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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. While his practice focuses on the life sciences – particularly patent litigation, trade secrets litigation, and commercial litigation involving scientific or clinical disputes – he has also successfully represented clients in other industries and in a variety of types of commercial litigation, particularly class action defense.

In helping to explain life sciences technologies to judges, juries, and arbitrators, Tom draws on his prior experience as a research chemist and college dean. He has handled patent and trade secret litigation matters involving all forms of biotechnology (including drugs, vaccines, devices and delivery vehicles, diagnostics, sequencing, molecular and cellular engineering, 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). In private arbitration, he has led successful teams in disputes over collaboration agreements, licensing agreements, clinical trial agreements, supply agreements, and trade secrets.

According to the editors of IAM Magazine in its "Patent 1000" publication, “Wintner shines in trial courts, at the Federal Circuit, at the PTAB and in arbitral forums, with a talent for complex pharmaceutical and biotechnology litigations.”

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.

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. While his practice focuses on the life sciences – particularly patent litigation, trade secrets litigation, and commercial litigation involving scientific or clinical disputes – he has also successfully represented clients in other industries and in a variety of types of commercial litigation, particularly class action defense.

Experience

Trial/District Court/ITC (Patent/Trade Secrets/Commercial)

  • Aviceda Therapeutics, Inc. v. Trial Runners, LLC, No. 23-cv-12468-IT (D. Mass. 2023): Lead counsel for plaintiff in breach of contract action between biotechnology company and CRO regarding clinical trial agreement.
  • Chr. Hansen HMO GmbH v. Glycosyn LLC v. Abbott Lab’s, No, 22-11090-NMG (D. Mass. 2022): Co-lead counsel for patent owner in case involving methods of engineering bacteria to produce 2’-fucosyllactose used in infant formula.
  • Sigma-Aldrich Co. v. Quantabio, LLC; QIAGEN Beverly, LLC; and QIAGEN GmbH, No. 22-cv-00090-JAR (D. Mo.): Counsel for defendant in license dispute involving detergents for stabilization of nucleic acids used in amplification reactions.
  • In the Matter of Certain Graphics Systems, Components thereof, and Digital Televisions Containing the Same, Investigation No. 337-TA-1318 (International Trade Commission, March 2023): Trial counsel for complainants in case involving texture decompression in digital graphics applications; obtained Initial Determination of infringement and validity from ALJ.
  • Palleon Pharmaceuticals Inc. v. Aviceda Therapeutics, LLC, No. 21-10755 (D. Mass.): Lead counsel in successfully defended Aviceda in biotechnology trade secrets action involving glycobiology; obtained dismissal of complaint against company and co-founders.
  • SoClean, Inc. v. Sunset Healthcare Solutions, Inc., No. 21-10131 and 20-10351 (D. Mass.): Lead counsel in patent and trademark infringement actions involving devices for sanitizing CPAP machines; successfully obtained preliminary injunction on trademark claims (affirmed by Federal Circuit on appeal).
  • Nanoco Technologies Ltd. v. Samsung Electronics Co., No. 20-00038 (E.D. Tx.): Trial counsel in patent infringement action involving nanoparticle quantum dot semiconductors and methods of producing same; obtained $150 million settlement prior to 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 trial counsel for patent owner in case involving methods of engineering bacteria to produce 2’-fucosyllactose; obtained Initial Determination of infringement and validity from ALJ; obtained affirmance and Limited Exclusion Order from Commission and from Federal Circuit Court of Appeals.
  • Amgen, Inc. v. Tanvex BioPharma USA, Inc., No. 19-01374 (S.D. Cal.): Lead counsel in BPCIA (biologics/biosimilars) case involving methods for refolding proteins.
  • 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, and defeated subsequent motion to reopen case following arbitration.
  • 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), affirmed, No. 2018-1051 (Fed. Cir. Dec. 10, 2018): Trial counsel for plaintiff in Hatch-Waxman action involving chemical compound and polymorph patents covering Livalo, an HMG-CoA reductase inhibitor; patents held valid and infringed over anticipation, obviousness, and double-patenting challenges; defendants’ ANDA approval enjoined.
  • 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.
  • Mitsubishi Chemical Corp. v. Barr Laboratories, Inc., 718 F. Supp. 2d 382 (S.D.N.Y. 2010), affirmed, No. 2010-1432, 2011 WL 3288394 (Fed. Cir. Aug. 2, 2011): Trial counsel for plaintiff in Hatch-Waxman action involving high concentration formulation of Argatroban Injection, an anticoagulant; patent held valid over anticipation and obviousness challenges; defendant’s ANDA approval enjoined.
  • Hy-Ko Products Company v. The Hillman Group, Inc., No. 08-1961 (N.D. Ohio): Trial counsel in patent infringement action involving key cutting and duplication technology.
  • Roquette Frères v. SPI Pharma, Inc., No. 06-540 (D. Del. Oct. 4, 2010): Trial counsel in successful defense of jury trial involving claims directed to pulverulent mannitol.

Appellate (Patent/Trade Secrets)

  • Sydnexis, Inc. v. Eyenovia, Inc., Nos. 2023-2402, 2023-2403, 2023-2411 (Fed. Cir.): Counsel for appellee in review of consolidated PTAB Final Written Decisions involving patents directed to formulations of atropine to treat myopia and pre-myopia.
  • Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLC, No. 23-1783 (Fed. Cir.): Counsel for appellee in review of PTAB Final Written Decision involving patents directed to methods of treatment of type-1 hypersensitivity reactions with intranasal epinephrine formulations.
  • Samsung Electronics Co., Ltd. v. Nanoco Technologies Ltd., Nos. 22-1847, -1848, -1849, -1850, -1852 (Fed. Cir.): Obtained dismissal of appeal of IPR decisions following settlement of related district court action.
  • Jennewein Biotechnologie GmbH v. International Trade Commission, No. 2020-2220 (Fed. Cir.): Obtained affirmance of ITC claim construction and judgment as to infringement and Limited Exclusion Order in appeal involving methods of engineering bacteria to produce 2’-fucosyllactose.
  • SoClean, Inc. v. Sunset Healthcare Solutions, Inc., No. 2021-2311 (Fed. Cir.): Obtained affirmance of district court preliminary injunction order.
  • CellInfo, LLC v. American Tower Corporation et al., No. 20-2047 and 23-2034 (1st Cir.): Obtained dismissal of appeals.
  • Quest Diagnostics Investments LLC v. Laboratory Corporation of America Holdings, No. 2021-1820 (Fed. Cir.): Lead appellate counsel in appeal of IPR decision involving tandem mass spectrometry for detection of vitamin D metabolites.
  • Quest Diagnostics Investments LLC v. Laboratory Corporation of America Holdings, No. 2021-1115 (Fed. Cir. Dec 27, 2021): Lead appellate counsel in appeal of IPR decision involving tandem mass spectrometry for detection of low levels of testosterone.
  • 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 pharmaceutical patents over anticipation, obviousness, and obviousness-type double patenting challenges.
  • Green Cross Corp. v. Shire Human Genetic Therapies, Inc., Appeal No. 2017-2071 (Fed. Cir.): Dismissed prior to decision.
  • 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.

Patent Office Proceedings (IPRs/PGRs)

  • Eyenovia, Inc. v. Sydnexis, Inc., IPR2022-00384, -00414, and -00415: On behalf of Petitioner in IPRs involving formulations of atropine to treat myopia and pre-myopia, obtained Final Written Decision invalidating all claims of all challenged patents.
  • Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLC, IPR2021-01324: Representing Patent Owner in IPR involving method of treatment of anaphylaxis with intranasal epinephrine formulation; obtained Final Written Decision of validity on key claims.
  • Samsung Electronics Co. v. Nanoco Technologies Ltd., IPR2021-00182, -00183, -00184 -00185, and -00186: On behalf of Patent Owner, obtained Final Written Decision upholding all challenged claims of five patents directed to quantum dot compositions, methods of manufacture, and formulations.
  • Laboratory Corporation of America Holdings v. Quest Diagnostics Investments LLC, IPR2019-00738, IPR2019-01425: Represented diagnostic company patent owner in defense of IPRs involving methods of using tandem mass spectrometry to detect biological metabolites.
  • 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 involving methods of using tandem mass spectrometry to detect biological metabolites.
  • Laboratory Corporation of America Holdings v. Quest Diagnostics Investments LLC, IPR2019-01618: On behalf of diagnostic company patent owner, obtained dismissal of IPR involving methods of using tandem mass spectrometry to detect biological metabolites.
  • Jennewein Biotechnologie GmbH v. Glycosyn LLC, PGR2019-00023: On behalf of biotechnology patent owner, obtained decision denying institution of PGR involving methods of engineering bacteria to produce 2’-fucosyllactose.
  • 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.
  • 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.

Arbitration 

  • Co-lead counsel for synthetic biology company in fast-track JAMS arbitration involving contractual counterparty’s claim for over $40 million arising from alleged breach of collaboration agreement; following discovery, briefing and an evidentiary hearing, three-member panel issued a final award in June 2023 that found in favor of our client and denied all claims asserted by counterparty.
  • Counsel for respondent in commercial arbitration involving contracts relating to biodefense vaccine development and manufacture; following discovery, briefing and an evidentiary hearing, three-member panel issued a final award in July 2022 that found in favor of our client and issued an award of $0 damages; award confirmed following denial of motion to vacate. See Soligenix, Inc. v. Emergent Product Development Gaithersburg, Inc. et al., No. 2022-0880-PAF (Del. Ch. July 19, 2023).
  • Co-lead counsel in commercial arbitration involving trade secrets and the cell tower industry; following discovery, briefing and an evidentiary hearing, obtained final award in 2023 that found in favor of our client.
  • Lead counsel in commercial arbitrations involving supply contracts in the glass recycling industry; following discovery, briefing, and an evidentiary hearing, obtained 7-figure judgment and award of attorney's fees (2019).
  • 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, and defeated subsequent motion to reopen case following arbitration.
  • 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.

Class Action Defense

  • Pezzuto v. Essex Apartments Property Owner, LLC and Entrata, Inc., No. 2377-cv-00902 (Essex Super. Ct.): Lead counsel in landlord-tenant class action alleging improper assessment of fees.
  • Peters v. Olympia Beacon Square, LLC, No. 2379-cv-00288 (Hampden Super. Ct.): Lead counsel in landlord-tenant class action involving electricity charges.
  • Ubiera v. Greystar Management Services, L.P. et al., No. 2384-cv-01886 (Suffolk Super. Ct.): Lead counsel in landlord-tenant class action alleging violations of the MA Security Deposit Statute.
  • Anderson v. JRK Property Holdings, Inc. et al, No. 23-cv-10746-FDS (D. Mass. 2023): Lead counsel in landlord-tenant class action involving water/sewer submetering.
  • Peebles et al v. JRK Property Holdings, Inc. et al, No. 23-cv-10523-NMG (D. Mass. 2023): Lead counsel in landlord-tenant class action involving security deposits and cleaning/damage charges.
  • Louis et al v. Saferent Solutions, LLC et al, No. 1:22-cv-10800-AK (D. Mass. 2022): Lead counsel in action involving housing vouchers and tenant screening.
  • Conley v. Roseland Residential Trust, No. 18-10629-WGY (D. Mass. 2020): Lead counsel in class action involving novel questions of law regarding gas and water/sewer submetering in Massachusetts; obtained summary judgment in favor of defendant and denial of state-wide class certification; obtained voluntary dismissal of appeal by plaintiffs/appellants. See also Conley v. Roseland Residential Trust, No. 20-1399 (1st Cir.).
  • Phillips v. Equity Residential Management, L.L.C., No. 13-12092 (D. Mass.): Successfully resolved class action filed by tenants alleging violations of the MA Security Deposit Statute; obtained favorable ruling from SJC on certified question regarding availability of treble damages in certain circumstances under the MA Security Deposit Statute, G.L. c. 186, § 15B, followed by favorable ruling from First Circuit Court of Appeals. 478 Mass. 251 (2017), 85 N.E.3d 12 (Mass. 2017); 844 F.3d 1 (1st Cir. 2016).
  • 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.
  • Baker v. Equity Residential Management, L.L.C., No. MICV2013-03630 (Mass. Super. Ct.): Obtained favorable settlement in putative class action involving alleged heat and hot water violations pursuant to G.L. c. 186, § 14.
  • Perry v. Equity Residential Management, L.L.C., No. 12-10779 (D. Mass.): Successfully resolved seven class actions filed by Massachusetts tenants MA challenging various fees collected in advance of move-in; won summary judgment on certain challenged fees
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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. 
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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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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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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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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.
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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®.
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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.
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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.
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News & Press

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Mintz is pleased to announce that 31 attorneys have been named Massachusetts Super Lawyers and 35 attorneys have been named Massachusetts Rising Stars for 2024.

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Our Intellectual Property Practice earned national recognition in the 2024 edition of IAM Patent 1000 – The World’s Leading Patent Practitioners. The guide recognized Mintz with four firm-wide rankings and 14 individual attorney recommendations, including a gold ranking for Intellectual Property Chair Michael Renaud.

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Mintz is pleased to announce that 32 attorneys have been named Massachusetts Super Lawyers and 27 attorneys have been named Massachusetts Rising Stars for 2023.

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Life sciences trade secret cases continue to climb, driven by evolving restrictions on certain types of patents and patent litigation, a spike in companies’ use of confidential data, and increased employee mobility — and changes linked to the 2016 Defend Trade Secrets Act. In an article for IAM, Member Tom Wintner and Associate Nick Armington explain how these trends are shaping IP protection in the sector.

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BOSTON– Mintz’s award-winning Intellectual Property (IP) Practice again earned national recognition in the 2023 edition of IAM Patent 1000 – The World’s Leading Patent Practitioners. The guide recognized Mintz with three firm-wide rankings and 10 attorneys received a total of 11 individual recommendations.

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BOSTON – Mintz has earned top rankings in the 2023 edition of Legal 500 United States guide. The firm is recognized in 14 practice categories, and 59 individual attorneys are also recognized in the guide, some in more than one category.

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Member Thomas Wintner spoke to Managing IP on the Government's claim that Moderna should be immune from patent infringement under Section 1498.

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Mintz secured a $150 million settlement for Nanoco Group plc in the company’s patent infringement litigation against Samsung Electronics Co. Ltd. and Samsung Electronics America Inc. Mintz Member Michael Newman led a team that represented the maker of cadmium-free quantum dots and other nanomaterials in a federal district court in Texas and before the US Patent and Trademark Office.

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35 Mintz attorneys have been named Massachusetts Super Lawyers and 25 Mintz attorneys have been named Massachusetts Rising Stars for 2022.

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Best Lawyers® recognized 108 firm attorneys in the 2023 edition of The Best Lawyers in America©. Notably, two Mintz attorneys – Poonam Patidar and Scott M. Stanton – received 2023 “Lawyer of the Year” awards, and 28 firm attorneys were included in the inaugural edition of Best Lawyers: Ones to Watch.

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Law360 reported that the U.S. Court of Appeals for the Federal Circuit recently upheld the International Trade Commission's finding that a pair of bacteria strains used by German-based Jennewein infringed a Glycosyn milk patent. The article included a quote from Mintz Intellectual Property Member Michael Newman, noting that, in addition to Mr. Newman, Glycosyn was represented by Member and Chair of the firm's Intellectual Property Division Michael Renaud, Members Thomas Wintner and James Wodarski, and Associates Courtney Herndon and Matthew Karambelas.
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.”
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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. While his practice focuses on the life sciences – particularly patent litigation, trade secrets litigation, and commercial litigation involving scientific or clinical disputes – he has also successfully represented clients in other industries and in a variety of types of commercial litigation, particularly class action defense.

Recognition & Awards

  • IAM Patent 1000 “World’s Leading Patent Practitioners: Bronze” (2020 - 2024)

  • Included on the Massachusetts Super Lawyers - Intellectual Property list (2018 - 2019, 2021 - 2024)

  • Recognized in the Legal 500 United States for Healthcare: Life Sciences (2023, 2024)

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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. While his practice focuses on the life sciences – particularly patent litigation, trade secrets litigation, and commercial litigation involving scientific or clinical disputes – he has also successfully represented clients in other industries and in a variety of types of commercial litigation, particularly class action defense.

Involvement

  • Board of Trustees, Massachusetts Social Law Library
  • Board of Trustees, YMCA Camp Belknap, Wolfeboro, New Hampshire (Chair, 2019-2022)
  • Editor, Massachusetts Discovery Practice (MCLE, 4th ed. 2021)
  • Member, American Chemical Society
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