The fourth case scheduled to be argued next week that attracting an amicus brief is Immunex Corp. v. Sandoz Inc. A patent case, it drew interest from Samsung Bioepis and the Association for Accessible Medicines, respectively, concerning the issues of obviousness and double patenting. Both amici argue for reversal of the lower court decision in favor of the appellants, Sandoz Inc., Sandoz International GMBH, and Sandoz GMBH. Here is our argument preview.
The Sandoz companies filed this appeal. In their joint opening brief, they present three questions:
- “Whether the patents-in-suit are invalid for [obviousness-type double patenting], where Immunex—which owns all substantial rights in those patents, including the ability to control patent prosecution—had already obtained earlier-expiring patents claiming obvious variants of the same inventions.”
- “Whether the claims-in-suit are invalid for lack of written description, where the original specification did not disclose the key claimed features of etanercept and Immunex had to amend the specification to add them.”
- “Whether the district court’s ruling on obviousness was infected by legal error.”
On the first issue of obviousness-type double patenting, Sandoz contends that Immunex has improperly extended its patent term by violating “the equitable prohibition on obviousness-type double patenting” (“ODP”). Sandoz highlights that Immunex is “now well into [its] third decade of exclusivity for claims covering the protein etanercept, the active ingredient in Immunex’s biologic product Enbrel.” Sandoz argues that Immunex was able to achieve the prohibited extended patent term by reaching an agreement with Roche. Sandoz contends that the agreement “functioned as an assignment by providing Immunex with all substantial rights to [Roche’s pre-GATT patent] applications—including complete control over prosecution, the exclusive right to commercial use, the ability to sue for infringement and control infringement litigation, and the right to grant royalty-free sublicenses.” According to Sandoz, “Immunex used its exclusive prosecution authority to amend the claims and specifications to shoehorn etanercept into the Roche applications.” Sandoz urges that “Immunex cannot evade ODP by mislabeling the 2004 Agreement with Roche as a ‘license’ rather than an assignment.”
On the second issue, Sandoz argues that the patents-in-suit fail to satisfy the written description requirement because the Roche priority applications did “not disclose the full-length p75 receptor, much less the p75-IgG1 etanercept protein claimed by the patents-in-suit.” Sandoz contends that the district court erred by employing a “hindsight- and obviousness-based approach to written description” to reach a conclusion that the p75 sequence was disclosed. Further, Sandoz maintains that the priority application failed to disclose the specific species (p75-IgG1) within the genius of full-length p75 compounds.
On the third issue, Sandoz contests the district courts holding that “a skilled artisan would not have been motivated to combine the p75 receptor with an immunoglobulin to create etanercept.” While the district court based its conclusion on the idea that “the potential to stimulate inflammation would have taught away from” combining the prior art, Sandoz argues that the district court erred by not taking into account “evidence showing a motivation to create etanercept for other purposes.”
In their response brief, Immunex Corporation, Amgen Manufacturing, Ltd., and Hoffmann-La Roche Inc. (collectively, “Immunex”) argue that “common-ownership-based ODP arises only when the relevant inventions were entirely owned by the same entity at the time of the invention.” Immunex criticizes what it characterizes as an importation of the “’all-substantial-rights’ test from prudential standing into ODP” as unprecedented and leading to perverse consequences. Immunex contends that the relevant agreement did not create a “common ownership” and that the court should “dispose of Sandoz’s double-patenting theory at the threshold.”
Immunex also argues that Sandoz’s written description and obviousness arguments fail. Immunex claims that Sandoz is simply attempting “a do-over.” Immunex points out that both issues present questions of fact reviewed for clear error on appeal, and then argues that Sandoz failed to show clear error at the trial court on both issues.
In its reply brief, Sandoz argues against what it characterizes as Immunex’s claim that “any company can obtain multiple terms for obvious variants of the same invention by taking over patents by assignment.” With regard to the written description requirement, Sandoz contends that Immunex is “hid[ing] behind the district court’s findings, but cannot defend the court’s key legal error—relying on the claims themselves to show compliance with Section 112.” And regarding obviousness, Sandoz argues that “because Immunex repurposed the applications to claim etanercept, rather than a method of using it to treat autoimmune disorders, the district court’s obviousness analysis was fundamentally flawed.”
As mentioned, Samsung Bioepis (“Samsung”) and the Association for Accessible Medicines (“AAM”) filed amicus briefs in support of the the Sandoz companies.
Samsung’s brief addresses only the issue of obviousness. Samsung argues that the governing “precedent dictate[s] that the obviousness analysis must focus on the claimed invention and take a flexible approach in assessing whether there were any motivations to make it, without limiting the analysis to any one particular motivation.” And it criticizes the district court for “improperly consider[ing] development of a therapeutic agent as the sole possible motivation for a skilled artisan to make the claimed invention” because “no such limitation exists in the asserted claims” and “the prior art and asserted patents disclosed numerous non-therapeutic uses” for the claimed invention.
AAM’s brief addresses only the issue of obviousness-type double patenting (“ODP”). AAM argues that ODP is the only remedy to ensure that Immunex does not “enjoy a third decade of exclusivity courtesy of the patents-in-suit.” Specifically, AAM argues that a “superficial characterization of a patent transfer as a license should not permit an end-run around double-patenting.” Instead, AAM argues that the common ownership requirement should be satisfied if a party possesses “all substantial rights” in the patents-in-suit. AAM also contends that “plaintiff’s ply would provide patentees with a blueprint for evergreening.” In AAM’s view, if the district court’s decision is allowed to stand “a brand-name drug patent holder can simply take over substantially all rights to a patent application from another party, while leaving that party with nominal rights to posture the transaction as a license rather than assignment.” According to AAM, “[t]his strategy would harm innovation by extending monopolies and inhibiting the price competition that AAM’s members seek to deliver.”
We will keep track of this case and report on developments.