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Joseph D. Rutkowski

(he/him/his)

Special Counsel

[email protected]

+1.617.348.1873

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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.
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viewpoints

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In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s decision holding claims directed to polymorphic form “β” of rifaximin invalid as obvious. 

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Advice that may have served House of Pain in their 1992 hit song, “Jump Around,” to “bring a shotgun” to battle likely does not translate well to plaintiffs in federal litigation contemplating bringing a “shotgun” pleading to court. In this article we explore types of shotgun pleadings identified by courts and outline potential responses to a shotgun pleading.

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On January 9, 2023, the U.S. Court of Appeals for the Federal Circuit in In re Stingray IP Solutions, LLC, No. 23-102 granted a writ of mandamus, vacating a decision of the Eastern District Court of Texas which had transferred a patent infringement suit filed against foreign defendants to the Central District of California based on defendants’ post-suit consent to jurisdiction there.

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On December 19, 2022, U.S. Magistrate Judge Robert W. Lehrburger of the Southern District of New York recommended denying a motion to dismiss claims of willful infringement of eight patents asserted in a Second Amended Complaint (“SAC”). The recommendation finds (1) that pleading willful infringement does not require allegations of egregious infringing conduct and (2) that requisite knowledge of the asserted patents and alleged infringement could be satisfied by the filing of the Original Complaint along with plaintiff’s email (“pre-SAC email”) informing the defendants of additional alleged infringement of two patents prior to filing the SAC.

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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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On July 12, 2022, U.S. District Judge Alan D. Albright of the Western District of Texas denied alleged infringer Lenovo’s motion to dismiss ACQIS’s willful and indirect infringement and enhanced damages claims, holding that patent owners need not allege egregious infringing behavior to assert a claim of willful infringement.

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On March 16, 2022, U.S. District Judge William Alsup of the Northern District of California certified two of the hot button issues splitting district courts on the standard for pleading willful infringement, holding that:

  • The complaint itself is insufficient to provide the requisite knowledge of the asserted patents and alleged infringement; and
  • Patent owners need not otherwise allege egregious infringing behavior as part of a willful infringement claim.

Recognizing the split among district courts on these issues, the court certified its decision for interlocutory appeal to the Court of Appeals for the Federal Circuit under 28 U.S.C. § 1292(b). Thus, the Federal Circuit may soon have an opportunity to resolve this long-standing split among districts, which, according to Judge Alsup, has consumed a “vast amount of resources” in litigation around the country.

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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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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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News & Press

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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.
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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.
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.
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Events & Speaking

Recognition & Awards

  • Dean’s Award for Environmental Law, Boston University School of Law

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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
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Joseph D. Rutkowski

(he/him/his)

Special Counsel

Boston