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OAKWOOD LABORATORIES v. TAP PHARMACEUTICAL PRODUCTS INC.

May 2, 2003

OAKWOOD LABORATORIES, L.L.C., AND UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, PLAINTIFFS,
v.
TAP PHARMACEUTICAL PRODUCTS, INC., TAP HOLDINGS, INC., TAKEDA CHEMICAL INDUSTRIES, LTD., AND ABBOT LABORATORIES, DEFENDANTS.



The opinion of the court was delivered by: David H. Coar, United States District Judge

MEMORANDUM OPINION AND ORDER

Oakwood Laboratories, LLC filed suit against TAP Pharmaceutical Products alleging that it infringed U.S. Patent No. 4,818,542 (the "542 patent") by manufacturing and selling sustained release leuprolide acetate products. On April 4, 2003, this Court held a hearing in accordance with Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-81 (Fed.Cir. 1995). This Court's construction of the claims at issue in this case is set forth below.

I. Legal Standard

In Markman, the Federal Circuit held, and the Supreme Court affirmed, that it is the courts' responsibility as a matter of law to construe the claims of patents for the jury. 52 F.3d at 979. Claim construction is "the process of giving proper meaning to the claim language," the fundamental process that "defines the scope of the protected invention." Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed.Cir. 1997). Claim construction analysis must begin with the words of the claim, which define its scope. Teleflex, Inc. v. Ficosa North America Corp., 299 F.3d 1313, 1324 (Fed.Cir. 2002). "(T)he language of the claim frames and ultimately resolves all issues of claim interpretation." Abtox. Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed.Cir. 1997).

The words used in the claims are interpreted in light of the intrinsic evidence of record, including the written description, the drawings, and the prosecution history, if in evidence. Teleflex, 299 F.3d at 1324 The intrinsic evidence may provide context and clarification about the meaning of claim terms. Id. In the absence of an express intent to impart a novel meaning to claim terms, there is a heavy presumption" that a claim term carries its ordinary and customary meaning. Teleflex, 299 F.3d at 1325. The ordinary meaning of a claim term may be determined by reviewing a variety of sources, including the claims themselves, other intrinsic evidence including the written description and the prosecution history, and dictionaries and treatises. Id. (citations omitted). In all cases, however, the ordinary meaning must be determined from the standpoint of a person of ordinary skill in the relevant art. Id.

Of all the intrinsic evidence, courts have indicated that the specification is the "single best guide to the meaning of a disputed term." Vitronics, Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996). "Usually, it is dispositive." Id. In Teleflex, the court indicated that "[o]ne purpose for examining the specification is to determine if the patentee has limited the scope of the claims." 299 F.3d at 1325. As an example of such an instance, the court said "an inventor may choose to be his own lexicographer if he defines the specific terms used to describe the invention with reasonable clarity, deliberateness, and precision." Teleflex, 299 F.3d at 1325. In addition, the specification may be consulted to resolve ambiguity if the ordinary and customary meanings of the words used in the claims are not sufficiently clear to allow the scope of the claim to be determined form the words alone. Id. "The patentee may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope." Id.

On the other hand, while the claims must be read in view of the specification, limitations From the specification are not to he read into the claims. Id. at 1326. "That claims are interpreted in light of the specification does not mean that everything expressed in the specification must be read into all the claims." Raytheon Co. v. Roper Corp., 724 F.2d 951, 957 (Fed.Cir. 1983). The Teleflex court sought to explain this seeming contradiction:

If everything in the specification were required to be read into the claims, or if structural claims were to be limited to devices operated precisely as a specification, described embodiment is operated, there would be no need for claims. Nor could an applicant, regardless of the prior art, claim more broadly than that embodiment. Nor would a basis remain for the statutory necessity that an applicant conclude his specification with "claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." 35 U.S.C. § 112. It is the claims that measure the invention.
299 F.3d at 1326. The Teleflex court distilled these concerns to hold that "claims take on their ordinary meanings unless the patentee demonstrated an intent to deviate from the ordinary and accustomed meaning of a claim term by redefining the term or by characterizing the invention in the intrinsic record using words or expressions of manifest exclusion or restriction, representing a clear disavowal of the claim scope." 299 F.3d at 1327.

More recently, the Federal Circuit addressed this seemingly ambiguous area of law in Texas Digital Systems, Inc., 308 F.3d 1193 (Fed.Cir. 2002), where it held that:

the intrinsic record also must be examined in every case to determine whether the presumption of ordinary and customary meaning is rebutted. Indeed, the intrinsic record may show that the specification uses the words in a manner clearly inconsistent with the ordinary meaning reflected, for example, in a dictionary definition. In such a case, the inconsistent dictionary definition must be rejected. In short, the presumption in favor of a dictionary definition will be overcome where the patentee, acting as his or her own lexicographer, has clearly set forth an explicit definition of the term different from its ordinary meaning. Further, the presumption also will be rebutted if the inventor has disavowed or disclaimed scope of coverage, by using words or expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.
308 F.3d at 1204 (citations omitted). It would appear, then, that the intrinsic record, including the specification, would generally "trump" the claim language in construing the claim. The court, however, went on to caution:
Consulting the written description and prosecution history as a threshold step in the claim construction process, before any effort is made to discern the ordinary and customary meanings attributed to the words themselves, invites a violation of our precedent counseling against importing limitations into the claims. For example, if an invention is disclosed in the written description in only one exemplary form or in only one embodiment, the risk of starting with the intrinsic record is that the single form or embodiment so disclosed will be read to require that the claim terms be limited to that single form or embodiment. Indeed, one can easily be misled to believe that this is precisely what our precedent requires when it informs that disputed claim terms should be construed in light of the intrinsic record. But if the meaning of the words themselves would not have been understood to persons of skill in the art to be limited only to the examples or embodiments described in the specification, reading the words in such a confined way would mandate the wrong result and would violate our proscription of not reading limitations from the specification into the claims.
308 F.3d at 1204-05 (citations omitted).

If the meaning of the disputed terms are still ambiguous after consideration of intrinsic evidence, courts will consider extrinsic evidence. Kopykake Enters., Inc. v. Lucks Co., 264 F.3d 1377, 1381 (Fed Cir. 2001). Although a dictionary is considered extrinsic evidence, "[j]udges are free to consult such resources at any time in order to better understand the underlying technology and may also rely on dictionary definitions when construing claim terms, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 n. 6 (Fed.Cir. 1996).

Once the court has ascertained the meaning to one of ordinary skill in the art of the disputed term, the court will examine the written description and drawings to be certain that the patentee's use of the term is consistent with the meaning determined by the court. Rexnord Corps v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. 2001). A claim construction that excludes the preferred embodiment "is rarely, if ever, correct and would require highly persuasive evidentiary support." Rexnord, 274 F.3d at 1342 (quoting Vitronics, 90 F.3d at 1583). The drawings and written description are examined "to determine whether the patentee has disclaimed subject matter or has otherwise limited the scope of the claims." Rexnord, 274 F.3d at 1343. The court should also examine the prosecution history to determine whether the patentee has ascribed a special meaning to the term that is ...


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