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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)

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

Federal Circuit Clarifies the Requirements for a Teaching Away by the Prior Art

October 23, 2017 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski

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.

Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

June 14, 2017 | Blog | By Thomas Wintner, Joe Rutkowski

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”).

Amgen Sues Coherus Under BPCIA After Completing Patent Dance

May 17, 2017 | Blog | By Thomas Wintner, Joe Rutkowski

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.

Federal Circuit Reiterates That Patent Prosecution Disclaimers Must Be “Clear and Unmistakable”

March 16, 2017 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski

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.”

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.

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.

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.

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.

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

Speaker