High Court Won't Review Biogen DNA Patent Priority Loss

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By Tony Dutra and John T. Aquino

The Supreme Court rejected a chance March 21 to weigh in on a DNA-related patent inventorship priority battle in a loss for challenger Biogen MA Inc.

Patent holder Japanese Foundation for Cancer Research and exclusive licensee Bayer Pharma AG benefited from the high court's denial of review. The denial, which keeps the Federal Circuit's decision in place, also will affect where a gene editing case currently before the patent board will be appealed.

The issue presented in Biogen's petition for review concerned the patent law before Congress reformed it in the America Invents Act.

Prior to the AIA, those who challenged a decision by the Patent and Trademark Office's patent board as to who invented a technology first could do so in a federal district court rather than through an appeal to the U.S. Court of Appeals for the Federal Circuit.

The question in the case related to the timing of exactly when that change took effect.

The Federal Circuit went ahead and ruled on the merits of the case, dealing a blow to Biogen's case of prior invention directed to the DNA sequences coding for human fibroblast interferon (hFIF) proteins, which promote viral resistance in human tissue.

Case Transferred From District Court

An interference is a priority dispute before the PTO's Patent Trial and Appeal Board.

Until patent reform, a patent was awarded to the “first inventor,” and an interference decided which inventor had priority. The AIA changed the law so that a patent is awarded to the first to file and eliminated interferences for patent applications filed after March 16, 2013.

The Biogen-Japanese Foundation for Cancer Research interference was declared on July 13, 2013. The PTAB awarded the foundation priority for claims directed to hFIF .

On Dec. 2, 2013, Biogen filed litigation asking the U.S. District Court for the District of Massachusetts to reverse the PTAB decision.

The district court transferred the case to the Federal Circuit. It cited the AIA Technical Corrections Act (TCA), which became law on Jan. 14, 2013, and said that the change in jurisdiction “shall apply to interference proceedings that are declared after September 15, 2012.”

The Federal Circuit, acknowledging that “the effective date provisions in the AIA are far from a model of clarity,” pieced together text in the legislation with additional language in the AIA TCA and concluded that for any interference declared after Sept. 15, 2012, there is only one way to contest the PTAB's priority decision—a direct appeal to the Federal Circuit .

In its petition for Supreme Court review, Biogen contended that certain evidentiary tools available in district court, such as live testimony and cross-examination, generally aren't available at the PTAB and can't be added to the record that the Federal Circuit reviews.

In its opposition to Supreme Court review, the Japanese Foundation for Cancer Research argued, “Biogen does not say what further evidence it would adduce in the district court—much less why such evidence would support a contrary result, given that the interference here involves subject matter already lost in two prior interferences.”

Appeal Location Clearer for Pending Cases

The Japanese Foundation for Cancer Research also argued that the number of interferences and value of a district court option are “minor.” But the interference battle over CRISPR genome editing technology that was declared in January in Broad Institute, Inc. v. Regents of the Univ. of California, P.T.A.B., Int. No. 106,048, interference declared 1/11/16, which, if appealed, will head to the Federal Circuit, suggests that the dollar amounts involved are far from minor.

In addition, the case of Stanford University v. The Chinese Univ. of Hong Kong in the Federal Circuit, which concerns a patent on noninvasive prenatal diagnosis, was viewed as being on hold until the Supreme Court decided what it would do in . That interference was declared on March 12, 2013, and so the Supreme Court's denial should keep the case in the Federal Circuit.

To contact the reporters on this story: Tony Dutra in Washington at adutra@bna.com and John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com