Eleven Professors File Amicus Brief in Sandoz v. Amgen

As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11 professors “teach and write on patent law and policy, and the economics of the biopharmaceutical industry,” and “are concerned with the integrity of the legal system that secures innovation to its creators and to the companies that commercialize it in the marketplace.”

The amicus brief filed by the 11 professors makes three primary arguments. First, the professors argue that biopharmaceutical firms need to know that their patent rights will be enforceable and that a meaningful return on investment will be possible. Given the complexity and risk associated with developing a new biologic drug, the professors assert that “the success of the biopharmaceutical sector depends on the availability of meaningful patent protection.”

Second, the professors argue that resolving patent infringement issues prior to market entry of generic and biosimilar drugs … ensures that innovators benefit from meaningful enforcement of their patent property rights.” The professors contend that the “premarket patent litigation begins with a premarket information exchange process that depends on the biosimilar applicant providing information to the innovator.” And that “every subsequent step in the process that culminates in the innovator bringing its patent infringement case … is measured from” from that initial exchange. The professors also contend that the BPCIA scheme would be thwarted if the information exchange step was optional; that “if a biosimilar applicant elected to ignore paragraph (2)(A), the biologic drug innovator might not learn of the pending biosimilar application,” and even if “the innovator knew of the application it might know nothing more than the fact that the FDA accepted the application for review.” Further, the professors assert that the Federal Circuit fundamentally misunderstood the role of § 271 (e)(2)(C)(ii) when they concluded that Congress intended to excuse biosimilar applicants from compliance with those provisions and that the conclusion, “effectively penalize[s] the biologic drug innovator for the biosimilar applicant’s failure to comply with the process laid out in § 351(l).”

Third, the professors assert that Novartis/Sandoz is attempting to “secure from the courts an outcome it was unable to obtain from Congress.” The professors submit that the final language of the patent provisions reflect years of discussions relating to patent protection, patent infringement, and the procedures that should be included. The professors contend that Novartis/Sandoz consistently opposed any legislation that combined the biosimilar regulatory pathway with patent resolution processes and ultimately failed to convince Congress to support a bill without patent provisions. The professors submit that “Novartis/ Sandoz should take its case back to Congress.”