On June 19, 2017, the U.S. Patent and Trademark Office (USPTO) announced that it would be extending the Cancer Immunotherapy Pilot Program, which permits patent applications pertaining to cancer immunotherapy to be examined in an expedited fashion. As earlier discussed in this blog, the Pilot Program was established in support of the Obama White House’s National Cancer Moonshot initiative. The goal of the Pilot Program is to complete examination of an application within 12 months of special status being granted. Patent applications that qualify for the Pilot Program will be advanced out of turn for examination without meeting all the current requirements for accelerated examination.
Matthew Show, PhD is an Associate based in our San Francisco office. He specializes in advising clients in biotechnology, pharmaceutical, and medical device patent law, applying his extensive knowledge of biochemistry and molecular biology to provide clients with strategic counseling with respect to patent preparation and prosecution. His practice also includes due diligence and patentability analyses for clients underwriting stock offerings or engaging in mergers and acquisitions.
U.S. patent law elevates the importance of “the inventor” to an extent unseen in the rest of the world. Unlike many other countries, ownership of patent applications in the United States initially vests in the inventors listed on the application. This is true even where a contractual obligation for inventors to assign their ownership rights to others exists, such as the case in many employment or academic settings. This post summarizes two cases where an incorrect determination of inventorship on a patent application resulted in negative consequences for patent owners and/or licensees of an issued patent.
The Federal Circuit reversed the invalidation of two patents directed to providing security for credit card purchases in an opinion released earlier today. The patents at issue, U.S. Patent Nos. 7,840,486 and 8,036,988, disclose methods for effecting secure credit-card purchases by minimizing merchant access to credit card numbers. Both patents were the subject of inter partes reviews launched by a subsidiary of MasterCard Inc. after patent owner John D’Agostino sued for infringement of the claims of both patents in Delaware federal court in April of 2013.
On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves Apotex’s proposed filgrastim product, which is a biosimilar version of Amgen’s Neulasta®. At issue is whether the 180-day “Notice of Commercial Marketing” period provided by 42 U.S.C. § 262(l)(8)(A) of the BPCIA is always mandatory, and whether the Federal Circuit’s decision improperly extended the 12-year exclusivity period for reference product sponsors from 12 to 12 ½ years by holding that a biosimilar applicant cannot give effective Notice of Commercial Marketing for its biosimilar product until after it receives FDA license approval.
As previously discussed on this blog, the Federal Circuit held in Amgen Inc. v. Apotex Inc. that even though Apotex participated in the “information exchange” (a.k.a. the “patent dance”) envisioned by § 262(l) of the BPCIA, the statute’s “requirement of 180 days’ post-licensure notice before commercial marketing … is a mandatory one enforceable by injunction.”
Patent applicants who have filed a priority application (such as a U.S. Provisional application) may wish to abandon and then refile that priority application to extend the time available for filing a utility application. This post discusses some of the pitfalls of pursuing such a strategy as well as ways to ensure that refiling a priority application does not endanger the right to eventually claim priority.
The United States (U.S.) and the European Patent Convention (EPC) (as well as most countries of the world) are party to the Paris Convention for the Protection of Industrial Property (“Paris Convention”), signed in Paris France on March 20, 1883. The “Convention priority right,” was established by Article 4 of this treaty. Article 4 provides that an applicant from one contracting State shall be able to use its first filing date (in one of the contracting States) as the effective filing date in another contracting State, provided that the applicant, or his successor in title, files a subsequent application within 12 months (for patents and utility models) from the date of the first filing.
Specifically, the priority right is established by Article 4(A) which states that “Any person who has duly filed an application for a patent, or for the registration of a utility model, or of an industrial design, or of a trademark, in one of the countries of the Union, or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority during the periods hereinafter fixed.”
Our Biosimilar webinar series continued this month with Tom Wintner’s BPCIA Patent Litigation presentation. Tom discussed the general framework of litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), including the “patent dance” information exchange under 42 U.S.C. §262(l), and three case studies that inform our current understanding of emerging judicial interpretation of BPCIA requirements.
For those who missed the webinar, some of the key takeaways include the following:
- Biosimilar litigation is ultimately about patent litigation, but much of the underlying patent issues have been obscured because current litigation focuses on when and how the BPCIA applies and the BPCIA’s requirements when it does apply.
Mintz Levin attorneys Michael D. Van Loy, Robert T.S. Latta, and Matthew D. Show expertly analyze the implications of the “July Guidance” published on July 30, 2015, by the United States Patent and Trademark Office (“USPTO”) in Mintz Levin’s Intellectual Property Alert titled USPTO Issues Newly Updated Guidance on Subject Matter Eligibility that Further Clarifies Examination Standards under 35 U.S.C. § 101 in Light of Alice v. CLS Bank. The July Guidance provides further clarity regarding criteria to be used by USPTO examiners in determining subject matter eligibility under 35 U.S.C. § 101 since the landmark Supreme Court decision in Alice (Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347 (2014)) and Mayo (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)). While cases such as Alice and Mayo have presented significant changes related to the process of USPTO patent application examination, the Supreme Court has not provided clear guidance regarding court precedent in subject matter eligibility cases. In an attempt to provide improved direction, the USPTO has published “examination guidance” three times since Alice was decided.
In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction to prevent Sandoz from marketing its drug Zarxio®. Amgen v. Sandoz, No. 14-cv-04741-RS (N.D. Cal. Mar. 19, 2015). The ruling was consistent with the judge’s earlier statements regarding Amgen’s motions during a hearing held on March 13, 2015.
On March 6, 2015, the U.S. Food and Drug Administration (FDA) granted approval for Zarxio®, making the pharmaceutical company Sandoz the first company to win approval of a “biosimilar” product. Zarxio® is biosimilar to Amgen’s Neupogen® (filgrastim), which was originally approved for use in 1991 to stimulate the proliferation and differentiation of white blood cells. On July 24, 2014, Sandoz announced that the FDA had accepted its Biologics License Application (BLA) for filgrastim, an application which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).