Michael Shen is a partner in Haynes and Boone's Intellectual Property Litigation Section. He has more than a decade of experience litigating IP matters before various federal district courts and the Federal Circuit as well as Section 337 investigations before the International Trade Commission. For the past few years, Mr. Shen has focused on assisting generic pharmaceutical companies with litigations under the Hatch-Waxman Act arising from the filing of Abbreviated New Drug Applications (ANDA). Mr. Shen also advises his clients on matters ancillary to Hatch-Waxman litigations, including invalidity and infringement issues and development of effective pre-trial and trial strategies based on the specific complexities of each case.
In addition to ANDA litigations, Mr. Shen has second-chaired numerous patent litigation cases on behalf of patentees and alleged infringers in technological fields such as electrical connectors, electronics, chemical processes, industrial and food chemicals, and medical devices. Mr. Shen's practice also includes counseling clients and rendering legal opinions regarding various IP issues with a focus on helping Chinese companies enter the U.S market.
Mr. Shen has been invited on multiple occasions to give presentations in China and Taiwan on patent and ANDA litigation, antitrust and ITC issues. Mr. Shen co-authored a chapter on ANDA litigation from the perspective of the generic pharmaceutical industry in the ABA/BNA Patent Litigation Strategies Handbook and is an editor of the Patent Litigation Chapter in the ABA's Annual Review of Intellectual Property Law.
Mr. Shen was a partner at a major intellectual property boutique prior to joining Haynes and Boone.
Representative ITC Matters
In re Certain Rubber Antidegradants (337-TA-652). Represented Chinese manufacturer of rubber antidegradants, and successfully obtained dismissal terminating investigation before any discovery.
In re Certain Sucralose (337-TA-604). Represented Chinese manufacturer of sucralose (aka Splenda®). Successfully obtained finding of non-infringement and invalidity after a 5-day trial.
In re Certain Rubber Antidegradants (337-TA-533 on Remand). Represented Chinese manufacturer of rubber antidegradants. Obtained ruling of non-infringement under doctrine of equivalents.
Representative Federal Court Matters
- Eisai Inc. v. Banner Pharmacaps Inc. (D. Del. 2011). Representing Banner in ANDA case concerning Targretin (bexarotene).
- GlaxoSmithKline LLC v. Banner Pharmacaps Inc. (D .Del. 2011). Representing Banner in ANDA case concerning Avodart (dutasteride).
- GlaxoSmithKline LLC v. Impax Labs. (D. Del. 2011). Representing Impax in ANDA case concerning Jalyn (dutasteride + tamsulosin).
- Shinonogi Pharma et al. v. Impax Labs. (D. Del. 2010). Representing Impax in ANDA case concerning Fenoglide (fenofibrate).
- In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (D. Del. 2009). Representing Impax in ANDA case concerning Amrix.
- Pfizer et al. v. Impax Labs. (D. N.J. 2008). Representing Impax in ANDA case concerning Detrol LA (tolterodine tartrate).
- Purdue Pharma et al. v. Impax Labs. (D. Del. 2008). Represented Impax in ANDA case concerning Ultram ER (tramadol). Dismissed.
- Flexsys America v. Sinorgchem Shandong et al. (N.D. Ohio 2005). Represented Chinese defendant in parallel action related to ITC investigations concerning rubber antidegradants. Obtained summary judgment of non-infringement.
- Impax Labs. v. Aventis (Fed. Cir. 2005 and 2007). Represented Impax in appeals relating to Rilutek (riluzole), a drug used for treating Lou Gehrig's disease.
- FCI USA v. Molex (D. Del. 2007) and FCI USA v. Tyco Electronics (E.D.Tex. 2006). Represented patentee in asserting patents relating to shieldless, high-speed backplane electrical connectors. Obtained favorable licensing terms for FCI.
- Calmedica v. Novoste (N.D. Ga. 2004). Represented defendant in case relating to radioactive catheter systems. Case voluntarily dismissed by plaintiff after obtaining favorable Markman ruling.
- Air Liquide America v. P.H. Glatfelter (M.D. Pa. 2004). Represented patentee in case relating to process for bleaching wood pulp using ozone. Obtained favorable settlement.
- FCI USA v. Foxconn Electronics (N.D. Cal. 2003). Represented patentee in a case relating to BGA electrical connectors. Settled after obtaining favorable Markman ruling.
- FCI USA v. Hon Hai Precision Industry (N.D. Cal. 2001). Represented patentee FCI in case relating to BGA computer sockets. Obtained summary judgment of infringement and jury verdict of willful infringement with past damages award of $8 million.
- Laerdal Medical v. Philadelphia Cervical Collar (D.N.J. 1999). Represented patentee in patent and trade secret case relating to emergency cervical collars. Obtained favorable settlement.
- Alcon Labs. v. Bausch & Lomb (N.D. Tex. 1999). Represented patentee Alcon Labs. in case relating to Tobradex™ eyedrops. Obtained preliminary injunction.
Speeches
"Section 337 Litigation Before the ITC," June 12, 2010, Chongqing IP Office Training Program, Chongqing, China.
- "The Most Significant Differences In Patent Litigation Between China and the U.S.," June 12, 2010, Chongqing IP Office Training Program, Chongqing China.
- "Section 337 Investigations - Recent Developments in the ITC," April 26, 2008, Chinese Anti-Monopoly Law and the Regulation of Intellectual Property Rights Abuse Seminar, Beijing, China.
- "Recent Developments in Antitrust," January 20, 2007, International Conference in Globalization and the Protection of Intellectual Property Rights, Beijing, China.
Publications
- "'Pay-for-Delay' Settlements: Antitrust Violation or Proper Exercise of Pharmaceutical Patent Rights?" co-author, Business Law Today, ABA Business Law Section, January 27, 2011.
- ABA/BNA Patent Litigation Strategies Handbook, Chapter 6: Waxman-Hatch Litigation From the Perspective of the Generic Pharmaceutical Industry.
- International Pharmaceutical Law & Practice, Chapter 19: United States.
Awards
- 2008 Thurgood Marshall Award for Capital Representation