http://pharmalive.com/News/index.cfm?articleid=747957

         NEWTOWN, Dec. 3, 2010--With an abundance of pharma products going off patent during the next several years, M&As – like that between Pfizer and Wyeth – and joint ventures have become increasingly more common as companies seek to replace revenue loss associated with the impending patent cliff for their blockbuster products. Another primary strategy being employed is extending patent life through new dose ranges, unique methods of administration, and/or gaining approvals for new indications.

Patent-infringement litigation against generic drug manufacturers remains commonplace as branded drug manufacturers struggle to prevent rapid and severe loss of revenue associated with generic entry. However, some of these lawsuits are more often being settled using reverse payments known as “pay-for-delay” deals in which the generic company will agree not to launch a generic drug for a certain period of time in exchange for financial compensation from the innovator company. The Federal Trade Commission reports that these types of settlements cost American consumers $3.5 billion per year as they miss out on generic drug pricing that can be as much as 90% less than brand prices. In early July 2010, the U.S. House of Representatives approved a ban on patent agreements between brand-name and generic drug companies.

Protein biological drugs make up four of the 15 top-selling pharmaceutical products. These drugs can be extremely expensive for patients, with some treatment courses costing more than $100,000 per year. Unlike small-molecule drugs, there had not been a regulatory framework set up for FDA to approve biosimilar protein drugs until recently. As patents for many protein drugs expire in the upcoming years, there will be significant biosimilar competition. However, with a legal pathway for biosimilar approvals still not officially in effect, there are significant and unresolved legal and patent issues associated with follow-on biologics. Because biosimilars can differ from the original products, unlike small-molecule generics, clear legal frameworks will need to emerge quickly as generic companies will increasingly seek to compete in the biological product marketplace and innovator companies intend to protect their patents.

“The pharmaceutical industry has not previously experienced so many mega-brands losing patent protection in such a short time span, and subsequently some companies will struggle to replace billions of dollars in lost revenue due to a lack of promising new medicines emerging from their own pipelines” says Andrew Humphreys, editor-in-chief of UBM Canon Data Products Group. “However, there will always be a robust patient demand for prescription drugs, and pharmaceutical companies are wisely adapting and directing their focus to areas of significant potential. Focus is being directed toward the BRIC markets, disease areas such as oncology and diabetes, and biopharmaceuticals and specialty-driven products to ensure future success.”

PharmaLive’s newest Special Report, Drug Patent Review and Outlook 2010, explores strategies that pharma companies are pursuing to offset the revenue loss associated with losing patent protection on major blockbuster drugs. The 400+ page report provides expert analysis of the patent process for pharmaceutical products, patent litigation, and the emergence of a legal framework for biosimilars. Comprehensive statistical data details patent and marketing-exclusivity expiration dates, code descriptions, and more. This report can be found at www.PharmaLive.com/SpecialReports.

About UBM Canon Data Products Group

UBM Canon Data Products Group, a division of UBM Canon, publishes PharmaLive Special Reports and Appliance Market Research Reports, which provide financial, company, and product statistical data and qualitative analysis for the global pharmaceutical, biotechnology, medical device, and appliance industries; maintains eKnowledgebase and MDRWeb, comprehensive market-intelligence tools serving the pharmaceutical, biotechnology, and medical-device sectors; and manages company-wide Site Licenses for PharmaLive.com, Med Ad News, and R&D Directions.

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