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Friday, March 13, 2009
Inside Medical Devices
Protect IP for combination products carefully
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A trend in health care is combination products that pair biologics, drugs and medical devices. By combining technologies, these products provide patients with more targeted and specialized treatments that can improve the efficacy, safety and delivery of medicines while minimizing side effects.
Combination products, however, face unique hurdles in entering the marketplace. A sophisticated patent and regulatory strategy that emphasizes the benefits of converging technology is necessary to succeed in the exploding combination products market.
The market for combination products has nearly doubled in five years to an estimated $10 billion in 2009. Approximately 90 percent of that value is attributed to drug-eluting stents, which have revolutionized treatment in cardiology since appearing in 2003.
In orthopedics, bone fracture fixation devices combine biologics and orthopedic implants to regenerate bone. In ophthalmology, ocular implants combined with drugs control local extended release to treat various eye conditions. Additionally, combination products may combine diagnostics and therapeutics to predict, regulate and monitor pathological responses. As new combinations are created, vast opportunities and benefits exist for companies willing to develop complex combination products.
In today’s challenging economic climate, a strategic patent portfolio is crucial to a company’s growth and survival by providing numerous business advantages, including securing venture capital funding and gaining leverage for collaborations with other companies.
Comprehensive coverage
Developing a strong portfolio first requires comprehensive patent coverage of the device, the biologic, and the device/biologic combination. Comprehensive coverage should include patent claims directed to compounds, diagnostics, therapeutics, methods of treatment, use and manufacture, and any other novel aspects of the combination product. Further development of the portfolio should include patenting improvements to the technology to form a “picket fence” of protection around the core technology.
Implementing comprehensive patent coverage for combination products requires sophisticated and effective patent counsel. Because patent attorneys generally specialize in either biologics or medical devices, two separate attorneys may be needed to handle combination products. Ideally, these attorneys should work together in the same firm to effectively prosecute patents directed toward each aspect of the product. Finding sophisticated patent counsel for combination products may be challenging, but is crucial for maximizing patent coverage.
Before patent prosecution begins, attorneys should conduct a freedom-to-operate search to determine whether the company is free of third-party patents and can practice its invention. Once the FTO search is completed on every aspect of the device and biologic, the combination product can be designed to avoid infringing any third-party patents discovered, and patent applications can be filed covering potential design-around opportunities. Conducting an FTO search early in the process is critical to determining how a company can market its combination product.
For companies entering into joint ventures, issues surrounding ownership of the product may emerge. For example, one company may claim ownership of the device and a second company may claim ownership of the drug or biologic, thereby clouding ownership of the combination product. Ownership disputes can be resolved by assigning patent rights entirely to one party or jointly between the parties. Alternatively, ownership disputes may be resolved by exclusive or non-exclusive licensing of the patent rights.
Regulatory Challenges
Combination technologies also present a host of regulatory issues. A product submitted for U.S. Food and Drug Administration approval is assigned to a particular center within the FDA based on its overall intended therapeutic effects. Incorrect classification may send the product to an unfavorable center, resulting in more clinical trials and delayed approval. To avoid an unfavorable destination at FDA, companies should explain why the combination product should be assigned to either a device or biologics center in the FDA filing.
Combination products are the next wave in patient health care. A careful patent and regulatory strategy can address hurdles unique to those products and ensure success in a growing market.
David J. Dykeman and Joanna Toke are patent attorneys in the law firm of Greenberg Traurig LLP in Boston. They can be reached at dykemand@gtlaw.com and tokej@gtlaw.com.
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