Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.
Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.
To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101. In Part 1 of this three-part series, we reviewed the origin of the three “patent ineligible” subject matters, the evolution of the U.S. Supreme Court’s jurisprudence on the issue, and how the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Labs, Inc. changed the patent-eligibility landscape for life science patents.
Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.