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Patent application changes coming for medical breakthroughs

There are many exciting legislative and regulatory changes on the horizon relating to patents. As […]

There are many exciting legislative and regulatory changes on the horizon relating to patents. As you have probably been hearing, President Obama is throwing his support behind these major changes as they promote job creation and economic growth.  Now, the words “exciting” and “legislative/regulatory” are not usually used in the same sentence, but with the next generation of medical and pharmaceutical treatments, therapies and technologies depending on a strong and reliable patent system, these changes do have serious implications to the medical industry nationwide. 

The first of these changes involves pending legislation moving from a “first-to-invent system” to a “first-inventor-to-file system.”  Currently, every industrialized nation in the world except the U.S. uses the patent priority system commonly referred to as “first-inventor-to-file system.” As business and competition become more global, inventors are increasingly filing patent applications around the globe.  So what does this mean for patent applicants, other than a race to the Patent Office?  Under the new “first-inventor-to-file” system, patent applicants must be more vigilant of competition and should file early and not delay their applications to avoid forfeiting valuable patent rights. 

The next related change is the new program designed to decrease application pendency.  The U.S. Patent and Trademark Office announced that it will begin accepting requests for expedited patent examination on May 4, 2011.  This new accelerated program guarantees that applications will go from filing to final disposition in 12 months, rather than the current period of three years or more.  This fast track program is called Track One.  Track Two is a suggested standard processing track, which in theory will remain the same or decrease waiting time as applicants select the Track One and Track Three options.  Track Three is a delayed application option which offers patent applicants an additional 30 months after the application is filed to gauge the commercial merits of their inventions. 

Of course, everything comes with a cost and the guarantee of completing the accelerated examination (i.e., Track One) will cost an additional $4,000 on top of the standard examination fees.  Expedited examination will reduce waiting time for applications, which benefits small inventors and large corporations alike…provided they are willing to pay the $4,000 fee. 

We all know that the medical industry constantly improves and grows as a result of technology breakthroughs.  The inventions behind these breakthroughs must be protected.  Miles White, CEO of Abbott Laboratories said, “Today, creating a single new medication costs, on average, about one billion dollars.  This monumental funding comes only from private investors. Without a guarantee of a return on their investment, that financing will go somewhere else.”  Clearly, patents are crucial to this process and to the industry as a whole.  As patent law evolves, the medical industry must be on top of those changes in order to stay in the game.


Steven M. Auvil

Steven M. Auvil is a partner and Chair of Benesch's Intellectual Property Practice Group.

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