Limbach: High-stakes lawsuit raises key questions.
At the end of 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.1 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 small percentage 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 with a disposable test strip. The methods covered by the two Roche patents include two key features in combination. The first is a small sample size used by the test strips. The patents claim methods of using a blood sample size of less than 1μl, a drop almost as small as the head of a pin. The second key patented feature is a fast testing time. The claims cover methods that display a result within 10 seconds of detecting a blood sample in the test strip capillary chamber.
Meters and test strips are used by diabetic patients and their healthcare providers to periodically test blood glucose levels. According to the American Diabetes Association, there are 20.8 million adults and children in the United States—or 7% of the population—who have diabetes. Unfortunately, 6.2 million people (nearly one-third of the total) are unaware that they have the disease.
Frequent glucose testing is key to controlling the impact of the disease. People with diabetes typically test themselves at least several times a day using a handheld meter with disposable test strips. Testing typically involves pricking a fingertip or forearm to draw a drop of blood, which is then applied to a single-use test strip and inserted in the meter. With regular testing, a diabetic person is better able to adjust diet, exercise, insulin intake, and other factors that affect blood glucose levels. Keeping glucose levels under tight control has been shown to dramatically improve the health and longevity of people with diabetes.
For many years, companies have been working hard to improve testing systems by enabling the use of smaller blood samples, and delivering glucose level results more quickly. A smaller sample size provides the benefits of less pain, less mess, quicker healing time, and the ability to draw the sample from an ‘alternate test site,' such as the forearm, rather than sensitive fingertips. Shorter test times are clearly more convenient for the user.
The Roche patents in suit claim the benefit of a provisional patent application that was filed in November 2001. By that time, many manufacturers of blood glucose test strips and meters had 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 1μl or less . However, Roche was able to obtain its patent claims by demonstrating that its invention was complete by March 1998. The company presented the proof in a declaration to the U.S. Patent and Trademark Office (PTO). This maneuver, known as swearing behind a prior art reference date, is a tool useful in jurisdictions that award patents to those who invent first, rather than those who file a patent application first. The United States is now the only country that awards a patent to the person or company that is the first to invent a technology. In all other countries, the patent goes to the applicant who is first to file a patent application (provided the applicant actually invented the technology, rather than merely filing on an idea invented by another).
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. Several factors may work against Roche in its suit. For example, 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. Further, 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.2 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 that may weaken Roche's position involves the fact that the Roche patents appear to claim the desired results—a faster testing method using smaller sample size—rather 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.
Many interesting issues are presented by the Roche case. The defendants may present prior art that was not previously considered by the patent office, and will likely argue that the patents are invalid, unenforceable, and not infringed, and that injunctions are not warranted. The defendants may also ask PTO to reconsider the validity of the patents in formal reexamination proceedings. Such a move could stay the proceedings in U.S. district court, or the court and PTO proceedings could be conducted concurrently.
At this early stage, of course, the outcomes of the case and of the counter actions that the defendants may take are all unclear. Abbott, Bayer, and LifeScan each have sizable test strip patent portfolios covering other aspects of glucose meters and test strips. Now that Roche has sued these companies, they may very well decide that this is the best time to assert their patents against Roche, either in this case or in separate law suits. As is the case in most lawsuits, the parties may decide to settle the case at some point before trial.
The financial stakes of the case are enormous, and the way in which the patent law issues play out will be well worth watching for the general lessons they may offer.
1. Roche Diagnostics Operations Inc. et al. v. Abbott Diabetes Care Inc. et al., Case no. 1:07-cv-00753-JJF, U.S. District Court for the District of Delaware (November 21, 2007).
2. KSR International Co. v. Teleflex Inc., 550 U.S., 82 USPQ2d 1385 (2007).
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