Joseph’s practice focuses on intellectual property litigation and counseling on issues related to intellectual property rights. Joseph’s primary focus is in patent litigation, including the intricacies of pharmaceutical litigation under the Hatch-Waxman Act and BPCIA. He has extensive experience in every stage of litigation, from pre-suit investigations through trial and appeal – including case initiation, fact and expert discovery, motion practice, and successful preparation for and participation in trials involving patent infringement allegations.
Joseph has represented clients across a wide range of technologies including pharmaceuticals, medical and mechanical devices, consumer products, and telecommunications services. He has also worked on numerous high-stakes Hatch-Waxman litigations for major pharmaceutical companies through trial and appeals. Beyond patent litigation, Joseph has experience in disputes involving unfair competition, breach of contract, trademarks and trade secret misappropriation, and educational institutions. In addition to litigation, he provides product analyses, enforcement advice, and evaluates infringement, validity, and competitive landscape analysis issues in relation to patent opinions and due diligence work.
In addition to his intellectual property and complex commercial litigation experience, Joseph served, pro bono, as lead counsel for a homeless shelter in numerous housing court matters, including summary process jury trial, alternative dispute resolution, contract negotiations, and strategic assessments.
Prior to joining Mintz, Joseph was an associate in the Boston litigation practice of another international law firm. During law school, Joseph was an editor on the Boston University Law Review. Before beginning his legal career, he was a business and systems integration consultant, working with Fortune 100 financial services and technology clients to design and implement enterprise-wide IT systems across US markets.
Experience
- Kowa Pharmaceuticals America et al v. Amneal Pharmaceuticals, LLC, 1:14-cv-2760 (S.D. NY) - Represented plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Nissan Chemical Industries, Ltd. in litigation which involved compound, formulation, and polymorph patents directed toward quinoline-type mevalonolactones (or, pitavastatin calcium) relating to the drug product Livalo®. Several of the cases successfully resolved pre-trial, and after a 10-day trial plaintiffs prevailed on all issues in two court decisions against the remaining defendants, Amneal and Apotex. Mintz represents Kowa and Nissan in the appeal filed by Amneal and Apotex in the Federal Circuit. The team also defeated institution of three inter partes reviews filed by generic manufacturer defendants in these cases.
- Member of a trial team that represents major international pharmaceutical companies and has successfully litigated cases at both the district court and appellate level in ANDA patent infringement actions under the Hatch-Waxman Act. Representative civil actions including: Takeda Pharmaceutical Company Limited et al v. Mylan, Inc. et al, (S.D.N.Y. 12-cv-00024).
- Philips Medical Systems (Cleveland), Inc. v. GL Leading, Inc., 1:19-cv-02648 (N.D. Ill.) – Representing divisions of Philips Healthcare in an action brought against domestic and foreign competitors and former employees, claiming, inter alia, breach of contract and misappropriation of trade secrets under federal (DTSA) and state (ITSA) laws relating to the design and manufacture of X-ray tubes used in commuted tomography products.
- Horizon Medicines LLC v. Teva Pharmaceuticals USA, Inc., 2:20-cv-08188 (D.N.J.) –Represented ANDA applicant in Hatch-Waxman patent infringement litigation involving fixed-dose oral combination product. Client settled on favorable terms during claim construction.
- Nanoco Technologies, Ltd. v. Samsung Electronics Co., 2:20-cv-00038 (E.D. Tex.) –Representing nanomaterial developer and manufacturer in patent infringement action involving nanoparticle quantum dot semiconductors and methods of producing same.
- Rehrig Pacific Co. v. Polymer Logistics (Israel), Ltd., et al., 2:19-cv-04952 (C.D. Cal.) – Represented retail-ready packaging provider and defended against competitor’s claims of patent infringement. Successfully transferred action from U.S. District Court for the Southern District of Georgia to Central District of California and obtained dismissal of willful infringement and enhanced damages claims through strategic use of Rule 12(b)(2) and 12(b)(6) motion practice. Client subsequently settled on favorable terms.
- Rehrig Pacific Co. v. Polymer Logistics (Israel), Ltd., et al., 2:19-cv-04952 (C.D. Cal.) – Represented retail-ready packaging provider and defended against competitor’s claims of patent infringement. Successfully transferred action from U.S. District Court for the Southern District of Georgia to Central District of California and obtained dismissal of willful infringement and enhanced damages claims through strategic use of Rule 12(b)(2) and 12(b)(6) motion practice. Client subsequently settled on favorable terms.
- Kowa Company, Ltd. v. Amneal Pharmaceuticals, LLC, 2018-1051 (Fed. Cir.) – Represented pharmaceutical plaintiffs in appeal following successful Hatch-Waxman patent infringement judgment involving compound, formulation, and polymorph patents directed toward HMG-CoA reductase inhibitors relating to the drug product Livalo® (pitavastatin). Obtained affirmance of district court judgment upholding client’s patents over anticipation, obviousness, and obviousness-type double patenting challenges.
- Green Cross Corporation v. Shire Human Genetic Therapies, Inc., 2017-2071 (Fed. Cir.) – Represented South Korean biopharmaceutical company, successfully defeating a motion to dismiss for lack of standing to challenge a final written decision from the Patent Trial and Appeal Board in an inter partes review proceeding. Client subsequently settled on favorable terms.
- Inline Plastics Corp. v. EasyPak, LLC, 2014-1305 (Fed. Cir.) – Represented Inline Plastics while obtaining dismissal of invalidity counterclaims and entry of judgment on infringement to expedite appeal and reversal and remand of case-dispositive claim construction. Inline achieved highly-favorable settlement on remand.
- Dallakian v. IPG Photonics, 14-cv-11863 (D. Mass.) – Represented laser systems maker, successfully defending against claims for correction of inventorship and trade secret misappropriation. Obtained voluntary dismissal after defendant secured expedited discovery and early summary judgment motion.
- MeadWestvaco v. Rexam, 12-1518 (Fed. Cir.) – Represented consumer products maker plaintiff-appellee following a bench trial awarding it permanent injunctions against two direct competitors. Obtained affirmance over numerous challenges to patent infringement and validity from both defendant-appellants in consolidated appeal, leaving in place injunctions issued by trial court.
viewpoints
Celgene v. Sun Pharma Global: Satisfying Subject Matter Jurisdiction Under § 271(e)(2)
April 13, 2020 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide) Abbreviated New Drug Application (ANDA) product infringes three patents not listed in the Orange Book for Revlimid® and for which Sun did not make any Paragraph IV certifications.
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Year in Review: The Most Popular IP Posts of 2019
January 6, 2020 | Blog | By Christina Sperry
As 2020 begins and intellectual property (IP) strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2019. According to many readers, hot topics included § 112 written description, prosecution history estoppel, and venue in the wake of TC Heartland.
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Fox Factory v. SRAM – According to CAFC, No Presumption of Nexus for Bicycle Chainring Patents; IPR Decision Reversed and Remanded
January 2, 2020 | Blog | By Adam Samansky, Andrew DeVoogd, Joe Rutkowski
On December 18, 2019, the United States Court of Appeals for the Federal Circuit, in Fox Factory v. SRAM, Nos. 2018-2024 and 2018-2025, reversed the Board’s Final Written Decision in a pair of inter partes reviews (“IPRs”) that the challenged claims of U.S. Patent No. 9,182,027 (“the ’027 patent”) were not invalid as obvious, and remanded for further proceedings.
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Federal Circuit Reverses PTAB Finding Tarceva® Method of Treatment Claims Invalid for Lack of Reasonable Expectation of Success Based on over 99.5% Failure Rate among Treatment Candidates
October 15, 2019 | Blog | By Peter Cuomo, Joe Rutkowski
In a precedential opinion on October 4, 2019, the United States Court of Appeals for the Federal Circuit, in OSI Pharmaceuticals v. Apotex, No. 2018-1925, reversed the Board’s Final Written Decision in an inter partes review (“IPR”) finding that claims of United States Patent No. 6,900,221 (the “‘221 patent”) were invalid as obvious.
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ANDA Applicant Dismissed for Lack of Venue Under § 1400(b) as District of New Jersey Departs from its own and the District of Delaware’s Prior Rulings
August 21, 2019 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over Mylan in a patent infringement action arising from Mylan’s submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the drug, Jublia®.
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District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland and In re Cray
June 27, 2019 | Blog | By Joe Rutkowski
On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan Pharmaceuticals Inc. (“MPI”) in connection with Novartis’s Hatch-Waxman patent infringement claim arising from MPI’s submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the drug, Gilenya® (fingolimod).
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Dueling Declaratory Judgment Suits Result in a Dismissal and Boomerang Transfer Back to the First-filed Forum Under TC Heartland
April 24, 2019 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court could exercise personal jurisdiction over a generic drug manufacturer in connection with the patentee’s action seeking a declaratory judgment of noninfringement, venue was not appropriate in the Eastern District of Texas under the applicable patent venue statute, 28 U.S.C. § 1400(b).
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Federal Circuit Dismisses Appeal of IPR Final Written Decision for Lack of Standing After Appellant Terminated Development of Potentially Infringing Pharmaceutical Product
February 11, 2019 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On February 7, 2019, the United States Court of Appeals for the Federal Circuit, in Momenta Pharmaceuticals v. Bristol-Myers Squibb, No. 2017-1694, dismissed Momenta’s appeal of a Final Written Decision in an Inter Partes Review (“IPR”) because Momenta had terminated its potentially infringing drug development program. According to the panel, this left Momenta without a sufficiently concrete interest in the action to satisfy the standing requirements of Article III of the United States Constitution.
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District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland
October 24, 2018 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On October 18, 2018, the United States District Court for the District of Delaware, in Bristol-Myers Squibb v. Mylan Pharmaceuticals Inc., No. 17-00379, held that venue was not proper in Delaware over Mylan Pharmaceuticals Inc. (“MPI”) in connection with a claim for patent infringement arising from Mylan’s submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the drug, apixaban.
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Federal Circuit Holds Federal Circuit Law Applies to Patent Venue Challenges and Places Burden on Plaintiffs to Establish Venue
May 29, 2018 | Blog | By Peter Cuomo, Joe Rutkowski
On May 14, 2018, the United States Court of Appeals for the Federal Circuit, In re: ZTE (USA) Inc., No. 2018-113, held that Federal circuit law governs the burden of proof for venue challenges under 28 U.S.C. § 1400(b) and that the burden of proof rests on the plaintiff to demonstrate proper venue upon a defendant’s motion to dismiss for lack of venue.
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News & Press
As ANDA Suit Venue Options Shrink, Del., NJ Rule For Now
November 29, 2021
Mintz Members Peter Cuomo and Adam Samansky and Associate Joseph Rutkowski were quoted in an article published by Law360 on the potential implications of the Federal Circuit’s recent ruling in Celgene Corp. v. Mylan Pharmaceuticals Inc., which cemented a prior decision in Valeant v. Mylan holding that patent suits against generic drugmakers must be filed where the company is incorporated or where it performed actions related to its Abbreviated New Drug Application.
Law360 covered developments in a trade secret lawsuit involving X-ray tubes brought on by Mintz client Philips Medical Systems, Inc. against Chinese companies Kunshan GuoLi Electronic Technology Co. Ltd. and its subsidiary, Kunshan Yiyuan Medical Technology Co. Ltd.
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.
Events & Speaking
Speaker
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Aug
31
2017
Paragraph IV Challenges: Exploring 2017 Trends, Developments and Updates
The Knowledge Group
Webinar
Recognition & Awards
Dean’s Award for Environmental Law, Boston University School of Law
Involvement
- Member, Alan D. Lourie Boston Intellectual Property American Inn of Court
- Member, American Intellectual Property Law Association
- Member, Boston Bar Association
- Member, Boston Patent Law Association
- Member, Massachusetts Bar Association
