SCOTUS Asked to Certify Question Regarding a Treatment Patent Using a Synthetic Protein

On Tuesday a petition for writ of certiorari was filed in the Supreme Court of the United States. The petition, filed in the case of Biogen MA Inc., Petitioner v. EMD Serono, Inc., et al., requests that the court certify a question regarding the validity of a patent for treatment using a synthetic version of a protein, where the natural protein was previously used. 

“The patent in this case claims a method of medical treatment that requires use of a ‘recombinant,’ or synthetic version, of a human protein.  That synthetic, recombinant version does not exist in nature.  The Federal Circuit held, in violation of this Court’s longstanding precedent, that the claim term ‘recombinant’ must be ignored in assessing whether the method of treatment is novel.  The question presented is:  Whether courts may disregard the express claim term ‘recombinant’ so as to render a method-of-treatment patent anticipated—and thus invalid—in light of prior-art treatments that used the naturally occurring human protein, where it is undisputed that the recombinant protein was not used in the prior art?” the petition said. 

Interferon-B is a protein that occurs naturally in the human body and is used by the body to fight certain types of disease, including many viral conditions. However, interferon-B is not produced in large quantities by the human body and the process of extracting it is complicated, expensive, and prone to contamination. 

Dr. Walter Fiers created a process by which genetically modified e. coli bacterium could be forced to create a recombinant form of interferon-B. This recombinant form is not structurally identical to naturally occurring interferon-B, but is sufficiently similar to produce the desired immune response in recipients.

The patent was assigned to Biogen once granted. This patent received a very long review process by the patent examiner and was granted 29 years after the process was initiated. In the meantime, other competitors came up with their own recombinant versions. Biogen filed suit for patent infringement against these competitors and as a part of their defense, EMD Serono and Pfizer challenged the claims in the patent, stating that they were non patentable under a theory that the innovation could have been anticipated from the prior literature. 

Biogen countered this argument, arguing that the unique structure of the e-coli recombinant interferon-B, the lack of successful attempts at creating commercially viable production of interferon-B in any format prior to this method, and the delay prior to any competitor being successful in creating their own versions leads to the inference that the method was novel and could not have been anticipated by the prior body of work.

Biogen is represented by Jeffrey Lamken of Mololamken. No Supreme Court counsel has officially been listed by EMD Serono or Pfizer, however appellate representation was provided by Gibson, Dunn & Crutcher.