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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. Tom counsels clients in a variety of industries, including life sciences, health care, education, and real estate. He has extensive experience with patent litigation and other intellectual property matters, especially those involving pharmaceutical and biologic drugs and diagnostics. Tom also has extensive experience with class action litigation 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 particular experience in patent cases involving pharmaceuticals, biotech, diagnostics, the Hatch-Waxman Act (for small molecule drugs), and the Biologics Price Competition and Innovation Act (for large-molecule biologics/biosimilars).  He also handles matters before the International Trade Commission and the Patent Trial and Appeal Board.

Outside of intellectual property, Tom handles a variety of commercial litigation matters, including class action defense.

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

  • 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.):  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.
  • Massachusetts Housing Court (various).

Appellate

  • 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.) 
  • 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

  • Indivior Inc. v. Rhodes Pharmaceuticals L.P., IPR2018-00795 (pending).
  • 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 

  • Iona and Alexander Conley v. Roseland Residential Trust and NWP Services Corp., No. 18-cv-10629-WGY (D. Mass.): Putative class action involving utility submetering and MA Security Deposit Statute.
  • 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)

Involvement

  • Board of Trustees, Massachusetts Social Law Library
  • Board of Trustees, YMCA Camp Belknap, Wolfeboro, New Hampshire
  • Editor, Massachusetts Discovery Practice (MCLE, 3rd ed. 2017)
  • Member, American Chemical Society

Languages

- French

- German

- Spanish

Recent Insights

News & Press

Viewpoints

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. 
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).
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.
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”).
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.
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.
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price Competition and Innovation Act (“BPCIA”) “patent dance” information exchange process may expose the biosimilar maker to eventual infringement damages in the form of lost profits, and preclude limiting damages to a reasonable royalty.
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to commercialize a biosimilar version of Genentech’s cancer drug, Avastin®.
Nondisclosure or confidentiality agreements (NDAs) are among the most common documents attorneys draft and review for clients.  They are so common, in fact, that where a client needs to execute a large number of facially distinct but substantively similar NDAs, it may make sense for the client to draft and review these documents itself.
Our colleague Patricia Moran wrote an excellent post on our sister blog, Employment Matters. Moran notes that employers should consider changes to their compensation structures that will affect their employee benefit plans.

News & Press

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.”