ACCOLADES• TOP 5 Defense Firm in ANDA Cases by Lex Machina

• TOP 10 Law Firm for Pharmaceutical Industry by BTI Consulting Group

• Named THE TOP PERFORMING FIRM in inter partes review. (Patexia’s data analysis of cases from 2012–2016 concluded that Duane Morris has a 90 percent success rate.)

• Ranked a TOP FIRM representing petitioners before the PTAB, according to Unified Patents’ institutional success index.

• U.S. News-Best Lawyers recognizes Duane Morris with TOP-TIER national rankings in Patent Litigation and IP Litigation.

GENERIC PHARMACEUTICALS AND BIOSIMILARS

FULL SERVICE INCLUDES:• Hatch-Waxman Litigation and IPR

• FDA Regulation of Generic Drugs and Biosimilars

• Licensing, Contract Manufacturing and Other Agreements

• Trademark, Copyright and Trade Secret Prosecution and Litigation

• Corporate Practice: Business Growth and Operations; Regulatory and Compliance Services; International Trade and Customs; International Taxation

• Products Liability

• Commercial, Employment and Licensing Litigation

Duane Morris lawyers have significant experience with the complexities involved in bringing generic pharmaceuticals to market. Our experience involves a wide variety of technologies, including biotechnology processes and products; chemical processes, synthesis and products; medical devices; formulations; experiments; and polymorphic products.

OUR GENERIC PHARMACEUTICALS AND BIOSIMILARS PRACTICE team, composed of Ph.D.-attorneys, patent agents and a team of experienced litigators, as well as transactional lawyers, represents global generic pharmaceutical companies in their quest to enter the U.S. market with new products. We have significant experience in representing clients in litigation related to abbreviated new drug applications (ANDAs) filed under the Hatch-Waxman law, including inter partes review (IPR), as well as generation of non-infringement, invalidity and freedom-to-operate opinions with respect to patents listed in the Orange Book. Duane Morris coordinates with international networks of law firms to secure and maintain patent protection in the U.S. and abroad. We are proud to represent some of the largest generic pharmaceutical companies in the world.

BIOCHEMISTRY AND BIOTECHNOLOGYOur registered patent attorneys and agents have experience related to recombinant protein and antibody engineering technologies, rationally designed polypeptides and polynucleotides, production of biologic drugs, targeted drug delivery, and optimization and humanization of immunotherapeutics, to name a few.

EXAMPLES OF OUR WORK• Bayer Intellectual Property GMBH, Bayer Pharma AG, and Janssen

Pharmaceuticals, Inc. v. Prinston Pharmaceutical Inc., et. al., 15-CV-00902 (SLR) (D.Del.). Patent infringement action regarding Prinston’s ANDA to make a generic version of Janssen’s Xarelto®, the active ingredient of which is rivaroxaban.

• Eli Lilly & Co. et al. v. Amneal Pharmaceuticals LLC, 14-CV-02025 (SEB) (DML) (S.D. Ind.). Patent infringement action regarding Amneal’s ANDA to make a generic version of Lilly’s testosterone replacement product Axiron®, the active ingredient of which is testosterone.

• Inter Partes Review Nos. 2014-01041 and -01043. Representing Petitioner Metrics, Inc. in IPR of U.S. Patent Nos. 8,129,431 and 8,669,290, owned by Senju Pharmaceutical Co., Ltd., and listed in the FDA Orange Book for Senju’s ophthalmic product Prolensa®, the active ingredient of which is bromfenac sodium.

• Senju Pharmaceutical Co., Ltd., et al. v. Metrics, Inc. et al., 14-CV-3962 (JBS) (KMW) (D. N.J.). Patent infringement action regarding Metrics’ ANDA to make a generic version of Senju’s ophthalmic product Prolensa®, the active ingredient of which is bromfenac sodium.

• Astrazeneca, AB v. Wockhardt Bio AG, et al., 14-CV-667 (GMS) (Consolidated) (D. Del.). Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Astrazeneca’s diabetes product Onglyza®, the active ingredient of which is saxagliptin.

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www.duanemorris.com | © Duane Morris LLP 2017 | November 2017

This publication is for general information and does not include full legal analysis of the matters presented. It should not be construed or relied upon as legal advice or legal opinion on any specific facts or circumstances. The invitation to contact the attorneys in our firm is not a solicitation to provide professional services and should not be construed as a statement as to any availability to perform legal services in any jurisdiction in which such attorney is not permitted to practice.

• Cephalon, Inc. et al. v. Actavis LLC, 1:14-CV-00122 (GMS) (D. Del.). Patent infringement action regarding Actavis’ ANDA to make a generic version of Cephalon’s anti-cancer product Treanda®, the active ingredient of which is bendamustine hydrochloride.

• Otsuka Pharmaceutical Co., Ltd. v. Wockhardt Ltd. et al, 3:13-CV-06604 (D. N.J.). Represented Wockhardt in Paragraph IV litigation involving Otsuka’s oral Abilify®. Negotiated a settlement and license agreement permitting entry into the market prior to the expiration of the Orange Book Patents.

• Intelgenx Corp. v. Wockhardt Bio, AG, No. 13-5074-JBS-JS (D. N.J.). Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Edgemont Pharma’s antidepressant product Forfivo®, the active ingredient of which is bupropion hydrochloride.

• Janssen Pharma et al. v. Actavis Elizabeth, et al., 2:13-CV-04507 (CCC) (D. N.J.). Patent infringement action regarding Actavis’ ANDAs to make a generic version of Janssen’s pain products Nucynta® and Nucynta® ER, the active ingredient of which is tapentadol hydrochloride.

• Apotex Inc. et al. v. Otsuka Pharmaceutical Co., Ltd., No. 12-571 (U.S. Supreme Court). Represented Mylan Inc. as amicus curiae in support of petition of Apotex Inc. for writ of certiorari regarding appeal from a decision of the Federal Circuit upholding the validity of the patent covering the product Abilify®, the active ingredient of which is aripiprazole.

• In re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 12-514 (U.S. Supreme Court). Represented Generic Pharmaceutical Association (GPhA) as amicus curiae in support of petition of Mylan Pharmaceuticals, Inc. for writ of certiorari regarding appeal from a decision of the Federal Circuit upholding the validity of the patent covering the product Amrix®, the active ingredient of which is cyclobenzaprine hydrochloride.

• Warner-Chilcott Co. LLC et al. v. Ranbaxy, Inc., et al., 12-CV-2474 (FSH) (Consolidated) (D. N.J.). Patent infringement action regarding Ranbaxy’s ANDA to make a generic version of Warner-Chilcott’s osteoporosis product Atelvia®, the active ingredient of which is risedronate sodium.

• Pfizer Inc., et al. v. Wockhardt, Ltd., et al., 12-CV-817 (SLR) (Con-solidated) (D. Del.). Patent infringement action regarding Wock-hardt’s ANDA to make a generic version of Pfizer’s antidepressant product Pristiq®, the active ingredient of which is desvenlafaxine succinate.

• Aventis Pharma S.A. and Sanofi-Aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Case No. 08-496 (GMS) (D. Del. 2010). Patent infringement action regarding Apotex’s ANDA to make a generic version of Sanofi-Aventis’ anti-cancer product TAXOTERE®, the active ingredient of which is docetaxel. Following a two-week trial, obtained an order for Apotex striking down the patents in issue as invalid and unenforceable due to Sanofi-Adventis’ inequitable conduct in procuring the patents. Affirmed sub nom, Aventis Pharma S.A. and Sanofi-Aventis U.S., LLC v. Hospira, Inc., (Fed. Cir. 2012).

• Abbott Laboratories et al. v. Wockhardt, Ltd., et al., No. 11-cv-7046 (D. N.J.). Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, with Abbott and Alkermes regarding the drug Tricor.

• Genentech, et al. v. Sandoz, Case No. 11-CV-1925 (N.D. Cal. – J. White). Representing Sandoz in ANDA litigation regarding VALCYTE®, the active ingredient of which is valganciclovir.

• Shire LLC, et al. v. Sandoz Inc., No. 11-CV-01110 (RBJ) (KMT) (D. Col.). Patent infringement action regarding Sandoz’s ANDA to make a generic version of Shire’s ADHD product Intuniv®, the active ingredient of which is guanfacine hydrochloride.

• Avanir Pharmaceuticals, Inc., et al. v. Wockhardt, Ltd., et al., 11-CV-704 (Consolidated) (LPS) (D. Del.). Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Avanir’s PBA product Nuedexta®, the active ingredients of which are dextromethorphan hydrobromide and quinidine hydrobromide.

• Pfizer Inc., et al. v. Apotex, Inc., Case No. 10-CV-5257 (S.D. N.Y.) (LAK). Patent infringement action regarding Apotex’s ANDA to make a generic version of Pfizer’s migraine product Relpax®, the active ingredient of which is eletriptan hydrobromide.

FOR MORE INFORMATIONFor more information, please contact VINCENT L. CAPUANO, Ph.D., at 857.488.4250 or any of the lawyers listed on www.duanemorris.com.

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> Joint ventures in Myanmar, Oman, Shanghai and Singapore

> Alliances in Mexico and Sri Lanka

> Leadership positions with international networks of independent law firms

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