Thomas Wolski, partner at The Webb Law Firm, says biotech firms must file more patent applications earlier to overcome the threats of US legal uncertainty and unclear guidance.
Uncertainty in US laws is one of the threats that the biotech industry has and continues to face when it comes to patents. And it seems like every patent case that the Supreme Court takes these days has a strong chance of reversing the Federal Circuit’s decision.
To compound the problem, Congress’s patent laws do not provide clear guidance. Take, for example, the American Invents Act (AIA), which was passed in 2011. After the AIA was passed, some advised that private sales may be acceptable.
In floor statements, Senator Leahy said that the AIA was intended to do away with precedent that private offers for sale could invalidate a patent. This was important, especially to smaller biotech companies, because it would make it easier for smaller companies to find partners early to help bring products to market as they are going through the FDA approval process. Sometimes, the FDA process required testing would lead to new and unexpected results, providing additional basis for patentability, or possibly new inventions.
Uncertainty and protection
The truth of the matter is that it remains uncertain whether the AIA permits smaller biotech companies entering into partnering agreements without possibly hurting their patents that are filed thereafter.
The Supreme Court has recently heard oral arguments in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. to clarify at least some of this uncertainty. However, the Supreme Court’s decision may not completely answer all pending questions about the on-sale bar. For example, it is unlikely that the Supreme Court will agrees one of Helsinn’s arguments that the on-sale bar does not make secret sales an invalidating sale under the AIA, an issue that the Federal Circuit expressly declined to decide.
To protect itself, the biotech industry can do several things.
First, it should tighten the communication between its technical side and commercial side. Second, it can take a tiered approach and file more patent applications. Third, it can file patents applications earlier to avoid any possible issues that may arise.
These suggestions require discipline to make sure that their intellectual property assets are in place before making moves to develop its vertical distribution chain.
While this uncertainty seems to suggest that US patent laws are unfair, we need to keep in mind that there is just more patent litigation in the US then elsewhere. A lot of the uncertainty in the US system stems from the one-year grace period provided by US laws, and reliance on that grace period.
While it seems logical to do away with the one-year grace period, the consequence is a shorter patent term, and less exclusivity in the market place; and we all know that in this space, every day of patent terms matters.
Thomas C. Wolski concentrates his practice on many aspects of intellectual property, including: patent prosecution, licensing and client counseling on intellectual property, and intellectual property litigation.
He has obtained patents for clients in areas of small and large molecule therapeutics, cancer diagnostic and treatments, hormone replacement therapies, engineered tissue, engineered and cultivated organisms (e.g. plants, microbes and viruses), and medical devices. Tom has handled cases involving medical devices, dietary supplements, emulsions, and valves, as well as trademarks, copyrights, trade secrets, licenses, and employment contracts. In addition, he has negotiated many licenses and intellectual property transfers.
Tom joined The Webb Law Firm in 2007 as an associate and became a partner in 2012. Before joining the firm, he practiced in New York City where he handled complex litigation across the country, encompassing a wide-range of commercial matters. He also was a laboratory manager and research specialist at the University of Pittsburgh in molecular biology and biochemistry, focusing his studies on premature birth and cardiovascular diseases.