USA Trends and Developments Contributed by: Ed Haug, Andrew Wasson and Wan Chieh (Jenny) Lee, Haug Partners LLP
Patent Litigation Trends in the Life Sciences in the US While there have been a number of trends in pat - ent litigation in the life sciences recently, in this chapter the authors focus on two particularly pressing and notable trends. First, the authors address the growing clamour around the proper “listability” requirements for Orange Book pat - ents and comment on likely behaviour of gener - ic applicants going forward. Second, now that some time has passed, the authors discuss the ramifications of the Amgen v Sanofi Supreme Court case on the use of invalidity for lack of enablement under Section 112 as a defence in life sciences litigation. Orange Book listability will likely remain a pressing topic in Hatch-Waxman litigation While always an important issue, the determi - nation of whether a patent meets the require - ments for listing in the Orange Book has recently taken on increased significance. The debate about the correct standard for “listability” and whether specific patents have been correctly listed in the Orange Book continues to play out in multiple fora. In the context of Hatch-Waxman innovator-versus-generic patent litigation, high- profile attempts to oust (or “delist”) a patent from the Orange Book have already begun. The authors expect that such attempts will continue, with generic companies becoming even more aggressive with the types of patents that they target for delisting. The “Orange Book” is an FDA publication with the official title, “Approved Drug Products with Therapeutic Equivalence Evaluations” and is a central component to Hatch-Waxman’s pat - ent resolution mechanisms. The Orange Book contains a list of patents that claim an innovator drug or a method of using it. Generic applicants seeking to market a drug referencing the inno -
vator drug are obligated to address each and every patent listed in the Orange Book for the innovator drug that the generic seeks to refer - ence. When a generic applicant chooses to chal - lenge a patent listed in the Orange Book, the generic applicant generally must certify that the generic product will not infringe the patent, or that the patent is invalid or unenforceable (ie, a “paragraph iv” certification). The generic appli - cant is obligated to send notice of its certifica - tion to the NDA holder and patent assignee as well as a detailed statement describing the basis for its position. Critically, if a patent infringement suit is brought, the FDA is barred from approv - ing the generic application for 30 months (the 30-month stay). The FTC periodically raises the concern that improper listing of patents in the Orange Book could give rise to unjustified stays of generic approval with alleged anti-competitive effects. Consequently, ensuring that patents are prop - erly listed in the Orange Book is of tantamount importance. The general requirements for list - ing a patent in the Orange Book are specified in the Hatch-Waxman statute itself. The Act directs that applicants must submit patent information for listing a patent that: “(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) pat - ent or a drug product (formulation or composi - tion) patent” or “(II) claims a method of using such drug for which approval is sought or has been granted in the application” (21 USC Sec - tion 355(j)(2)(A)(iv)). In addition, the Act requires submitting patent information only for patents where “a claim of patent infringement could rea - sonably be asserted if a person not licensed by the owner of the patent engaged in the manufac - ture, use, or sale of the drug...”. Within the broad category of “drug”, the FDA has long-stated that drug substance (ingredient) patents and drug
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