Practice Areas & Industries: Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.

Practice/Industry Group Overview

Emerging medical technologies face fierce competition
Saving lives, enhancing patients’ quality of life, improving healthcare delivery, and creating less-invasive ways to diagnose and treat diseases are top priorities for the medical device industry. The industry has had explosive growth and related challenges in recent years. Innovators face 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 Food and Drug Administration’s safety and marketing regulations that 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.

Finnegan represents key innovators, including established multinational leaders as well as small, start-up companies, with IP assets that promise advancements in the field. Whatever the size of the company, having a legal advisor with specialized knowledge and experience is essential. Finnegan has delivered successful, sophisticated legal strategies to help medical device clients protect, advocate, and leverage their valuable IP assets.

Understanding both the law and breakthrough science and technology
In high-stakes cases involving some of the most complex medical devices, our professionals rely on their deep legal and technical backgrounds. Our lawyers include former patent examiners in the medical device field, and many have degrees in the sciences and technologies behind medical devices and procedures, including mechanical and electrical engineering, biology, and chemistry. We provide insight and advice to clients on multidisciplinary issues that can have critical legal and business implications. As discoveries fuel the convergence of the medical device, pharmaceutical, and diagnostics industries, having a legal team with diverse experience and knowledge of these industries becomes essential. We remain on top of the industry’s cutting-edge issues and highly responsive to the complicated legal questions that often arise.

Services Available

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

• Advanced algorithms
• 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
• Diagnostic instruments and methods
• Therapeutic devices
• Implantable devices
• Medical supplies
• Monitoring equipment
• Neuroscience
• Oncology
• Orthopedics and spine
• Pain care
• Surgical devices
• Protection for cutting-edge advancements

Our clients are involved in diverse medical technologies, such as interventional cardiology, endoscopic surgery, diabetes management, and diagnostic tools and methods that allow for earlier detection of diseases and less invasive drug-delivery methods. We understand the highly competitive nature of the industry and the demands of investors and shareholders to generate value — and we know that these require early and strong protection of IP rights. From determining the competitive landscape for new products to developing winning litigation strategies, we provide a full range of services to our medical device clients:

• 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.
• Analyzing the value of competitors’ patents.
• Counseling on transactional decisions.
• Preparing and negotiating licenses and other transactions to commercialize IP rights.
• Monitoring the field to advise clients on the need for clearance opinions or the possibility of an interference issue.
• Determining priority in complex interferences.
• Counseling on research and development options that minimize patent obstacles.
• Providing due diligence for merger and acquisition targets.
• Counseling on business-related matters, including antitrust and competition issues.
• Providing trademark prosecution and counseling services.
• Advising on potential litigation strategies and deploying experienced trial and appellate teams.

A diverse client base
We work with innovative clients of all sizes, including Fortune 100, Global 1000, and start-ups in the medical device industry. Our experience ranges from working with the in-house legal counsel of large companies on prosecution, due diligence, licensing, and high-stakes litigation to advising senior management of start-up companies on strategic business decisions to help get the company off the ground.  Our clients include:

• Abbott Labs
• Acclarent
• Becton, Dickinson and Company
• Boston Scientific
• The BrainScope Company
• Covidien
• ExploraMed
• Hologic, Inc.
• Home Diagnostics, Inc.

Representative Engagements

A victory at trial for innovator of cardiovascular stents
Finnegan won a significant victory for Guidant (now Abbott) in the U.S. District Court for the District of Delaware. After a two-week trial, the jury returned a verdict in Guidant’s favor on all counts, finding that all 12 of the asserted patent claims were valid and that all 12 of the accused Medtronic coronary stents infringed the asserted claims. The district court also held that none of the 12 accused Guidant stents infringed any of Medtronic’s four asserted patents and further dismissed Medtronic’s claims against Guidant for trade secret misappropriation and unfair competition.

Abbott Laboratories’ dominance in the coronary stent market is protected
Abbott Laboratories’ motion to enforce a settlement agreement with Medinol Ltd. was recently granted. The court adopted Abbott’s interpretation of a settlement between the parties, which gave Abbott an unrestricted license to Medinol’s stent patents. After a two-week jury trial on the validity of Medinol’s remaining patent claims (but before the jury verdict was announced), the parties settled. When a disagreement arose over a material term during the drafting of the settlement agreement, Finnegan went back to court to enforce the agreement as the parties had stated on the record.

Finnegan acts quickly after secure certification exam compromised
When an organization that certifies medical personnel discovered that its secure certification exam had been compromised, Finnegan acted quickly to minimize the harm by obtaining an expedited certificate of registration from the U.S. Copyright Office and negotiating a favorable settlement for the client.

Finnegan secures an award of priority in transdermal drug delivery interference
On behalf of Minnesota Mining and Manufacturing Co., we provoked an interference in the PTO between 3M’s patent application and a patent issued to Adhesives Research, Inc. The subject matter was a type of transdermal drug delivery system that uses an adhesive composition, and both parties introduced evidence of actual reduction to practice. We were successful in obtaining an award of priority against the patentee in the PTO and thereafter prevailed in a Section 146 action for review of the PTO decision brought by the losing patentee in the U.S. District Court for the District of Columbia.

Interference victory for inventors of electrosurgical scissors
We provoked an interference for Boston Scientific against a patent owned by Everest Medical. We were able to prove that the Boston Scientific inventors were the true first inventors and the Board entered a judgment of priority of invention for Boston Scientific. The subject matter was electrosurgical scissors.

Organon Teknika–U.S. market remains open for virus diagnosis and quantification kits
We represented Organon Teknika against Hoffman-La Roche’s patent infringement claims in the ITC. Hoffman-La Roche asserted that its patents for polymerase chain reaction (PCR) were infringed by Organon’s nucleic acid sequence-based amplification (NASBA) kits for diagnosis and quantification of certain viruses. We reached a favorable settlement agreement without trial, thereby permitting Organon to market its NASBA kits in the U.S.

Priority of invention of hemodialysis catheter
We represented the University of Missouri and Covidien (formerly Tyco Healthcare) against C.R. Bard and VasCath, successfully obtaining an award of priority against the patentee in this longrunning interference. Navigating this interference through the PTO, two district courts and two trips to the Federal Circuit, we were able to achieve finality of the award of priority and secure important patent rights for our client. The technology at issue was a type of hemodialysis catheter for removing toxins from the blood of patients with kidney failure.

Protecting patents for a leader in medical devices
Finnegan has represented Boston Scientific in a variety of patent matters since 1995. The work has included prosecution of hundreds of U.S. and foreign patent applications in the medical device area. Finnegan has also represented Boston Scientific in interferences, due diligence investigations of target companies, product freedom-to-operate opinions, reissue applications, and European oppositions.

Strategic alliance in medical diagnostics
Our client had the technology and the IP but not the market presence. A major pharmaceutical company needed a portfolio of diagnostic products. We assisted our client in a lengthy negotiation over a partnership arrangement that allowed both companies to prosper. While IP was an important part of the transaction, we assisted in creating contractual protection of the client’s business interests, particularly in the event of a separation.

Successfully proving noninfringement for Topcon Instrument’s glaucoma device
We defended Topcon Instrument against a multipatent ITC case brought by Cambridge Instruments involving devices for diagnosing glaucoma. In a one-week trial held just two months after the case began, we established that Topcon’s instruments were not covered by the patents, and the ITC judge thus denied Cambridge Instruments’ motion for temporary relief.

Successfully reversing a summary judgment on an innovative surgical method
The district court had granted summary judgment against firm client Origin (a subsidiary of Guidant Corp.) and a jury awarded nearly $13 million in damages, finding that the infringement was willful. The matter involved infringement of a patent on a method for using a balloon to create a space for surgery. On appeal, the Federal Circuit agreed with our interpretation of the patent claims and vacated both the judgment of infringement and the jury’s verdict that the infringement was willful.

Summary judgment allows Home Diagnostics Inc. to meet the needs of diabetics
Home Diagnostics Inc. (HDI) is one of the largest cobranders of blood glucose products for diabetics and offers low-cost alternatives to products offered by competitors. After a three-year battle with Roche, the district court granted a summary judgment of noninfringement in favor of HDI, concluding that no reasonable juror could find that HDI products infringed Roche’s patent relating to blood glucose monitors.