What the Dietary Supplement Industry Needs to Know About the New U.S. Patent Laws

Under the America Invents Act (AIA), the U.S. patent laws were amended in ways that represent the biggest changes in decades to U.S. patent law.  The most significant changes of the AIA are effective March 16, 2013 and have forever altered the way U.S. patents will be offensively and defensively used in the supplement industry.

The biggest change in the AIA relates to who is entitled to a U.S. patent.  Prior to March 16, 2013, an inventor who was the first to actually invent an invention was entitled to a U.S. patent regardless of who first filed a patent application at U.S. patent office.  This first-to-invent" system was very unique among the developed nations of the world.  Now, the U.S. will operate under a first-inventor-to-file" system (broadly speaking, a first-to-file" paradigm), whereby the first person to file an application for his or her invention will be entitled to an invention, regardless of who actually invented the invention first ( 35 U.S.C.§ 102). 

Advocates of the AIA contend the changes simplify the patent application process and bring U.S. patent law into better harmony with the patent laws of other countries, most of which already operate with a first-to-file" system.  Opponents to the AIA contend that the first-to-file" system favors larger, well-funded companies with sophisticated internal patent procedures who are better equipped to win a race" to the patent office by first filing a new patent application before smaller company or individual can do so.  One exception the first-to-file" system is that first to file an application cannot simply copy the invention of another and then race to the U.S. patent office to file a first application.  Instead, the first to file inventor must be able show that his or her invention was developed independently of others.  If a dispute arises as to whether the first to file applicant was not an independent inventor, the AIA allows for a derivation" proceeding to be filed, in order to determine actual inventorship.

In light of these changes, several best practices have developed for those in the dietary supplement industry.

First, those wishing to obtain patent protection must be diligent in filing their patent applications as soon as possible to obtain priority and avoid potential derivation proceedings.  Practical steps for increasing diligence include implementing more frequent invention brainstorming sessions and quicker action from company management in making patent decisions.  Demanding timely turnaround from patent attorneys in pursuing patent applications is one way to be more proactive.   

Second, patent filers will often want to file a provisional application soon after the conception of an invention.  A provisional application is a less formal application that requires much less time for a patent attorney to prepare than a more detailed non-provisional" application.  The presumably earlier filing date for a provisional patent application can eliminate the scope of prior art that can be used to prevent your patent from being granted.  One disadvantage of a provisional application is that the law requires a second application, the non-provisional" patent application, to be filed within one year on the same invention before the patent office will grant the patent. 

Third, patent filers should maintain detailed records of their invention process so that they can prevail in a derivation proceeding should another attempt to copy their invention and be the first to file.

For those found defending themselves against charges of infringement, the AIA also contains some important advantages.  Because the date of invention is no longer relevant to prior art, the patent owner now loses his previous advantage to present evidence, known as swearing behind," to show that his invention originated before the prior art.  Further, U.S. patent law now moves to a more restrictive time bar" system for patentability, such that if the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public anywhere in the world before the effective filing date of a patent application, the patent application cannot be granted.  Previously, foreign offers for sale and public uses did not qualify as § 102(b) prior art.  As such, potential companies who may be accused of patent infringement should strongly consider using or publishing descriptions of their invention as soon as possible so that a competitor cannot later claim the invention is his own and file for a patent.  One downside to such a defensive" publication, however, is that the publisher will lose his ability to file his own patent application for the invention in many foreign absolute bar countries.  Also, one who publishes a defensive" publication must file an application in the U.S. within one year of such a publication to preserve its U.S. patent rights should be they be desired.

In summary, the AIA contains many groundbreaking changes to U.S. patent law that will impact the supplement industry for years to come.  A correct understanding of these changes provides a unique opportunity for many industry players to gain a competitive advantage over others who do not incorporate these new changes into their intellectual property strategies. 

See more about the American Invents Act at the USPTO website's sepcial AIA section.

Also, check out the recent article, Assessing an IP Portfolio, by Rakesh Amin.

Joseph E. Cwik , a partner at Husch Blackwell LLP , concentrates his practice in the area of intellectual property litigation.  As a trial lawyer, he has represented numerous clients in disputes involving patents related to dietary supplements, nutraceuticals and pharmaceuticals.

Rakesh Amin , a partner at Amin Talati , helps clients safely navigate the minefield of U.S. food, drug, dietary supplement, cosmetic and medical device regulations. He also practices patent, trademark, copyright, trade secret, internet and unfair competition law, including the prosecution, maintenance and licensing of intellectual property, as well as intellectual property and false advertising litigation.