Sandoz Files IPR Peitions Against Humira Ulcerative Colitis and Crohn's Disease Patents

On August 21, 2017, Sandoz filed two IPR petitions against Humira patents claiming a method for treating ulcerative colitis or Crohn's disease with a total body dose of 40 mg of Humira.  Sandoz argues that these patents are invalid based on the PTAB’s decision that invalidated a similar Humira method patent claiming the same dose for treating rheumatoid arthritis.

IPR2017-01988 8,974,790	1. A method for treating ulcerative colitis in a human subject, comprising administering subcutaneously to a human subject having ulcerative colitis a total body dose of 40 mg of a human anti-TNFα antibody once every 13-15 days for a time period sufficient to treat the ulcerative colitis, wherein the anti- TNFα antibody comprises [Humira].
IPR2017-01987 8,911,737	1. A method for treating Crohn's disease in a human subject, comprising administering subcutaneously to a human subject having Crohn's disease a total body dose of 40 mg of a human anti-TNF.alpha. antibody once every 13-15 days for a time period sufficient to treat Crohn's disease, wherein the anti- TNFα antibody comprises [Humira].
IPR2016-00172 8,889,135 Invalidated by the PTAB	1. A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having rheumatoid arthritis a total body dose of 40 mg of a human anti- TNFα antibody once every 13 -15 days for a time period sufficient to treat the rheumatoid arthritis, wherein the anti- TNFα antibody comprises [Humira].

Sandoz argues that the only difference between claim 1 of these patents and claim 1 of the ’135 patent invalidated by the Board is the substitution of “ulcerative colitis” or “Crohn's disease” for “rheumatoid arthritis.” According to Sandoz, the prior art (Salfeld) taught that Humira was useful to treat UC, Crohn’s disease, and RA with a dosage range applicable to all three indications.   In fact, the only disclosure in the patents that relates to UC or Crohn's disease was lifted directly from Salfeld. 

Amgen v. Hospira

Federal Circuit:  [O]nce a patent is listed by the sponsor, the BPCIA’s (Biologics Price Competition and Innovation Act) information exchange further requires the applicant to “provide to the . . . sponsor, with respect to each patent listed . . . a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed.” 42 U.S.C. § 262(l)(3)(B)(ii) In other words, once a sponsor lists a patent under paragraph (l)(3)(A), the applicant must once again come forward with additional disclosures under paragraph (l)(3)(B) that inform whether “a claim of patent infri http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-2179.Opinion.8-8-2017.1.PDFngement . . . could” or could not “reasonably be asserted.” If the applicant fails to comply with its obligation to respond under paragraph (l)(3)(B), the sponsor would have a reasonable basis for asserting a claim of patent infringement. . . Thus, if a sponsor forms a belief based on an inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11.

These considerations dispel the notion that Amgen would have needed to bring suit simply based on its own unsupported belief. Hospira, in fact, agrees that Amgen could have validly listed its cell-culture patents under paragraph (l)(3)(A) and that Hospira would have been obligated to respond with “detailed statement[s]” under paragraph (l)(3)(B). In this scenario, Amgen would have had an opportunity to assess the reasonableness of its litigation position long before filing suit and being exposed to Rule 11 sanctions or antitrust liability. Thus, the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A).5 The denial of discovery in this case does not undermine the purpose of the BPCIA.

The district court correctly denied Amgen’s motion to compel on the ground that the composition of Hospira’s cell-culture media was of “no relevance to the patents that are asserted.” J.A. 37. Amgen has not established a clear and indisputable right to discovery of the information it seeks. It therefore has not established the prerequisites for this court to issue a writ of mandamus. 

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-2179.Opinion.8-8-2017.1.PDF

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Del. Mag. Judge: Claim Term “Molecular Weight” Is Indefinite

In Integra Lifesciences v. Hyperbranch Medical Technology, the Defendant took the position that the term "molecular weight" in the claims of U.S. Patent 6,566,406 was indefinite:

1. A method for preparing a biocompatible crosslinked polymer hydrogel, comprising: providing a biocompatible small molecule crosslinker with a molecular weight of 2000 or less, the crosslinker having n crosslinker functional groups, wherein n is two or more, and wherein the crosslinker functional groups are either electrophilic or nucleophilic; providing a synthetic biocompatible functional polymer with a molecular weight of at least about 7 times more than the crosslinker. . .

It was undisputed that, when determining the molecular weight of a polymer, different

statistical measures could be used and that these would yield different numerical values for a given polymer.  Defendant relied heavily on the decision of the United States Court of Appeals for the Federal Circuit in Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015) in support of its argument, a case that analyzed indefiniteness with respect to the same term.  In Teva, the Federal Circuit held that:

[I]t is undisputed that "molecular weight" or average molecular weight can be ascertained by any of three possible measures: Mp, Mn, and Mw. The claims do not indicate which measure to use.  The specification never defines molecular weight or even mentions Mp, Mw, or Mn. And the term "average molecular weight" does not have a plain meaning to one of skill in the art .... During prosecution of the related patents, which with respect to molecular weight have identical specifications, examiners twice rejected the term "molecular weight" as indefinite for failing to disclose which measure of molecular weight to use (Mp, Mn, or Mw). And the patentee in one instance stated that it was Mw and in the other stated it was Mp . ... We hold that claim 1 is invalid for indefiniteness by clear and convincing evidence because read in light of the specification and the prosecution history, the patentee has failed to inform with reasonable certainty those skilled in the art about the scope of the invention. On this record, there is not reasonable certainty that molecular weight should be measured using Mp.

In this case, the magistrate judge also found that the claim term “molecular weight” was indefinite:

The claims and the specification of the '406 patent do not directly speak to this issue at all. Nor is the Court persuaded that the POSITA would follow [the patentee’s expert’s]  9-step pathway to "Mn" in order to fill in the gap. That pathway relies in significant part on a single citation in the later-issued '705 patent to the Aldrich Catalog. And that very citation, on its face, does not direct anyone to consult the Aldrich Catalog for purposes of assessing measurements of molecular weight. Even if one did turn to the Aldrich Catalog for this purpose, the catalog does nothing to clearly indicate what measurement should be used; instead, it makes reference to different types of molecular weight measurements, a fact that would only solidify a POSITA's uncertainty. All of this, along with Dr. Mays' tendency to cherry-pick (without explanation) which portions of the Aldrich Catalog a POSITA would look to in the first place, renders the outcome here clear. See Butamax Advanced Biofuels, LLC v. Gevo, Inc., 117 F. Supp. 3d 632, 641 (D. Del. 2015) (finding claim indefinite where various methods could have been used to make the calculation called for by the claim limitation at issue, and "[b]ased on the broad and ambiguous language of the specification, the court does not find commonsensible [the expert's] conclusory assertion that a [POSITA] would be directed by the specification to use the MegAlign program (and its online help manual not referred to in the specification)" to do so). The Court agrees with Defendant that this case is similar to Teva, and that the conclusion reached here should be the same as the conclusion the Federal Circuit reached in that case.

http://www.ded.uscourts.gov/sites/default/files/opinions/cjb/2017/august/15-819.pdf

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