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 arbitration involving complex chemistry or biology – 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, 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 arbitration involving complex chemistry or biology – 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)
- 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.
- 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 defense of biotechnology trade secrets action.
- 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)
- Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLC, No. 23-1783 (Fed. Cir.): Counsel for appellee in review of PTAB Final Written Decision involving methods of treatment of type-1 hypersensitivity reactions with intranasal epinephrine formulation.
- 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 (1st Cir.): Pending.
- 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
- 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
viewpoints
Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent Term or Face Double-Patenting
September 7, 2023 | Blog | By Peter Cuomo, Thomas Wintner, James Whittle, PhD
Supreme Court Unanimously Affirms Amgen Repatha® Antibody Patents Invalid for Lack of Enablement
May 25, 2023 | Blog | By Joe Rutkowski, Peter Cuomo, Thomas Wintner, Adam Samansky, Terri Shieh-Newton
N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA
September 21, 2021 | Blog | By Thomas Wintner, Adam Samansky, Joe Rutkowski
In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act (“BPCIA”) against a foreign parent corporation that did not file or sign the relevant abbreviated Biologics License Application (“aBLA”).
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Genus Claims: Foiled again by Written Description
September 16, 2021 | Blog | By Thomas Wintner
In late August of 2021, the Federal Circuit reversed a jury verdict of $1.2 billion in favor of Juno Therapeutics and Sloan Kettering Institute because the jury’s finding that four of the asserted patent claims did not lack adequate written description under 35 U.S.C. § 112 was not supported by substantial evidence.
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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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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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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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New revised USMCA trade deal affects intellectual property rights, but not exclusivity period for biologics
December 17, 2019 | Blog | By Thomas Wintner, Nana Liu
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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Assertion of Patents Results in Loss of Sovereign Immunity for Public Universities
December 28, 2017 | Blog | By Thomas Wintner
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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News & Press
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.
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.
DoJ Filing In Moderna Patent Case Poses Immunity Questions
February 22, 2023
Member Thomas Wintner spoke to Managing IP on the Government's claim that Moderna should be immune from patent infringement under Section 1498.
Mintz Guides Nanoco Group in $150M Patent Litigation Settlement
February 03, 2023
BOSTON – Nanoco Group plc, a world leader in the development and manufacture of cadmium-free quantum dots and other nanomaterials, has announced a $150 million settlement in its litigation with Samsung Electronics Co., Ltd. and Samsung Electronics America, Inc. alleging infringement of Nanoco’s patented technology.
35 Mintz attorneys have been named Massachusetts Super Lawyers and 25 Mintz attorneys have been named Massachusetts Rising Stars for 2022.
Fed. Circ. Upholds ITC Infringement Finding On Milk Patent
September 20, 2021
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.
Federal Circuit Affirms ITC Victory for Glycosyn
September 17, 2021
PTAB Says Mass. Biotech's Milk Patent Ineligible For Review
September 18, 2019
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.
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.
Victory on Appeal After Lengthy Litigation Over Cholesterol Inhibitor
December 14, 2018
Mintz Secures Full Patent Victory for Kowa Pharmaceuticals and Nissan Chemical in Lengthy Battle
September 22, 2017
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.
Sandoz Seeks High Court Take on Biosimilar Law
February 17, 2016
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.”
Mintz Further Expands IP Practice with Eighteen Attorneys
January 09, 2015
Events & Speaking
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 arbitration involving complex chemistry or biology – 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 - 2023)
- Included on the Massachusetts Super Lawyers - Intellectual Property list (2018 - 2019, 2021 - 2022)
- Recognized in the Legal 500 United States for Healthcare: Life Sciences (2023)
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 arbitration involving complex chemistry or biology – 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
Recent Insights
Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent Term or Face Double-Patenting
September 7, 2023 |Blog
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.
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.
