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

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Tfda officehe FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated.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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Rapid Litigation v. CellzDirect – A Break in the 101 Wall

July 5th, 2016

On Julybreak-in-wall 5, 2016, a three judge Fed. Circuit panel of Moore, Prost and Stoll (Appeal no. 2015-1570) reversed the district court’s holding that claims to a method of isolating “hardy” twice -frozen hepatocytes (as I called them in my post of April 26 summarizing the oral argument) were patent-ineligible as no more than a law of nature accompanied by routine cryopreservation steps. (Please go here and read my summary of the oral argument – it will save me some typing time.) )A copy of the decision can be found at the end of this post.)

In that post, I noted that Judges Moore and Stoll hold technical degrees and appeared undaunted by Mayo and the resulting Mayo/Alice test for patent-eligibility. Although Judge Prost did not ask as many questions of the parties during oral argument, she joined in the decision.

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Bascom v. AT&T — Patent Eligibility Meet Patentability

July 5th, 2016

…..Or Judge reverseNewman proposes a blended approach when “Abstract Idea” or “Inventive Concept” is at issue. In Bascom v. AT&T, Appeal no. 2015-1763 (June 27, 2016, Fed. Cir.), panel of Judges Newman, O’Malley and Chen reversed the district court’s finding that Bascom’s U.S. Pat. No. 5,987,606 failed step two of the Mayo/Alice test, since was simply a combination of conventional steps carried out using generic computers. (A copy of the decision can be found at the end of this post.) The panel reversed, calling this a close case but found an inventive concept in claims to an individualized internet content filtering system patent eligible since “an inventive concept can be found in the non-conventional and  non-generic arrangement of known, conventional pieces.”

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USPTO will “Fast Track” Cancer Immunotherapy Applications

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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