Photo of Terri Shieh-Newton

Terri Shieh-Newton is a Member in the firm and is based in the San Francisco office. Her practice focuses on strategic patent counseling, comprehensive portfolio management, construction of valuable portfolios, preparation and prosecution of patent applications, interferences, reissues, and reexaminations in the life sciences and clean technology sectors. Terri manages and conducts due diligences, conducts freedom-to-operate analyses, and renders patentability and invalidity opinions. She also evaluates patent landscapes for clients seeking to enter competitive markets, and advises clients on third-party challenges and risk mitigation strategies.

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.

Continue Reading Extension of U.S. Patent and Trademark Office’s Cancer Immunotherapy Pilot Program

Effective June 29, 2016, the United States Patent and Trademark Office (USPTO) implemented a pilot program to provide for earlier review of patent applications pertaining to cancer immunotherapy.  The Cancer Immunotherapy Pilot Program was established in support of the White House national $1 billion initiative to achieve ten years’ worth of cancer research in the next five years as part of the National Cancer Moonshot initiative. The Cancer Immunotherapy Pilot Program aims to complete examination of an application within 12 months of the special status being granted. The patent applications that qualify will be advanced out of turn for examination without meeting all the current requirements of the accelerated examination program.

The Cancer Immunotherapy Pilot Program will run 12 months until June 29, 2017. Applicants who are interested in participating in the program should file a petition to make special under the Cancer Immunotherapy Pilot Program.

Continue Reading USPTO Fast-Tracks Cancer Immunotherapy Patent Applications

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.”

Continue Reading Pitfalls When Refiling a Priority Application under Article 4 of the Paris Convention

Join us for the first webinar in our five-part Biologics/Biosimilars series, “Legal and Regulatory Overview” tomorrow, January 7, 2016 at 3:00 PM ET, featuring Terri Shieh-Newton and Joanne Hawana!

Mintz Levin is running a series of webinars to educate our clients and friends on developments in the biosimilars space. A cross-practice team of professionals from the IP, Health and Litigation sections are collaborating to present on Patent Prosecution, Health Regulatory, FDA, Patent Litigation, Transactional and Products Liability issues. Anyone working in the biotechnology space will be interested in at least one (and probably more) of these presentations.

Subsequent presentations:

Part II: FDA/Regulatory — January 28 | 3:00 pm ET

Part III: BPCIA Patent Litigation — February 25 | 3:00 pm ET

Part IV: Transactions and Patent Portfolios — March 17 | 3:00 pm ET

Part V: Post-Market Legal and Regulatory Issues — April 7 | 3:00 pm ET

Additional Information about each of the five sessions is available here, as is a link to the registration page from which you may sign up for any or all of the seminars.

Terri and JoanneMintz Levin is running a series of webinars to educate our clients and friends on developments in the biosimilars space.  A cross-practice team of professionals from the IP, Health and Litigation sections are collaborating to present on Patent Prosecution, Health Regulatory, FDA, Patent Litigation, Transactional and Products Liability issues.  Anyone working in the biotechnology space will be interested in at least one (and probably more) of these presentations. The first webinar, “Part 1: Legal and Regulatory Overview,” will be held January 7, 2016, and will feature Terri Shieh-Newton, PhD, and Joanne Hawana.

Subsequent presentations:

Part II:  FDA/Regulatory — January 28  |  3:00 pm ET

Part III: BPCIA Patent Litigation — February 25  |  3:00 pm ET

Part IV: Transactions and Patent Portfolios — March 17  |  3:00 pm ET

Part V:  Post-Market Legal and Regulatory Issues — April 7  |  3:00 pm ET

Additional Information about each of the five sessions is available here, as is a link to the registration page from which you may sign up for any or all of the seminars.

 

 

 

Fed CircuitOn June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed the Northern District of California’s finding that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting paternally-inherited cell-free fetal DNA (“cffDNA”) in maternal plasma or serum were invalid because these claims were not directed to patent eligible subject matter (Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 2014-1139, 2014-1144 (Fed. Cir., June 12, 2015)). The inventors of the ‘540 patent established methods for detecting paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The Court applied a 2 part test as set forth in Mayo (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (U.S. 2012)) and held that “[w]here claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine, and well understood applications in the art.” Continue Reading Fed Circuit: Sequenom’s Diagnostic Method Claims Invalid Under §101

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).

Continue Reading District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio