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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

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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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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On November 5, 2021, the U.S. Court of Appeals for the Federal Circuit in Celgene Corp. v. Mylan Pharmaceuticals Inc., Case No. 21-1154, affirmed a decision from the District Court of New Jersey dismissing a suit brought by Celgene Corporation (“Celgene”) under Rule 12(b)(6) for improper venue as to defendants Mylan Pharmaceuticals Inc. (“MPI”) and Mylan Inc. and for the failure to state a claim against defendant Mylan N.V. Celgene had brought suit after MPI submitted an ANDA seeking approval to market a generic version of the drug Pomalyst used to treat multiple myeloma. In assessing venue, the court held that it was MPI’s ANDA submission to the U.S. Food and Drug Administration (“FDA”), and not the sending of a notice letter to Celgene in New Jersey, that was the artificial act of infringement pursuant to the Hatch-Waxman Act. The district court thus held, and the Federal Circuit affirmed, that venue in New Jersey was improper.
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Federal Circuit Clarifies that Willful Infringement Does Not Require Egregious Conduct

October 26, 2021 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski

On September 28, 2021, in a precedential opinion, the United States Court of Appeals for the Federal Circuit, in SRI Int’l, Inc. v. Cisco Systems, Inc., Nos. 2020-1685, -1704, clarified its decision from a prior appeal in the same case to hold that a finding of willful infringement requires only deliberate or intentional infringement, not egregious, wanton, malicious, or bad-faith infringement conduct.
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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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PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

August 24, 2021 | Blog | By Peter Cuomo, Joe Rutkowski, Nana Liu

The PTAB recently published the first update to its 2019 study of AIA trials involving petitions challenging Orange Book-listed patents and biologic patents through June 2021. Highlights of these pharmaceutical patent challenge statistics include, e.g., the number of these petitions filed, the number of instituted trials, and the trial outcomes since fiscal year 2013.
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On March 24, 2021, U.S. District Judge Colm F. Connolly of the District of Delaware, granted a defendant’s motion to dismiss claims for contributory and induced infringement and enhanced damages under 35 U.S.C. § 284 because the complaint alleged knowledge of the asserted patents solely based on averments in prior original and amended complaints in the same lawsuit.
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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 Patent Law Association
  • Member, Massachusetts Bar Association
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Joseph D. Rutkowski

(he/him/his)

Special Counsel

Boston