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Amgen decision puts billions in antibody patents at risk


By Jesse Schwartz
Published: July 25th, 2018

Universities and their licensees are facing the potential loss of billions of dollars from some of their most valuable assets in the wake of a recent decision on antibodies from the Federal Circuit Court of Appeals.

TTOs should expect more PTAB challenges for antibody patents after the ruling, experts caution, and the best defense is understanding the complex legal reasoning that led to the vulnerability of these profitable patents.

The court revised the “written description” requirement for patentability of antibody inventions, and that, in turn, prompted a “clarification” memorandum from the U.S. Patent and Trademark Office (USPTO) that set forth new guidelines for examination of the written description requirement of 35 U.S.C. § 112(a) for claims directed to antibodies. (The Fed Circuit decision is available online here.)

The court essentially is demanding more specificity in how antibodies are characterized. The USPTO will no longer grant broad patents for a suite of antibodies attached to a specific target, now requiring a patent to cover an inventor’s specific antibody with a particular target.

These immune-system molecules figure prominently in patents that generate about $100 billion per year, according to some estimates, so the impact of the ruling could be substantial.

These developments will bring a new rash of PTAB reviews challenging antibody patents, predicts Dariush Adli, PhD, Esq. founder and president of ADLI Law Group in Los Angeles. The ability to license antibody IP also could be undermined.

“Given the high commercial value of antibody inventions, such challenges should be expected,” Adli says. “The value of the antibody patents may be affected by this ruling. It all depends on the specific patent and how it will be impacted by the new decision and guidelines.”

Antibody patents as a group will receiving significantly more challenges based on Section 112, agrees Douglas Q. Hahn, JD, shareholder with the Stradling law firm in Newport Beach, CA. Given the limited scope of the PTAB review, he expects this to happen mainly in the district courts.

A detailed article on the Amgen decision and its impact on university patents and licensing appears in the July issue of Technology Transfer Tactics. To subscribe and access the full article, along with more than 11 years of archived best practices and success strategies for TTOs, CLICK HERE

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