Michael Shen is a partner in Haynes and Boone's Intellectual Property Litigation Section. He has 15 years of dedicated experience litigating IP matters, particularly patent litigations. He has tried cases both before a judge and jury before various federal district courts and has handled appeals at the Federal Circuit. He also has trial experience before the International Trade Commission where he has successfully represented Chinese companies in Section 337 investigations. Mr. Shen has second-chaired numerous patent litigations on behalf of both patentees and alleged infringers in diverse technologies such as electrical connectors, electronics, chemical processes, industrial and food chemicals, medical devices, and pharmaceuticals. For the past several years, however, Mr. Shen has focused his practice on assisting generic pharmaceutical companies with patent litigations under the Hatch-Waxman Act arising from the filing of Abbreviated New Drug Applications (ANDA).
In addition to litigation, Mr. Shen's practice also includes counseling clients and rendering legal opinions regarding various IP issues. His counseling experience includes advising his generic pharmaceutical clients on matters ancillary to ANDA litigations, including rendering opinions on invalidity and infringement issues and developing effective pre-trial and trial strategies based on the specific complexities of each case. Utilizing his cultural background and language skills, Mr. Shen is also able to provide valuable counseling advice to assist Chinese companies in navigating IP issues when entering the U.S. market.
Mr. Shen has been invited on multiple occasions to give presentations in China and Taiwan on patent and ANDA litigations, antitrust laws, and ITC investigations. 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 was an editor of the Patent Litigation Chapter in the ABA's Annual Review of Intellectual Property Law.
Mr. Shen was a partner at a prominent intellectual property boutique prior to joining Haynes and Boone. In addition to his law degree, he holds a B.S. in Chemical Engineering.
In re Certain Rubber Antidegradants
Representative ITC Matters
(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. and Impax Labs (D .Del. 2011). Representing Banner in ANDA case concerning Avodart (dutasteride) and Jalyn (dutasteride + tamsulosin). Trial in January 2013 and awaiting decision.
- Shinonogi Pharma et al. v. Impax Labs. (D. Del. 2010). Represented Impax in ANDA case concerning Fenoglide (fenofibrate). Settled favorably.
- 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). Represented Impax in ANDA case concerning Detrol LA (tolterodine tartrate). Settled favorably.
- 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 claim construction ruling for client.
- 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.
- "Abbreviated New Drug Application (ANDA) Litigation," Nov. 15, 2012, Taipei, Taiwan.
- "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," Jan. 20, 2007, International Conference in Globalization and the Protection of Intellectual Property Rights, Beijing, China.
- "Recent U.S. Court Decisions Regarding Section viii 'Carve-Outs,'" co-author, Haynes and Boone Alert, May 15, 2012.
- Annual Review of Intellectual Property Law Developments 2011, editor, ABA Section of Intellectual Property Law.
- "'Pay-for-Delay' Settlements: Antitrust Violation or Proper Exercise of Pharmaceutical Patent Rights?" co-author, Business Law Today, ABA Business Law Section, Jan. 27, 2011.
- ABA/BNA Patent Litigation Strategies Handbook, Chapter 6: Waxman-Hatch Litigation From the Perspective of the Generic Pharmaceutical Industry, co-author.
- International Pharmaceutical Law & Practice, Chapter 19: United States, co-author.
- 2008 Thurgood Marshall Award for Capital Representation
09/30/2013 - The IP Beacon, September 2013
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.
07/26/2013 - No Written Description for Claim to Species Based on Generic Disclosure Says the Federal Circuit
In Novozymes A/S v. DuPont Nutrition Biosciences APS
, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.
06/28/2013 - Method Claims Invalid for Lack of Enablement: The Federal Circuit’s Recent Decision in Wyeth and Cordis Corp. v. Abbott Laboratories
In Wyeth and Cordis Corp. v. Abbott Laboratories
, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope.
05/16/2013 - Nuggets in the Ashes: A Few Guideposts Unearthed from CLS Bank v. Alice Corporation
The Federal Circuit released the results of its en banc
hearing of a case involving the issue of what is patent eligible subject matter under section 101 of the Patent Act.
05/15/2012 - Recent U.S. Court Decisions Regarding Section viii "Carve-Outs"
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” This alert provides a detailed discussion of these cases.
03/31/2011 - Hatch-Waxman Litigation Alerts: New Jersey Amends Local Patent Rules
01/27/2011 - "Pay-for-Delay" Settlements: Antitrust Violation or Proper Exercise of Pharmaceutical Patent Rights?
How the judiciary and Congress are dealing with the increased use of reverse payment settlements in the pharmaceutical industry.
10/01/2010 - The IP Beacon, October 2010