Jarvik Heart, Inc.’s PTE Request Based on PMA Shell/Module Submission Dates Flatlines; Ruling on Initiation of PTE “Review Period” Mirrors FDA Policy for “Fast Track” Products
Under Title II of the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension by the U.S. Patent and Trademark Office (“PTO”) if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review period” is composed of a “testing phase” and a “review phase.” The Patent Term Extension (“PTE”) statute at 35 U.S.C. § 156 defines the testing and review phases depending on the type of product subject to regulatory review (e.g., a drug, a biological products, or a medical device).
For a medical device subject to a Premarket Approval Application (“PMA”), the “testing phase” begins on “the date a clinical investigation on humans involving the device was begun and [ends] on the date [a PMA] was initially submitted with respect to the device.” The “review phase” is the period between PMA submission and approval. For a drug or a biological product, the “testing phase” begins on the effective date of an Investigational New Drug Application (“IND”), and ends on the date a New Drug Application (“NDA”) or a Biologic License Application (“BLA”) is initially submitted to FDA. The “review phase” is the period between NDA/BLA submission and approval.
Under certain circumstances a company may obtain an interim PTE prior to product approval. There are two types of interim patent extensions available: (1) interim patent extensions available during the “review phase” (35 U.S.C. § 156(d)(5)); and (2) interim patent extensions available during PTO’s review of a PTE application (35 U.S.C. § 156(e)(2)). Under 35 U.S.C. § 156(d)(5), the PTO may grant an interim patent extension while a PMA (or an NDA or a BLA) is undergoing FDA review if the patent owner (or his agent) “reasonably expects that the applicable regulatory review period . . . that began for a product that is the subject of such patent may extend beyond the expiration date of the patent term in effect. . . .” (emphasis added). The patent owner (or his agent) must submit to PTO an application “during the period beginning 6 months, and ending 15 days, before such [patent] term is due to expire.” If PTO determines that, except for receipt of FDA’s permission to market or use a product commercially, the patent would be eligible for a statutory extension of the patent term under 35 U.S.C. § 156, then PTO publishes a notice in the Federal Register announcing the interim patent extension for the particular product, and issues to the applicant a certificate of interim patent extension for a period of not more than one year. The applicant may apply for additional interim patent extensions under 35 U.S.C. § 156(d)(5), however, PTO generally limits subsequent applications for a particular patent to four one-year interim patent extensions (thus, a total of five years).
In early February 2008, Jarvik Heart, Inc. (“Jarvik”) requested an interim PTE for U.S. Patent #4,994,078 (“the ‘078 patent”) covering the company’s Jarvik 2000 Heart Assist System. (A copy of the PTE application is available via PTO’s Patent Application Information Retrieval service.) The request was made pursuant to 35 U.S.C. § 156(d)(5) on the basis that Jarvik submitted a PMA Shell to FDA in November 2007, and on January 14, 2008, after FDA acceptance of the PMA Shell, the company submitted Module 1 of the PMA to FDA. (A PMA Shell is an outline of those PMA sections that will be necessary to complete a PMA, and includes all modules needed -submitted as PMA Modular Submissions- to support the filing and approval of a specific medical device. Additional information on FDA’s modular approach to PMA submission and review is available here.) Jarvik contended that the submission of the PMA Shell and Module 1 began the “review phase” period for PTE purposes. The PTO disagreed and the ‘078 patent expired on February 19, 2008.
In the PTO’s final decision denying Jarvik’s interim PTE request, the Office notes that one of the requirements under 35 U.S.C. § 156(d)(5) for an interim PTE is that the “review phase” for a medical device “which must have begun for a product would continue beyond the original expiration of the patent term” (emphasis in original). “Neither the PMA Shell nor the Module 1 constitutes ‘an application . . . initially submitted with respect to the device under [FDC Act § 515].’ Therefore, the applicable regulatory review period . . . has not begun,” states the PTO in its decision letter. The PTO also goes on to note that “the FDA does not consider the submission of a PMA shell or a first PMA module to trigger the beginning of the [‘review phase’],” and cites FDA’s previous decision with respect to a PTE request from Advanced Neuromodulation Systems for the company’s Genesis Neurostimulation System.
FDA’s policy with respect to the initiation of the “review phase” for PTE purposes for medical devices subject to the PMA Shell/Module approach mirrors FDA policy for NDAs and BLAs submissions made pursuant to the Agency’s “Fast Track” approach under FDC Act § 506. The Fast Track program was created in 1997 by the FDA Modernization Act to help facilitate the development and expedite the review of drugs and biologics for serious or life-threatening conditions that demonstrate a potential to address unmet medical needs. Under FDC Act § 506, companies may request Fast Track designation for their product at the time they submit an IND to FDA or at any time thereafter. The benefits of Fast Track designation include the option of submitting an NDA or a BLA for “rolling review” (i.e., submission in sections rather than all components simultaneously).
Under current FDA guidance on Fast Track products, FDA’s review clock for the application “will not begin until the applicant informs the Agency that a complete BLA or NDA has been submitted.” For PTE “review phase” determinations on Fast Track products, FDA has determined that the date a final reviewable unit is submitted to the Agency is the date the “review phase” begins. FDA recently noted this policy in a Federal Register notice concerning a PTE request for the Fast Track-designated biological product KEPIVANCE (palifermin).