Teva Pharmaceutical Industries Ltd., a major player in the generic drug market worldwide, recently filed suit against Perrigo Co. for planned infringement on their patent rights to the ProAir inhaler. Designed for use by asthma patients, the ProAir inhaler delivers aerosolized albuterol sulfate directly to nasal passages and lungs to relieve inflammation caused by the condition. Teva alleges that Perrigo intends to release a generic version of the inhaler prior to the expiration of the ProAir patents in 2017 and 2023 and is asking for legal relief against what the company is referring to as “irreparable harm” as a result of the alleged planned infringement.
Patent suits in the pharmaceutical industry are nothing new. Just last year, Teva lost its bid to have Pfizer’s patents for Viagra ruled invalid and unenforceable, a move that would have allowed Teva to sell its generic version in the U.S. Teva’s lawsuit is primarily notable because it serves as a preemptive action against patent infringement by Perrigo. Teva is not alleging current patent infringement on the part of Perrigo; instead, it is acting on information that Perrigo plans to release a competing product in conjunction with its manufacturing partner, Catalent. By asserting its patent rights now, Teva hopes to avoid the damage caused by the widespread availability of alternatives to its ProAir products.
Numerous patents on pharmaceutical formulations are due to expire in the next few years, reducing the profit margins for some pharmaceutical firms to a considerable degree. Some pharma companies are already planning to release slight reformulations of their current drug in order to retain patent rights for an extended period of time. These new patents are likely to be challenged in court; as a result, many pharmaceutical research and manufacturing firms will require the services of a competent pharmacy lawyer in order to defend against patent challenges by generic manufacturing companies. Other pharmaceutical companies are retooling to offer branded generic versions of their products; these medications will provide a compromise between the no-name value of generics and the expensive but reliable quality promised by name-brand pharmaceuticals.
As more generics become available, the need to protect patents and profits will continue to be a concern for the pharmaceutical industry. Experts predict preemptive cases like that filed by Teva to become more common as pharma companies attempt to maximize profits from their existing patents before they pass into the public domain. While generics offer significant financial advantages for patients, the reduced profits they represent can limit the research and development budget for smaller pharma companies. By aggressively protecting patent rights and applying for extensions and related patents as appropriate, companies can optimize their financial situation and remain viable in the modern medical marketplace.