reliable diagnostic conclusions for patients based on one or, oftentimes, many many mutations that are compared to those of other patients and to reference databases. Under “Scope,” the FDA has stated:

“[T]his paper discusses factors and principles to identify genetic databases that are of sufficient quality to support a regulatory submission…..[T]his paper discusses data quality and database operations as applied to the clinical interpretation of human genetic variants, i.e., for establishing the link between variants and the risk or diagnosis of disease or other states of health.”

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USPTO will “Fast Track” Cancer Immunotherapy Applications

Tuesday, July 5th, 2016

fast-trackOn June 29, 2016, Director Lee promulgated rules to implement a one-year pilot program to effectively grant “Fast Track” status to applications with at least one claim to treating cancer using immunotherapy. (A copy of this document can be found at the end of this post.) I am sure that much will be written about this program, but the requirements for achieving this top-of-the-pile on the Examiners’ desk are much like the current “Fast Track” program. But let’s cut to the chase to see just what type of claim qualifies for the “Cancer Immunotherapy Pilot Program:

“The applications must contain at least one claim encompassing a method of ameliorating, treating or preventing a malignancy in a human subject where the steps of the method assist or boost the immune system in eradicating cancerous cells. For example, this can include the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells. The Pilot Program also will consider claims drawn to the co-administration of biological adjuvants (e.g., interleukens, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation or surgery. Claims to administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth are included. The Pilot Program will also consider in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.”

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“Unclean Hands” Doctrine Erases Merck’s Damage Award

Thursday, June 16th, 2016

unclean-handsIn my last post on the district court’s ruling in Gilead v. Merck, I implied that Gilead had convinced the Judge that Merck had employed inequitable conduct (“IC”) in conducting its negotiations with Pharmasset, the company Gilead later purchased to obtain the rights to the HCV drug, sofosuvir or Solvaldi®. However, I was reading and writing at an usually high speed and missed the fact that the judge’s finding was based on the pre-IC, unclean hands defense.

I skipped over the section on Therasense, a 2011 Fed. Cir. decision that redefined the IC doctrine, and missed the Judge’s comments distinguishing the two doctrines. In both opinions, it was noted that the unclean hands defense originated with three early S. Ct. decisions in which the “guilty parties” employed egregious misconduct to obtain their patents. The remedy in each case was to bar the wrongdoers ability to sue for infringement of the patents.

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Supreme Court Rewrites the Law of Enhanced Damages

Tuesday, June 14th, 2016

This is a guest post by Janice M. Mueller of Chisum Patent Academy.

faculty-janice-e1402304436911Today the Supreme Court rewrote the law of enhanced damages for willful patent infringement by issuing a unanimous decision in No. 14-1513, Halo Elecs., Inc. v. Pulse Elecs., Inc., 2016 WL 3221515 (U.S. June 13, 2016), and the companion case, No. 14-1520, Stryker Corp. v. Zimmer, Inc., 2016 WL 3221515 (June 13, 2016). Swept away as “unduly rigid,” “inelastic,” impermissibly encumbering” district courts’ discretion, an “artificial construct,” and simply inconsistent with the text of 35 U.S.C. 284, the Federal Circuit’s elaborate framework for determining whether infringement damages should be enhanced (and reviewing such determinations on appeal), as set forth in In re Seagate Tech. LLC, 479 F.3d 1360 (Fed. Cir. 2007) (en banc) and Bard Peripheral Vascular, Inc. v. W.L. Gor & Assoc., Inc., 682 F.3d 1003 (Fed. Cir. 2012), is no longer good law.

You can read the entire post here.