This Q&A is one in a series featuring MBHB partners discussing 2014 developments in intellectual property law and the 2015 outlook.
MBHB Attorneys Kevin E. Noonan, Ph.D., Donald L. Zuhn, Jr., Ph.D. and Michael S. Borella, Ph.D. are the featured presenters for a live MBHB webinar set for Jan. 20, 2015 entitled, “Top Patent Law Stories of 2014. Click here for details
Kevin E. Noonan, Ph.D. is a partner with McDonnell Boehnen Hulbert & Berghoff LLP. An experienced biotechnology patent lawyer, Dr. Noonan brings more than 20 years of extensive work as a molecular biologist studying high-technology problems in serving the unique needs of his clients. His practice involves all aspects of patent prosecution, interferences, and litigation. Dr. Noonan is a frequent speaker, commentator and author on a variety of intellectual property law topics. He is a founding author of the Patent Docs weblog, a site focusing on biotechnology and pharmaceutical patent law.
What were the top three IP issues or cases in 2014?
KN: There were several. The continued fallout over the Mayo/Myriad cases was the most important issue of the year, primarily due to the USPTO’s Guidance released in March, followed by roadshows, public meetings, requests for comments from the public and a promise from the Office that revised Guidance would be issued in October. The Federal Circuit is also reviewing two cases – Myriad v. the world and Ariosa v. Sequenom – where district courts have tried to apply the holdings of these cases.
Also, the failure of patent troll litigation in the last Congress was a key occurrence this year and its prospects in the next Congress will be important to watch in 2015. During the summer, the Senate nearly passed a bill similar to the Goodlatte bill which passed in the House, but failed to bring it to the floor after a threat from the trial lawyers over the “loser pays” provisions. Recently, the number of patent troll cases filed has decreased by 40 percent (allegedly due to the Supreme Court’s Alice decision rather than any change in NPE litigation behavior), so the political water pressure in 2015 may not be as high for a bill as expansive as Goodlatte.
Lastly, indications by the Patent Office suggest that it may reconsider some of the practices adopted by the PTAB that have made it “the place where patents go to die” – particularly, the standard for granting motions to amend claims and application of the “broadest reasonable interpretation” standard for claim construction.
What do you anticipate will be the most influential topics or cases in biotech in 2015 and why?
KN: The revised Guidance, for all the reasons above, and how the Federal Circuit interprets Mayo in view of diagnostic method claims. I also expect we’ll see less of an impact from the Court’s Nautilus decision from this term on the proper standard for indefiniteness. I think this is mostly because while the Court’s decision has the capacity to make mischief, most biotech claims are sufficiently specific that they avoid these kinds of indefiniteness problems.
There may also be an attempt (most likely by the FTC) to get the Supreme Court to weigh in on the extent to which non-monetary payments can fall within the scope of antitrust liability in reverse payment settlement agreements in ANDA cases. And, while I expect it would take most of the year, there’s a small chance we could see the first lawsuit filed under the BPCIA (but it’s fairly unlikely).
Are there any budding trends you’ve seen recently that may turn into more prominent issues in the next year?
KN: The high cost of biologic drugs will begin to be an issue because those costs ($100,000-$200,000) for a course of treatment and the typically short-term benefit (weeks or months of additional life) are unlikely to be supported by payors, including the Federal government. I would expect that there will be some movement on how to better subsidize these costs without it turning into a “death panel,” but the fear will be that the “haves” will be able to get treatments the “have-nots” cannot afford.
Are there any influential decisions or issues that will remain at the forefront next year?
The Supreme Court will decide the standard for how patent claims are construed, and whether appellate courts (the Federal Circuit) should defer on fact findings by the district courts. A decision overturning the Federal Circuit might have some influence at the margins and may reduce somewhat (but not entirely) the frequency with which the Federal Circuit overturns claim construction decisions by the district courts.