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
An Overview of Shotgun Pleadings in the Federal Courts
August 7, 2023 | Blog | By Joe Rutkowski, Peter Cuomo
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
Federal Circuit Resolves District Court Split, Holds Foreign Defendant Cannot Defeat Rule 4(k)(2) Personal Jurisdiction by Unilateral Post-suit Consent to Jurisdiction in Alternative Forum
January 23, 2023 | Blog | By Joe Rutkowski, Adam Samansky, Peter Cuomo
Southern District Magistrate Judge Holds That Pleading Willful Patent Infringement Does Not Require Allegations of “Egregious” Infringing Activity and That Requisite Knowledge May Be Provided by a Prior Complaint in the Same Action
January 3, 2023 | Blog | By Peter Cuomo, Joe Rutkowski, Adam Samansky
Eastern District of Texas Holds Willful Infringement Knowledge Requirement May Be Satisfied by Informing Non-Party of Infringement Claims Before Adding That Party as a Defendant
October 19, 2022 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On October 5, 2022, U.S. Magistrate Judge Roy S. Payne of the Eastern District of Texas recommended denying-in-part a motion for summary judgment of no willful infringement, holding that requisite knowledge of the asserted patent and alleged infringement of that patent could be satisfied by notice of the lawsuit before the moving defendant was added as a party.
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Judge Albright Holds Willful Infringement Pleading Does Not Require Allegations of Egregious Infringing Behavior
July 22, 2022 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
Judge Alsup Certifies Two Hot Button Issues on Standard for Pleading Willful Infringement for Interlocutory Appeal to the CAFC
March 23, 2022 | Blog | By Joe Rutkowski, Peter Cuomo, Adam Samansky
Plaintiff Can Assert Patent Infringement and Seek Injunctive Relief in Second-Phase BPCIA Litigation Per Illinois District Court Decision
February 24, 2022 | Blog | By Adam Samansky, Joe Rutkowski, Tianyi Tan
On January 26, 2022, in what appears to be a case of first impression, U.S. District Court Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant defendant’s motion to dismiss patent infringement claims brought in the second phase of the parties’ Biosimilar Price Competition and Innovation Act (“BPCIA”) litigation. In so doing, Judge Lee held that the reference product sponsor (“RPS”) plaintiff is not limited to only declaratory judgment actions in the second phase of litigation under the BPCIA.
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D. Del. Says ANDA Specification Trumps All Else in Infringement Analysis
February 17, 2022 | Blog | By Peter Cuomo, Adam Samansky, Joe Rutkowski, Tianyi Tan
On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff’s motion to exclude defendant’s expert testimony for being “based on an erroneous legal theory” in a suit alleging defendants’ proposed generic Abbreviated New Drug Application (“ANDA”) product would infringe Exela’s patents under the Hatch-Waxman Act. Judge Noreika’s decision in this case reinforces the Federal Circuit’s holding in Sunovion and serves as a reminder that ANDA product infringement is primarily assessed by comparing the asserted claims with the ANDA specification, rather than other ANDA submission materials further describing the ANDA product.
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California District Court Sides with Majority Position, Dismissing Willful and Induced Infringement Claims that Relied on Original Complaint for Knowledge of Asserted Patent
February 8, 2022 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On January 18, 2022, U.S. District Judge R. Gary Klausner of the Central District of California sided with the majority of divided district courts, dismissing claims of willful and induced infringement that based the defendants’ required knowledge of the asserted patents on its receipt of the original complaint for patent infringement. Ravgen Inc. v. Quest Diagnostics Inc., No. 21-cv-09011 (C.D. Cal. Jan. 18, 2022) ECF 146 - Order dismiss willful infringement
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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
