Since 2012, there have been a few new administrative methods to challenge the validity of an existing patent from the United States Patent and Trademark Office (USPTO).
Basically, each is a form of a post-grant review. They are known formally as inter partes review (IPR), post-grant review and covered business method patent review.
“In each of these ‘post-grant’ proceedings, a board of administrative patent judges determines whether or not the claims of the patent are valid based on prior art, evidence, and arguments presented by both the patent owner and the challenger,” according to an analysis by Cooley’s Max Colice. “The patent owner and the challenger can even conduct limited discovery and argue before the board of administrative patent judges.”
The process is quicker than earlier options used at the USPTO, with a decision expected 18-24 months after a petition is filed. The new processes are less expensive than fighting it out in federal district court, too.
With data from Cooley’s PTAB Digest database, which lists most inter partes reviews, the USPTO invalidated some or all challenged patent claims in 86 percent of cases.
To get an idea of the popularity of IPR, as of the middle of the summer, 1,562 petitions for inter partes review were filed since IPR became available as an option, according to data from Wilmer Hale. (The effective date for inter partes review in the America Invents Act was Sept. 16, 2012.) Eighty-eight of these petitions have been filed on biological/pharmaceutical patents.
As a note, IPR was formerly known as inter partes reexamination before the America Invents Act.
Under IPR, patent validity can be challenged based on prior art, related to patents or printed publications, according to the USPTO. Grounds for a patent being invalid include anticipation or obviousness categories. The Patent Trial and Appeal Board decides petitions for IPR. “In … 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,” the USPTO added.
When it comes to post grant review it became effective on Sept. 16, 2012. Patents can be challenged under such arguments as novelty, obviousness, written description, enablement, and indefiniteness. The Patent Trial and Appeal Board decides petitions for post grant review.
Post-grant reviews provide litigant a lower burden of proof than found in other proceedings, and the patent examiners hearing the cases have expertise in the field, perhaps more than would be found in a local federal court. For these and other reasons, “they should be part of your troll-fighting arsenal,” advises Jason Schwent, an attorney with Thompson Coburn.
In an interview with InsideCounsel, Edmund Walsh, an attorney at Wolf Greenfield, a Boston-based IP law firm, points out there is a lot of similarities between post-grant review and IPR. The main difference, he adds, is what issues you can bring up during the trial held by the USPTO. IPR limits the documents that can be used when compared to post-grant review, where the document selection is more expansive.
Walsh says it is more likely that a producer of generic medications would use forms of post-grant review. On the other hand, a larger pharma company when challenging patents may opt to file a lawsuit in a federal district court rather than a submit claim at the patent office. These big companies tend to have more resources available to them. And the resources will likely be needed if they intend to fight in federal court. Wolf Greenfield’s Charles Steenburg pointed out in an interview that the estimated cost of litigation in federal court is in excess of $5 million. But with IPR or post-grant review, it is “well under the $5 million figure,” he added.
Generic companies have seen a success rate of about 70 percent, as far as patents being invalidated.
“That’s pretty high odds compare to going to district court,” Walsh said. He adds that post-grant challenges are “becoming an expedited way of resolving patent disputes. … People have a fair amount of confidence in it, and it is widely used.”
Looking ahead, Steenburg said the line between the big pharma companies and the generic companies is becoming less clear. For instance, Teva Pharmaceuticals, which was a major generic provider, has launched a number of original drugs.
“They are on both sides of these issues,” Steenburg explained.