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Handheld Devices


patent strategies I


Optimizing


Maintain a competitive edge by creating a strategic patent portfolio. By David J. Dykeman


n the midst of sweeping healthcare reform, the United States Patent and Trademark Offi ce (USPTO) is retooling its requirements and the U.S. Supreme Court is issuing far-reaching opinions that impact pat- ent and licensing strategy. Medical technology companies need to carefully navigate this new world that governs the development, prosecution and management of their patent portfolios.


Among the healthcare reforms, the shift to complete disease treatment cost reimbursement will likely drive in- novation and investment, resulting in an uptick in patent fi lings. However, medical device innovators will also see more competition, increased regulatory challenges, and greater pricing pressures.


The emergence of medical mobile phone apps for cardiac monitoring to ultrasound imaging is an industry game changer. With point-of-care diagnostics becoming more common in clinical settings, patent protection is crucial for developers of handheld medical devices used to diagnose medical conditions, prescribe drugs or order laboratory tests. Developers need to maintain a competi- tive edge through a strategic patent portfolio that focuses on protecting core technology, exploring new patent areas and establishing worldwide patent protection. A strategic patent portfolio protects a company’s core technology, which in turn helps secure funding and estab- lishes a competitive advantage in the marketplace. Broad patent protection can be used both offensively, to block competitors from the marketplace, and defensively, to serve as a bargaining chip against potential patent infringe- ment suits. Patents should be fi led to cover all aspects of the core technology, including the whole device, key compo- nents, disposables, diagnostics and methods of treatment, use and manufacture. As the device evolves, incremental improvements should be patented to form a “picket fence” of protection around the core technology. Developing a strategic portfolio also requires fi nding ways to patent areas not already covered, known as “white space,” which will determine how much room exists within a particular patent area for new innovations. By leveraging white space, handheld medical device companies can de- velop an immediate strategy for building core technology, future expansion and design-around opportunities. To further strengthen a patent portfolio and expand


26 May 2011


a company’s global presence, handheld medical device companies should fi le international patent applications in countries with large markets for the product, as well as countries where competitors’ manufacturing facilities are located. This international strategy protects the company against potential infringers who may wish to make, use or sell the company’s inven- tion around the world. Cross-licensing with com- petitors is another method to enhance a patent portfolio. Cross-licensing opportunities arise when companies have


David J. Dykeman is a registered patent attorney and shareholder in the international law fi rm of Greenberg Traurig LLP. For more information on Greenberg Traurig:


www.rsleads.com/105ht-205


overlapping patents, and practicing one patent results in infringement of another patent. With cross-licensing, companies can mutually agree to share patents without the exchange of license fees and with a promise not to sue. A major challenge for handheld devices is protecting a device that serves the same purpose as its larger predeces- sor, but is smaller, portable and simpler to use. For example, a patent offi ce examining a pocket-size visualization tool may view as prior art all patents on larger stationary imaging devices, such as ultrasound and CT scan systems. Thus, patents covering handheld devices often focus on the new and improved features that allow portability and point-of- care use, including the diagnostic wands and methods of using handheld devices. Two recent court cases concerning patentable subject matter will also have a lasting impact on patent fi lings in the handheld device industry. The U.S. Supreme Court, in its June 28, 2010 Bilski v. Kappos decision, confi rmed the pat- entability of certain algorithms and business methods – key areas of innovation for the handheld devices industry. In a welcome development for the medical diagnostics


industry, the Court of Appeals for the Federal Circuit recently upheld patent claims covering methods for de- termining the optimal dosage of a drug to give patients with particular autoimmune diseases in its Dec. 17, 2010 Prometheus Laboratories v. Mayo Collaborative Services decision. These decisions offer stronger patent protection for handheld medical diagnostic systems that promise elegant, simple and low-cost solutions to major global problems.


HMT HEALTH MANAGEMENT TECHNOLOGY www.healthmgttech.com


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