Representative Matters
Served as lead defense counsel for BioDelivery Sciences Int’l, Inc. (BDSI) in two patent litigations, after BDSI was acquired by Collegium Pharmaceutical, Inc. in March of 2022. Cases were pending in the Eastern District of North Carolina where BDSI’s products Bunavail® (buprenorphine and naloxone) buccal film and Belbuca® (buprenorphine) buccal film were accused of infringing Aquestive Therapeutic’s U.S. Patent No. 8,765,167. The parties had been litigating for nearly a decade in federal district courts and in multiple proceedings before the Patent Trial and Appeal Board. After appearing as substitute counsel for BDSI, Robins Kaplan developed and asserted strategic patent infringement defenses and—in a little over eight months—reached a favorable settlement achieving complete freedom to market for BDSI. Aquestive Therapeutics, Inc. v. BioDelivery Sciences Int’l, Inc., Civ. No. 19-505-D (E.D.N.C.); Indivior Inc. v. BioDelivery Sciences Int’l, Inc., Civ. No. 15-350-D (E.D.N.C.)
Represented Bioeq AG with respect to intellectual property matters and licensing for Biologics License Application Number 761165 for the proposed biosimilar ranibizumab product, including a license agreement among Bioeq, Coherus, and Genentech, Inc. Coherus owns the BLA for CIMERLI (ranibizumab-egrn) and commercial rights in the U.S. and its territories. Coherus licensed CIMERLI from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG. Coherus announced the commercial availability, beginning October 3, 2022, of CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all approved indications. CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.
Trial counsel to the Trustees of the University of Pennsylvania in a patent infringement action against Eli Lilly, BMS, and ImClone related to the manufacture and sale of Erbitux. Penn asserted US Patent No. 7,625,558 related to treatment of certain cancers using antibodies to erbB receptors followed by radiation therapy. The case was resolved on confidential terms. The Trustees of the University of Pennsylvania v. Eli Lilly and Company, et al., No. 15-6133 (E.D. Pa.)
Represented Gurnet Point Capital in its acquisition of Radius Health, Inc. Performed patent, regulatory, and scientific diligence in support of transaction valued at $890 million. Radius markets Tymlos, a twice-daily injection indicated for post-menopausal women at risk for osteoporosis.
Represented Collegium Pharmaceutical, Inc. at the Patent Trial and Appeal Board in a Post-Grant Review challenging Purdue’s U.S. Patent No. 9,693,961. Collegium prevailed in demonstrating that all claims of the patent were invalid for lack of written description support and anticipation. Collegium Pharm., Inc. v. Purdue Pharma L.P., PGR2018-00048 (Final Written Decision Nov. 19, 2021).
Represented Collegium Pharmaceutical, Inc. in Hatch-Waxman patent litigation concerning a Section 505(b)(2) application for a pain treatment drug. Obtained summary judgment of non-infringement. Purdue Pharma L.P. v. Collegium Pharm., Inc., 335 F. Supp. 3d 149 (D. Mass. 2018).
Represented Collegium Pharmaceutical, Inc. in Hatch-Waxman patent litigation concerning the filing of its Supplemental NDA for a pain treatment drug. Argued motion to dismiss and obtained full dismissal of lawsuit. Purdue Pharma L.P. v. Collegium Pharm., Inc., No. 17-cv-11923 (D. Mass. 2018).
Represented Collegium Pharmaceutical, Inc. in its acquisition of BioDelivery Sciences International Inc. (“BDSI”). Performed patent and regulatory diligence for transaction valued at over $600 million. The acquisition included BDSI’s Belbuca, Symproic, and Elyxyb drug products.
Represented Collegium Pharmaceutical, Inc. in its purchase of the Nucynta franchise from Assertio Therapeutics, Inc. Performed patent and regulatory diligence for transaction valued at $375 million.
Defended Club Car, LLC in IPRs brought by competitor Yamaha Golf Car Company. Obtained complete victory in each of the four IPRs. PTAB ruled that no patent claim was invalid as anticipated or obvious. Yamaha Golf Car Co. v. Club Car, LLC, IPR2017-02141, et seq. (Final Written Decision Apr. 2, 2019).
Represented Medtronic in seventeen IPRs challenging five patents directed to guide extension catheters. Medtronic, Inc. v. Teleflex Innovations S.À.R.L., IPR2020-00126, et seq. (filed Nov. 12, 2019).
Represented Upsher-Smith Laboratories in Hatch-Waxman litigation concerning five Orange Book listed patents for the acne drug, Absorica. Sun Pharmaceutical Industries, Inc. v. Upsher-Smith Laboratories, No. 19-cv-02546 (D.N.J. 2019).
Represented Zenara Pharma Private Limited in Hatch-Waxman litigation concerning four Orange Book listed patents for a Gaucher disease drug, Cerdelga. Genzyme Corp. v. Zenara Pharma Private Limited, No. 18-cv-01795 (D. Del. 2018).
Represented Collegium Pharmaceutical Inc. in brand-on-brand pharmaceutical litigation relating to the sale of Nucynta. Purdue Pharma L.P. v. Collegium NF, LLC., No. 18-cv-00226 (D. Del. 2018).
Lead counsel in action that obtained habeas corpus relief for detained individual. Abdulkadir v. Sessions, No. 18-cv-2353 (NEB/HB), 2018 U.S. Dist. LEXIS 219431 (D. Minn. Nov. 13, 2018).
Represented Teva Pharmaceuticals in Hatch-Waxman litigation involving seven Orange Book listed patents for the extended-release Alzheimer’s drug, Namenda XR. Part of a team that invalidated six patents, on indefiniteness grounds, prior to trial. Forest Labs., Inc. v. Teva Pharms. USA, Inc., C.A. No. 14-121, 2016 U.S. Dist. LEXIS 322 (D. Del. Jan. 5, 2016), aff’d 716 F. App’x 987 (Fed. Cir. 2017). Upon completion of a four-day bench trial on the remaining patent, the matter settled for value. (Prior to joining Robins Kaplan LLP.)
Represented Teva Pharmaceuticals in Hatch-Waxman litigation concerning its ANDA for a pain management drug. After an eight-day bench trial, the court found each asserted patent was either not infringed and/or invalid. Purdue Pharma L.P. v. Teva Pharms., USA, Inc. (In re OxyContin Antitrust Litig.), 994 F. Supp. 2d 367 (S.D.N.Y. 2014), aff’d sub nom. Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir. 2016). (Prior to joining Robins Kaplan LLP.)
Represented Rust-Oleum in a trademark matter in the District of Minnesota. Was part of a team that defeated a motion for preliminary injunction. Plasti-Dip Int’l Inc. v. Rust-Oleum Brands Co., Civil No. 14-1831, 2014 U.S. Dist. LEXIS 174560 (D. Minn. Dec. 16, 2014). (Prior to joining Robins Kaplan LLP.)
Represented Breckenridge Pharmaceuticals in a Hatch-Waxman litigation relating to a cachexia drug, Megace ES. Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc., No. 13-cv-01114 (D. Del.) (Prior to joining Robins Kaplan LLP.)
March 2023
June 28, 2022
September 4, 2020
