Bio/Patent Discoveries Face Tougher Road to Patent Eligibility

This article, authored by Susan Gorman, was first published by Richard Ina of the Ina Wealth Management Group in the Spring 2015 issue of  The Executive Quarterly.

Protecting innovation has become far more difficult in the last few years, especially in the biotech and pharma fields. The Supreme Court has shifted its attention toward intellectual property, deciding more patent cases since 2010 than it has in the previous two decades. Additionally, the passage of the America Invents Act in September 2011 moved the United States from awarding patents on a First-To-Invent basis to a system rewarding the First-Inventor-To-File.  Now, Congress is considering additional patent law reform.

Despite the challenging landscape, there are some steps that can be taken to increase the probability of success for companies who want to protect the inventions at the core of their business and stay competitive.

Eligible Subject Matter 

The first step is to determine how to present the innovation so that it will be deemed patent eligible.  Prior to 2012, the Supreme Court had decreed that “anything under the sun that is made by man” was patent eligible. Since then, the Supreme Court has started to focus on what is not patentable, including DNA, proteins and many isolated/purified natural products. This turn of events is particularly difficult for those of us in the biotech/pharma sector whose roots are in the natural world.

Yet, there is still some hope.

Late last year, the United States Patent and Trademark Office (USPTO) issued revised Guidelines that provide good examples of patent eligible claims despite the fact that the underlying product or process is “natural.”  Thoughtful consideration of these examples allows companies to identify the “significantly more” that the Supreme Court says is needed to jump the eligible subject matter hurdle. For example, an isolated/purified product that has a marked difference in its characteristics compared to its naturally occurring counterpart can be eligible subject matter, such as a purified protein having a crystalline structure that is not found in nature or which has a different polysaccharide profile when produced by recombinant organisms.  While the scope of such eligible claims is not as broad as pre-2012, generally they are still able to provide solid protection for the company’s product/process.

Timing is Everything

The move to the First-Inventor-To-File system encourages early filing of applications, but this approach has drawbacks.  If an application is filed too early, the description of the innovation may be incomplete.  This can be particularly problematic if what is missing is needed to place the invention into the eligible subject matter realm.  Also, while pharmaceutical companies perform comparative tests of their new drug treatment to a closely related known drug, the tests are frequently performed after a patent application has been filed, which may affect the ability to rely on those results.  Consequently it is more important than ever to consider timing when filing applications.

So while it is more difficult to obtain broad protection of biotech/pharma innovations, a focused approach to application preparation and filing can ensure that an innovation can obtain solid protection without unduly compromising the scope of the protection.

Susan Gorman, founder of Gorman IP Law, is a scientist and a lawyer focused on helping companies leverage intellectual property assets to maintain a competitive advantage, enhance market share, plan for growth and better manage resources and expenses. Through a proprietary process, Gorman IP Law helps businesses build a formal IP strategic plan that defines your business goals, establishes benchmarks and allows you to better project costs. Dr. Gorman can be reached at

The information contained herein has been prepared by Gorman IP Law, APC, for informational purposes only and is not legal advice.