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
Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers
January 12, 2017 | Blog | By Adam Samansky, Joe Rutkowski
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.
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Federal Circuit Finds Personal Jurisdiction over Mylan in Two Hatch-Waxman Appeals
March 24, 2016 | Blog | By Adam Samansky, Joe Rutkowski
On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits filed in the state.
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BPCIA Patent Litigation Webinar Recap
March 11, 2016 | Blog | By Thomas Wintner, Joe Rutkowski, Matthew Show
Our Biosimilar webinar series continued this month with Tom Wintner’s BPCIA Patent Litigation presentation. Tom discussed the general framework of litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), including the “patent dance” information exchange under 42 U.S.C. §262(l), and three case studies that inform our current understanding of emerging judicial interpretation of BPCIA requirements.
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ICYMI: Biosimilars and FDA Regulatory Webinar
February 2, 2016 | Blog | By Joe Rutkowski
Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation.
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Biosimilars and FDA Regulatory Webinar Recap
February 2, 2016 | Blog | By Joe Rutkowski
Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation.
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Federal Circuit Hears Argument on Personal Jurisdiction in Two Hatch-Waxman Appeals
January 12, 2016 | Blog | By Adam Samansky, Joe Rutkowski
On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal jurisdiction over generic pharmaceutical manufacturers in Hatch-Waxman litigation.
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Court Denies Generic Drug Manufacturer's Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds
March 18, 2015 | Blog | By Peter Cuomo, Joe Rutkowski
On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss a Hatch-Waxman patent infringement action for an alleged lack of personal jurisdiction following the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014).
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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 Intellectual Property Law Association
- Member, Massachusetts Bar Association
