USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
drug sponsors as covering those products under the Hatch-Waxman Act. As discussed in 2.1 Infringing Acts , an ANDA applicant must provide a certification or label carve-out for each patent listed in the Orange Book. 21 USC 355 (j)(2)(A)(vii)) and 355 (j)(2)(A)(viii). If the applicant certifies that the patent will not be infringed or is invalid, the applicant must also give notice of such Paragraph IV certification to the patent owner and the holder of an approved NDA for that product. The recipient of the Paragraph IV certifica ‑ tion has 45 days after receiving notice to file an action “for infringement of the patent that is the subject of the certification.” 21 USC 355 (c)(3) and 355 (j)(5)(B). If such action is brought, approval of the ANDA will not become effective before expiration of a 30-month period (the “30-month stay”) or upon a judicial deci ‑ sion that the patent is invalid or not infringed. Id. 2.5 Reimbursement and Pricing/Linkage Markets In the USA, decisions on pricing and reimbursement are generally not linked to patent status. Biologic applicants operate under the BPCIA, not the Hatch-Waxman Act. The BPCIA amended the Patent Act to provide that it “shall be an act of infringement to submit... an application seeking approval of a bio ‑ logical product” regarding patents that are or could be identified pursuant to Section 351 (l)(3) of the Public Health Service Act. 21 USC 271 (e)(2)(C). The BPCIA provides for pre-litigation and litigation phases. As discussed in 1.7 Pre-Action Discovery/ Disclosure, the biosimilar applicant has the option of participating in the “patent dance” under 42 USC 262 (l)(2). During the patent dance, the biosimilar appli ‑ cant provides certain technical information about its product (under confidentiality terms), the patentee provides a list of patents which it believes it could rea ‑ sonably assert, the parties exchange contentions, and ultimately, the parties negotiate a list of patents that are subject to immediate litigation. Only listed patents at this stage are subject to a declaratory action of 3. Biosimilar Market Entry 3.1 Infringing Acts
infringement, validity, or enforceability until the appli ‑ cant provides notice to the patent owner that it will begin commercial marketing of the biosimilar in not less than 180 days. 42 USC 262 (l)(9)(A). Although an aBLA applicant cannot be forced to engage in the patent dance ( Amgen Inc v Sandoz Inc , 137 S Ct 1664 (2017)), failure to do so bars the appli ‑ cant from initiating a declaratory judgment action – whereas the patent owner may immediately bring a declaratory judgment action for any patent claiming the biosimilar. 42 USC 262 (l)(9)(C). A second phase commences once the biosimilar applicant provides the NCM. At that point, a PI can be sought and all listed patents not in litigation can be asserted. If the NCM is given before a first wave litiga ‑ tion commences, both waves fold into one. 42 USC 262 (l) (3); 42 USC 262 (l)(8)(B). The RPS may assert any patents identified in the patent dance or that are subsequently granted. 3.2 Data and Regulatory Exclusivity The BPCIA provides the following exclusivities. • 12-year Biologic – 12-year reference product exclusivity for biologics; aBLAs can be filed 4 years after the reference product was first licenced. 42 USC 262 (k)(7)(B). • Paediatric exclusivity – 12-year exclusivity may be extended by six months. Unlike the Hatch-Waxman Act, a six-month period is not added onto Orange- Book patent expiration. • Orphan drug exclusivity (same as generics). • Up to one-year Interchangeability Exclusivity – the first biosimilar deemed interchangeable to a refer ‑ ence product by the FDA can be awarded up to 12 months of exclusivity, during which time no other biosimilar may be deemed interchangeable. 42 USC 262 (k)(6)(A). “Interchangeability” means that a biosimilar can be substituted for its reference product by a pharmacist without the intervention of the prescribing healthcare provider, provided it is expected to produce the same clinical result in any given patient and the risks of alternating or switching are not greater than using the reference product alone. Depending on various fac ‑
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