Medical Device Practice

Many of the world’s most successful medical device manufacturers, investors, and inventors have one thing in common: they achieve success in IP portfolio development, strategy, assessment, and litigation by working with Fish & Richardson. Fish represents more than 100 medical device clients–some of the most accomplished medical device companies in the world. Our clients range from large multinational corporations and venture-funded companies to individual inventors, who are often medical doctors. We represent clients from an early stage and serve them as they grow into successful industry leaders, providing long-term plans and solutions. Our support includes a full range of IP transactional, regulatory, and technology litigation services, backed by in-depth knowledge, experience, and involvement in the medical device industry.

Fish & Richardson’s Medical Device Practice

An In-Depth Understanding of Your Industry Is Key to Delivering Business ResultsWe believe the combination of industry knowledge and specific understanding of our clients’ business is a key factor to success in all that we do. To that end, our team is passionate about learning not only your technology, but also your unique business. We combine that knowledge with our deep institutional understanding and appreciation for the medical device industry as a whole, acquired from the prior industry experience of our attorneys, our participation in industry conferences, and our experience representing cutting-edge medical device clients.

We understand that a nuance unique to your business or the medical device industry can make or break a patent prosecution or litigation strategy. Our seasoned attorneys have mastered these complexities and will help you successfully navigate the subtleties of the legal issues to position you for success.

We Offer a Full Suite of Medical Device ServicesBy partnering with one of the world’s largest and most accomplished IP and technology legal practices, you will enjoy several benefits. We offer services to support all of your medical device IP and regulatory needs, so you need only communicate your technology and legal concerns once. Our full suite of services includes:

Transactional Medical Device Services> IP Strategy Formulation – Our extensive knowledge of how IP

impacts success in the medical device industry uniquely qualifies Fish to help you formulate a winning IP strategy. We will help you seize unique market opportunities and achieve competitive advantage, while making the most effective use of your IP budget.

> IP Portfolio Development – As the world’s #1 patent prosecution practice, Fish is adept at medical device patent application preparation and prosecution. Our medical device patent prosecution team prosecutes more patents across a broader range of medical device areas than does any other medical device IP practice. Fish offers the full range of services for protection of intellectual property, and our patent services include patent drafting and prosecution in the United States by our U.S. practitioners and in Europe by our Munich office practitioners, as well as worldwide patent portfolio management in coordination with our network of firms around the globe.

> IP Transactions – We offer a full spectrum of transactional IP services, including freedom-to-operate and patent landscape evaluations, opinion and strategy advice to evaluate and navigate IP owned by other companies, licensing and other agreements related to IP, and IP due diligence in support of funding and acquisition transactions.

> Regulatory and Government Affairs – Our regulatory practice group provides U.S. Food and Drug Administration (FDA) and Federal Communications Commission (FCC) regulatory strategy advice and filings, and is also a ready source of regulatory information to our other medical device IP practitioners. Our medical device regulatory practice includes obtaining marketing authorizations from the FDA, and assisting you with FDA test procedures and reporting requirements, import rules, and labeling requirements. In addition, Fish attorneys are at the leading edge of regulatory issues regarding wireless health technologies and consumer electronics devices that supply medical information, and work with leading medical technology companies to navigate regulatory requirements unfamiliar to them.

> Trademark and Copyright – Fish attorneys also work with clients to develop and maintain strong brands. In addition to trademark prosecution, counseling, and enforcement, we regularly review advertising copy, product packaging, and other promotional materials, and provide advice on best practices for advertising claims. Fish offers similar counseling and support on copyright issues. We often handle claims of false and misleading advertising and unfair competition, which can threaten a company’s brand and reputation.

The Preeminent Medical Device IP & Technology Legal Practice in the World Founded in 1878 by acknowledged patent bar leader Frederick Fish, Fish & Richardson is one of the largest IP & technology legal practices in the world. Fish is unique among today’s leading firms in that we offer clients recognized leadership in both IP litigation and IP portfolio development. That dual expertise brings value to our clients that our competitors cannot match. For clients developing IP portfolios we provide ready access to litigation expertise that may expose potential problems early enough to be addressed, and for clients in active litigation we provide ready access to deep Patent Office expertise to help develop winning litigation positions.

With more than 400 attorneys and technology specialists, Fish offers extensive experience in IP strategy, counseling, licensing, IP litigation, and commercial litigation. More than 300 of our attorneys and technology specialists hold undergraduate and graduate degrees in science and technology disciplines; more than 80 hold PhDs. More than 40 Fish attorneys devote the majority of their time to the medical device industry and our medical device clients, and dozens more Fish professionals devote significant time to our medical device practice. This experience enables us to help clients navigate difficult or unusual situations because, in many cases, someone on our team has seen it before.

Litigation and Trial Services> Patent Litigation, Trials, and Dispute Resolution – As the

perennial #1 patent litigation practice in the U.S. and the world’s #1 post-grant practice, Fish is uniquely suited to provide a comprehensive and well-coordinated litigation strategy covering all of the important forums in which an IP dispute may play out. Every year we handle nearly twice as many patent litigation cases as our nearest competitor, and we have extensive experience in federal courts across the nation, including all of the most commonly used patent litigation forums and the International Trade Commission (ITC). Fish also offers unmatched jury trial skills and experience, having conducted trials in some of the most important competitor medical device cases.

> International Trade Commission Litigation – Fish was active in the ITC long before the recent “rush” to appear in its chambers, and we have the track record to prove it. Fish handles more ITC patent litigation than any other law firm—about 15 percent of all active patent cases at the ITC each year. The National Law Journal recently named Fish “#1 in International Trade Commission Filings” (2014).

> Patent Office Post-Grant Proceedings – Fish was named the #1 most active law firm at the Patent Office’s Patent Trial and Appeal Board (PTAB) for 2014, having represented clients in 154 proceedings—more than any other firm—and also ranked as the most active firm representing petitioners at the PTAB. In addition, Fish has been involved in more PTAB proceedings involving medical device patents than any other law firm. Our clients benefit from the seamless integration we can bring of Patent Office and court expertise and experience, to develop and execute an integrated litigation strategy across court and Patent Office fronts.

> Business Litigation, Such as False Claims Act/Qui Tam and Product Liability Cases – Fish also brings its technical savvy to other business litigation involving our medical device clients, including False Claims Act/qui tam and product liability cases. Our unmatched ability to understand the intimate details of medical devices gives our clients the winning edge in these types of cases.

> Appellate Court Practice – Fish was recently named to the National Law Journal’s “Appellate Hot List” for significant appellate wins and an impressive overall track record. We have handled almost 150 appeals over the past five years covering a broad range of venues (district court, ITC, and PTAB) and technologies (medical devices, pharmaceutical, computer hardware) on nearly every imaginable issue (validity, infringement, damages, standing, inventorship, and many more). We provide to our clients the most experience and the widest-ranging appellate practice in the country. For example, we have 25 former Federal Circuit clerks in our ranks, which allows us to provide an appellate team specifically tailored to the subject matter and issues on appeal. Furthermore, we are consistently called upon for our highly regarded amicus curiae counsel and have filed numerous amicus briefs in the Federal Circuit and Supreme Court for Fortune 500 clients.

We Have a Deep Bench of Technological Expertise We have prosecuted and litigated patents across a wide range of medical devices, a sampling of which includes: > Angioplasty catheters> Blood oxygenators> Blood pressure measurement systems> Blood pumps> Brain computer interface systems> Cardiac diagnostic equipment> Cardiac rhythm management (implantable pacemakers

and defibrillators)> Cardiovascular atherectomy systems> Cerebrospinal fluid shunt valves> Continuous glucose monitoring systems> Continuous positive airway pressure (CPAP) systems for sleep apnea> Coronary stents> Deep brain stimulation> Diagnostic technologies> Digital health technologies> Drug delivery devices> Electrocardiography (ECG) analysis> Electrochemical pumps> Endoscopes> External defibrillators> Glucose sensors (subcutaneous and intravascular)> Heart-lung machines> Heart valve reconstruction and repair> Hospital microfluidic blood diagnostic systems> Hospital software systems> Imaging systems (e.g., magnetic resonance imaging

and computed tomography)> Implantable pressure sensors> Kidney dialysis systems and processes> Magnetic resonance imaging devices> Medical records computing and networking systems> Minimally invasive surgical tools> Orthopedic hip and knee implants> Pathology software> Percutaneous heart valves> Pressure-controlled intermittent coronary sinus

occlusion procedures> Pressure sensing vascular guide wires> Prosthetic organs and joints and orthopedic devices> Proton therapy systems> Radiation therapy systems> Renal denervation devices> Spinal implants> Spinal surgical tools and procedures> Stent grafts> Sterilization technologies and systems> Surgical instruments (for use in atherectomy and

arthroscopic surgery)> Tissue heart valves> Ultrasound devices> Vagal nerve stimulation systems for epilepsy and depression> Wearable insulin pumps> Women’s healthcare devices> X-ray systems

IndustryRecognition“Tier 1” patent prosecution practice and “Tier 1” patent litigation practiceThe Legal 500 (2015)

“Tier 1” rankings for patent prosecution, patent litigation, and ITC litigationManaging Intellectual Property (2015)

#1 PTAB Law Firm in the U.S.Managing Intellectual Property (2015)

#1 Patent Contentious Law Firm of the YearManaging Intellectual Property (2015)

“Tier 1” rankings in Intellectual Property Litigation, Patent Litigation, Patent Law, Technology Law, and Trademark LawU.S. News and Best Lawyers, Best Law Firms survey (2012-2016)

Top National Rankings for Patent Prosecution and Patent LitigationIAM Patent 1000: The World’s Leading Patent Practitioners (2015)

Success StoriesSmith & Nephew v. Arthrex – In March 2015, the Federal Circuit upheld the $85 million jury verdict for Fish’s client Smith & Nephew against its competitor, Arthrex—the third time the Federal Circuit has ruled on the case. In 2013, the Federal Circuit reinstated Smith & Nephew’s win and the Supreme Court denied cert. The litigation has spanned 11 years and includes the Federal Circuit overturning the case (2009); retrying and winning the case (2011); the district court granting JMOL, the Federal Circuit’s reversal, and the Supreme Court denying cert (2013); and the Federal Circuit upholding its 2013 ruling (2015).

St. Jude Medical v. Volcano – In 2014, Fish successfully represented patent owner Volcano before the Patent Office’s Patent Trial and Appeal Board, avoiding inter partes review of a Volcano patent on vascular imaging systems, setting precedents in the Patent Office and in the Federal Circuit regarding the scope of review in inter partes review proceedings.

Baxter v. Fresenius – In 2013, Fish completed a clean sweep of its defense of patent infringement claims against Fresenius. After having obtained a defense verdict on all patents but one in Federal District Court, Fish obtained a Federal Circuit affirmance of the final patent after a successful ex parte reexamination challenge to the patent’s validity, in a landmark ruling endorsing Patent Office validity challenges on patents found valid in the federal courts.

Fish & Richardson is a global patent, intellectual property (IP) litigation, and commercial litigation law firm with more than 400 attorneys and technology specialists across the U.S. and Europe. Fish is a Tier 1 Patent Law Firm, a “Powerhouse” for complex patent work, top PTAB firm, and has been named the #1 patent litigation firm for 12 consecutive years. Fish is the leading law firm for the world’s greatest innovators and influential industry leaders and has represented visionaries in technology, business, and the arts since 1878. For more information, visit www.fr.com.

These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice. The material contained in this brochure has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel.

©2016 Fish & Richardson P.C. All Rights Reserved. Document No. MDP-0100

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