Maintain a competitive edge by creating a strategic patent portfolio.
In the midst of sweeping healthcare reform, the United States Patent and Trademark Office (USPTO) is retooling its requirements and the U.S. Supreme Court is issuing far-reaching opinions that impact patent 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 innovation and investment, resulting in an uptick in patent filings. 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 competitive 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 establishes 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 infringement suits. Patents should be filed to cover all aspects of the core technology, including the whole device, key components, 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 finding 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 develop an immediate strategy for building core technology, future expansion and design-around opportunities.
To further strengthen a patent portfolio and expand a company's global presence, handheld medical device companies should file 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 invention around the world.
Cross-licensing with competitors is another method to enhance a patent portfolio. Cross-licensing opportunities arise when companies have 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 predecessor, but is smaller, portable and simpler to use. For example, a patent office 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 filings in the handheld device industry. The U.S. Supreme Court, in its June 28, 2010 Bilski v. Kappos decision, confirmed the patentability 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 determining 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
David J. Dykeman is a registered patent attorney
and shareholder in the international law firm of
Greenberg Traurig LLP.
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