Greenblum & Bernstein, P.L.C.


Recent News in Intellectual Property


October 2016

In This Issue:

·    Yeda v. Abbott: 20-Year Dispute Regarding Expired Patent for TBP-II Decided in Favor of Abbott

·    FDA Approves Amgen’s Biosimilar for Humira

·    National Cancer Challenge Winners Announced

·    Method of Cryopreservation is Patent Eligible

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Walter Schlapkohl, Ph.D., Esq.

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Abbott’s Disclosure of Partial N-terminal Sequence and Other Protein Properties in Priority Application Sufficient to Obtain Priority Benefit and Avoid Invalidity

On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit upheld a district court’s finding that written description support to obtain benefit for claims covering a TNF-α-binding protein (TBP-II) could be satisfied inherently where there was no dispute that the only protein containing the N-terminal sequence set forth in the priority application is the same protein as claimed in the patent (Nos. 2015-1662, 2015-1663).

Yeda Research and Development Co., Ltd. had appealed two decisions by the U.S. District Court for the District of Columbia, in which the District Court held that Abbott’s U.S. Patent No. 5,344,915 is not invalid as anticipated.  The invalidity turned on whether the ‘915 patent would obtain the benefit of the filing dates from either of two German priority applications for claims directed to a TNF-α-binding protein having a specific N-terminal sequence.  By obtaining the benefit of either German priority application, Abbott could avoid prior art that would otherwise anticipate its claims.

Neither priority application disclosed the full N-terminus as claimed in the disputed patent.  However, the priority applications did disclose a partial N-terminal sequence, a protocol for obtaining the protein from its biological source, as well as, for example, its molecular weight and biological activity.  In its decision, the Federal Circuit held that the disclosure of at least one of the priority applications inherently disclosed the remaining amino acids in the N-terminal sequence and that the disclosure serves as adequate written description support for the patent claiming TBP-II.

FDA Approves Amgen’s Biosimilar for AbbVie’s Humira 

On September 23, 2016, the Food and Drug Administration (FDA) gave its fourth approval regarding a biosimilar to Amgen Inc.’s “Amjevita” (adalimumab-atto).  The biosimilar was approved for all seven indications requested, including rheumatoid arthritis, plaque psoriasis, and Crohn’s disease. Amgen filed for marketing approval for the biosimilar in November 2015 and FDA accepted Amgen’s abbreviated Biological License Application in January 2016.  The product was approved as a biosimilar, not as an “interchangeable” product. 

AbbVie Inc., the holder of at least 10 (and possibly as many as 61) patents that cover the blockbuster originator product Humira, has alleged infringement by Amgen in a proceeding against AbbVie before the U.S. District Court for the District of Delaware.  AbbVie is seeking to stop Amgen from manufacturing and marketing its newly-approved biosimilar and asserts that Amgen has failed to comply with certain provisions related to the “patent dance” as required by the Biologics Price Competition and Innovation Act (BPCIA). Amgen asserts that the patents at issue are invalid and/or not-infringed, and has filed a counterclaim asserting that it is actually AbbVie which has failed to comply with certain provisions of the “patent dance.”


National Cancer Challenge Winners Announced

On September 19, 2016, the USPTO announced the winners for the Cancer Moonshot Challenge.  The Challenge, which is part of Vice President Biden’s broader National Cancer Moonshot initiative, was launched in August with the aim of leveraging the USPTO’s patent data to find creative, new ways to fight cancer.  The USPTO’s patent data can often be an early indicator of meaningful areas of research and development. The Challenge called for contestants to provide visualizations of patent data that would “illuminate trend lines for new insights”.

Dolcera won the first place prize of $5,000 for its visualization of the relationship between levels of research funding, patenting and testing on one hand, and the genetics and epidemiology of cancer on the other.  Booz Allen Hamilton and Omnity won second place and $3,000.  Thomson Reuters and Georgetown Lombardi Comprehensive Cancer Center took the third place price of $2,000.

Earlier this year the USPTO launched the “Cancer Immunotherapy Pilot Program,” to fast-track examination for cancer therapies.  Petitions under this program may be filed without a government fee and are being accepted through June 2017.

Method of Cryopreservation is Patent Eligible

According to a July decision by the U.S. Court of Appeals for the Federal Circuit, method claims directed to hepatocyte cryopreservation are patent eligible.  Hepatocytes are a type of liver cell often used in testing, diagnostic, and treatment methods.

In Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., the Federal Circuit found that even though the claims recited a natural law (that hepatocytes are capable of surviving multiple freeze-thaw cycles), the claims were nevertheless directed to a new, useful technique for their preservation that produces a “tangible and useful result.”  The patent at issue, U.S. Patent No. 7,604,929, was based on the inventors’ discovery that some fraction of hepatocytes is capable of surviving multiple freeze-thaw cycles.  With the discovery in hand, the inventors developed an improved process for preserving them, which was the subject of the claims in the ‘929 patent.  Prior to this, the prevailing belief was that hepatocytes could be frozen only once and then had to be either utilized or discarded.

The decision by the Federal Circuit, which vacated and remanded the decision of the district court finding the ‘929 patent invalid under §101, was a welcomed affirmation of patent subject matter eligibility for life science patent holders in what remains a contentious area of recent patent case law.