LEONARD P. STARK, District Judge.
On March 20, 2015, Plaintiff Noven Pharmaceuticals, Inc. ("Noven" or "Plaintiff') filed suit against Defendant Actavis Laboratories UT, Inc. ("Actavis" or "Defendants") alleging infringement of U.S. Patent No. 8,231, 906 (the "'906 patent"), which is directed to a transdermal product for the delivery of the hormone estradiol. On May 12, 2015, Actavis filed a third-party complaint against Noven's parent company, Hisamitsu ("Hitsamitsu" or "Third-Party Plaintiff'), and a counterclaim against Noven.
The parties submitted claim construction briefs. (See D.I. 48, 49, 56, 57) The Court held a claim construction hearing on May 3, 2016. (See D.I. 68 ("Tr.")) At the hearing, in addition to presenting argument, Defendants presented the testimony of an expert, whom Plaintiff cross-examined.
The ultimate question of the proper construction of a patent is a question of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "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) (internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.
"[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 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," the context of the surrounding words of the claim also must be considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment ... [b]ecause claim terms are normally used consistently throughout the patent ...." Id. (internal citation omitted).
It is likewise true that "[d]ifferences 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., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "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. It bears emphasis that "[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." Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence," "consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[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.
In some cases, "the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period." Teva, 135 S. Ct. at 841. Extrinsic evidence "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." 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 1318-19. Where the intrinsic record unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90 F.3d at 1583).
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." Osram GmbH v. Int'l Trade Commm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (quoting Modine Mfg. Co. v. U.S. Int'l Trade Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
The parties disagree about whether the upper bound of the coat weight range claimed by the patent, 15 mg/cm
Actavis argues that the numbers in the claims have three significant figures. Accordingly, Actavis urges the Court to construe "15 mg/cm
To support its position, Actavis presented the testimony of an expert, Dr. Bozena Michniak-Kohn, a Professor of Pharmaceutics at Rutgers University, who specializes in topical, transdermal, and buccal drug delivery. (Tr. at 40-41) The Court finds Dr. Michniak-Kohn is qualified to testify and that her testimony is sufficiently reliable to be helpful to the Court. Even though Dr. Michniak-Kohn has no industry experience, no knowledge of how to measure coat weight, and no direct experience with measurements of Vivelle-Dot® (see Tr. at 73-76), she has conducted pertinent research and teaches in the relevant area (see id. at 41-43). Accordingly, Noven's objections are OVERRULED.
The Court found Dr. Michniak-Kahn's testimony credible. Ultimately, however, the Court is not persuaded by her opinion, in light of the intrinsic evidence.
Dr. Michniak-Kahn's opinion that a person of ordinary skill in the art ("POSA") would understand "15" to mean "15.0" proceeds in several steps. First, she opined that the claimed coat weights are the arithmetical product of the coat weight of a prior art transdermal drug delivery product — Vivelle-Dot® &mdash: and a scale-up factor. Second, she stated that the coat weight of Vivelle-Dot® is 10.0 mg/cm
Assuming, arguendo, that the claimed coat weight of 15 is the arithmetical product of the coat weight of Vivelle-Dot® and a scale-up factor,
For her opinion, Dr. Michniak-Kohn relies on the following portion of the specification:
'906 pat. col. 13: 18-31. Dr. Michniak-Kohn testified that a POSA would read this string of scale-up factors — 1.25, 1.33, 1.5, 1.67, 1.75, 2, and 3 — as all being carried out to three significant figures, that is: 1.25, 1.33, 1.50, 1.67, 1.75, 2.00, and 3.00. (Tr. at 49-50, 53-54) But the Court is not persuaded. As Plaintiff observes, the actual number of significant figures given in this list of scale-up factors is sometimes one ("2 or 3"), sometimes two ("1.5"), and only sometimes three ("1.25, 1.33, ... 1.67, 1.75"). As the expert's opinion is contradicted by the intrinsic evidence, the Court rejects it.
Another problem with Actavis's proposed construction is that it requires the Court to believe the patentee gave careful thought to how it used significant figures in some portions of the specification (e.g., when drafting the description of the 12.5 mg/cm
In sum, Actavis has provided the Court no persuasive basis to limit the scope of the claims in the manner proposed by Actavis. Accordingly, the Court will construe the disputed term to have its plain and ordinary meaning to a POSA in the context of the patent-in-suit. To such a person, the "15 mg/cm
The Court construes the disputed term as explained above. An appropriate Order follows.