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Andrulis Pharmaceuticals Corp. v. Celgene Corp.

United States District Court, D. Delaware

June 26, 2015

Andrulis Pharmaceuticals Corp., Plaintiff,
Celgene Corp., Defendant.

Kenneth L. Dorsney, Esq., Morris James LLP, Wilmington, DE; Paul J. Skiermont, Esq. (argued), Skiermont & Puckett LLP, Dallas, TX; Sarah Spires, Esq., Skiermont & Puckett LLP, Dallas, TX; Steve Udick, Esq., Skiermont & Puckett LLP, Dallas, TX; Attorneys for Plaintiff.

Mary B. Graham, Esq., Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE; Calvin P. Griffith, Esq. (argued), Jones Day, Cleveland, OH; John Evans, Esq., Jones Day, Cleveland, OH; Jennifer Swize, Esq., Jones Day, Washington, DC; Attorneys for Defendant.


RICHARD G. ANDREWS, District Judge.

Plaintiff asserts claim 2 of U.S. Patent No. 6, 140, 346 (the "'346 Patent") against Defendant. (D.I. 89 at 9). The patent at issue broadly relates to the treatment of cancers using methods and combinations that include thalidomide and other agents. ( See '346 Patent, Abstract). The specification states that the invention relates to a "novel method for treating cancers with thalidomide alone or in combination with other antiangiogenic and anti-cancer agents." ('346 Patent at 1:8-10). Presently, the parties have requested that the Court construe five terms.[1] The Court has considered the parties' joint claim construction brief (D.I. 89), the parties' claim construction appendix (D.I. 90), and held oral argument on the matter. (D.I. 138).


"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." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources in light of the statutes and policies that inform patent law.'" SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), aff"d, 517 U.S. 370 (1996). Ofthese sources, "the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (internal quotation marks and citations omitted).

"[T]he words of a claim are generally given their ordinary and customary meaning.... [Which is] 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 filing date of the patent application." Id. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314 (internal citations omitted).

When a court relies solely upon the intrinsic evidence-the patent claims, the specification, and the prosecution history-the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015). The court may also make factual findings based upon consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and citations omitted). Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

"A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GmbHv. Int'l Trade Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks and citation omitted).


The asserted claim 2 of the '346 Patent reads:

A method for the treatment of neoplastic diseases in a mammal which comprises administering to said afflicted mammal enhanced therapeutically-effective amounts of thalidomide in combination with effective amounts of other alkylating agent selected from the group consisting of mechlorethamine, cyclophosphamide, ifosamide, melphalan, chlorambucil, busulfan, thiotepa, carmustine, lomustin, cisplatin, and carboplatin wherein said neoplastic diseases are sensitive to said enhanced combination.

('346 Patent, Claim 2) (relevant terms italicized).

1. "administering"

a. Plaintiff's proposed construction: Ordinary and customary meaning. Alternatively: "to mete out"

b. Defendant's proposed construction: delivering into a [mammal's] body

c. Court's construction: delivering into or onto a [mammal's] body

Drawing from its expert Dr. Robert M. Williams, Plaintiff argues that a person skilled in the art would understand "administering" within the context of medicine. (D.I. 89 at 17). Plaintiff argues that a lay juror with experience with prescription medicine would also likely understand the term. Plaintiff disagrees with Defendant's more limiting construction because in the context of medicine administering is not limited only to "applying onto or into" a patient, but could also include to give, to mete out, or to supervise the formal taking of. (D.I. 89 at 17-18). Plaintiff also points out that the specification identifies that "therapeutic treatment with thalidomide can utilize any type of administration, " implying that the term cannot be limited only to "applying onto or into" a patient. (D.I. 89 at 17-18; '346 Patent at 10: 16-20).

Defendant argues that its construction of "administering" as "deliver into a [mammal's] body" is the ordinary meaning of the term in the context of a claimed treatment targeting a disease. (D.I. 89 at 19). According to Defendant, the "only way to treat diseases in the body using the claimed drugs is to deliver the drugs into the body." ( Id ). Defendant also points to the specification's examples of administrating involving delivery into the body, such as oral, topical, injection, or intravenous administration. (D.I. 89 at 20; '346 Patent at 10: 16-20).

Plaintiff responds that it is concerned that Defendant is trying to remove prescribing medication from the meaning of administering. (D.I. 89 at 18). More specifically, Plaintiff argues that Defendant is attempting to direct the claim language at "diseases" rather than "patients." (D. 89 at 24). Defendant responds that Plaintiff is attempting to depart from the ordinary meaning of the term. (D.I. 89 at 27). Defendant argues that "Andrulis does not, and cannot, point to anything in the patent disclosing methods of prescribing, dispensing, or overseeing drugs." (D.I. 89 at 28).

Administering as understood by a person of ordinary skill in the art must be limited to delivering a drug into or onto a mammal. If Plaintiffs proposal of "to mete out" is accepted, the term would be so overly broad as to cover nearly any action associated with dispensing a drug. It would not be appropriate for "administering" in the claim to cover the acts of pharmacists, sales people, or essentially anyone giving or handing the drug to a patient. Instead, administering must be tied to the process of administering the medicine in the context of immediately providing treatment. Administering a drug must mean that it is directly delivered into or onto a patient. Therefore, when the specification states that the treatment "can utilize any type of administration including oral administration, topical application, intramuscular injection and intravenous infusion, " what is noteworthy about all of those examples of administration is that they describe delivering the drug into or onto the body. ('346 Patent at 10:16-19). It is true that the patent describes "any" administration "including" administrations that deliver into or onto the body, suggesting that other types of administrations are not necessarily foreclosed.[2] But within the context of the patent, Plaintiff does not provide any evidence for a meaning of administration beyond those that deliver the drug ...

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