Experience

Medical Device and Diagnostics

About

Medical Device and Diagnostics is part of our work in Life Sciences.

Using innovation to improve medical care and patients' daily lives

Finnegan works with innovative clients of all sizes, including Fortune 100, Global 1000, and startups in the medical device and diagnostics industries. Saving lives, enhancing patients’ quality of life, improving healthcare delivery, and creating less-invasive ways to treat diseases are top priorities for the medical device industry. The competitive diagnostics industry seeks to improve testing with faster and more accurate results, as well as to develop new methods to detect evolving targets. Innovators face numerous challenges, including a highly litigious patent environment, tight profit margins, short product lifecycles, reimbursement programs that can affect product viability, and costly research and development activities that often require lengthy clinical trials. In addition, new devices must comply with the U.S. Food and Drug Administration’s safety and marketing regulations, which may require public disclosure of sensitive design information—all before the device is brought to market. To remain competitive, companies must protect and enforce their intellectual property rights.

Understanding the law, science, and technology

At Finnegan, we have the legal experience and technical expertise to help clients address the many issues that arise in developing, protecting, and commercializing medical device and diagnostic inventions. Our experience ranges from working with in-house legal counsel at large companies on prosecution, due diligence, licensing, and high-stakes litigation, to advising senior management of startup companies on strategic business decisions to help get the company off the ground. We understand the highly competitive nature of the medical device industry, the demands of investors and shareholders to generate value, and the importance of securing early and strong protection of IP rights. We also help clients navigate the complex and evolving patent laws that bring challenges to protecting diagnostic inventions.

From determining the competitive landscape for new products to developing winning litigation strategies, we help by:

Litigating high value products in district and appellate courts with experienced trial and appellate teams
Developing and executing prosecution strategies to both protect a client’s products and analyze those of its competitors, which helps ensure that the client realizes value from its IP assets
Advising on and participating in post-grant proceedings, including inter partes reviews and reexaminations
Analyzing the value of competitors’ patents
Preparing and negotiating licenses and other transactions to commercialize IP rights
Counseling on research and development options that minimize patent obstacles
Providing due diligence for merger and acquisition targets
Providing trademark prosecution and counseling services

We work with medical device clients across a broad range of disciplines and technology, including:

Diabetes and blood glucose self-testing
Digital-signal processing
Drug-delivery systems
Drug-eluting heart stents
Electronic medical devices
Endoscopy and urology/gynecology systems
Interventional cardiology devices
Medical supplies
Monitoring equipment
Orthopedics
Surgical devices
Therapeutic devices

We work with diagnostics clients across a broad range of disciplines and technology, including:

Genetic screening
Immunological screening
Screening using spectrometry
Screening using artificial intelligence
Cancer diagnostics
Microbial diagnostics
Prenatal diagnostics

Everyone in this industry

Experience

Finnegan represents BrainCo, a developer of brain-machine interface (BMI) wearables that combine electroencephalography (EEG) signal processing with artificial intelligence (AI) and machine learning (ML) to enable users to control electronic devices using brain signals. The firm works with BrainCo to develop and implement its intellectual property strategy, including drafting and prosecuting utility and design patent applications, in support of the company’s efforts to build a robust patent portfolio covering innovations and designs related to BMI technologies used in toys, smart home appliances, and robotic devices.

Successfully represented Bausch & Lomb and Eye Therapies in a Hatch-Waxman patent infringement litigation and parallel PTAB challenges concerning an ANDA for generic versions of over-the-counter Lumify® ocular drops. The cases settled favorably for our clients.

3:21-cv-16766, D.N.J., Judges Kirsch, Singh
IPR2022-00146, PTAB, Judges Hulse, New, Pollock
IPR2024-00467, PTAB, Judges Flax, Pollock, Yang
IPR2022-00142, PTAB, Judges Flax, Hulse, New, Pollock

Representing Aerin Medical Inc. and The Foundry, LLC in a patent infringement case involving medical devices for treating nasal airways. Finnegan is also representing patent owners Aerin Medical Inc. and The Foundry, LLC in a series of inter partes review (IPR) challenges to the asserted patents.

1:23-cv-00756, D. Del., Judge Hall
IPR2024-00275, -00276, -00277, -00278, -00279, -00280, -00282, -00669, PTAB

Representing Bay Materials, LLC in district court patent litigation involving multilayer polymer sheet material used in clear dental aligners.

1:21-cv-01610, D. Del., Judges Andrews, Hall

Represented Intuitive Surgical Operations on appeals from petitions for inter partes review (IPR) filed by Auris Health, Inc.

21-1473, -1732, -1733, Fed. Cir., Judges Prost, Dyk, Reyna
IPR2019-01173, -01533, -01547, PTAB, Judges Franklin, Hulse, Jenks, Worth, Yang

Represented defendants Kettenbach GmbH and Co. KG, Kettenbach LP and Xinial Systems GmbH and Co. KG in a case brought against the Defendants’ dental products for patent and trademark infringement, as well as false advertising, in the United States. After Defendants obtained a final written decision from the U.S. Patent and Trademark Office (USPTO) finding all asserted patent claims in the case to be unpatentable, the parties settled.

2:21-cv-06613, E.D.N.Y., Judge Reyes