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Third time’s a charm for patent reform?

So, for the third consecutive session of the U.S. Congress, Sen. Patrick Leahy (D-Vt.), the chairman of the Senate Judiciary Committee, has introduced patent reform legislation, along with former committee chairman Sen. Orrin Hatch (R-Utah) and other senators [notably: Jeff Sessions (R-Ala.), the committee’s ranking Republican, and fellow senators Chuck Schumer (D-N.Y.), Jon Kyl (R-Ariz.) and Ted Kaufman (D-Del.)].

It’s legislation that, if passed, would affect more than just pharmas and biotechs, obviously, but certainly those types of companies are among the ones who most rely on patent protections to keep themselves going. Here’s what the Pharmaceutical Research and Manufacturers of America (PhRMA) has to say about the proposed reform, by way of PhRMA Senior Vice President Wes Metheny:

“Senator Leahy’s patent reform bill would strengthen the patent system while protecting patent owners and maintaining incentives for innovation. The bill balances the diverse interests of various stakeholders across American business sectors while maintaining strong and reliable intellectual property protection. A strong patent system is crucial to America’s economic competitiveness and our global leadership in medical innovation, especially in these economically trying times.

“The U.S.patent system provides American businesses with incentives that drive innovation and create jobs across the country. By creating a positive environment for innovative R&D, the patent system encourages the development of ideas into life-changing products and further encourages the ideas of the future.

“This couldn’t be more true than in the biopharmaceutical research sector. In a field where the development of an average new medicine can take 10-15 years and cost more than $1.3 billion, the incentives provided by intellectual property play a key role in encouraging this costly – and risky – investment.

“In the end, the benefits are great. Life expectancy is at an all-time high and previously life-threatening diseases are now viewed as controllable conditions, largely on the strength of the innovative R&D taking place through America’s biopharmaceutical sector. Meanwhile, the sector – one of the most research-intensive in the world – employs more than 650,000 direct biopharmaceutical workers and supports a total of more than 3 million jobs.

“America’s biopharmaceutical research companies have a real and significant effect on healthcare and on the economy. This just wouldn’t be true without a reliable and predictable patent system.

“Senator Leahy’s bill – and the support of its cosponsors – demonstrates their appreciation for the importance of intellectual property protection to the U.S. economy and to the jobs – and life-saving innovation – that it provides.”

“With this agreement, we are closer than ever to advancing patent reform legislation through the Senate,” said Leahy in a prepared statement Feb. 3. “Senator Hatch and I have worked through many Congresses to make meaningful reforms to the nation’s patent system, and I appreciate his commitment to this effort. This compromise may not be everything that everyone wants, but it makes important reforms to the outdated patent system. Strengthening American patents will improve the quality of our inventions and innovations, which will translate into jobs and economic growth in Vermont and across the country. Congress is committed to strengthening our economy, and the Patent Reform Act is an important component of that effort. I hope the leaders will soon schedule floor time for this important legislation.”

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February 3, 2011 Posted by | Corporate, Government, Lawsuits & Legal Matters | , | Leave a comment

Look out! The brand-name ground crumbles beneath you!

OK, how’s that for a dramatic headline? Perhaps somewhat more dramatic than the actual news from Datamonitor that inspired it, but I’m not above a little marketing.

Anyway, here’s the scoop from the folks at Datamonitor about the effect of brand erosion in the United States and elsewhere when products stumble (or are pushed) over the edge of the patent cliff, in their own words:

U.S. most susceptible to brand erosion post patent expiry

Small molecule brands in the US experience the greatest degree of brand erosion following patent expiry and exposure to direct generic competition, according to a new report from independent market analyst, Datamonitor.

Following the United States, brand erosion is next most severe in the United Kingdom, Germany and France, with brand erosion the lowest in Australia, Italy, Russia, Spain and Japan.

Brands tended not to experience generic erosion in China following patent expiry since they often face generic competition from the outset, and instead continue to grow both in terms of volume and value.

Maura Musciacco, healthcare analyst at Datamonitor comments: “Brands in the U.S., regarded as the most mature of all generics markets, experienced the greatest degree of brand erosion following patent expiry and exposure to direct generic competition. On average, sales and volume decline by 72% and 70%, respectively, after 6 months of generic competition.

“The key driver for the uptake of generics drugs is the cost-savings they bring, a quality that is undoubtedly even more in demand as the U.S. contemplates adoption of universal healthcare.”

Brand erosion was greater in terms of speed and severity in the hospital setting, most likely reflecting the greater brand loyalty among patients in the retail setting. While in terms of erosion by therapy areas, sales and volume erosion was the greatest among infectious disease, oncology, and cardiovascular small molecule brands.

“Pharma is facing slowing sales growth in the developed pharmaceutical markets, driven by increasing generic competition leading to sales erosion of branded small molecule drugs post patent expiry. However, the speed and severity of brand erosion is by no means equal across countries, prescribing setting, therapy area and formulation type; factors which are of key importance when managing and forecasting branded drug sales,” concludes Maura.

January 12, 2011 Posted by | Corporate | , , , , , | Leave a comment