Pharma Companies Could Hit Refresh on Patent Review Process

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By Dana A. Elfin

Collegium Pharmaceutical Inc. is asking the Patent Trial and Appeal Board to cancel an opioid-related patent granted to Purdue Pharma LP, and it’s invoking a seldom used patent review procedure to do it.

Collegium is taking advantage of a procedure known as post-grant review. Under this procedure, the petitioner can claim a patent is invalid for any reason, making post-grant review a more powerful tool than the more widely used procedure, inter partes review. In the inter partes procedure, a challenger can only claim an invention is not novel or obvious based on other patents, or based on documents that were available before it was patented but were missed or not adequately considered during the original examination.

Out of the total number of post-grant reviews filed so far, only 27 pharmaceutical patent petitions have been filed. But attorneys tell Bloomberg Law life sciences companies could employ the procedure more often as a litigation tool to challenge patents standing in the way of generic and biosimilar drugs.

“Everyone else is just waiting to see if someone else will figure out how to use this procedure in the most effective way,” Erica Pascal, an attorney and founder of San Francisco-based Ingensity IP, which advises life sciences companies on intellectual property strategies, told Bloomberg Law in a March 15 telephone call.

Targeted Approach

The post-grant review proceeding, created under the America Invents Act of 2011, is used infrequently because it only applies to patents issued since March 16, 2013, and the applicant must file the petition within the first nine months of a patent’s issue. The number of post-grant review petitions filed rose to 42 in 2017 from 29 in 2016. However, very few of these petitions were in the pharmaceutical patent litigation area. Patent litigators say the life sciences industry can make more effective use of this tool, especially because it doesn’t limit the grounds on which a patent can be challenged.

According to Pascal, life sciences companies will benefit from developing and implementing a selective and targeted approach for using the post-grant review (PGR) process to challenge patents.

For example, Pascal said, PGRs can provide a strategic advantage in challenging certain types of drug patents, including manufacturing process patents for small molecule drugs and combination patents covering products combining drugs and devices and biosimilars.

The pharmaceutical industry eventually will make more use of the technique as more recently issued patents hit the Food and Drug Administration’s Orange Book, Brad Pedersen, patent attorney at Patterson Thuente Pedersen PA in Minneapolis, told Bloomberg Law in a March 15 telephone call. “Going forward, PGRs may be a much bigger part of the portfolio of strategies that counsel will use,” he said. The Orange Book is a listing of patents drug companies claim cover their products.

Inherent Restrictions

But because of certain restrictions inherent in the procedure, “it will still be the ‘road less traveled’” for life sciences companies, Scott McBride, a patent litigator with McAndrews Held Malloy Ltd. in Chicago, said.

According to McBride, the procedure is less used because of the broader estoppel provisions, the smaller universe of patents eligible for the procedure, and the timing restrictions requiring challenges to be filed within nine months of the patent’s issuance.

Estoppel is a legal construct where a court bars a party from making claims in a subsequent infringement action the party could reasonably have raised in earlier proceedings. So PGR petitioners who are subsequently sued for infringement in federal court can’t make arguments that “reasonably could have been raised” during the PGR before the Patent Trial and Appeal Board (PTAB), J. Steven Baughman, a partner at Paul, Weiss, Rifkind, Wharton & Garrison, said. “I believe this is likely to continue leading petitioners to consider PGRs only in fairly specific circumstances,” he said.

The limiting and preclusive effect of estoppel in PGRs is so broad, McBride said, “you’re going to want to bring all your defenses in that PGR, and that’s a sizeable task.”

“These limitations diminish its use more than it being overlooked as a tool in the arsenal of accused infringers,” he said.

“The problem is the 9-month window,” Scott McKeown, a Washington-based partner in Ropes & Gray LLP’s intellectual property litigation practice and chair of the firm’s PTAB group. told Bloomberg Law March 15. “Where you will see it used is to [fight back] at efforts in evergreening,” he said. Evergreening refers to techniques through which companies try to extend their patent protection by making small changes to their products, such as changing drug delivery systems.

Meanwhile, in the Collegium matter, the PTAB will have about six months to decide whether it will review the Purdue patent, U.S. Patent No. 9,693,961. Stamford, Conn.-based Purdue is suing Collegium, based in Canton, Mass., for patent infringement over that same patent and other related patents in federal court in Boston.

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