But the dramatic rise in generics manufacturer challenges to brand patents has significantly complicated product management. Now, for many brands—whether they are blockbusters from large companies or small life-blood products for single-product companies—timing certainty has left the product management equation.
Once considered a "legal" problem by brand companies, the in-house legal staff could manage the patent challenge quietly and without interaction from the brand team. Now, many companies face generic challenges for a majority of their product portfolios and a large portion of their revenue. Paragraph IV challenges can no longer be considered a legal problem but instead have become a business and portfolio problem with profound implications. (See "Paragraph IV Primer,")The good news is that through timing analysis of Paragraph IV certifications, companies can use planning models, such as the ones commonly used in R&D activities, to help manage sales force support, promotion, manufacturing, and product and portfolio planning.
As of March 2005, 104 pharmaceutical products were under active patent challenge. Between November 1, 2003 and March 2005, 35 generic challenges were concluded by court opinion or settlement. (These figures include antibiotics and drugs covered by the Drug Efficacy Study Implementation [DESI] program—products that are challenged but not under the Paragraph IV mechanism.)
The rate of acceleration is illustrated in "Generic Challenges." In 2001 and 2002, generics companies filed 35 and 33 abbreviated new drug applications (ANDA), respectively, with Paragraph IV challenges. In 2003 and 2004, they filed 96 and 97 challenges, respectively. (These figures include only those challenges yielding a patent infringement action.)
The trend is not only happening with larger companies such as Teva, Mylan, and Andrx, but it is also becoming a tactical strategy of many smaller generics companies to focus on select products to challenge. At present, approximately 54 generics companies have an active certification pending. Of those companies, 40 have certifications pending on three or fewer products.