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Thomas H. Wintner

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[email protected]

+1.617.348.1625

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Tom is an intellectual property and commercial litigator who is equally at home handling cases in trial and appellate courts, as well as in arbitration.  He has extensive experience with patent litigation, trade secrets, and other intellectual property matters, especially in the life sciences.  Tom also has extensive experience with non-IP commercial litigation matters on behalf of life sciences, health care, higher education, and real estate clients.  He has successfully defended numerous class actions in both federal and state court.

Tom's intellectual property work draws on his prior experience as a research chemist and college dean. He has handled patent and trade secret matters involving all forms of biotechnology (including molecular and cellular engineering, diagnostics, sequencing, etc.), the Hatch-Waxman Act (for small molecule drugs), and the Biologics Price Competition and Innovation Act (for large-molecule biologics/biosimilars).  He also has led successful trial teams before the International Trade Commission and the Patent Trial and Appeal Board (IPRs/PGRs).

Tom clerked for the Honorable Boyce F. Martin Jr. on the United States Court of Appeals for the Sixth Circuit. Before attending law school, he served as Associate Dean of the Faculty at Williams College.

Education

  • University of Virginia (JD)
  • Harvard University (MA, Bioorganic Chemistry, NSF Fellow)
  • University of Siegen (Fulbright Scholar)
  • Williams College (BA, Chemistry, summa cum laude)

Experience

Trial

  • In the Matter of Certain Human Milk Oligosaccharides and Methods of Producing the Same, Investigation No. 337-TA-1120 (International Trade Commission, May 2019): Co-lead counsel for patent owner in trial involving methods of engineering bacteria to produce oligosaccharides; obtained Initial Determination of infringement and validity from ALJ; obtained affirmance and Limited Exclusion Order from Commission, covering infringing 2’-fucosyllactose oligosaccharides.
  • Kowa Company, Ltd., et al. v. Amneal Pharmaceuticals, LLC, et al., Nos. 14-2758 and 14-7934 (S.D.N.Y., April 11, 2017 and September 19, 2017) (Crotty, J.), affirmed, No. 2018-1051 (Fed. Cir. Dec. 10, 2018): Client’s chemical compound and polymorph patents covering Livalo, an HMG-CoA reductase inhibitor, held valid and infringed over anticipation, obviousness, and double-patenting challenges; defendants’ ANDA approval enjoined.
  • Mitsubishi Chemical Corp. v. Barr Laboratories, Inc., 718 F. Supp. 2d 382 (S.D.N.Y. 2010) (Koeltl, J.), affirmed, No. 2010-1432, 2011 WL 3288394 (Fed. Cir. Aug. 2, 2011): Client’s patent covering high concentration formulation of Argatroban Injection, an anticoagulant, held valid over anticipation and obviousness challenges; defendant’s ANDA approval enjoined.
  • Daley/Taylor v. Avellino, Nos. NACV2009-09/10 (Mass Super. Ct. May 9, 2011) (Cratsley, J.): Successfully obtained reversal of jury verdict on appeal, based on statute of limitations grounds.
  • Roquette Frères v. SPI Pharma, Inc., No. 06-540 (D. Del. Oct. 4, 2010) (Sleet, C.J.): Successfully defended patent infringement action involving pulverulent mannitol.

Appellate

  • Conley v. Roseland Residential Trust, No. 20-1399 (1st Cir.): (Pending).
  • Kowa Company, Ltd., et al. v. Amneal Pharmaceuticals, LLC, No. 2018-1051 (Fed. Cir. Dec. 10, 2018): Obtained affirmance of district court judgment upholding client’s patents over anticipation, obviousness, and obviousness-type double patenting challenges.
  • Phillips v. Equity Residential Management, L.L.C., 85 N.E.3d 12 (Mass. 2017): Obtained answer to certified question in favor of client regarding availability of treble damages in certain circumstances under the MA Security Deposit Statute, G.L. c. 186, § 15B. 
  • Green Cross Corp. v. Shire Human Genetic Therapies, Inc., Appeal No. 2017-2071 (Fed. Cir.): Dismissed.
  • Phillips v. Equity Residential Management, L.L.C., 844 F.3d 1 (1st Cir. 2016): Obtained favorable ruling and settlement in landlord-tenant class action, following certification of question to Supreme Judicial Court.
  • Heien, et al. v. Archstone, et al., 837 F.3d 97 (1st Cir. 2016): Obtained affirmance of district court’s substantial limitation on fee award to class counsel (6.8% of amount sought) in a class action settlement over fees paid by prospective tenants.
  • Daley/Taylor v. Avellino, No. 2012-P-0736 (Mass. App. Ct. April 18, 2013): Obtained complete reversal of judgment on jury verdict, based on statute of limitations grounds.
  • Rota-McLarty v. Santander Consumer USA Inc., 700 F.3d 690, (4th Cir. 2012): Obtained reversal of district court judgment denying motion to compel arbitration in a putative class action.
  • DeLia v. Verizon Communications Inc., 656 F.3d 1 (1st Cir. 2011): Obtained affirmance of district court summary judgment in favor of client on various employment law claims.
  • Mitsubishi Chemical Corp. v. Barr Laboratories, Inc., No. 2010-1432, 2011 WL 3288394 (Fed. Cir. Aug. 2, 2011): Obtained affirmance of district court judgment upholding client’s patent over anticipation and obviousness challenges.
  • Boston Telecommunications Group, Inc. v. Wood, 588 F.3d 1201 (9th Cir. 2009): Obtained reversal of district court’s dismissal on forum non conveniens grounds, overcoming abuse of discretion review.
  • Simmons v. Galvin, 575 F.3d 24 (1st Cir. 2009): Application of the Voting Rights Act of 1965 to felon disenfranchisement laws. Appealed to US Supreme Court (No. 09-920) and referred to Solicitor General (May 3, 2010), but certiorari ultimately denied (Oct. 18, 2010).

Patent Office Proceedings

  • Laboratory Corporation of America Holdings v. Quest Diagnostics Investments LLC, IPR2019-00738, IPR2019-01425, IPR2019-01618: (Pending).
  • Laboratory Corporation of America Holdings v. Quest Diagnostics Investments LLC, IPR2019-01517: On behalf of diagnostic company patent owner, obtained decision denying institution of IPR.
  • Jennewein Biotechnologie GmbH v. Glycosyn LLC, PGR2019-00023: On behalf of biotechnology patent owner, obtained decision denying institution of PGR.
  • Indivior Inc. v. Rhodes Pharmaceuticals L.P., IPR2018-00795, Paper No. 23 (Oct. 4, 2018): Decision involving methods of opioid substitution therapy using buprenorphine sublingual film.
  • Ethertronics, Inc. v. Nextivity, Inc., DER2016-00021, Paper No. 35 (PTAB Oct. 2, 2017): On behalf of respondent, obtained decision denying institution of derivation proceeding.
  • Green Cross Corp. v. Shire Human Genetic Therapies, Inc., IPR2016-00258, Paper No. 89 (PTAB March 22, 2017): Decision involving actual reduction to practice of recombinant protein.
  • Mylan Pharmaceuticals, Inc. v. Nissan Chemical Industries, Ltd., IPR2015-01069, Paper No. 24 (PTAB Oct. 20, 2015):  On behalf of pharmaceutical company patent owner, obtained decision denying institution of IPR.
  • Sawai USA, Inc., et al. v. Nissan Chemical Industries, Ltd., IPR2015-01647, Paper No. 9 (PTAB Feb. 4, 2016): On behalf of pharmaceutical company patent owner, obtained decision denying institution of IPR.
  • Sawai USA, Inc., et al. v. Nissan Chemical Industries, Ltd., IPR2015-01648, Paper No. 9 (PTAB Feb. 4, 2016): On behalf of pharmaceutical company patent owner, obtained decision denying institution of IPR.

Other Litigation 

  • SoClean, Inc. v. Sunset Healthcare Solutions, Inc., No. 20-10351-IT (D. Mass.): Lead counsel in patent infringement action involving devices for disinfection of CPAP machines.
  • Conley v. Roseland Residential Trust, No. 18-10629-WGY (D. Mass. 2020): Obtained summary judgment in favor of defendant and denial of state-wide class certification on novel questions of law regarding gas and water/sewer submetering in Massachusetts.
  • Amgen, Inc. v. Tanvex BioPharma USA, Inc., No. 19-01374 (S.D. Cal.): Obtained settlement in BPCIA (biologics/biosimilars) case involving methods for refolding proteins.
  • Lead counsel for commercial arbitration involving the glass recycling industry: obtained 7-figure judgment and award of attorney's fees following hearing (2019).
  • Co-lead counsel for commercial arbitration involving trade secrets and the cell tower industry.
  • CellInfo, LLC v. American Tower Corporation, et al., No. 18-11250 (D. Mass. 2018): Won motion to dismiss in favor of arbitration in trade secrets action.
  • Phillips v. Equity Residential Management, L.L.C., No. 13-12092-RWZ (D. Mass.): Successfully resolved class action filed on behalf of tenants alleging violations of the MA Security Deposit Statute; obtained favorable ruling from SJC on certified question.
  • Rhodes Pharmaceuticals L.P. v. Indivior Inc., No. 16-cv-01308-MSG (D. Del.): Obtained pre-institution stay of litigation in favor of IPR proceedings.
  • Baker v. Equity Residential Management, L.L.C., No. MICV2013-03630 (Mass. Super. Ct.) (pending): Putative class action involving alleged heat and hot water violations pursuant to G.L. c. 186, § 14.
  • Perry, et al. v. Equity Residential Management, L.L.C., No. 12-10779 (D. Mass.):  Successfully resolved seven class actions filed on behalf of tenants in MA challenging various fees collected in advance of move-in; won summary judgment on certain challenged fees.
  • Takeda Pharmaceutical Co. v. Mylan, Inc., No. 12-00024 (S.D.N.Y.): Hatch-Waxman action involving multiple Orange Book–listed patents covering  ActoplusMet XR, an extended-release combination product for treatment of type 2 diabetes.
  • Hy-Ko Products Company v. The Hillman Group, Inc., No. 08-1961 (N.D. Ohio): Patent infringement action involving key duplication technology.
  • Boston Telecommunications Group, Inc. v. Wood, No. 02-05971 (N.D. Cal.): Dispute over investment in cable television venture.
  • American Tower, Inc. v. Woodcrest Co., No. 2009-1309 (Ark. Cir. Ct., Pulaski County): Dispute over cell tower lease.

Recognition & Awards

  • Included on the Massachusetts Super Lawyers - Intellectual Property list (2018-2019)
  • Identified in the IAM Patent 1000, a listing of the “World’s Leading Patent Practitioners” (2020)

Involvement

  • Board of Trustees, Massachusetts Social Law Library
  • Chair, Board of Trustees, YMCA Camp Belknap, Wolfeboro, New Hampshire
  • Editor, Massachusetts Discovery Practice (MCLE, 3rd ed. 2019)
  • Member, American Chemical Society

Languages

- French

- German

- Spanish

Viewpoints

Education and Nonprofits Viewpoint Thumbnail

COVID-19 Tuition and Fees Lawsuits: Defending University Practices and Defeating Class Claims

June 26, 2020 | Blog | By Thomas Wintner, Mathilda McGee-Tubb

Across the United States, students have brought over 100 class action lawsuits against public and private colleges and universities seeking refunds of tuition, fees, and room and board expenses after schools closed their physical facilities, including their classrooms and residence halls, in response to the COVID-19 pandemic.
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Intellectual Property Viewpoints Thumbnail

Federal Circuit Upholds Application of Dedication-Disclosure Doctrine at the Pleading Stage

May 15, 2020 | Blog | By Thomas Wintner, Adam Samansky, Nana Liu

On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, No. 19-1924. 
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Viewpoint Thumbnail

Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

December 20, 2019 | Blog | By Thomas Wintner, Peter Cuomo, Nana Liu

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion for new trial, in Amgen Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102.  
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Viewpoint Thumbnail
On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”).  The USMCA, if ratified by each respective country, would replace the North American Free Trade Agreement (“NAFTA”), which has been in effect since January 1, 1994. 
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On December 19, 2017, an expanded panel of the Patent Trial and Appeal Board (PTAB) ruled that the state of Minnesota waived its Eleventh Amendment immunity to challenges to patent validity by inter partes review (IPR) by filing suit in federal court alleging infringement of the same patent being challenged by IPR. 
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Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

December 18, 2017 | Blog | By Thomas Wintner, Joe Rutkowski

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize biosimilars applicants who fail to disclose information about their abbreviated Biologics License Applications (“aBLAs”) or manufacturing processes as required by 42 U.S.C. § 262(l)(2)(A).
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In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did not infringe an Amgen protein folding patent.
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Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

June 14, 2017 | Blog | By Thomas Wintner, Joe Rutkowski

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”).
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Amgen Sues Coherus Under BPCIA After Completing Patent Dance

May 17, 2017 | Blog | By Thomas Wintner, Joe Rutkowski

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product.
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On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010.
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News & Press

An article published by Law360 reported that following the U.S. International Trade Commission’s initial decision that Jennewein Biotechnologie GmbH’s imports infringe a Glycosyn LLC patent on human milk oligosaccharides, the Patent Trial and Appeal Board denied Jennewein’s petition for post-grant review of a related patent.

The Mintz team representing Glycosyn at the ITC includes Michael Newman, Thomas Wintner, Michael Renaud and James Wodarski; and the Mintz team representing Glycosyn at the PTAB includes Michael Newman, Thomas Wintner, Peter Cuomo and Daniel Weinger.
Mintz has secured a string of substantial victories in Hatch-Waxman litigation for innovative drug manufacturers Kowa Pharmaceutical Co., Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries Ltd.
Tom Wintner is quoted in this Law360 article on Sandoz’s efforts to have the U.S. Supreme Court review a Federal Circuit ruling that “found biosimilar makers must wait until their products receive U.S. Food and Drug Administration (FDA) approval before providing 180-day advance notice of sales.”