In an effort to lay the groundwork for generic entry and reduced drug prices, the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), with the support of the Laura and John Arnold foundation, has petitioned the PTAB seeking Inter Partes Review of Gilead’s U.S. Patent Nos. 7,429,572 & 7,964,580, which purport to encompass sofosbuvir, one of the active components of anti-Hepatitis C drugs Sovaldi®, Harvoni®, and Epclusa®.  

On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17. The new law requires pharmaceutical companies to give 60 days’ notice to state and health insurers if they plan to raise the price of a medication by 16 percent or more over a two year period, and to justify such increased prices.

Partner, Kerry S. Taylor, Ph.D. was interviewed by Steve Seidenberg for his article entitled, “US Perspectives: In US, New Legal Ploy May Protect Bad Patents” that was published on October 18, 2017 on the Intellectual Property Watch website.

The PTAB has released its September 2017 statistics.  These statistics mark the end of the USPTO’s 2017 fiscal year (the USPTO’s fiscal year runs from October 1 to September 30 of each year).  A total of 1,901 IPR petitions were filed in FY2017, with the following break-down by technology area:

The PTAB extended the deadline for issuing its IPR final written decision on a motion to amend by up to six months to provide additional time to consider the impact of the Federal Circuit’s recent en banc Aqua Products opinion in Minerva Surgical, Inc. v. Hologic, Inc., IPR2016-00868, Papers 56 & 57 (P.T.A.B. Oct. 5, 2017).

On October 18, 2017, the PTAB designated as “precedential” a major portion of its prior decision in General Plastic Industrial Co., Ltd. v. Canon Kabushki Kaisha. The decision was previously designated “informative,” but now, as a “precedential” decision, binds all members of the Board.

Sovereign immunity refers to the doctrine that the government cannot be sued without its consent.  Specifically, the 11th Amendment precludes federal courts from exercising jurisdiction over states in suits brought by private citizens or subjects of a foreign state. “Sovereigns” include federal and state governments under the 11th Amendment, as well as, Native American Tribes under treaties.  The U.S. Supreme Court has held that sovereign immunity is also available as a defense in administrative proceedings, which are similar to federal court litigation.  Federal Maritime Comm’n v. South Carolina Ports Authority, 535 U.S. 743.  In 2017, the Patent Trial and Appeal Board (PTAB) has addressed the issue of sovereign immunity several times in the context of Inter Partes Review (IPR) proceedings.  The recent cases, along with the currently pending IPR, Mylan Pharmaceuticals, Inc., et al. v. Allergan Inc., (IPR2016-01127, -1128, -01129, -01130, -01131, -01132) are discussed below. 

In view of the Federal Circuit’s en banc holding in Aqua Products, Inc. v. Matal, No. 2015-1177, (Fed. Cir. Oct. 4, 2017), the Board authorized additional briefing to the petitioner in three related IPRs in which the patent owner filed motions to amend. Kingston Technology Company, Inc. v. Polaris Innovations, Ltd., IPR2016-01621, -01622 & -01623; Paper 26 (P.T.A.B. Oct. 10, 2017). 

Since 2014, the USPTO has periodically issued examination guidance, analysis examples, and other insights to guide evaluation of patent subject matter eligibility under 35 U.S.C. § 101.  These documents are available on the USPTO’s website and can be helpful in crafting arguments for or against the patent eligibility of claims during examination or in litigation.  The summary below is intended to assist the reader in locating relevant materials for a particular eligibility inquiry.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa under Accelerated Approval, Priority Review, and Orphan Drug designations. These designations indicate that Aliqopa is a drug for treating serious conditions, fills an unmet medical need, and provides incentives to encourage the development of drugs for rare diseases.