USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
tors, there may be less exclusivity or none at all (eg, depending on launch delays), and during the exclusiv ‑ ity period, the FDA may still approve other biosimilars. It is only prohibited from deeming any others inter ‑ changeable. 3.3 Acceptable Pre-Launch Preparations The safe harbour provision of 35 USC 271 (e)(1) also shelters activities of biosimilar applicants conducted solely for the purpose of developing and submitting information under federal law. 3.4 Publicly Available Drug and Patent Information The FDA maintains the Purple Book, or List of Licensed Biological Products, which contains biological prod ‑ ucts regulated by the Centre for Drug Evaluation and Research. This includes not only reference prod ‑ ucts but also licensed biosimilars. The Purple Book includes the date of licensing for the product, the date of expiration for exclusivity periods, and certain patent information, as discussed further below. Unlike the Orange Book, however, the RPS is not required to submit patent information upon approval or immediately after patent grant (if after approval). Instead, the sponsor need only submit to the FDA the patent lists that they serve on biosimilar applicants during the patent dance (within 30 days of providing the biosimilar applicant with the list) or that are assert ‑ ed in litigation (also within 30 days). The FDA updates the Purple Book every 30 days. 42 USC 262 (k)(9)(A). Additionally, there is no need for the biosimilar appli ‑ cant to make any certifications with respect to Purple Book patents. Rather, the Purple Book merely pro ‑ vides notice as to which patents have already been listed or asserted with respect to previous applicants. 3.5 Reimbursement and Pricing/Linkage Markets Unlike the Hatch-Waxman Act, the BPCIA: • does not require any patent certifications, rather it provides for an optional information exchange (the patent dance);
• does not have the automatic 30-month stay tied to a patent certification, but it does require aBLA applicants to provide a six-month NCM; • does not have an automatic stay of approval if there is a final finding of infringement, although 35 USC 271 (e)(4)(D) does provide for an automatic injunction until patent expiry if there is: (a) a final finding of infringement from which no further appeal may be taken (apart from seek ‑ ing certiorari at the Supreme Court); and (b) the reference product’s regulatory exclusivity has not yet expired; and • has different exclusivities.
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates There is no equivalent to a Supplementary Protection Certificates (SPC) in the United States. However, a patent term extension (PTE) is available for certain patents claiming drug products – and methods of use or manufacture of drug products – that are subject to regulatory review before commercial marketing or use. 35 USC 156 (a). To obtain a PTE, the BLA or NDA holder must submit an application for extension within 60 days of receiving permission from the FDA to market the product. Only one patent may receive a PTE per reference product. 35 USC 156 (c)(4). The PTE determination is made by the FDA and USPTO together. The FDA is responsible for initially calculating the length of the regulatory review for the product, which is published in the Federal Register. 35 USC 156 (d)-(2)(A)(ii). After a chance for comment by interested parties, the USPTO calculates the final PTE length, which is capped at five years. 35 USC 156 (g)(6)(A). 4.2 Paediatric Extensions The USA has paediatric exclusivity as indicated in 2.2 Regulatory Data and Market Exclusivity and 3.2 Data and Regulatory Exclusivity .
265 CHAMBERS.COM
Powered by FlippingBook