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Size Matters in Obviousness Analysis

The US Court of Appeals for the Federal Circuit affirmed in part and reversed in part two Patent Trial and Appeal Board (Board) decisions, finding that the Board erred in its construction of certain claim terms relating to an artificial heart valve that does not require removal of the damaged native heart valve. St. Jude Medical, LLC v. Snyders Heart Valve LLC, Case Nos. 19-2108, -2109, -2140 (Fed. Cir. Oct. 15, 2020) (Taranto, J.).

St. Jude filed two petitions for inter partes review (IPR) of a patent for an artificial heart valve and a system for inserting the valve. Both petitions were instituted by the Board and resulted in final written decisions. In the first decision, the Board found that St. Jude failed to establish unpatentability of the challenged claims, rejecting St. Jude’s contention that all challenged claims were anticipated by and obvious over the Leonhardt prior art reference. In the second decision, the Board found that certain claims were anticipated by the Bessler prior art reference, but rejected St. Jude’s contentions as to all other claims. St. Jude appealed, arguing that the Board erred in the first decision by erroneously construing the term “band” and erred in the second decision by finding that St. Jude failed to prove that a skilled artisan would have made a particular combination of Bessler and the Johnson prior art. Snyders cross-appealed in the second decision as to the claims the Board found were anticipated by Bessler.

The Federal Circuit affirmed the Board’s conclusions in the first decision, finding that not only was the Board’s construction of the term “band” proper, but that it was actually broader than St. Jude’s proposed construction—and that St. Jude expressly accepted the Board’s construction. The Board construed the heart valve band to mean “a structure generally in the shape of a closed strip or ring” (replacing St. Jude’s “circular” with “closed”). In the prior art, Leonhardt discloses a graft material which extends the length of the entire structure. The Federal Circuit agreed with the Board’s finding that Leonhardt’s graft material was “like a sleeve” as opposed to “a closed strip or ring.” St. Jude argued that an ordinary skilled artisan’s understanding of the term “band” does not include a length restriction, that a Leonhardt’s material was just a long band, and that the Board effectively changed its construction of the term. The Federal Circuit, however, was not persuaded by St. Jude’s unlimited-length definition of “band,” instead turning to dictionary definitions that included terms like “thin” and “narrow,” and looking to the patent specification that did not explicitly disclaim any length restrictions. The Court ultimately rejected St. Jude’s arguments, finding that St. Jude should have proposed a claim construction that precluded any limitations on length if it wished to argue such. The Federal Circuit affirmed the Board’s findings as to first decision.

The Federal Circuit next addressed Snyder’s cross-appeal. Snyder disputed the board’s construction of the “size[] and shape[]” of a frame that the patent requires must be inserted [...]

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Product-by-Process Analysis Applies to Method of Treatment Claims

In a case relating to use of recombinant human interferon-β (IFN-β) proteins for the treatment of viral diseases, the US Court of Appeals for the Federal Circuit ruled that a “product-by-process” analysis applies even when the product-by-process limitation is nested within a method of treatment claim. Biogen MA Inc. v. EMD Serono, Inc., et al., Case No. 19-1133 (Fed. Cir. Sept. 28, 2020) (Linn, J.).

The claims at issue relate to a method of treating a viral condition, a viral disease, cancers or tumors by administration of a pharmaceutically effective amount of recombinant IFN-β. The claims contained a product-by-process limitation that partially defined the recombinant IFN-β in terms of the method or process by which it is made:

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 . . .

It was undisputed that native IFN-β proteins comprise sequences identical to those recited in the claims at issue, and that native IFN-β had been used in the prior art to treat viral conditions. At issue was whether the use of native IFN-β to treat viral conditions anticipated the use of recombinantly produced IFN-β for the claimed treatment.

When considering product-by-process claims, the Federal Circuit has long held that “an old product is not patentable even if it is made by a new process.” See, e.g., Amgen v. Hoffmann-La Roche (Fed. Cir. 2009). The district court granted Biogen’s judgment as a matter of law (JMOL) motion and reversed the jury verdict on anticipation, reasoning that the Amgen analysis did not apply here because the claims were directed to a method of treatment and not a product. Further, the “source limitations” (i.e., the limitations requiring that the IFN-β be produced using recombinant methods) overcame the shortcoming of the prior art. Namely, the unavailability of native IFN-β in sufficient quantity to facilitate practical treatment “lies at the heart of the benefit of this invention” and should be given “force and effect in the anticipation analysis.” Serono appealed.

The Federal Circuit reversed, explaining that the nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself. The Federal Circuit reasoned that “an old method of administration of an old product made by a new process is not novel and cannot be patented.” Further, the Court found that the district court erred in considering the advantages of the recombinant process—the new capability of manufacturing sufficient quantities of IFN-β through recombinant technology—as a reason not to apply the product-by-process analysis. The proper anticipation analysis does not turn on the source of the claimed polypeptide, but on a comparison of the claimed recombinant polypeptide and the prior art native polypeptide.

In granting JMOL, the district court alternatively reasoned that under a product-by-process analysis, the native IFN-β could not anticipate recombinant IFN-β, because the prior art did not disclose that the native and recombinant IFN-β shared an identical three-dimensional structure or that [...]

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Lights Turned Out on Validity Finding

Finding that the Patent Trial and Appeal Board’s (PTAB) anticipation and obviousness decisions resulted from an erroneous interpretation of the claim language and a misunderstanding of case law, the US Court of Appeals for the Federal Circuit vacated the PTAB’s decision and remanded for further consideration. Technical Consumer Products v. Lighting Science Group Corp., Case No. 19-1361 (Fed. Cir. Apr. 8, 2020) (Stoll, J.).

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Room Temp Prior Art Has Chilling Effect on Broadening Claim Language

In a case involving a patented method for purifying antibodies, the US Court of Appeals for the Federal Circuit determined that the process of chilling a composition to below room temperature could be found both obvious and anticipated by a process that purified that composition at room temperature. Genentech, Inc. v. Hospira, Inc., Case No. 18-1933 (Fed. Cir. Jan. 10, 2020) (Chen, J) (Newman, J, dissenting).

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