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Joseph D. Rutkowski

Associate

[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 Hatch-Waxman pharmaceutical litigation. He has extensive experience in every stage of litigation, from pre-suit investigations through 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 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 500 financial services and technology clients to design and implement enterprise-wide IT systems across US markets.

Education

  • Boston University School of Law (JD, magna cum laude)
  • Rensselaer Polytechnic Institute (BS, Information Technology: Management Information Systems, summa cum laude)

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 Levin 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).
  • MeadWestvaco v. Rexam, Appeal No. 12-1518 (Fed. Cir.) - Represented plaintiff-appellee before the Federal Circuit following a bench trial awarding the company with permanent injunctions against two direct competitors. While considering numerous challenges to infringement and validity from both defendant-appellants in a consolidated appeal, the Federal Circuit affirmed, inter alia, the district court’s decisions on infringement and did not disturb injunctions awarded to our client.
  • Dallakian v. IPG Photonics, No. 14-cv-11863 (D. Mass.) - Represented IPG Photonics while successfully defending against claims for correction of inventorship and trade secret misappropriation.

Recognition & Awards

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

Involvement

  • Member, American Intellectual Property Law Association
  • Member, Boston Bar Association
  • Member, Boston Patent Law Association
  • Member, Massachusetts Bar Association

Recent Insights

News & Press

Events

Viewpoints

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.
On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for the District of New Jersey by construing the claimed chemical structure diagram to encompass at least the specific enantiomer depicted, refusing to limit the claim to only cover a racemic mixture of the (+) and (–) enantiomers, absent clear indication that the depicted enantiomer should be excluded from the claim.
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize biosimilars applicants who fail to disclose information about their abbreviated Biologics License Applications (“aBLAs”) or manufacturing processes as required by 42 U.S.C. § 262(l)(2)(A).
In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did not infringe an Amgen protein folding patent.
In a precedential opinion issued on October 11, 2017, the United States Court of Appeals for the Federal Circuit reversed the Patent Trial and Appeals Board’s (“PTAB”) finding of non-obviousness where the prior art taught away from some, but not all, of the embodiments covered by the challenged claims.
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious.
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”).
On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product.
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price Competition and Innovation Act (“BPCIA”) “patent dance” information exchange process may expose the biosimilar maker to eventual infringement damages in the form of lost profits, and preclude limiting damages to a reasonable royalty.
On March 3, 2017, the United States Court of Appeals for the Federal Circuit reaffirmed, in a precedential opinion, that prosecution disclaimers may only limit the scope of a claim where the disclaimer is “both clear and unmistakable to one of ordinary skill in the art.”

News & Press

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

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