Over the past five years, the Supreme Court has been active in issuing major opinions that affe

Over the past five years, the Supreme Court has been active in issuing major opinions that affect patent prosecution strategy. For instance, its 2007 decision in KSR International Co. v. Teleflex invoked a narrow interpretation of the obviousness test, and, as a result, medtech companies should elaborate on unexpected results and technical difficulties to avoid obviousness rejections. Since 2010, several Supreme Court decisions have addressed what is patentable subject matter, including the patentability of method claims for personalized medicine and diagnostics. While some cases have reached final decisions, others are expected to be heard by the Supreme Court soon and will affect patentable subject matter, patent prosecution, and patent licensing. Recent and upcoming Supreme Court rulings indicate a willingness of the Court to address perceived problems in the patent system. To build and maintain a strong patent portfolio, medtech companies will need to pursue patent strategies that account for these major Supreme Court decisions.

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Patent reform presents widespread changes to current patent laws, from altering basic

filing procedures in a new first-inventor-to-file system to addressing issues in USPTO funding and operations. The reform introduces new challenges and opportunities to medtech companies and, as a result, medtech companies must carefully navigate the new patent system to maximize their competitive edge in the industry.

Larger, well-established companies emerge as clear winners of patent reform, with the capability of filing many applications quickly under first-inventor-to-file and monitoring and reacting to competitors’ patents and patent applications through post-grant opposition review and third-party prior art submission. Smaller companies, on the other hand, may encounter more difficulties adjusting to these new provisions and, as a result, may be forced to assume a more defensive, rather than offensive, patent strategy.

Regardless, all medtech companies stand to benefit from a more streamlined patenting process aspiring to produce higher-quality patents under faster timeframes. The America Invents Act is a landmark bill that, after a period of almost 60 years, introduces much-needed patent reform. Yet medtech companies must remain vigilant as USPTO initiatives and sweeping U.S. Supreme Court decisions continue to reshape the U.S. patent system.