Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Around half of pharmaceutical patents survive a patent board validity challenge, which is better than other fields, a new analysis released June 14 said.
Inter partes review (IPR) was created by the America Invents Act to allow third-party challenges to the validity of patents before the Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). Across all fields, 91 percent of the IPR challenges that go to PTAB trial result in all or some of the claims being invalidated. This caused Randall Ray Rader, former chief judge of the U.S. Court of Appeals for the Federal Circuit, to call the PTAB “a death squad” for patents.
A new analysis by law firm Fitzpatrick, Cella, Harper & Scinto continued the pattern of reports finding that IPRs’ impact on biopharma patents isn’t as severe as for other technologies. “In short, PTAB is not a ‘death squad’ for” pharmaceutical and biologic patents, the analysis concluded. Biopharma attorneys, however, have told Bloomberg BNA that even an invalidation rate of 50 percent for some or all claims of patents that were painstakingly reviewed by the PTO continues to be a concern.
The Fitzpatrick analysis of petitions filed from Sept. 16, 2012, through March 31, 2017, found that across all technologies, after an IPR petition was filed, IPRs were instituted at a rate of 53 percent. For pharmaceutical patents, the rate was 44 percent, and for biologic drugs, it was 41 percent.
For pharmaceutical patents, the Fitzpatrick analysis found all claims survived an IPR in 50 percent of final written decisions, and for biologic drugs, all claims survived in 37.5 percent, both better than the average across all sectors of 19 percent for the survival of some or all of the claims.
A 2016 Bloomberg BNA report also concluded that biopharma patents fare better in IPRs than patents for other technologies. It concluded IPR challengers stand about a 50-50 chance of having the PTAB grant an IPR petition. If it does, there’s a 40 percent chance the challenger will succeed in canceling some or all of the patent’s claims.
A 2017 Bloomberg BNA/American Intellectual Property Law Association study found a softening in the negative attitude held against IPRs by attorneys across all sectors.
The Fitzpatrick analysis found that based on March 2017 PTAB statistics:
To contact the reporter on this story: John T. Aquino in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)