In November, Roche Diagnostics Operations Inc. (Indianapolis) took on every major player in the blood glucose test strip industry by filing a lawsuit in U.S. District Court for the District of Delaware. The Roche suit seeks to enjoin meter and test strip sales by the defendants, which include Abbott Diabetes Care (Alameda, CA), Bayer Healthcare (Tarrytown, NY), and LifeScan (Milpitas, CA), a Johnson & Johnson company. The parties to the lawsuit make up all but a few percent of the blood glucose test strip market, which has estimated annual sales of about $8 billion.
Roche accuses the defendants of infringing two recently issued U.S. Patents (nos. 7,276,146 and 7,276,147), both of which cover methods of determining blood glucose concentrations using a disposable test strip. The methods covered by the two patents include two key features in combination. The first is a small sample size used by the test strips. Many of the patent claims cover methods using sample sizes of less than 1 µl, which is a blood drop almost as small as the head of a pin. The second key patented feature is fast testing times. The claims cover a testing method wherein a result is displayed within 10 seconds of detecting a blood sample in the test strip capillary chamber.
The Roche patents in suit claim the benefit of a provisional patent application that was filed in November 2001. At that time, many manufacturers of blood glucose test strips and meters already provided testing systems that delivered results in times approaching 10 seconds or less. Many of the systems also used a sample size of around 1 µl or less.
To obtain allowance of its patent claims, however, Roche has shown that it perfected such a system at least as early as March 1998. The company accomplished this legal maneuver by 'swearing behind' its November 2001 filing date with a Rule 131 declaration, demonstrating that the company's date of invention was much earlier than the filing date of its patent application.
The United States is now the only country that awards a patent to the person or company that is the first to invent the technology.
The Roche suit highlights the need for medical device companies to conduct timely and appropriate tests demonstrating their technology developments, and to document the results properly. This case may well turn on whether Roche conducted the proper tests, documented them sufficiently, and worked diligently to reduce its invention to practice under the patent laws. However, the long delay between the development of the test strip technology and Roche's filing of a patent application may also raise the issue of whether the company abandoned its patent rights in this technology.
The case also raises issues of obviousness. To be patentable, a technology must be new, useful, and nonobvious. In a recent decision, KSR v. Teleflex, the U.S. Supreme Court clarified the standard for determining what constitutes an obvious combination of prior-art technologies. This landmark case generally makes it easier to show that a particular invention was obvious at the time it was created, therefore making it easier to invalidate an existing patent. Since the inventiveness of the two Roche patents involves making test strips faster and able to use smaller sample sizes, the patents may be vulnerable to the argument that these goals were obvious to anyone working in the test strip field in the late 1990s.
A similar argument may derive from the fact that the Roche patents arguably claim the desired resultsa faster testing method using smaller sample sizerather than claiming how the results are achieved. The U.S. Supreme Court has long held that a patent claim must include novel method steps or structural limitations, rather than merely claiming the functional result that is obtained.
At this point, it is unclear what direction the case will ultimately take. The only things that are truly clear about the Roche suit is that the stakes involved are enormous, and that the case will be well worth the watching. Douglas C. Limbach, attorney, Shay Glenn LLP (San Mateo, CA)