PHARMACY

GPhA, PhRMA weigh in on patent-reform legislation

BY Alaric DeArment

WASHINGTON — A bill that would make the biggest changes to patent laws in more than half a century has drawn mixed responses from the drug industry.

The bill, S. 23, The Patent Reform Act of 2011, sponsored by Sen. Patrick Leahy, D-Vt., would make the first significant changes to patent laws in 60 years.

The Generic Pharmaceutical Association and the Pharmaceutical Research and Manufacturers of America, the respective lobbies for the generic and branded drug industries, both praised the bill on the whole, but the GPhA had reservations about a provision that it said would weaken the inequitable conduct clause.

Currently, a patent can be ruled unenforceable in a court of law if the court determines that the patent’s holder intentionally withheld information or deceived the Patent and Trademark Office in any way. For the generic drug industry, this has opened the opportunity for numerous challenges to patents covering branded drugs, allowing generic drug makers to launch their versions of the drugs ahead of patent expiration.

“Weakening current inequitable conduct standards will simply result in providing innovators with a greater incentive to be less than honest when seeking patents, thereby making it harder for companies to challenge dubious patents and bring affordable generic medicines to consumers,” a statement from the GPhA read.

Meanwhile, the PhRMA did not mention the inequitable conduct clause, but spoke in favor of the bill nonetheless. “Senator Leahy’s patent-reform bill would strengthen the patent system while protecting patent owners and maintaining incentives for innovation,” PhRMA SVP Wes Metheny said. “The bill balances the diverse interests of various stakeholders across American business sectors while maintaining strong and reliable intellectual property protection.”

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PHARMACY

Lilly, JDRF enter research agreement

BY Alaric DeArment

INDIANAPOLIS — Drug maker Eli Lilly and the Juvenile Diabetes Research Foundation will fund research to find ways to regenerate insulin-producing cells in patients with Type 1 diabetes.

The two announced Thursday that ideas included finding ways to grow new insulin-producing cells within a person’s body. Type 1 diabetes, also known as juvenile diabetes, is an autoimmune disease in which the immune system attacks beta cells, the cells that allow the body to produce insulin. As many as 3 million people in the United States have Type 1 diabetes.

“The goal of this research agreement [between Eli Lilly and JDRF] is to understand how selected cells can be reprogrammed in order to convert them into insulin-producing cells in the body,” Lilly chief scientific officer for diabetes drug discovery Philip Larsen said. “This research is an example of regenerative medicine, a new frontier in science that replaces or regenerates new cells, tissues or organs, and while this particular research is early-stage, it may ultimately lead to new approaches to treating Type 1 diabetes.”

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PHARMACY

NCPA responds to repeal of 1099 reporting provision

BY Allison Cerra

ALEXANDRIA, Va. — The National Community Pharmacists Association expressed its support of the Senate’s decision to repeal the 1099 tax reporting mandate for businesses.

The Senate announced it passed an amendment that repealed a requirement for businesses to file 1099 forms with the Internal Revenue Service beginning in 2012 any time they spend more than $600 a year with any other business. NCPA EVP and CEO Kathleen Jaeger said that the business tax provision would have shifted community pharmacies focus from "clinical to clerical."

“We applaud the Senate for this bipartisan vote to repeal the 1099 provision, because full compliance with this requirement would prove daunting for independently owned pharmacy small businesses with limited staff and financial resources," Jaeger said. "Most importantly, our patients would suffer because the pharmacists would have less time to spend with them [to provide] invaluable prescription drug services and counseling."

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