The U.S. Supreme Court issued an opinion Tuesday that could knock down one more wall to the reimportation of prescription drugs and fling open the door to the reprocessing of single-use medical devices. Although the decision in Impression Products Inc. v. Lexmark International Inc. deals with printer cartridges, its impact could cut into the biopharma and med-tech space. The Supreme Court ruled 7-1 that once a patentee sells a product, it can no longer control that item through patent laws, as the sale – whether domestic or international – “exhausts” its patent rights. “When a patentee sells an item, that product ‘is no longer within the limits of the [patent] monopoly’ and instead becomes the ‘private, individual property’ of the purchaser,” according to the majority opinion written by Chief Justice John Roberts. Thus, Lexmark could not sue Impression Products for patent infringement for purchasing used Lexmark cartridges abroad, overriding a microchip designed to prevent third-party reloading and then selling the refilled cartridges in the U.S. In so ruling, the Supreme Court reversed a Federal Circuit decision that had relied on the appellate court’s 1992 decision in Mallinckrodt Inc. v. Medipart Inc., which held that “clearly communicated” post-sale restrictions were a patent right that could be enforced by an infringement suit. The Pharmaceutical Research and Manufacturers of America had filed a brief in support of Lexmark, saying that a reversal of the Federal Circuit decision could lead to a “gray market” for prescription drugs driven by distributors buying the drugs abroad and then selling them in the U.S. The Medical Device Manufacturers Association noted in its brief that many medical devices are designed, labeled and expressly sold as “single-use” to meet FDA requirements and ensure their efficacy and patient safety. Striking down the Federal Circuit decision could allow for the reprocessing of such devices. Kevin Noonan, a partner with McDonnell Boehnen Hulbert & Berghoff LLP, pointed out that the Supreme Court ruling could have ramifications on so-called “label licenses” involving method and composition claims in biotech patents.
Amgen Inc., of Thousand Oaks, Calif., filed suit to force the FDA to grant it a six-month pediatric exclusivity for Sensipar (cinacalcet hydrochloride) as required by the Best Pharmaceuticals for Children Act (BPCA). Responding to an unmet medical need and the off-label use of Sensipar in children, the FDA issued a written request in 2010 asking Amgen to conduct four studies evaluating the drug in pediatric patients on dialysis with chronic kidney disease and hyperparathyroidism (HPT). Amgen submitted complete data for three of the four studies. The final study – in secondary HPT patients between the ages of 28 days and 6 years who were on dialysis – proved particularly challenging, Amgen said in the suit. The age of the patients, the small population size (300 children nationwide), delays caused by a 14-month partial clinical hold following the death of a patient and additional requirements the FDA imposed when it lifted the hold – all factors outside the sponsor’s control – resulted in fewer patients completing the study than had been projected. As a result, the FDA notified Amgen last week that it was denying pediatric exclusivity because Amgen “failed to fairly respond” to the written request, according to the suit filed three days later in the U.S. District Court for the District of Columbia. Amgen said the FDA based the denial on the company’s failure to provide sufficient safety data from the fourth study, which prevented the agency from making an appropriate safety assessment in younger children to support a pediatric labeling description. Amgen maintained that the FDA’s denial violates the BPCA’s meaning of “fairly respond.” The BPCA does not require, as a condition for pediatric exclusivity, that studies demonstrate whether a drug is safe and effective in children or be adequate to support pediatric labeling, Amgen said.
The EMA and the European Commission Wednesday published the first in a series of guidances to help drug companies prepare for the U.K.’s withdrawal from the EU. The question-and-answer document covers information related to the location of a company in the context of centralized procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance, and the sponsor’s manufacturing and batch release sites. For instance, the guidance specifies that companies in the U.K. with centrally authorized medicinal products will need to transfer their marketing authorizations to a holder established in the EU. The guidance is posted on the EMA website.
The EMA released an action plan Wednesday that’s intended to foster innovation and support small and medium-sized enterprises (SMEs) in the development of novel drugs. The plan is in alignment with the agency’s new framework for collaboration with academia and the EU Innovation Network. It includes a series of new and enhanced actions in four key areas: awareness of the agency’s SME initiative, training and education, support for the development of innovative medicines, and engagement with SMEs, EU partners and stakeholders.