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Biogen v. EMD Serono – “A Nest of Limitations”

By now, other commentators have posted on this Fed. Cir. decision (Appeal no. 2019 -1133, Sept. 28, 2020)—and found it to be a routine reversal of a district court’s relying on “source limitations” to find claims to a recombinant IFN-B polypeptide not anticipated by prior art disclosing the native polypeptide. The main claim in question [shortened here for readability] of U. S. Patent No.7,588,755 follows:

          “A method for immunomodulation or treating a viral condition…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:

  1. DNA sequences which are capable of hybridizing to any of the DNA inserts of [4 plasmids under hybridizing conditions…] and which code for a polypeptide displaying antiviral activity ; and
  2. 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 Fed. Cir. panel rejected Biogen’s arguments that the terms “recombinant” and “produced by a non-human host transformed by a recombinant DNA molecule” are structural limitations, stating:

“The key question for anticipation here, as in Amgen [v. Hoffman La Roche Ltd, 580 F.3d 1340 (Fed. Cir. 2009)] is thus whether the recombinant product is identical to the prior art product—not whether the prior art product was [also] made recombinantly. …Biogen’s only basis for novelty of the method of treatment claims at issue here is the novelty of the recombinant IFN-B that is administered. The composition is claimed in terms of the process by which it is manufactured. If the novelty of the recombinant IFN-B composition requires comparing its structure to the structure of native INF-B as Amgen requires, it would defy all reason to excuse that analysis for a method of administration claim using that composition. Such a rule would have the absurd result that 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….There is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated.”

This ruling seems inevitable (and correct) but what would the outcome have been if the product by processes limitation had been drafted out of the nest as mature claim limitations? In other words, it seems that the anticipation argument would fail if the method-of-treatment claim had included positively-recited production steps, viz:

  1. A method for treating a viral condition comprising:
    1. transforming a non-human host cell with a recombinant DNA molecule comprising one of the [four DNA sequences of claim 1] operably linked to an expression control sequence];
    2. expressing [one of the 4 DNA sequences] to yield a recombinant polypeptide displaying anti-viral activity; and
    3. administering to a patient in need of such treatment a composition comprising a therapeutically effective amount of said polypeptide.

This claim is not anticipated by publications disclosing native IFN-B isolated from human cells “in small amounts.” There are no product by process claims “nested” in this claim, and each claim limitation must now be given weight. Is this claim overly narrow? How do you think Serano manufactures its IFN-B?


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