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Will the PTAB Be A Roadblock for Biotech? Stories from Sessions at BIO 2016

June 8, 2016
We're at the beginning of day 3 here at BIO 2016, and that means we've already had a full day of high quality programming for our Intellectual Property track! Let's take a look at one of yesterday's most popular sessions.

Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects

Moderated by William Kubetin, Managing Editor at Bloomberg BNA


  • Kevin Noonan, Partner at McDonnell, Boehnen, Hulbert & Berghoff LLP

  • Teresa Stanek Rea, Partner at Crowell & Moring LLP

  • Michael Tierney, Lead Administrative Patent Judge at U.S. Patent and Trademark Office (USPTO)

The USPTO's inter partes review (IPR)  has emerged as one of the most concerning elements of the 2011 America Invents Act. An administrative trial method for challenging patents, it has generated criticism that legitimate biopharma patent claims are being invalidated.

Yesterday's panel walked through a case study of the procedures of IPR, examining the processes both petitioner and patent holder would use within the USPTO system.

Panelists introduced arguments for the petitioner's claim and Judge Tierney offered insights on how PTAB judges would evaluate and likely rule through each part of the process.

Topics of discussion ranged from USPTO's evaluation of priority determination, prior art, obviousness, and claim construction.

Judge Tierney closed with practice tips for both petitioner and patent holders when subject to the IPR process. Some key takeaways included:

  • The petitioner must demonstrate that there is a reasonable likelihood that he/she would prevail as to at least one of the claims challenged.  In instituting a review, the Board may take into account whether, and reject the petition or request because, the same or substantially same prior art or arguments previously were presented to the Office.

  • Include intrinsic reference in claim construction

  • Expert testimony must have underlying facts or data of record

  • Petitioners should address specific teachings that disclose claim elements, and support reasoning why claimed elements were known in prior art, used for a known purpose, and yielded predictable results.

In the question and answer session, BIO's Deputy General Counsel for IP, Hans Sauer expressed skepticism about recent assertions that IPR petitions against biopharma patents were declining.

When panelists pointed out to Dr. Sauer that petitions to challenge biotech pharma patents had decreased by 25% for the first four months of 2016 compared to those filed for the same period in 2015, he was quick to point out that seven to 15 biotech pharma IPR petitions is still significant. The drop off could likely be due to a decrease in filings from Kyle Bass and hedge fund entities, who filed over 33 challenges against drug related patent claims in 2015.

As Jacob Sherkow, associate professor at NYU's Innovation for Law and Technology said in Bloomberg BNA's  2016 Life Sciences Law & Industry Report:

"If there's seven to 15 challenges a month, and one out of 15 wins, that's one patent invalidated by a generic drug maker each month."

Check out more of our IP Coverage later this week here in San Francisco!