Safeguarding the Value of Patent Assets - Pharmaceutical Executive


Safeguarding the Value of Patent Assets

Pharmaceutical Executive

Removing IP roadblocks

In the zeal to invent, one might overlook the fact that patents provide only the right to exclude others from practicing the claimed invention; they do not provide the right to practice one's own invention. Without "freedom to practice," even the best technology and patents may have no commercial value. Indeed, freedom to practice analysis is a key consideration investors typically check as part of their due diligence.

All is not lost, however, where a blocking patent calls into question your freedom to practice. One might, for example, license the technology from a willing licensor, such as a university. Or, if the potential blocking issue is recognized early enough in development, the intended product might be redesigned.

Blocking patents also can be removed (or limited) by offensive strategies in the US patent office (PTO) or federal district court. To facilitate third party challenges, recently expanded PTO procedures allow third parties to submit information and arguments relevant to patentability before and after a patent issues. Some of the procedures to challenge another's patent or application may be used anonymously and others allow for extensive participation in the PTO's patentability evaluation. While the statistical chances of wholly or partially invalidating a patent with post-issuance PTO procedures are high, factors such as cost, timing, anonymity, type of information, and estoppel must be considered when evaluating which procedure to use. Importantly, each challenge procedure has time limits on when it can be used, meaning that companies must remain continuously diligent and vigilant in tracking and evaluating competitor's patents and pending applications.

Strategy: a process, not a conclusion

Consider a company founded on antibody discovery. Ideally, its patents should protect the specific catalog of antibodies and their uses, and also analogous "me too" antibodies a competitor may develop. But suppose the business plan is modified to include diagnostic services? Or suppose a competitor gets a patent that blocks use of the lead antibodies? How can these changes be captured and addressed?

The antibody company should conduct a regular IP maintenance plan, as is done with one's investment portfolio. The IP maintenance plan involves regularly revisiting and updating patent strategies to adapt to changes in business objectives, the competitive landscape, and other market pressures. The plan also incorporates routine due diligence analyses (freedom to operate and right to exclude) before critical milestones, such as transactions or launch of a new product. Where necessary and possible, the company's own patents and applications can be re-targeted to cover the new business objectives, and third party patents can be considered (and dealt with) before it is too late.

Although there is no "one-size-fits-all" approach to how a patent portfolio should be designed, the process of strategically aligning (and re-aligning) IP to advance specific business goals is a universal approach to adding and maintaining corporate value.

Mary Henninger, PhD, is an attorney in Finnegan's Atlanta office. She can be reached at
. Mark Feldstein, PhD, is a partner in Finnegan's Washington, DC office. He can be reached at


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