Grant of JMOL reversed as “an old method of administration of an old product made by a new process is not novel and cannot be patented”

Biogen MA Inc. v. EMD Serono, Inc. et al. (Pfizer Inc., Bayer, Novartis)

Docket No. 2019-1133

NEWMAN, LINN, HUGHES

September 28, 2020

Brief Summary:  DC instructed to reinstate jury verdict of invalidity for anticipation of Biogen’s IFN-b method of treatment claims that include product-by-process limitations (e.g., “an old method of administration of an old product made by a new process is not novel and cannot be patented”). Summary:   Serono appealed DC judgment as a matter of law (“JMOL”) ruling Biogen’s claims (US 7,588,755) directed to methods of treatment using recombinant interferon b (“IFN- b”, sold as Rebif for multiple sclerosis (MS)) not anticipated and not invalid based on written description or enablement, overturning the jury verdict of no induced infringement and sustaining the verdict of contributory infringement, and that the claims were not patent ineligible.  The only issue addressed in this opinion is anticipation.   The claims include “the step of administering to a patient” recombinant IFN-b “produced by a non-human host transformed by a recombinant DNA molecule…capable of hybridizing to” specified DNA sequences.  The DC, “focusing on the process of making IFN-b, concluded it need not analyze whether native IFN-b and recombinantly produced IFN-b were identical” because the prior art did not teach “a method of treatment using recombinant IFN-b” and “categorized the ‘produced’ and ‘transformed’ limitations as meaningful ‘source limitations.’”  The DC also concluded that a product-by-process analysis “did not apply to the claims here because the ‘product’ itself was sufficiently described”.  The FC panel disagreed and explained that “the recombinant IFN-b composition that is administered…is claimed in terms of the process by which it is manufactured” which is a “product-by-process limitation within a method of treatment claim” that does not “change how novelty of that limitation is evaluated” (Purdue Pharma, FC 2016 (“conversion of oxycodone free base” a product-by-process limitation)).   It agreed with Serono “that a source limitation alone cannot confer novelty unless the product itself is novel” since “an old product is not patentable even if it is made by a new process” (Amgen, FC 2009 (“simply because prior art urinary EPO was not made recombinantly was not enough to avoid anticipation”).  “The key question” here, the FC panel wrote, “as in Amgen, is…whether the recombinant product is identical to the prior art product-not whether the prior art product was made recombinantly.”  Addressing Biogen’s arguments, the FC panel stated that “an old method of administration of an old product made by a new process is not novel and cannot be patented.”  Biogen was also found to have defined IFN-b as a linear amino acid sequence in the specification and that “the claimed antiviral activity limitation” is not defined in the claim by “any specific three-dimensional structure that gives rise to that activity.”  The FC panel found the DC “erred in concluding the mere absence of recombinantly produced IFN-b in the prior art was sufficient to grant JMOL of no anticipation.”  The FC panel also disagreed with the DC’s “conditional grant of a new trial” on anticipation and reversed and remanded the decision “with instructions to reinstate the jury verdict” of invalidity for anticipation.