FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Generics Makers May Increasingly Use PTO to Challenge Brand Drug Patents

Aug. 8, 2014
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Hatch-Waxman patent infringement lawsuits no longer are the only way for generic drugmakers to challenge brand drug patents. There is growing interest in taking disputes before the Patent and Trademark Office’s recently created patent review board, which some experts say offers cheaper, faster and more generics-friendly reviews than standard court proceedings.

Few generics so far have brought challenges before the PTO’s Patent Trial and Appeal Board, created by the 2011 America Invents Act (AIA), but that could change as the approach catches on more broadly and uncertainty around the new avenue fades, patent attorneys say. The law created three methods for reviewing patents, of which the inter parties reviews (IPR) are the most likely to be used by generics.

Since the board took its first IPR case in September 2012, 92 challenges had been filed against biotech and pharma patents as of mid-July, said Michael Fuller, an intellectual property attorney with Knobbe Martens.

Review board challenges take roughly 18 months to conclude, versus two to three years for a Hatch-Waxman court challenge, Fuller explained during a recent webinar hosted by the Intellectual Property Owners Association to discuss IPR drug patent challenges under the AIA. As such, the challenges generally are cheaper to pursue, he said.

They’re also easier to litigate because lawyers are arguing not in front of a district court judge or lay jury, but instead in front of a panel of three patent review board jurists, all of whom have extensive technical and scientific backgrounds. With technically trained judges, your results are going to be a lot more predictable, Dianna DeVore, a patent attorney with Oblon Spivak, said.

In addition, generic challengers may find more success with the review boards than through normal Hatch-Waxman litigation. Whereas district court proceedings begin with a presumption of a patent’s validity, there is no such assumption under the AIA, said Fuller.

Almost all of the IPR biotech and pharma decisions so far have invalidated the patents in question, Fuller said; many on grounds that the patented procedure was obvious for others to try.

Generics companies that have filed IPR drug patent challenges include Apotex, Ranbaxy, Accord, Hospira and Amneal, according to the webinar. Brand firms facing PTO board include Eli Lilly, Wyeth and Endo.

Despite the apparent advantages, Fuller cautioned that the federal circuit court has yet to chime in on USPTO reviews. Many review board decisions will be struck down on appeal, Fuller predicted.

While most of the drug patent challenges have fallen under the IPR, Scott McKeown, co-chair of the post-grant practice group at Oblon Spivak, said he also expects AIA drug patent challenges under what’s called the post grant review process. The third type of AIA challenge is called the covered business method review, which is unlikely to see many drug patent proceedings because it applies to corporate practices rather than production. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.