PHARMACY

Patent Reform Act of 2009 gets mixed response from drug industry organizations

BY Alaric DeArment

ARLINGTON, Va. A bill that would reduce penalties for companies that infringe on others’ patents has drawn responses from the organizations representing the generic and branded pharmaceutical and biotech industries.

The Patent Reform Act of 2009, introduced in the Senate by Senators Patrick Leahy, D-Vt., and Orrin Hatch, R-Utah, and companion legislation introduced in the House by Reps. John Conyers, D-Mich., and Lamar Smith, R-Texas, would allow innovators suing for patent infringement to collect only damages proportionate to the actual amount of money lost.

The Generic Pharmaceutical Association supported the legislation, albeit with the hope that it would benefit the generics industry.

“As Congress considers the Patent Reform Act of 2009, we encourage members to protect the integrity of the patent process, while also ensuring that Americans have access to affordable generic medicines,” GPhA president and CEO Kathleen Jaeger stated. “Consumers should benefit from patent reform, not pay the price. We echo Sen. Leahy’s position that patent reform is ‘about jobs, it is about innovation and it is about consumers,’ and we are committed to ensuring that reforms do not have the unintended consequences of erecting any barriers to the introduction of generic medicines that help consumers save money, particularly in these difficult economic times.”

On the other hand, the Pharmaceutical Research and Manufacturers of America, while supporting patent reform legislation, opposed attempts to limit damages awarded in patent-infringement lawsuits.

“By lowering the penalties for those found by a court to have infringed another’s patent, the bill would reduce the value of the patents that are the lifeblood of America’s innovative business sectors, which depend on intellectual property protection,” PhRMA SVO Ken Johnson said in a statement.

Johnson said a reliable patent system was needed for pharmaceutical and biotech companies that must invest, on average, 10 to 15 years and $1 billion to develop a new drug.

“We are concerned that the proposed framework will put this important incentive – and with it, the jobs that are provided by innovative industries – at risk,” Johnson said.

Meanhwhile, the Biotechnology Industry Organization also welcomed the legislation.

“While BIO continues to have concerns with some of the specific language in the bills introduced today, we understand that today’s introductions are just the beginning of the legislative process,” BIO president Jim Greenwood said in a March 3 statement. “We look forward to working in good faith with the chairmen, other senators and representatives and other stakeholders to achieve positive, meaningful and consensus-oriented reforms to the patient system – reforms that will further enhance patent quality and spur innovation and economic growth here at home.”

GPhA also expressed hope that the bill would not dilute the inequitable conduct doctrine, which penalizes companies that seek to cheat, mislead or deceive the Patent and Trademark Office in order to retain their patents by allowing courts to render their patents unenforceable. While not going into specifics, PhRMA called for “reform” of the doctrine, as recommended by the National Academy of Sciences, though in April 2005, members of the NAS said they supported eliminating or “significantly modifying” it in order to increase the predictability of patent dispute outcomes.

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Watson, Elan Corp. settle patent infringement suit

BY Alaric DeArment

CORONA, Calif. Generic drug maker Watson Pharmaceuticals has settled with Irish pharmaceutical and biotech company Elan Corp. concerning patent litigation surrounding Watson’s generic version of an Elan drug.

Under the terms of the agreement, Watson will pay Elan $18 million to settle disputes over the development, manufacturing, marketing and sale of its generic version of the pain drug Naprelan (naproxen sodium). Watson also agreed not to market or sell its version until the expiration of Elan’s patent for the drug, which will occur in 2014, according to the Food and Drug Administration’s Orange Book.

In August, the United States District Court for the Southern District of Florida ruled that Watson’s generic Naprelan infringed Elan’s ‘320 patent on the drug.

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Centice launches a Web site dedicated to Pass Rx

BY Alaric DeArment

MORRISVILLE, N.C. Centice Corporation has launched a Web site about its Pass Rx dispensing machine.

The company said it developed the site for pharmacists to learn about the Pass Rx system, including how to implement and use it.

“The launch of our new Web site will help get the word out about the availability and benefits of Pass Rx,” Centice president and CEO Ray Swanson said in a statement. “We are very excited to provide our customers with a new venue to learn more about Pass Rx and how the system can benefit their pharmacy by increasing their patients’ safety, improving the quality control process and overall workflow efficiency.”

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