On his website, patents expert witness Manfred E. Wolff writes:
In today’s competitive environment, existing pharmaceutical patents are at risk from a number of pitfalls.
In particular, “Designing Around” (i.e., developing a chemical entity, device, or method that avoids the claims of an existing patent) is a legal means for producing new products to compete with existing patented products.
Moreover, would-be competitors have enhanced incentives to invalidate patents. Under the terms of paragraph 4 of the Hatch-Waxman legislation, invalidation of a US patent provides 180 days of regulatory exclusivity to a generic manufacturer. The value of 180 days of exclusivity for the generic version of a patented $500 million drug is such that a legal challenge to the patent is highly attractive financially.
Manfred E. Wolff has been involved in strategic planning for pharmaceutical research since 1988, first with a subsidiary of SmithKline Beckman, and later as Senior Vice-President for R&D at Immunopharmaceutics, Inc. Since founding Intellepharm, Inc., he has conducted planning sessions for a number of biotechnology start-ups.