Evangeline Shih’s practice is focused on Hatch-Waxman litigation on behalf of innovator pharmaceutical companies and client counseling in the pharmaceutical industry. She handles all aspects of patent litigation, including pre-suit investigation, trial, and appeal. She also has considerable experience counseling clients on FDA and antitrust issues related to Hatch-Waxman litigation, obtaining patent protection, as well as formulating opinions and counseling clients with regard to freedom to operate, patentability, infringement, and validity analyses concerning a wide range of pharmaceutical, biological, and medical device products. In addition, she has experience before the U.S. Patent Trial and Appeal Board in post-grant covered business method and inter partes review proceedings. Evangeline was recognized as a “Rising Star” Super Lawyer in New York in 2011, 2012, and 2013 and as a Super Lawyer in New York since 2015. She has also been a member of the Advisory Board for the Fordham Law Neuroscience and Law Center since 2015.
Before joining the firm, Evangeline was a Partner in the New York office of Jones Day.
- Avanir Pharmaceuticals, Inc.
- Celgene Corporation
- Corcept Therapeutics Inc.
- Dow Chemical Company
- Gilead Sciences, Inc.
- Jazz Pharmaceuticals, Inc.
- Representing Celgene Corporation in proceedings relating to its Revlimid® (lenalidomide) product and Pomalyst® (pomalidomide) products.
- Representing Corcept Therapeutics Inc. in pending proceedings relating to its Korlym® (mifepristone) product.
- Representing Jazz Pharmaceuticals in pending proceedings relating to its Xywav® (sodium oxybate) product.
- Won a bet-the-company litigation for Avanir Pharmaceuticals, Inc. in a multi-defendant Hatch-Waxman action relating to its Nuedexta® (quinidine/dexamethorphan) product. Obtained ruling at the District Court in favor of Avanir, finding infringement and upholding the validity of the Company’s patents through 2026. This was affirmed by the Federal Circuit in 2015.
- Obtained favorable settlements for Celgene Corporation in Hatch-Waxman actions relating to its Istodax® (romidepsin) product.
- Obtained favorable settlements for Celgene Corporation in Hatch-Waxman actions relating to its Abraxane® (albumin-bound paclitaxel) product.
- Obtained favorable settlements for Gilead Sciences in two Hatch-Waxman actions relating to its Letairis® (ambrisentan) product.
- Obtained favorable settlements for Jazz Pharmaceuticals, Inc. in multiple Hatch-Waxman actions relating to its Xyrem® (sodium oxybate) product.
- Obtained a favorable settlement post-trial for King Pharmaceuticals, Inc. in a Hatch-Waxman action related to its Avinza® (morphine sulfate) product.
- Obtained a favorable settlement for Merz Pharmaceuticals, LLC in a Hatch-Waxman action relating to its Cuvposa® (glycopyrrolate) product.
- Obtained favorable settlements following a favorable claim construction and expert discovery for Merz Pharmaceuticals GmbH & Co. in a multi-defendant Hatch-Waxman action related to its Namenda® (memantine HCl) product.
- Obtained favorable settlements for Merz Pharmaceuticals GmbH & Co. in a multi-defendant Hatch-Waxman action related to its Namenda XR® (memantine HCl extended release) product.
- Obtained favorable settlements for Vivus, Inc. in two Hatch-Waxman actions relating to its Qsymia® (phentermine and topiramate-extended release) product.
- Successfully defended Jazz Pharmaceuticals, upholding the validity of the Company’s patent relating to methods of using the Company’s Xyrem® (sodium oxybate) product in an Inter Partes Review (IPR) proceeding. The USPTO denied institution of the IPR.
- Successfully defended Celgene Corporation, upholding the validity of the Company’s patent covering the active ingredient in the Company’s Revlimid® (lenalidomide) product in an Inter Partes Review (IPR) proceeding. The USPTO denied institution of the IPR.
- Successfully defended Dow Chemical Company, upholding the validity of the Company’s patents in two Inter Partes Review (IPR) proceedings. Obtained holding from the USPTO upholding the validity of all claims of the Company’s patents which was upheld on appeal at the Federal Circuit.
- Successfully defended Jazz Pharmaceuticals, defeating six Covered Business Method (CBM) patent reviews filed against the Company’s patents relating to its Xyrem® (sodium oxybate) product. In the first decisions of their kind, the USPTO denied institution of all six proceedings.
- Represented Adapt Pharmaceuticals in Hatch-Waxman actions relating to its Narcan® (naloxone) product.
- Represented Keryx Biopharmaceuticals, Inc. in Hatch-Waxman actions relating to its Auryxia® (ferric citrate) product.
- Represented Merck Sharp & Dohme B.V. in Hatch-Waxman actions relating to its Nuvaring® (etonogestrel/ethinyl estrodiol vaginal ring) product.
- Represented King Pharmaceuticals in a series of Hatch-Waxman actions related to its Skelaxin® (metaxalone) product.
- Represented King Pharmaceuticals in a series of Hatch-Waxman actions related to its Altace® (ramipril) product.
- Fordham University
(J.D., 2000)- International Law Journal:
- Associate Editor
- Associate Editor
- International Law Journal:
- Cornell University
(Cell, Biology and Genetics, 1995-1997) - Princeton University
(A.B., Molecular Biology, 1995)
- The State Bar of New York
- United States Court of Appeals:
- Federal Circuit
- United States District Courts:
- Southern District of New York
- Eastern District of New York
- Registered to Practice Before the United States Patent and Trademark Office
- Chinese
- Jones Day:
- Partner, 2011-2012
- Associate, 2004-2010
- Pennie & Edmonds:
- Associate, 2000-2003
- Super Lawyer Super Lawyer Metro New York (2015-present)
- “Rising Star” Super Lawyer Metro New York (2011, 2012, & 2013)
- Coauthor, “Who Let the Dogs Out? Lilly’s Zyprexa Patent Survives a Validity Attack,” Pharmaceutical Law Insight Vol 3 No 2 (2007).
- Coauthor, “Trk C Signaling Is Required for Retinal Progenitor Cell Proliferation,” J. of Neuroscience 20(8):2887-2895 (2000).