Sanofi-Aventis U.S. LLC/Genzyme et al. v. Immunex Corp.

IPR2017-01879 and -01884 (US 8,679,487 B2)
February 15, 2018

Brief summary: Sanofi’s IPR petitions against Immunex’s ‘487 patent directed to anti-IL-4R antibodies instituted on grounds of anticipation and obviousness. Sanofi’s previously denied IPR petition found not to prohibit filing of these IPRs under the PTO’s General Plastics decision (a “non-exhaustive” list of seven factors).

Summary: Sanofi filed two petitions for IPR of Immunex’s ‘487 patent relating to antibodies against the IL-4 receptor (IL4R). Immunex asserted the ‘487 patent against Sanofi in C.D. CA (No. 2:17-cv-02613, filed April 5, 2017). Illustrative claim 1 claims an anti-IL4R antibody defined by its variable region light and heavy chain amino acid sequences (SEQ ID NOS: 10 and 12, respectively). Under the broadest reasonable construction (§ 100 (b), Cuozzo (US 2016)), in both decisions, the Board determined “‘human antibody’…includes both partially human and fully human antibodies” and “‘antibody’ consistently with the specification’s express definition” (which defines the term “with reasonable clarity, deliberateness, and precision”).

The decisions explain that under General Plastics (IPR2016-01357 (Sept. 6, 2017)), the Board has discretion in determine whether or not to grant IPR after considering a “non-exhaustive” list of seven factors including “whether the petitioner previously filed a petition directed to the same claims of the same patent” (here, Sanofi/Genzyme’s IPR2017-01129 was denied (Oct. 4, 2017)), “whether the petitioner know of the prior art asserted in the second petition when filing the first petition, and whether at the time of filing the second petition, the petitioner already received the patent owner’s preliminary response to the first petition.” Denied IPR1129 alleged anticipation “because the claims were not entitled to the benefit of their earliest filing date.” IPR1879 and IPR1884 alleged anticipation (§ 102(e)) and obviousness (§ 103), respectively. The Board decided not to “exercise [its] discretion to deny the Petition[s] under § 314(a)” because “the grounds are sufficiently different in each petition” to persuade it that Sanofi “did not appear to ‘strategically stage [its] prior art and arguments in multiple petitions, using [Patent Owner’s preliminary response] as a roadmap, until a ground is found that results in the grant of review.’” The Board was “also persuaded that the delayed filing of the latter two petitions to allow time for Petitioner to complete the competition testing was reasonable, particularly because it was not an issue in the first petition.” The Board also declined to decline review under § 325(d) (discretion to decline “if ‘the same or substantially the same prior art or arguments previously were presented to the Office”) since “the Examiner did not have the benefit of Petitioner’s additional experimental evidence relating to competition”.

In IPR1879, Sanofi alleged anticipation of the ‘487 claims by a US application (“the ‘934 application”), parent application of that leading to the ‘487 patent (as a CIP) but from which priority was expressly disclaimed during prosecution of the ’487 patent. The decision explains that “[a]nticipation requires that ‘each and every element set forth in the claim is found, either expressly or inherently described, in a single prior art reference” and “[t]o establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill” (In re Robertson, FC 1999). The Board was persuaded that Sanofi “has shown sufficiently that the ‘132 Publication discloses each limitation of claim 1” and was not persuaded by Immunex’s argument that the document was not enabled or that it does “not describe an invention ‘by another’”. The Board explained that under Dynamic Drinkware (FC 2015), while “the burden of persuasion never shifts to Patent Owner”, Sanofi “satisfied its initial burden of production” regarding anticipation, and “[t]he burden of production” is now “shift[ed] to Patent Owner to argue or produce evidence” that the ‘132 Publication is does not anticipate or is not prior art (noting it found Immunex’s evidence “compelling”). Thus, institution was granted on the IPR1879 petition.

In IPR1884, Sanofi alleged obviousness over Eur. J. Immunol. article “Hart” and EP application “Schering-Plough”, and separately also including US patent “Hoogenboom”. The Board explained that it determines obviousness under KSR (e.g., “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently known in the prior art”, that “it can be important to identify a reason” for making the combination” with a reasonable expectation of success (KSR; PAR Pharm., FC 2014) concluded Sanofi “established a reasonable likelihood that it would prevail” (e.g., “humanization teachniques were well-developed” by the ‘487 filing date). The Board noted it “will have the opportunity to consider the issues fully” (e.g., expert testimony submitted at this stage) “once the records has been developed at trial.” Thus, institution was granted on the IPR1884 petition.

This entry was posted in Anticipation (35 USC 102), Claim Differentiation, Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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