USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
• claim the drug substance (active ingredient) or drug product (formulation or composition); or • claim a method of using the drug that has been sought or granted in the application. Applicants may “carve out” certain methods of use from approval, thereby potentially avoiding method-of-use patents. As discussed further earlier, 505(b)(2) and 505(j) applicants must file certain certifications as to these patents. One such paragraph IV certification serves as notice to any patent owners – and holders of approved applications of drugs claimed by the patent – that the NDA filer alleges the related patents will not be infringed or are invalid. The recipient of the paragraph IV certification has 45 days after receiving notice to file an action “for infringement of the patent that is the subject of the certification” (21 USC Sec - tions 355(c)(3) and 355(j)(5)(B)). If such action is brought, approval of the NDA will become effec - tive only after expiration of a 30-month period or upon a judicial decision that the patent is invalid or not infringed (21 USC Section 355(c)(3) and 355(j)(5)(B)).
If the applicant engages in the patent dance, the parties will negotiate a list of patents that are subject to immediate litigation. Only listed patents at this stage are subject to a declaratory action of infringement, validity or enforceability until the applicant provides notice to the patent owner that it will begin commercial marketing of the biosimilar in not less than 180 days (42 USC Section 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 applicant from initiat - ing a declaratory judgment action – whereas the patent owner may immediately bring a declara - tory judgment action for any patent claiming the biosimilar (42 USC Section 262(l)(9)(C)). 3.2 Data and Regulatory Exclusivity The BPCIA provides the following exclusivities for applicants. • Reference product exclusivity grants to new biologics approved under a BLA a four-year exclusivity period, during which no aBLA may be filed on the product, and a 12-year period during which the FDA may not approve any biosimilar products (42 USC Section 262(k)). • Paediatric exclusivity confers an additional six months of exclusivity if the reference product conducted paediatric studies pursuant to the FD&C Act Section 505A (42 USC Section 262(m)). • Biosimilar applicant exclusivity grants a one- year period of exclusivity to the first biosimilar of a licensed biologic that is approved under the BPCIA, thereby preventing the FDA from approving any other biosimilars to the same reference biologic (42 USC Section 262(k)(6) (A)).
3. Biosimilar Market Entry 3.1 Infringing Acts
Biologic applicants operate under a different framework from ANDA applicants, with the for - mer governed by the BPCIA. The BPCIA amend - ed the Patent Act to provide that it “shall be an act of infringement to submit... an application seeking approval of a biological product” with regard to patents that are or could be identified pursuant to Section 351(l)(3) of the Public Health Service Act (21 USC Section 271(e)(2)(C)).
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