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. Part 1 and Part 2 of this three-part series reviewed the origin and history of the patent-eligibility requirement and jurisprudence and how the U.S. Supreme Court’s decisions since Mayo Collaborative Services v. Prometheus Labs, Inc. significantly raised the patent-eligibility bar, and examined the impact of Mayo on life sciences patent litigation in lower courts.
“Patent dance” refers to the elaborate exchange of patent information between a biosimilar applicant and a biologics sponsor under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. It is intended to have the parties resolve any patent disputes expeditiously, preferably before the launch of the biosimilar product. Under the Act, within 20 days of FDA’s acceptation of an abbreviated biologics license application (aBLA), the biosimilar applicant “shall provide to the reference product sponsor a copy of the application … and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” This starts the dance.
The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.
India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.