Novelty is perhaps the principal, most fundamental requirement for patentability, and depriving the public of anything in the prior art must be avoided. The Federal Circuit recently reinforced the primacy of these rubrics in Biogen MA, Inc. v. EMD Serono, Inc.
The issues arose in litigation over Biogen's Rebif product for the treatment of multiple sclerosis comprising a recombinant interferon-β ("IFN-β"). Biogen asserted U.S. Patent No. 7,588,755 ("'755 patent") in this litigation; the Federal Circuit identified Claim 1 as being representative:
1. A method for immunomodulation or treating a viral condition[ ], a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
(a) DNA sequences which are capable of hybridizing to any of the DNA inserts of G-pBR322(Pst)/HFIF1, G-pBR322(Pst)/HFIF3 (DSM 1791), G-pBR322(Pst)/HFIF6 (DSM 1792), and GpBR322(Pst)/HFIF7 (DSM 1793) under hybridizing conditions of 0.75 M NaCl at 68° C. and washing conditions of 0.3 M NaCl at 68° C., and which code for a polypeptide displaying antiviral activity, and
(b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a);
said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.
The jury found the patent to be invalid under 35 U.S.C. § 102(b) as being anticipated by two prior art references that taught MS treatment using naturally occurring IFN-β. The jury also found that Defendants had not established by clear and convincing evidence that the asserted claims were invalid for obviousness, lack of enablement, or for failing to provide an adequate written description and that patients and prescribers directly infringed and Serono contributorily infringed but did not induce infringement.
The District Court granted Biogen's motion for judgment as a matter of law that the cited art did not anticipate the '755 patent claims, and granted a new trial contingent on the outcome of this appeal. Under the District Court's reasoning, the cited references did not disclose recombinant IFN-β and thus no reasonable jury could find these references anticipated the '755 patent claims. The District Court also found no anticipation because the claims recited administration of a "therapeutically effective amount" of recombinant IFN-β that "displays antiviral activity" not taught in the cited art. The District Court also held in this regard that "the jury lacked substantial evidence that the native IFN-β protein as disclosed in [the cited art] was structurally or functionally identical to the claimed three-dimensional...
