Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 1 of 10 PageID #: 6519
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`GILEAD SCIENCES, INC.,
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`LUPIN LTD., LAURUS LABS LIMITED,
`AND CIPLA LIMITED,
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`Plaintiff,
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`Defendants.
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`v.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 22-615 (MN)
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`At Wilmington, this 21st day of February 2025:
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`MEMORANDUM ORDER
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`The Court heard argument about the disputed claim terms of U.S. Patent Nos. 9,708,342
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`(“the ’342 Patent”), 10,385,067 (“the ’067 Patent”), and 10,548,846 (“the ’846 Patent) on
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`December 18, 2024. (D.I. 273). IT IS HEREBY ORDERED that the claim term of the ’342 Patent
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`and the ’067 Patent with an agreed-upon construction is construed as follows (see D.I. 251 at 1):
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`1.
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`“therapeutically effective amount” means “An amount of the claimed
`compound, which when administered to a patient in need thereof, is
`sufficient to effect treatment for disease-states, conditions, or disorders for
`which the compounds have utility” (’342 Patent, cls. 11; 12; ’067 Patent,
`cls. 1, 10).
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`Further, as announced at the hearing on December 18, 2024, IT IS HEREBY ORDERED
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`that the disputed claim terms of the ’342 Patent, ’067 Patent, and ’846 Patent are construed as
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`follows:
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`1.
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`2.
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`“about [5.5°, 16.1°, 23.3°] 2-θ ±0.2° 2-θ” means “within 0.2° 2-θ above or
`below the recited peak, as rounded to the nearest tenth of a degree (0.1°)
`2- θ” (’342 Patent, cl. 3; ’067 Patent, cls. 1, 10);
`“A method for treating an HIV infection in a human in need thereof” means
`“a method for alleviating or eliminating symptoms of an HIV infection
`and/or reducing HIV viral load in a human in need thereof, which may yield
`a variety of clinical outcomes, depending on the patient” (’067 Patent, cls.
`1, 10); and
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`

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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 2 of 10 PageID #: 6520
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`3.
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`“a multilayer tablet” means “a tablet with two or more layers in which at
`least one of the claimed components is in a separate layer, wherein a layer
`is a section or compartment of components” (’846 Patent, cl. 1).
`The parties briefed the issues (D.I. 263) and submitted exhibits containing intrinsic and
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`extrinsic evidence (D.I. 264; D.I. 265). The Court carefully reviewed all submissions in
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`connection with the parties’ contentions regarding the disputed claim terms, heard oral argument
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`(D.I. 273), and applied the legal standards below in reaching its decision.
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`I.
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`LEGAL STANDARDS
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`A.
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`Claim Construction
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`“[T]he ultimate question of the proper construction of the patent [is] a question of law,”
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`although subsidiary fact-finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc.,
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`574 U.S. 318, 325 (2015). “[T]he words of a claim are generally given their ordinary and
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`customary meaning [which is] the meaning that the term would have to a person of ordinary skill
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`in the art in question at the time of the invention, i.e., as of the effective filing date of the patent
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`application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc) (internal
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`citations and quotation marks omitted). Although “the claims themselves provide substantial
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`guidance as to the meaning of particular claim terms,” the context of the surrounding words of the
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`claim must also be considered. Id. at 1314. “[T]he ordinary meaning of a claim term is its meaning
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`to the ordinary artisan after reading the entire patent.” Id. at 1321 (internal quotation marks
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`omitted).
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`The patent specification “is always highly relevant to the claim construction analysis . . .
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`[as] it is the single best guide to the meaning of a disputed term.” Vitronics Corp. v. Conceptronic,
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`Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). It is also possible that “the specification may reveal a
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`special definition given to a claim term by the patentee that differs from the meaning it would
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`otherwise possess. In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at
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`2
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 3 of 10 PageID #: 6521
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`1316. “Even when the specification describes only a single embodiment, [however,] the claims of
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`the patent will not be read restrictively unless the patentee has demonstrated a clear intention to
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`limit the claim scope using words or expressions of manifest exclusion or restriction.” Hill-Rom
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`Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (internal quotation marks
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`omitted) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)).
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`In addition to the specification, a court “should also consider the patent’s prosecution
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`history, if it is in evidence.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.
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`1995) (en banc), aff’d, 517 U.S. 370 (1996). The prosecution history, which is “intrinsic
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`evidence, . . . consists of the complete record of the proceedings before the PTO [Patent and
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`Trademark Office] and includes the prior art cited during the examination of the patent.” Phillips,
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`415 F.3d at 1317. “[T]he prosecution history can often inform the meaning of the claim language
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`by demonstrating how the inventor understood the invention and whether the inventor limited the
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`invention in the course of prosecution, making the claim scope narrower than it would otherwise
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`be.” Id.
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`In some cases, courts “will need to look beyond the patent’s intrinsic evidence and []
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`consult extrinsic evidence in order to understand, for example, the background science or the
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`meaning of a term in the relevant art during the relevant time period.” Teva, 574 U.S. at 331.
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`Extrinsic evidence “consists of all evidence external to the patent and prosecution history,
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`including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d
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`at 980. Expert testimony can be useful “to ensure that the court’s understanding of the technical
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`aspects of the patent is consistent with that of a person of skill in the art, or to establish that a
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`particular term in the patent or the prior art has a particular meaning in the pertinent field.”
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`Phillips, 415 F.3d at 1318. Nonetheless, courts must not lose sight of the fact that “expert reports
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`3
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 4 of 10 PageID #: 6522
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`and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer
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`from bias that is not present in intrinsic evidence.” Id. Overall, although extrinsic evidence “may
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`be useful to the court,” it is “less reliable” than intrinsic evidence, and its consideration “is unlikely
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`to result in a reliable interpretation of patent claim scope unless considered in the context of the
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`intrinsic evidence.” Id. at 1318-19. Where the intrinsic record unambiguously describes the scope
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`of the patented invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc.
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`v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90 F.3d at 1583).
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`B.
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`Indefiniteness
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`“The primary purpose of the definiteness requirement is to ensure that the claims are
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`written in such a way that they give notice to the public of the extent of the legal protection afforded
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`by the patent, so that interested members of the public, e.g., competitors of the patent owner, can
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`determine whether or not they infringe.” All Dental Prodx, LLC v. Advantage Dental Prods., Inc.,
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`309 F.3d 774, 779-80 (Fed. Cir. 2002) (citing Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
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`520 U.S. 17, 28-29 (1997)). Put another way, “[a] patent holder should know what he owns, and
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`the public should know what he does not.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
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`Co., 535 U.S. 722, 731 (2002).
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`A patent claim is indefinite if, “viewed in light of the specification and prosecution history,
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`[it fails to] inform those skilled in the art about the scope of the invention with reasonable
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`certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). A claim may be
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`indefinite if the patent does not convey with reasonable certainty how to measure a claimed feature.
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`See Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1341 (Fed. Cir. 2015). But “[i]f such
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`an understanding of how to measure the claimed [feature] was within the scope of knowledge
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`possessed by one of ordinary skill in the art, there is no requirement for the specification to identify
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`4
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 5 of 10 PageID #: 6523
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`a particular measurement technique.” Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d
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`1312, 1319 (Fed. Cir. 2015).
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`Like claim construction, definiteness is a question of law, but the Court must sometimes
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`render factual findings based on extrinsic evidence to resolve the ultimate issue of definiteness.
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`See, e.g., Sonix Tech. Co. v. Publications Int’l, Ltd., 844 F.3d 1370, 1376 (Fed. Cir. 2017); see also
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`Teva, 574 U.S. at 334-36. “Any fact critical to a holding on indefiniteness . . . must be proven by
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`the challenger by clear and convincing evidence.” Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357,
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`1366 (Fed. Cir. 2003); see also Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338 (Fed.
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`Cir. 2008).
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`II.
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`THE COURT’S RULING
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`The Court’s ruling regarding the disputed claim terms of the ’342 Patent, ’067 Patent, and
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`’846 Patent was announced during the Markman hearing on December 18, 2024, as follows:
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`At issue, there are three disputed claim terms in three patents.[1] I
`am prepared to rule on the disputes. I will not be issuing a written
`opinion, but I will issue an order stating my rulings.
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` want to emphasize before I announce my decisions that although I
`am not issuing a written opinion, we have followed a full and
`thorough process before making the decisions I am about to state. I
`have reviewed the patents and all the evidence submitted by the
`parties. There was joint briefing on each of the disputed terms and
`we had argument today. All of that has been carefully considered.
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`As to my rulings, I am not going to read into the record my
`understanding of claim construction law and indefiniteness. I have
`a legal standard section that I have included in earlier opinions,
`including somewhat recently in REX Computing, Inc. v. Cerebras
`Systems, Inc., Civil Action No. 21-525 (MN). I incorporate that law
`and adopt it into my ruling today and will also set it out in the order
`that I issue.
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`
` I
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`U.S. Patent Nos. 9,708,342, 10,385,067, and 10,548,846.
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`1
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`5
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 6 of 10 PageID #: 6524
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`The first dispute is over the term “[about [5.5°, 16.1°, 23.3°] 2-θ
`±0.2° 2-θ].”[2] The disagreement is whether the claim allows for
`rounding experimental XRPD peak positions to the tenth of a degree
`to get within the allowed range.[3] Plaintiff argues that the XRPD
`peak position values should be rounded to the tenth of a degree[4]
`and proposes construing the term as “[within 0.2° 2-θ above or
`below the recited peak, as rounded to the nearest tenth of a degree
`(0.1°) 2-θ].”[5] Defendants argue that no rounding should occur[6]
`and construe the term as “[within 0.2° 2-θ above or below [5.5°,
`16.1°, 23.3°]].”[7] In the alternative, Defendants argue that the term
`is indefinite.
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`The crux of this dispute is whether, as Plaintiff argues, the word
`“about” in the claims applies to allow rounding to occur for the peak
`position values claimed[8] or, as Defendants posit, to the [±0.2° 2-θ]
`range, meaning no rounding allowed.[9]
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` agree with Plaintiff on this construction. The word “about”
`immediately precedes the peak position values, indicating that the
`word is intended to note imprecision in those values. If, as
`Defendants argue,[10] “about,” was meant to describe the recited
`“[±0.2° 2-θ]” range around the claimed peak positions, there is no
`dispute that the “plus or minu” portion of the claim would be
`rendered meaningless. The word “about” and the “plus or minus”
`have distinct functions in the context of the claim.
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`This construction is also supported by the specification which states
`that:
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` I
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`This term is found in claim 3 of the ’342 Patent and claims 1 and 10 of the ’067 Patent.
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`(D.I. 263 at 1-2).
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`2
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`3
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`(Id. at 2).
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`(Id. at 1).
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`(Id. at 11).
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`(Id. at 1).
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`(Id. at 15).
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`10
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`(D.I. 263 at 9).
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`(Id.).
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`6
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 7 of 10 PageID #: 6525
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`11
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`12
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`the
`that
`the art recognize
`in
`Those skilled
`measurements of the XRPD peak locations and/or
`intensity for a given crystalline form of the same
`compound will vary within a margin of error. The
`values of degree 28 allow appropriate error margins.
`Typically, the error margins are represented by “[±].”
`For example, the degree 28 of about “8.7[±]0.3”
`denotes a range from about 8.7[+]0.3, i.e., about 9.0,
`to about 8.7[-]0.3, i.e., about 8.4. Depending on the
`sample preparation
`techniques,
`the calibration
`techniques applied
`to
`the
`instruments, human
`operational variation, and etc, those skilled in the art
`recognize that the appropriate error of margins for a
`XRPD can be [±0.5; ±0.4; ±0.3; ±0.2; ±0.1; ±0.05];
`or less. In certain embodiments of the invention, the
`XRPD margin of error is [±]0.2.11
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`I do not think that the reference to “about” in column 6, line 34 of
`the patent changes the analysis or suggests that other parts of the
`specification do not say what they clearly seem to say.12
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`As to Defendants' assertion that if I do not adopt their construction,
`the term is indefinite, Defendants have the burden of proving
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`’342 Patent at 23:49-62. The specification thus applies the word “about” to the peak
`position values claimed, which includes the ± 0.2.
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`Defendants supplied the specification’s explanation that “[r]eference to ‘about’ a value or
`parameter herein includes (and describes) embodiments that are directed to that value or
`parameter per se. For example, description referring to ‘about X’ includes description of
`‘X.,’” (’067 Patent at 6:33-36), as support for their argument. (D.I. 273 at 11). However,
`this language does little more than make clear that X itself is included in a description
`“about X.” During oral argument, (id.), Defendants further cited to Plaintiff’s expert’s
`statement that, “The ‘0.2° 2-θ’ range is a commonly used standard of variability that
`permits skilled persons in the art of XRPD analyses to assess whether two peaks that appear
`to correspond to the same crystalline form but vary by a small amount are, in fact, the same
`peak.” (D.I. 264-1, Ex. 2, Chyall Decl. at 11). This, too, is insufficient support for
`Defendants’ argument that no rounding should be permitted. It ignores Dr. Chyall’s
`subsequent statement that “[g]iven the uncertainty associated with XRPD peak positions
`that are measured on laboratory instruments, a skilled person would understand that it is
`not typically meaningful to consider comparisons of the observed positions of XRPD peaks
`at a level of precision greater than a tenth of a degree 2θ . . . a skilled person would
`understand that when reporting XRPD peak positions, the standard procedure is to round
`these peak positions to the nearest tenth of a degree 2θ, because that is the level of precision
`that corresponds to a meaningful comparison between experiments.” (Id. at 12).
`Defendants did not provide expert rebuttal or opinion for this term.
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`7
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 8 of 10 PageID #: 6526
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`indefiniteness by clear and convincing evidence. Here, Defendants
`have not met that burden. I am not going to address the waiver issue
`that was raised briefly today because I just don’t have enough
`information.
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`And with that, I will adopt Plaintiff's proposal and construe “about
`[[5.5°, 16.1°, 23.3°] 2-θ ±0.2° 2-θ]” as “within [0.2° 2-θ above or
`below the recited peak, as rounded to the nearest tenth of a degree
`(0.1°) 2- θ].”
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`The second term is “A method for treating an HIV infection in a
`human in need thereof”[13] in the preamble. During the hearing,
`some of the parties came to an agreement on the meaning of this
`term, which I read into the record. [On December 19, 2024,
`remaining Defendant, Lupin Ltd., confirmed acceptance of the
`construction agreed upon during the hearing. (D.I. 272). Thus, the
`term “a method for treating an HIV infection in a human in need
`thereof” will be construed by agreement as “a method for alleviating
`or eliminating symptoms of an HIV infection and/or reducing HIV
`viral load in a human in need thereof, which may yield a variety of
`clinical outcomes, depending on the patient.” (D.I. 273 at 21).]
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`The third and final disputed term is “a multilayer tablet.”[14] The
`parties agree that the preamble is limiting. Plaintiff’s proposed
`construction is “a tablet with two or more layers, in which at least
`one of the claimed components is in a separate layer, wherein a layer
`is a section or compartment of components.”[15] Defendants offer
`the construction “at least a bilayer tablet in which at least one of the
`claimed components is in one of the separate layers of the at least a
`bilayer tablet.”[16]
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` I
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` agree with Plaintiff’s construction of this term. Plaintiff disagrees
`with Defendants’ use of “bilayer” in their proposed construction.[17]
`This is because “bilayer” in the context of the patent is a specific
`embodiment described in the specification as a two-layer tablet in
`which the first and second layers are ordered and oriented in a
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`13
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`14
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`16
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`This term appears in claims 1 and 10 of the ’067 Patent.
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`This term is found in claim 1 of the ’846 Patent.
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`(D.I. 263 at 47).
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`(Id.).
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`(Id. at 51).
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`8
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 9 of 10 PageID #: 6527
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`horizontal, striped fashion.[18] Because a “bilayer tablet” has a
`defined meaning within the patent, including the term in this
`construction would unduly narrow the claim scope.
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`Defendants focus on the meaning of “layer” and offer their expert’s
`declaration that, within the context of tablet formulation techniques,
`a layer must be at least a continuous mass, “one thickness course or
`fold,” lying over another continuous mass and containing at least
`the claimed components.[19]
`one of
` Defendants’ expert’s
`understanding, however, is not more instructive than the patent
`itself, which refers to “layer” as “a section or compartment.”[20]
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`[The specification, however,] says: “Unless otherwise specified, the
`terms ‘first layer,’ ‘second layer,’ ‘third layer’ and so forth do not
`specify a particular order or orientation of the multilayer tablet
`formulations disclosed herein. Rather, these terms are used to
`distinguish the sections of the composition from each other and to
`specify the characteristics or components of each section or
`compartment.”[21]
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`Ultimately, I think Defendants’ proposed construction introduces
`unnecessary confusion, and I think that Plaintiff’s construction is
`more consistent with the specification. Thus, I will construe “a
`multilayer tablet” as “a tablet with two or more layers in which at
`least one of the claimed components is in a separate layer, wherein
`a layer is a section or compartment of components.” And I will
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`18
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`19
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`20
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`21
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`See, e.g., ’846 Patent at 58:10-60; 67:41-62.
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`(D.I. 265-1, Ex. 13, Muzzio Decl. ¶¶ 31–32, 65–66, 70). To further substantiate their
`argument and construction, Defendants assert that the prosecution history informs that the
`bilayer tablet configuration was the primary reason for the examiner’s decision to allow
`the claims. (D.I. 263 at 61). Even if this were true, it would not provide adequate support
`for narrowing the formulation technique to a bilayer formulation, which is mentioned by
`the patent only as a “certain embodiment.” See, e.g., ’846 Patent at 50:14-18.
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`’846 Patent at 12:12-18.
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`Defendants’ definition of “layer” as being “at least a continuous mass” lying over another
`continuous mass is inconsistent with the intrinsic evidence. The specification contemplates
`configurations in which “the additional layer or layers are located on either side of the first
`and/or second layer, such that they are an outside layer of the table[t] and/or are disposed
`between the first and/or second layer and a coating layer. [And,] [i]n some embodiments,
`the additional layer or layers encapsulate the first and second layers” as types of multilayer
`tablets. (’846 Patent at 32:57-62). These configurations would not comport with
`Defendants’ idea of a layer simply being one mass lying on top of another.
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`9
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`Case 1:22-cv-00615-MN Document 280 Filed 02/21/25 Page 10 of 10 PageID #: 6528
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`reserve for trial the issue of whether any particular configuration
`meets this limitation.
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`The Honorable Maryellen Noreika
`United States District Judge
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`10
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