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 recombinant IFN-β protein," based in part on differences in glycosylation patterns in the recombinant IFN-β protein compared with the naturally occurring human IFN-β protein; the District Court relied on expert testimony in coming to its conclusion. Particularly, the District Court did not construe the claims as product-by-process claims.
The District Court sustained the jury's determination in all other respects (as well as granting Biogen's motion that the claims recited patent-eligible subject matter). This appeal followed.
The Federal Circuit reversed the District Court grant of JMOL on anticipation and grant of a new trial, in an opinion by Judge Linn joined by Judges Newman and Hughes. The panel found two sources of error in the District Court's grant of JMOL in favor of Biogen. First, in the Federal Circuit's judgment that the claims were indeed product-by-process claims and should have been construed that way. Second, the District Court's construction "required identity of three-dimensional structures not specifically recited in the claims rather than relying on the claimed and lexicographically defined 'polypeptide.'"
With regard to the differences between naturally occurring and recombinant IFN-β proteins, the Federal Circuit opined that the District Court unnecessarily "categorized the 'produced; and 'transformed' limitations in the '755 claims as meaningful 'source limitations.'" The District Court also identified the recombinant source of the recited IFN-β as "overcoming the shortcomings of the prior art" with regard to be able to access sufficient quantities of IFN-β to achieve practicable treatment of MS.
The Federal Circuit agreed with Serono that "a source limitation alone cannot confer novelty unless the product itself is novel" and that the District Court erred by ignoring the "longstanding rule" that an "old" product (i.e., one in the prior art) is not patentable by being made by a new process (in contrast with the process, which if new and otherwise in satisfaction of the statute is patentable), citing (among more recent precedent) Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884). Amongst that more recent (and in many ways more apt) precedent was Amgen Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), regarding comparison between recombinant erythropoietin and prior art human urinary EPO. The key question there, and here, is whether production of a protein recombinantly resulted in a new product (which, if the primary amino acid sequence is identical devolves into a comparison of glycosylation patterns). Merely reciting the recombinant origins of the protein at issue does not produce additional structural limitations distinguishing the proteins according to the opinion, the Court citing Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345, 1353 (Fed. Cir. 2016), for this proposition.
Here, the panel properly recognized that the only point of novelty Biogen can rely upon is that a therapeutically effective amount of recombinant IFN-β is administered (which was not in the prior art). The composition itself is claimed by its method of making ("recombinant") and to recognize novelty here based solely on administration would in the Court's opinion "defy all reason," because in that case "a recombinant composition could be non-novel, the method of administration could be non-novel, but the method of administration of the composition defined by the process of its manufacture would be novel as a matter of law."
And with regard to using a product-by-process analysis within a method of treatment claim, the panel cited to Purdue Pharma for the proposition that it is the novelty of the composition itself, rather than how it was made, that is the proper basis for deciding whether the claim recites novel subject matter.
The Court provided two rubrics for the principles it set forth. First, put succinctly, "the recombinant origin of the recited composition cannot alone confer novelty on that composition if the product itself is identical to the prior art non-recombinant product." And further, "an old method of administration of an old product made by a new process is not novel and cannot be patented."
The District Court's final point of error according to the panel was in considering the novelty of the process of making IFN-β -- recombinantly -- as giving "force and effect" to the "heart of the claimed invention." The error is in the consequence: by doing so the claim removed old products from the public domain, the cardinal sin that the novelty requirement seeks to avoid.
The Federal Circuit also found error in the District Court's emphasis on the three-dimensional structure (and differences between) naturally occurring and recombinant IFN-β. This preoccupation was contrary to the definition of the term "polypeptide" in the specification as "[a] linear array of amino acids connected one to the other by peptide bonds between the α-amino and carboxy groups of adjacent amino acids." This art-recognized definition is without regard to the three-dimensional structure of the polypeptide (indeed, it is a fundamental rubric of protein chemistry that the linear array -- termed the polypeptide's "primary structure" -- determines, with some limitations, its three-dimensional structure). Biogen acknowledged the identity of the "sequential order" of amino acids between naturally occurring and recombinant IFN-β as claimed, which should have been the end of it. But the District Court considered the further claim limitation that the recombinant IFN-β must be "therapeutically effective" and have "antiviral activity" as imparting significance to identity of three-dimensional structure.
The District Court's errors, according to the Federal Circuit, were three-fold. First, consideration of the three-dimensional structure was contrary to the definition in the specification, and thus a contradiction of the inventor's lexicographic choices. Second, there was no disclosure in the specification or limitation recited in the claims relating the three-dimensional structure of recombinant IFN-β to antiviral activity. And finally the jury was not given and Biogen did not request an instruction that required comparison of the three-dimensional structures of prior art naturally occurring IFN-β and recombinant IFN-β. But the jury was given proper instruction on the definition of novelty and that the linear amino acid sequence of naturally occurring IFN-β was identical to that of recombinant IFN-β and in the panel's opinion came to the right conclusion.
For these reasons the Federal Circuit remanded with instructions that the jury verdict of invalidity for obviousness be reinstated by the District Court.
* Although the Federal Circuit opinion identified Biogen's drug in this way, a review of the District Court litigation reveals that Biogen's drug is Avonex®; Rebif® is the trademark for Merck's IFN-beta product. We thank Henry Einav for the correction.
Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 2020)
Panel: Circuit Judges Newman, Linn, and Hughes
Opinion by Circuit Judge Linn