USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
3.3 Acceptable Pre-Launch Preparations The safe harbour provision of 35 USC Section 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 products regulated by the Center for Drug Evaluation and Research. This includes not only reference products but also licensed biosimilars. The Purple Book includes the date of licensing for the product, the date of expira - tion for exclusivity periods, and certain patent information. However, the Purple Book differs from the Orange Book in that BLA holders are only required to 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). The FDA updates the Purple Book every 30 days (42 USC Section 262(k)(9)(A)). As noted earlier, biosimilar applicants can choose whether to participate in the patent dance. If they choose to participate, biosimi - lar applicants must provide the patent owner a copy of their aBLA within 20 days of the FDA accepting the application. Thereafter, the patent owner and applicant negotiate what patents can be immediately asserted and which, if any, the RPS would be willing to license (42 USC Sec - tion 262(l)). This includes exchanging statements detailing – on a claim-by-claim basis – each par - ty’s positions regarding invalidity, enforceability and infringement for each patent.
3.5 Reimbursement and Pricing/Linkage Markets Unlike the Hatch-Waxman Act, the BPCIA: • outlines an information-exchanging mecha - nism (ie, the patent dance); • requires aBLA applicants to provide notice of commercial launch before launching; • does not have the automatic 30-month stay; and • has different exclusivities. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Under the Hatch-Waxman framework, patent term extension (PTE) is available for patents claiming drug products – and methods of use or manufacture of drug products – that are subject to regulatory review before commercial market - ing or use (35 USC Section 156(a)). In order to obtain PTE, the holder must submit an appli - cation for extension within 60 days of receiving permission from the FDA to market the product. The PTE determination is made by the FDA and USPTO together. The FDA is responsible for initially calculating the length of the regula - tory review for the product, which is published in the Federal Register (35 USC Section 156(d) (2)(A)(ii)). After a chance for comment by inter - ested parties, the USPTO calculates the final PTE length, which is capped at five years (35 USC Section 156(g)(6)(A)). Only one patent on a product can be extended for the same regulatory review period (35 USC Section 156(c)(4)). Although biologics are also eligible for PTE, the rules applicable for granting PTE are less settled.
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