Protecting Innovation: Special Considerations for the Scientist Turned Entrepreneur

Part 3: Patent Application Drafting

Drafting a patent application is not a trivial task. Founders/inventors in the life sciences and biotech fields who try to short-cut the process with “do-it-yourself” patent drafting do so at their peril.

Too often, these highly educated leaders in their field believe that drafting a patent application is no different than writing a peer reviewed journal article or a grant proposal.  But this is not the case because the patent application – even a provisional patent application – is a legal document. The Supreme Court recognized this as early as 1892 when it stated:

The specification and claims of a patent, particularly if the invention be at all complicated, constitute one of the most difficult legal instruments to draw with accuracy; and, in view of the fact that valuable inventions are often placed in the hands of inexperienced persons to prepare such specifications and claims, it is no matter of surprise that the latter frequently fail to describe with requisite certainty the exact invention of the patentee, and err either in claiming that which the patentee had not in fact invented, or in omitting some element which was a valuable or essential part of his actual invention.  Topliff v. Topliff, 145 U.S. 156, 12 S.Ct. 825, 36 L.Ed. 658. 

Legal terms and requirements that appear straight forward on their face require a comprehensive understanding of the current state of the law, past precedent and current court interpretation. Drafting a patent application without this understanding is often done to the peril of the inventor.

Among the common misconceptions of start-ups having little experience with the patenting process is the meaning of the legal terms “novelty” and “obviousness.”  To most scientists and engineers – in fact most lay people – “novelty” means just what the Merriam-Webster dictionary says: “The quality or state of being new, different, and interesting; something that is new or unusual; something novel.”

But in patent law, novelty doesn’t mean exactly that.  Instead, novelty means that when an Examiner searches the patent, scientific, and popular literature (“prior art”) that was published before the earliest filing date for the application, she or he cannot find one single publication that has each and every element of the claim.

Like novelty, the terms “non-obviousness” and “obvious” also have a special meaning in patent law.  Once more, the focus is on the elements of the claim.  But while novelty requires that each and every element of the claim is present in a single publication, to destroy non-obviousness and show that an invention is obvious, an Examiner is allowed to combine two or more references so that each and every element of the claim is represented.

These legal definitions tend to flummox most start-ups, especially when the publications are directed to areas of biotechnology that do not seem at all related to the start-up’s invention. Experienced patent drafters appreciate that while novelty may exist over two publications, the invention could be considered obvious even if the publications are focused on different aspects of biotechnology.  This then allows the drafter to further define the invention by including aspects that are absent from the prior art, which in turns provides the best chance to move through the patenting process to granted patent with the minimal amount of argument and expense.  Here, the benefits of conducting a prior art search before beginning to draft a patent application becomes apparent.

Another common error made by start-ups who draft their own applications is to inadequately present the innovation so that it is viewed as patent eligible subject matter.  Prior to 2012, the Supreme Court had decreed that “anything under the sun that is made by man” was patent eligible. Diamond v. Chakrabarty, 447 U.S. 303, 309 (190). 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 in the biotechnology sector whose roots are in the natural world.

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.”  79 Federal Register 241 (16 December 2014) pp 74618-74633. Thoughtful consideration of these examples allows the application drafter to identify the “significantly more” that the Supreme Court says is needed to jump the eligible subject matter hurdle.  See Mayo Collaborative Services v. Prometheus Labs., Inc., 132 U.S. 1289 (2012); Association for Molecular Pathology v. Myriad Genetics, Inc., 133 U.S. 2107 (2013);  CLS Bank v. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 U.S. 2347 (2014).

But most start-ups are not familiar with the particulars of the Supreme Court cases, although they may have heard of them through the media, and are not aware of how these decisions have affected the ability to obtain patent protection for biotechnology innovations.  As a result, an application drafted by a start-up frequently does not adequately differentiate the invention from the “natural” product or process.

In addition, 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.  The First-Inventor-To-File system encourages early filing of applications, but this approach can have drawbacks because 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 start-up companies may perform comparative tests of their new product or process to a known closely related one, 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.  Again, this can be a hard sell to start-ups who want to obtain patents as quickly as possible.

Working with biotechnology start-up companies can be extremely rewarding but does require a significant time and teaching investment on the part of the attorney.  Generally the science that biotech start-ups are based on is outstanding; the high failure rate for the start-ups tends to be more a function of poor business decisions and the lack of business experience than failure to perform scientifically.  Understanding the legal issues associated with biotechnology, whether they are related to intellectual property, regulatory, or environmental, increases the probability of a start-up’s success in the marketplace.

Susan Gorman, Ph.D., Esq., is principal of Gorman IP Law, a law firm 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 susan.gorman@gormaniplaw.com.

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