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

Panelists:

  • 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!

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BIO Releases Largest Study Ever on Clinical Development Success Rates

On Wednesday, BIO released the largest ever study of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.

“This study provides a wealth of information about drug development success rates across a broad range of indications,” said Cartier Esham, PhD, BIO’s Executive Vice President, Emerging Companies. “The results may be used to pinpoint disease areas and phases of development where the industry has been most successful in recent years, as well as areas presenting challenges along the capital intensive-pathway of drug development.”

Key findings from the study include:

  • Clinical trial programs that used selection biomarkers saw an overall likelihood of approval (LOA) from Phase I of 25.9%, compared to 8.4% when no selection biomarkers were used.
  • The overall LOA from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology.
  • Of the 14 major disease areas studied, Hematology had the highest LOA from Phase I (26.1%) and Oncology had the lowest (5.1%).
  • Oncology drugs were approved the fastest of all 14 disease areas.
  • Rare disease programs had higher success rates at each phase of development vs. the overall dataset.
  • Chronic diseases with high populations had lower LOA from Phase I vs. the overall dataset.

The study relied upon years of clinical program monitoring and data entry by Informa’s Biomedtracker service. BIO has long partnered with Biomedtracker to calculate success rates based on this data. More recently, BIO and Biomedtracker partnered with Amplion, the inventors of BiomarkerBase, to analyze the effects of biomarkers in clinical trial success.

“Combining Amplion’s biomarker database with Biomedtracker’s clinical transition records we were able to, for the first time, quantify the benefit of using selection biomarkers in drug development,” said study author David Thomas, CFA, BIO’s Senior Director of Industry Research. “In combination with the rare disease section of the report, these results appear to be revealing the overall strength in targeting well-defined, homogenous patient populations.”

A full version of the report is available for download here.

Thomas will be discussing the report on June 6 at the 2016 BIO International Convention during his session, “The State of the Innovation Industry.”

Filed under: Business and Investments, Health, Inside BIO Industry Analysis, , , , , , , , , ,