Greenblum & Bernstein, P.L.C.

BIOTECHNOLOGY And BIOSIMILARS

PRACTICE GROUP NEWSLETTER

Recent News in Intellectual Property

                                                                      November – December   2012   

In This Issue

·     Supreme Court Grants Cert in “Gene” and “Reverse Payments” Cases

·    News

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Jill M. Browning

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Supreme Court Grants Cert in “Gene” And

“Reverse Payments” Cases

The Supreme Court once again takes an active interest in patent-related cases, granting certiorari in two cases that will have significant relevance to the biotech and biosimilar industries.

On November 30, 2012, the Supreme Court granted certiorari in AMP v. Myriad, limiting the question to be addressed to only the first of three questions presented, namely:  “Are human genes patentable?”  The Supreme Court originally granted certiorari in this case in 2011, but remanded to the Federal Circuit to revisit its opinion in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., issued by the Supreme Court on March 20, 2012, finding that a process patent directed to correlations between blood test results and patient health was not eligible for patent protection under 35 U.S.C. §101 because it incorporates a law of nature.  The Federal Circuit issued its decision on reconsideration on August 16, 2012, concluding that the diagnostic method claims are not patent-eligible, but the drug screening method claims and the claims directed to isolated DNA are patent eligible under 35 U.S.C. §101.      

On December 7, 2012, the Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., et al., (Supreme Court No. 12-416) to resolve a split between the circuit courts regarding the standard by which agreements that resolve patent disputes between the manufacture of the branded drug and generic competitors include payments by the brand name manufacturer to the would be generic competitor.  The question presented to the Supreme Court to answer has been framed as follows: “Whether reverse-payment agreements are per se lawful unless the underlying patent ligation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held).”  See Petition for a Writ of Certiorari, filed by the FTC on October 4, 2012, from a decision of the court of appeals, 677 F.3d 1298 (11^th Cir. 2012).

Both of these cases will be watched carefully.  Decisions are expected in the late spring, 2013.

NEWS

·        Amgen will acquire deCODE Genetics for $415M.  DeCode is an Iceland-based company devoted to finding genetic risk factors for diseases.    

·        FDA approves GSK’s drug raxibacumab used to treat inhalational anthrax.  The drug is a monoclonal antibody developed by Human Genome Sciences and it is the first agent approved by the FDA directed to neutralize the toxins that are generated by the anthrax bacterium. 

·         EpiCept, a Swedish company, plans to merge with Immune Pharmaceuticals. The resulting company will focus on antibody drugs to treat cancer and inflammatory diseases.