The opinion of the court was delivered by: Sheridan, U.S.D.J.
This matter comes before the Court in order to construct four claim terms. See, Markman v. Westview Instruments, 517 U.S. 370 (1996). The claim terms in dispute are a) purgation; b) clinically significant electrolyte shifts; c) aqueous hypertonic solution; and d) effective amount. Before addressing the construction of each, some background information at the standard for claim construction is set forth.
Braintree is a small pharmaceutical company that manufactures colon preparation products. Such products became more prevalent in the sixties when the colonoscope was invented. The colonoscope allows a physician to examine the bowel of the colon to determine whether polyps or cancerous lesions appear. The colon needs to be visually clear in order to successfully perform a colonoscopy; and the usage of the colonoscope was initially stymied by large amount of fecal matter which clouded the pictures being observed on the colonoscope. As a result, the preparation for the colonoscopy required that the colon would be cleared. This preparation included drinking liters of a solution which caused diarrhea. Through the diarrhetic reaction, the colon was sufficiently cleared to allow a doctor to satisfactorily examine inside the colon. Since most patients disliked the taste and the large quantity of the solution imbibed, there was significant non-compliance with the preparation protocol. Due to the non-compliance, doctors often found that the colon was not clear enough to successfully perform the colonoscopy.
At the end of the nineties, a phospho soda solution was invented which substantially reduced the quantity of solution necessary to prepare the colon. Unfortunately, this product caused electrolyte abnormalities which resulted in unexpected dangerous side effects including heart and kidney failure as well as death in certain cases. As a result, the FDA required warnings to doctors. Due to the dangerous side effects, in the early 2000's, it was apparent that a new preparatory product was needed.
During that period of time, inventors Cleveland and Fordtran designed a reduced volume colonic purgative formulation that avoids the dangerous side effects and electrolyte imbalances. On September 5, 2005, U.S. Patent No. 6,946,149 (the '149 Patent) was granted to Braintree. Later, on June 30, 2009, an ex parte reexamination certificate was issued*fn1 .
The claims in dispute are claims 15 and 18. They state:
15. A composition for inducing purgation of the colon of a patient, the composition comprising about 100 ml to about 500 ml of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.
18. A composition for inducing purgation of the colon of a patient comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution consisting essentially of an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.
The Court held a Markman Hearing on June 15 and 18, 2012, in which David A. Peura, M.D., John F. Johanson, M.D., and David Goldfarb, M.D. testified. Each disputed term is discussed after the standard for claim construction is set forth.
I. STANDARDS FOR CLAIM CONSTRUCTION
There is a two-step analysis for determining patent infringement: "first, the court determines the meaning of the disputed claim terms, then the accused device is compared to the claims as construed to determine infringement." Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007) (citation omitted). When the court engages in claim construction to determine the meaning of disputed claim terms, it is decided as a matter of law. Markman v. Westview Instruments, 517 U.S. 370, 372 (1996). It is well established that "the construction of a patent, including terms of art within its claim, is exclusively within the province of the court." Id.
When construing claims, the court must focus on the claim language. As explained by the Federal Circuit:
It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude. Attending this principle, a claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to particularly point out and distinctly claimthe subject matter which the patentee regards as his invention.
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-16 (Fed. Cir. 2004) (citations omitted). When looking at the words of a claim, the words "are generally given their ordinary and customary meaning," which has been defined as "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective ...