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From Intellectual Property Law Daily, October 5, 2017

New trial needed in cholesterol drug patent dispute over written description and enablement

By Thomas Long, J.D.

In a patent dispute related to competing cholesterol medications, a district court erred by excluding post-priority-date evidence regarding written description and enablement of the two patents-in-suit and improperly instructed the jury on written description, the U.S. Court of Appeals for the Federal Circuit has held. Therefore, the district court’s judgment that the patents were not invalid was reversed in part and remanded for a new trial on written description and enablement. The appellate court also vacated the district court’s grant of a permanent injunction barring sales of the defending manufacturers’ drug. The district court’s denial of the defending manufacturers’ request for judgment as a matter of law (JMOL) of no written description and enablement was, however, affirmed, along with the district court’s grant of the complaining manufacturer’s JMOL of nonobviousness (Amgen Inc. v. Sanofi, October 5, 2017, Prost, S.).

Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S., LLC (collectively, "the appellants") appealed from a final judgment of the district court holding U.S. Patent Nos. 8,829,165 ("the ’165 patent") and 8,859,741 ("the ’741 patent") not invalid and granting a permanent injunction enjoining sales of the appellants’ Praluent® alirocumab ("Praluent"). The patents-in-suit generally related to antibodies that help reduce low-density lipoprotein cholesterol (LDL-C), or "bad cholesterol." Both were entitled "Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9)." Patent holders Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc. ("Amgen") developed the drug Repatha™, which uses the active ingredient "evolocumab." Evolocumab is a monoclonal antibody that targets PCSK9 to prevent it from destroying liver cell receptors (LDL receptors, or LDL-Rs) that are responsible for extracting LDL-C from the bloodstream. The patents disclosed the trial-and-error process Amgen used to generate and screen antibodies that bind to PCSK9 and block PCSK9 from binding to LDL-Rs.

The appellants’ own research regarding antibodies targeting PCSK9 resulted in development of Praluent. The active ingredient in Praluent is a monoclonal antibody that targets PCSK9 to prevent it from binding to and destroying LDL-R proteins. The LDL-R proteins then extract LDL-C, thereby lowering overall LDL-C levels in the bloodstream. In October 2014, Amgen sued the appellants, claiming that Praluent infringed the patents-in-suit. The appellants stipulated to infringement but challenged the patents’ validity on written description, enablement, and obviousness grounds.

During the course of litigation, the district court excluded all of the appellants’ post-priority-date evidence proffered to show that the patents-in-suit did not provide adequate written description. In addition, the district court instructed the jury, over the appellants’ objection, that written description can be satisfied "by the disclosure of a newly-characterized antigen … if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine." The district court denied the appellants’ motions seeking JMOL on written description and enablement and granted Amgen’s motion seeking JMOL of nonobviousness, after excluding two purported prior art references.

Exclusion of post-priority-date evidence. The Federal Circuit determined that the district court improperly excluded the appellants’ evidence about antibodies, including the appellants’ infringing Praluent, developed after the patents’ priority date of January 9, 2008. The evidence was proffered to show that the patents lacked written description support for purposes of 35 U.S.C. §112. Section 112 requires a patentee to convey in its disclosure that it had possession of the claimed subject matter as of the filing date. Demonstrating possession required a precise definition of the invention, disclosing "a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus."

The issue was whether the post-priority-date evidence could be used to determine whether the patent disclosed "a representative number of species." Although written description was judged based on the state of art as of the priority date, the evidence the appellants sought to introduce was not meant to illuminate the state of the art but to show that the patent did not disclose a representative number of species. In the Federal Circuit’s view, post-priority-date evidence of a particular species could reasonably bear on whether a patent failed to disclose a representative number of species falling within the scope of the genus that would allow one of skill in the art to visualize or recognize the members of the genus. The appellants offered Praluent and other post-priority-date antibodies as evidence showing that the claimed genus failed to meet this Section 112 requirement, not to show that there had been a change in the state of the art. Therefore, it was legal error for the district court to categorically preclude all post-priority-date evidence of Praluent and other antibodies. The appellate court reversed and remanded the district court’s decision for a new trial on written description. For many of the same reasons, the Federal Circuit held that a new trial was required on enablement as well.

Jury instruction on written description. The district court correctly instructed the jury that in order to satisfy the written description requirement, a patentee may disclose either a representative number of species falling within the scope of the genus or disclose structural features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus. However, according to the Federal Circuit, it was error for the district court to also instruct the jury that written description can be satisfied with respect to antibodies "by the disclosure of a newly-characterized antigen … if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine." The Federal Circuit agreed with the appellants’ argument that disclosing an antigen did not satisfy the written description requirement for a claim to an antibody. The instruction was improper because it permitted the jury to dispense with the required finding of a written description in the invention. It was not enough for the specification to show how to make and use the invention. An adequate written description had to contain enough information about the actual makeup of the claimed products, the appellate court said. Therefore, the district court was directed to adjust its jury instructions on remand accordingly.

JMOL—written description and enablement. In seeking reversal of the district court’s denial of JMOL on invalidity of the ’165 and ’741 patents, the appellants argued that the patents failed to provide written description support because they merely taught "where an antibody binds to an antigen" which "tells one nothing about the structure of any other antibody." Noting that the jury did not hear relevant post-priority-date evidence regarding written description and enablement, the appellate court stated that it was unable to determine whether the jury would have a legally sufficient evidentiary basis to determine if the patents provided sufficient written description or if the claims were enabled. Therefore, the court concluded that the appellants were not entitled to JMOL.

JMOL—nonobviousness. The Federal Circuit held that the district court properly excluded two purported prior art references offered by the appellants and therefore affirmed the grant of JMOL to Amgen on the issue of nonobviousness. The appellants sought to invalidate the patents-in-suit by proffering two published PCT applications: Novartis (WO 2008/12563) and Schering (WO 2009/055783). Neither reference predated the January 9, 2008 priority date of Amgen’s patents, although both applications claimed priority to provisional applications that did. The appellants did not proffer any evidence showing that the provisional applications contained representative species or common structural elements sufficient to satisfy the written description requirement for the monoclonal antibodies claimed in the PCT applications. Nor did they provide evidence that the claims of the PCT applications were enabled by the provisional application. Accordingly, the district court’s exclusion of the references, and the grant of JMOL of nonobviousness, was affirmed.

Permanent injunction. Because it vacated the district court’s judgment as to written description and enablement, the Federal Circuit also vacated the injunction. The appellate court also noted that the district court’s permanent injunction analysis was improper for two reasons: (1) although the district court determined that granting a permanent injunction would disserve the public interest, it granted one anyway, which was a clear violation of the Supreme Court’s holding in eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006).; and (2) the district court erroneously concluded that an injunction would disserve the public interest solely on the basis that it would take a class of drugs off the market.

The case is No. 2017-1480.

Attorneys: Daryl Joseffer (King & Spalding LLP) for Amgen Inc., Amgen Manufacturing Ltd., and Amgen USA, Inc. Paul D. Clement (Kirkland & Ellis LLP) for Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S., LLC.

Companies: Amgen Inc.; Amgen Manufacturing Ltd.; Amgen USA, Inc.; Sanofi; Aventisub LLC; Regeneron Pharmaceuticals Inc.; Sanofi-Aventis U.S., LLC

MainStory: TopStory Patent FedCirNews

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