Bulletproofing pharma patents

Maximising the strength of patent protection should be an important objective of any R&D pharma company. Christine Goddard and Janis Fraser of law firm Fish & Richardson offer their six top tips for success.

Bringing a single pharmaceutical drug product to market can be expensive. One estimate suggests that it requires an average outlay of more than $2.5 billion in research and development (R&D) expenses—and even then, there is no guarantee the drug will be a success.

Before undertaking such an enormous and risky investment, pharma companies need to have some assurance that they will be able to market a drug free of competition from generic copies long enough to provide a reasonable return on investment. In the US, the Hatch-Waxman statutory framework provides drugs with a basic period of protection from generic competition, but in most cases the three to five years of protection this provides is insufficient to deliver the needed incentive.

Generic companies assess the relative strength of a drug’s patent coverage when deciding which branded products to copy, and when. Weak patents invite attack, either in the courts or, with increasing frequency, in post-grant proceedings at the US Patent and Trademark Office (USPTO), with the intent of clearing the way for the generic company to enter the market. Therefore, maximising the strength of patent protection should be an important objective of any R&D pharma company. The creation of a ‘bulletproof’ patent—one that clearly covers the product, stands up to a validity challenge, and is enforceable against would-be competitors—necessarily involves careful strategy.