A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry.  In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.

As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886.  The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides.  Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale.  (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.)  The district court granted Momenta a … Read More »

New reports suggest that while generic drug makers are aggressively consolidating in the United States and United Kingdom, smaller generic drug manufacturers’ viability is threatened, forcing them to seek niche therapeutic areas.  Manufacturing biosimilar biologicals may be an answer for the smaller generic drug companies, due to several factors.  First, while manufacturing complexities create market entry barriers, recent shortages of the biologics supply in the U.S. have increased the market demand.  Also, low margins are causing large manufacturing companies to exit the biologics market.  Furthermore, the patents for many top selling biologics will expire in the next 3 to 5 years, creating an opportunity for new market entrants.  Finally, the new abbreviated approval pathway for biosimilars in the U.S. may be more conducive to the needs of smaller firms: efficient approval process, lower development costs, and protection for first generation biologics.

Background

In … Read More »

With more instances of Electronic Health Record (EHR) data breaches popping up in the news, skepticism is beginning to build as to whether or not the health care industry can handle the switch from paper to digital.  In the most recent incident, The Surgeons of Lake County, located in northern Chicago, fell victim to a data breach by hackers who were able to gain access to e-mails and electronic medical records.  Adding to the nation’s interest in this specific incident, the hackers have encrypted the data, holding it “hostage” for ransom from the health care facility.  The hackers are demanding payment in exchange for a password that will allow doctors to regain access to their patients’ electronic health records.

Aside from data breaches, EHRs have come under fire for other kinks and flaws related to their implementation.  In late July, a … Read More »

The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages.  See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls.  The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input.  The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.

Goals of the … Read More »