The opinion of the court was delivered by: Hurley, Senior District Judge
Plaintiff The Original Creatine Patent Company, Ltd. ("OCPC")commenced this action accusing defendant MET-Rx USA, Inc. ("MET-Rx") of direct and indirect infringement of two patents in violation of 35 U.S.C. § 271(a)-(b). Presently before the Court are the objections of both parties to the Report and Recommendation of Magistrate Judge James Orenstein regarding claim construction (the "R&R"). For the reason set forth below, both parties' objections are denied and the Court adopts the R&R in its entirety.
I. The Patents in Suit and the Terms at Issue
At issue in this litigation are two patents: U.S. Patent No. 5,767,159 (the "'159 Patent") and U.S. Patent No. 5,968,544 (the "'544 Patent"). Both relate to the use of creatine, also known as methyl guanidine acetic acid, a compound that the human body produces naturally and stores in skeletal muscle, as a dietary supplement. In general, the '159 Patent concerns a method for increasing the body's supply of creatine to improve muscle performance and the '544 Patent concerns a creatine-based composition for human consumption and a method of providing the same. A more detailed description of the patents is set forth below.
The '159 Patent essentially claims a method for administering creatine so as to increase the creatine content in muscle tissue to improve muscular strength and functioning. ('159 Patent col.1 ll.4-19.) As creatine was discovered in the nineteenth century, there is a great deal of prior art concerning its administration. The '159 Patent discloses a number of prior patents claiming the use of creatine-related ingredients in both medical and veterinary treatments. The specification differentiates the claimed invention from this prior art principally on the basis that (1) it uses creatine as opposed to creatine-related ingredients such as phosphocreatine and cyclocreatine, and (2) it calls for higher doses than found in the prior art. (Id. at col. 2 ll.48-67.) According to the specifications, the claimed invention can be used to improve muscle capacity and functioning in patients suffering from a variety of cardiac and respiratory conditions and to prevent the depletion of creatine during intense physical activity.
At issue is the first claim of the '159 Patent which provides:
A method for increasing the muscle performing capacity in mammals having no disorder in creatine metabolism but suffering from or running a risk of depletion of muscle phosphoryl creatine storage comprising administering daily to said mammals, either enterally or parenterally, at least 0.2 [grams of] creatine [per kilogram] of body weight and not less than an amount corresponding to 15 [grams of] creatine in a 70[kilogram] mammal. '159 Patent, col. 6 ll.19-25 ("Claim 1"). More specifically, the dispute concerns the construction of (1) "suffering from or running a risk of depletion of muscle phosphoryl creatine storage" which according to the R&R means "having reduced, or potentially reduced, phosphoryl creatine storage in muscle;" and (2) "not less than an amount corresponding to 15g creatine in a 70 kg mammal" which Judge Orenstein found requires no construction beyond its plain terms. (See R&R at 14, 24.)
The invention claimed in the '544 Patent concerns the human consumption of creatine compositions and a method of providing them so as to preserve their effectiveness. The composition is acidic and can be liquid, semi-liquid or powder. ('544 Patent col.2 ll.16-52.) The method of administration is described as a means of storing the composition in its liquid form or supplying it in a powder form for mixing with water to create an "isotonic drink" defined as a drink that "corresponds to the osmotic potential of human body fluids." (Id. col.2 ll.35-37, 53-58 & col.3 ll.10-15.) The invention concerns both the provision of the composition in its powder form, as well as its storage in liquid and semi-liquid form. The disputed term, "unitary doses," concerns the provision of the composition in its powder form and is found in claim 17 which provides: "A composition according to claim 9, provided as unitary doses." (Id. col.10 ll.43-44.) Claim 9 states: "A stable, dry powder composition comprising creatine, said composition being unflavored or fruit flavored, which, when mixed with water or an aqueous solution, provides an acidic drink for human consumption, said creatine being substantially stable at ambient temperature or below." (Id. col.10 ll.17-21.) In his R&R, Judge Orenstein recommended that the term "unitary doses" be construed to mean "10-20 grams of creatine composition that are individually packaged in sachets, bags, packets, cylinders, bottles, or other suitable packages." (R&R at 26-27.)
II. The Parties' Contentions
MET-Rx objects to Judge Orenstein's recommended construction of the term "not less than an amount corresponding to 15 g creatine in a 70 kg mammal" in claim 1 of the '159 Patent. It contends that the correct construction is "administering said creatine only to mammals of at least 70 kg body weight, in an amount not less than 15g." MET-Rx maintains that this construction is supported by (1) extrinsic evidence, (2) the prosecution history, (3) the requirement that a claim be definite; and (4) admissions made by the inventor during the prosecution of foreign counterpart patents.
OCPC objects to Judge Orenstein's recommended construction of "suffering from or running a risk of depletion of muscle creatine storage" in claim 1 of the '159 Patent and of "unitary doses" in claim 17 of the '544 Patent. It maintains that the recommended construction is inconsistent with and ignores the prosecution history of the two patents and erroneously links the two patents and invention. OCPC asserts that the correct construction of "suffering from or running a risk of depletion of muscle creatine storage" should be construed as referring to the depletion of creatine stores that ...