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Teva Pharmaceuticals USA, Inc. v. Amgen

September 10, 2010


The opinion of the court was delivered by: Stewart Dalzell


Dalzell, J.

Plaintiffs/Counter-defendants Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Ltd. ("Teva") seek a declaratory judgment against Amgen, Inc. that two of Amgen's patents are invalid. Defendants/counter-claimants Amgen Inc. and Amgen Manufacturing, Limited ("Amgen") have countersued Teva seeking a declaratory judgment to the effect that, once Teva starts to sell its product in the United States, it will infringe on Amgen's two patents-in-suit.

I. The Patents-In-Suit

The patents at issue in this case are United States Patent No. 5,580,755, entitled "Human Pluripotent Granulocyte Colony-Stimulating Factor" ("the '755 patent"), and United States Patent No. 5,582,823, entitled "Methods of Treating Bacterial Inflammation and Granulocytopoiesis By Administering Human Pluripotent Granulocyte Colony-Stimulating Factor" ("the '823 patent")(collectively, the "Amgen patents" or the "patents-in-suit"). Amgen owns these patents and used them to develop Filgrastim. Amgen asserts that Filgrastim falls within the scope of claim 1 of the '755 patent. Amgen markets its Filgrastim product in America as a parenteral solution under the trademark Neupogen(r). Neupogen(r) is administered to patients to treat neutropenia (an abnormal or dramatic decrease in the number of a kind of white blood cells, neutrophils, which help the body fight infection) by stimulating white blood cell production, thereby reducing the risk of infection to patients undergoing treatments such as chemotherapy. Amgen has also developed a product called Neulasta(r) which is based upon Filgrastim. The active ingredient in Neulasta(r) is Pegfilgrastim, a covalent conjugate of Filgrastim and monomethoxypolyethylene glycol. Amgen claims that Pegfilgrastim and its use fall within the scope of one or more claims of the '755 and '823 patents. The '755 Patent will expire on December 3, 2013. The '823 Patent will expire on December 10, 2013.

Teva has developed a Filgrastim-containing product called Neutroval, which has already been approved for sale in Europe. Teva began selling the product in Europe (where Amgen's patents expired in 2006) in November of 2008. Teva believes that it will receive FDA approval for Neutroval before Amgen's patents expire. Teva intends to sell it in the United States in advance of the expiration of Amgen's patents and without a license from Amgen.

Teva seeks a declaratory judgment that the '755 and '823 patents are invalid. Amgen seeks a declaratory judgment that Teva is infringing on its patent, and seeks to enjoin Teva from selling Neutroval in the United States. Amgen also requests an accounting of all products Teva has made that contain Filgrastim that Teva has imported, sold, used or offered to sell in the United States. To the extent that Teva imported, sold, used or offered to sell the products in this country, Amgen seeks damages for lost profits.

II. Background

Dr. Lawrence M. Souza invented the patents-in-suit that Amgen owns. Before Dr. Souza's inventions, no one had successfully obtained or made an isolated human pluripotent granulocyte colony-stimulating factor polypeptide ("hpG-CSF") product that could effectively treat neutropenia. In 1985, Dr. Souza succeeded in isolating and sequencing DNA that encodes a species of human G-CSF. Using Dr. Souza's inventions, Amgen developed Neupogen(r).

Teva has developed a product to compete with Neupogen(r) and filed a Biologics License Application ("BLA") with the U.S. Food & Drug Administration on November 30, 2009. If the FDA approves Teva's BLA, Teva's product will be the first competing filgrastim drug product in this country. Teva's Opening Brief on Claim Construction ("Teva Br.") at 7.

Now before us are the parties' requests for claim construction pursuant to Markman v. Westview Instrument, Inc., 52 F.3d 967 (Fed. Cir. 1995)(en banc), aff'd, 517 U.S. 370 (1996). On August 13, 2010, we heard protracted oral argument on claim construction. The following discussion explains our reasoning as to each contested claim construction.

III. Standards for Claim Construction

Courts give claim terms their ordinary and accustomed meaning as understood by one of ordinary skill in the pertinent art at the time of filing. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005)(en banc). "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." Id. at 1312 (internal quotation marks omitted). Construing the claims of a patent presents a question of law. See Markman, 52 F.3d at 977-78. "[T]here is no magic formula or catechism for conducting claim construction." Phillips, 415 F.3d at 1324. Instead, the court is free to attach the appropriate weight to relevant sources "in light of the statutes and policies that inform patent law." Id.

The 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 1313 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent 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." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d, 1576, 1582 (Fed. Cir. 1996).

While "the claims themselves provide substantial guidance as to the meaning of particular claim terms," a court must also consider the context of the surrounding words of the claim. Phillips, 415 F.3d at 1314. And because claim terms are normally used consistently throughout the patent, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment." Id. (internal citation omitted).

Differences among claims can also be a useful guide. For example, "the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim." SunRace Roots Enter. Co., v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).

The language in the specification "may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. And "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction," Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), aff'd, 481 F.3d 1371 (Fed. Cir. 2007) (after earlier remand).

In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980. The prosecution history, which is "intrinsic evidence, consists of the complete record of the proceedings before the [Patent and Trademark Office ("PTO")] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317 (internal quotation marks omitted). "[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

A court may also rely upon "extrinsic evidence," which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field."*fn1 Id. Nonetheless, courts must not lose sight of the fact that "expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1319.

Finally, "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." 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." Modine Mfg. Co. v. United States Int'l Trade Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996), abrogated on other grounds by Festo Corp. V. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000), quoted in Osram GmbH v. Int'l Trade Comm'n, ...

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