GPhA spotlights patent reform
BOCA RATON, Fla. —The theme of the recent Generic Pharmaceutical Association’s annual meeting held her was “Generics: The Right Choice for Better Health.” Hot-button issues examined at the three-day event ranged from the ongoing need for approval of biogeneric legislation in the United States to the overall impact generic drugs will have on Americans in 2008 and beyond.
Bruce Downey, chairman and chief executive officer of Barr Pharmaceuticals, started the meeting with an overview of what some of GPhA’s goals are for both the upcoming year and in the longer term. In addition to passage of biogeneric legislation, Downey emphasized the need to achieve an acceptable outcome on patent reform/patent settlements. In the past, GPhA has cautioned Congress on moving too quickly on patent-reform legislation, saying that careful analysis is needed.
GPhA is concerned that certain provisions in pending patent reform bills could weaken the integrity of the U.S. patent system. The association takes issue with provisions that increase the length of patent monopolies on expensive, branded drugs by limiting the ability to challenge faulty patents. Also a concern for GPhA is the elimination of the “best mode” requirement under which the inventor must disclose in the patent application the most efficient known method for producing the invention. Elimination of this requirement would give the inventor a further monopoly because everyone else will have to spend time reinventing the best way to make the product after the patent has expired.
Speakiing at a patent-reform panel, Elaine Herrmann Blais of the law firm of Goodwin Procter and Stark, voiced concerns that the House bill will allow companies to hold back the best mode of their drugs and still get exclusivity.
“A best-mode defense is the only way patentees abide by statutory requirements for patentability and provide a ‘fair and square’ exchange for their monopoly,” Blais said.
Jaeger talked about the need of the FDA to address problems that hamper the approval of generic drugs, such as the citizen petition process and the accountability and structure of the Office of Generic Drugs. Jaeger said the GPhA will continue to work with the FDA to address these problems in order to bring cheaper more affordable drugs to consumers.
Jaeger also mentioned how the user-fee program that the GPhA and FDA created recently has not come into fruition yet. Jaeger noted that, “As we saw with the brand pharmaceutical industry, negotiations are not easy. In the end, the FDA granted the brand companies specific performance goals in exchange for an investment of resources. We are looking for similar assurances of predictability for review and approval.”
She concluded her statement by discussing biogenerics and the future of their development and use in the United States. With the president calling for biogenerics in his budget submission to Congress, Jaegar worries about the involvement of the Biotech Industry Organization and Pharmaceutical Research and Manufacturers of America. According to her, “Now, we’re seeing BIO and PhRMA push for a pathway. With nowhere else to turn, BIO and PhRMA now want to come to the table to cut a deal. But the deal they want to cut…will cut patients out. They want unprecedented and excessive market exclusivity and patent protections to ensure their monopolies. We believe members of Congress will recognize that cutting such a deal will put brand profits before patient needs.”