Letter From the Editor
Welcome to the inaugural issue of Katten Patent Review, a publication that addresses legal issues and developments in the patent arena. We strive to offer valuable analyses and resources to keep you informed on the developments that could affect your business.
This issue contains articles on patent reform legislation, ANDA specifications and unpatentable subject matter (as a result of Alice). Several of the topics also are available as short training programs that are eligible for CLE credit. Please contact us for more information.
–Mimi Addy
National Head of the Patent Litigation Group
Alice Sends Business Method Patents Down the Rabbit Hole
Nearly one year after the Supreme Court's decision in Alice Corp. Pty Ltd. v. CLS Bank Int'l, courts are striking down business method patents in record numbers and they are doing so at the outset of litigation. In cases asserting business method patents, district courts are granting more than 50 percent of motions to dismiss based on lack of patentable subject matter. The Patent Trial and Appeal Board is finding more than 75 percent of challenged business method claims to be unpatentable. In view of the Supreme Court’s Alice decision and these first-year statistics, what can patent owners do to survive these challenges? What can accused infringers do to increase their chances of invalidating business method patents?
More Patent Reform, But Do We Need It?
Proposed legislation purports to address perceived abuses by patent assertion entities. But is it necessary? After the US Supreme Court’s decisions in Octane and Highmark, district courts are increasingly granting attorney fees to prevailing parties. Is a fee-shifting law needed?
Katten partner Eric Cohen addresses these questions in a recent IPO Law Journal article. He also asks if recent amendments to the Federal Rules of Civil Procedure requiring that discovery be proportional to the needs of the case, coupled with patent local rules and the patent pilot program, obviate the need for legislatively imposed case management procedures for patent cases.
The article addresses the ongoing debate of whether the Patent Trial and Appeal Board should continue to apply the broadest reasonable interpretation standard for claim construction in inter partes review proceedings.
A Winning Proposition: Amendments to ANDA Specifications
Since the enactment of Hatch-Waxman, patent litigation has been an integral aspect of the pharmaceutical industry. Katten attorneys Martin Masar and Thomas Maas recently offered their perspectives on a strategy for certain patent infringement litigation involving generic drugs. Their article, in Intellectual Property Westlaw Journal, provides tips and describes potential pitfalls for amendments to Abbreviated New Drug Applications (ANDA) to avoid infringement. These include directly addressing the inquiry, ensuring that specifications are wholly inconsistent with one or more claim element, and accounting for the timing of the amendment.
Polymorphous Perversity? Lessons and Landmines
Under Hatch-Waxman, polymorphs of an active substance are considered the same drug, but pharmaceutical companies often patent each one. This can result in litigation before the FDA approves generic versions. Generic manufacturers have the option of trying to design around polymorph patents, in addition to pursuing an invalidity challenge.
In a recent issue of Pharmaceutical Law & Industry Report, Katten attorneys Brian Sodikoff and Martin Masar discuss the risks and rewards of patenting polymorphs for both generic and brand firms. Brian and Martin review more than a dozen cases that show that this area is complex, fact-specific, and full of potential landmines for generic and brand pharmaceutical companies alike.
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