When to File: Considerations for When You Have Enough Information to Build a Strong Patent Application

Authored by Mark J. Feldstein, Ph.D. and Ryan P. O'Quinn, Ph.D.

The time and expense of developing and commercializing novel cancer therapies have few peers. While it is widely understood that patents are critical to successfully bringing a new product to market, their quality matters far more than their quantity. Of greatest value—both to large companies worried about generic attacks and to smaller companies looking for partnership or investment—are claims providing comprehensive coverage of a product and its potential FDA-approved indications. Knowing when to file a patent application to obtain the strongest protection requires balancing multiple competing considerations, which are unique for every product and every company.

Deciding When to Pull the Trigger

On the one hand, taking more time to produce additional data before the first patent filing may enable broader claims that both cover your product and block others from even entering the space. On the other hand, time may not be on your side. A pending business acquisition or investment, a competitor racing to market, or an important public presentation might call for a leaner, narrower, and earlier patent application. Critical decisions on what, when, and even why to file are best made when the technology, business objectives, and competitive factors in the market are all considered together.

A New Landscape at the Patent Office

Adding to these difficult challenges are seismic shifts in patent law over the last three years that are creating pitfalls for the unwary but offering huge opportunities for the prepared. In addition to having adopted a "first-to-file" system that creates a race among competitors to the Patent Office, there are now new adversarial proceedings before the Patent Office that allow competitors (and others) to launch relatively inexpensive but very fast and very effective attacks to invalidate another's patent. Being prepared for these attacks requires implementing a solid patent strategy well before an application is filed.

Yet the biggest developments relevant to oncology and bio-pharmaceuticals were a series of court decisions that dramatically limited what types of innovations can even be patented in the first place. The narrowing of patentable subject matter began with the U.S. Supreme Court's 2013 ruling that isolated human BRCA1 and BRCA2 genes used by Myriad Genetics to test for breast cancer could not be patented because they were "natural products." This decision has led to additional rulings further limiting the patentability of natural products and to the recent enactment of new Patent Office examination guidelines.