Patent Strategies - Effective Strategies for Extension of Product Lifecycles and Combating Aggressive Generics Markets
- Published: December 2010
M&As, like that between Pfizer and Wyeth, and joint ventures have been increasingly common over the past several years 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 dosage ranges, unique methods of administration, or gaining approvals for new indications. Marketing departments also come into play as a drug reaches expiration.
Pharma brands often see large ROI by increasing promotion in the years preceding patent expiration. Some drugs, such as Allegra and Prilosec, were heavily marketed prior to going generic and then were successfully introduced to the over-the-counter market. In another effort to recover lost revenue, a company may license authorized generics - the brand company's own product repackaged and marketed as a generic - either through a subsidiary or a third party. Patent-infringement litigation against generic drug manufacturers is not uncommon as branded drug manufacturers struggle to prevent rapid and severe loss of revenue associated with generic entry. Many of these suits have been settled using reverse payments or "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 delay generic entry of drugs by 17 months and 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. Four of the 15 top-selling pharmaceutical products are protein biological drugs.
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 for FDA to approve biosimilar protein drugs until recently. As the patents for many protein drugs expire in the next few years, there will be significant biosimilar competition. However, as the legal pathway for approvals is still not established, there are significant and unresolved legal and patent issues associated with follow-on biologics. Because biosimilars can differ from the original product, unlike small-molecule generics, clear legal frameworks will need to emerge quickly as generics companies will increasingly seek to compete in the biological product marketplace and innovator companies will seek to protect their patents.
Of the five top-selling pharmaceutical products worldwide in 2009, four have U.S. patents expiring during 2010 to 2012. Eighteen of the world’s 20 top-selling prescription brands are losing patent protection during a current five-year period. Prescription drugs that generated nearly $100 billion in 2009 sales are running out of patent protection in the next few years, and as a result the pharma arena is looking at its largest-ever revenue decline.
The following information is included in the patent charts for featured companies:
- Product generic names
- Product trade names
- Product dosage strengths
- Patent numbers
- Patent expiration dates
- Patent use codes
- Marketing exclusivity codes
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