Case 2:17-cv-01235-MRH Document 171 Filed 11/20/18 Page 1 of 52
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF PENNSYLVANIA
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`AMGEN INC., et al.,
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`Plaintiffs,
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`V.
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`MYLAN INC., et al.,
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`Defendants.
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`) 2:17-cv-01235
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`OPINION
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`Mark R. Hornak, United States District Judge
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`Amgen, Inc. ("Amgen") alleges that Mylan, Inc. ("Mylan") infringes two of its patents:
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`U.S. Patent No. 9,643,997 (the '"997 Patent") and U.S. Patent No. 8,273,707 (the '"707 Patent").
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`The parties dispute multiple claim terms in both patents. The parties have submitted proposed
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`constructions for the terms and the matter has been fully briefed. (ECF Nos. 100, 106, 110, 114,
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`130, 132). The Court heard argument on the parties' positions on September 21, 2018 and the
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`matter is now ripe for disposition.
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`I.
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`BACKGROUND
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`Amgen produces Neulasta® and a family of related FDA-approved pharmaceuticals that
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`are used to prevent infection in cancer patients receiving immunosuppressive anti-cancer drugs.
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`The active ingredient in some of these pharmaceutical products is pegfilgrastim, a modified form
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`of the protein filgrastim. Filgrastim itself is a modified form of the naturally occurring
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`glycoprotein granulocyte-colony stimulating factor ("G-CSF"). G-CSF stimulates the production
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`of certain white blood cells known as neutrophils. These cells are an essential component of the
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`Case 2:17-cv-01235-MRH Document 171 Filed 11/20/18 Page 2 of 52
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`human immune response to pathogens. Patients undergoing chemotherapy for the treatment of
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`cancer commonly experience a reduction of their white blood cell count as a side effect of the
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`treatment. This condition-neutropenia-leaves these patients particularly susceptible to life(cid:173)
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`threatening infections. By stimulating the production of neutrophils, G-CSF can reduce the risk
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`of these infections.
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`Filgrastim, the precursor to pegfilgrastim, is conventionally produced by inserting the
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`gene (i.e., the DNA) that encodes G-CSF into a bacterial cell. These cells are then grown on an
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`industrial scale and are stimulated to begin producing the protein through the cells' natural
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`mechanisms. Though these micro protein "factories" can work scientific wonders, they can also
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`make mistakes. The desired protein is often produced along with other native bacterial proteins,
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`and these cellular products aggregate in insoluble or semi-soluble inclusion bodies within the
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`cells. The desired proteins are also often misfolded during their synthesis, rendering them
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`ineffective. Accordingly, the produced filgrastim must be further isolated and purified before it
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`can be utilized as a pharmaceutical product.
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`The patents in suit are both generally directed to these protein purification techniques.
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`The following simplified description of these processes is provided for background purposes
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`only. Additional technical detail will be provided in context of the individual patents. In
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`simplified terms, proteins are three-dimensional biological structures that are composed of chains
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`of individual units called amino acids. To obtain their functional three-dimensional shape, chains
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`of amino acids fold up on themselves. The target proteins that the genetically modified bacteria
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`produce are often misfolded and tangled up with other proteins and other cellular debris within
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`the bacterial cells themselves. These masses are known as "inclusion bodies," and are roughly
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`akin to balls of yam with the target proteins interspersed within. The bacterial cells must first be
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`broken open, or "lysed," to obtain these inclusion bodies. Chemicals are then applied to
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`"solubilize," or dissolve, the components of the inclusion bodies, including the target proteins.
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`Continuing the yam ball analogy, this step would be like untangling the threads of yam making
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`up the yam ball. At this point, the target proteins are unfolded chains of amino acids, as if they
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`were straightened-out threads of yarn.
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`Other chemicals are then added to the solution that cause the protein to "refold" into its
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`active, functional three-dimensional shape. However, the proteins themselves are still in solution,
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`now known as a "refold solution," with other proteins from the inclusion bodies, cellular debris,
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`and other contaminants. The targeted threads of the yam ball have been folded ( or "knotted
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`into") their desired shape, but the rest of the yarn ball is still floating around with them. These
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`other components must be removed, and this is accomplished by taking advantage of regions of
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`the target proteins that have affinities for materials with certain chemical properties.
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`Column chromatography is a common technique that is employed for this purification
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`step. In simplified terms, a column is packed with a "separation matrix," which is often a solid
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`resin that contains regions that chemically attract regions of the target proteins. Solutions may be
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`introduced into the top of the column and flow downward, contact the separation matrix, and
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`flow out of the column. As the refold solution flows past the separation matrix, the proteins
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`"stick" to the matrix as the rest of the refold solution-which contains the contaminants and
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`other materials-flows out of the column to be collected and discarded. Some of the
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`contaminants will nonetheless stick to the separation matrix. Thus, a "washing buffer" is applied,
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`which is designed to wash away the remaining contaminants as it flows out of the column while
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`preserving the attractive forces between the target proteins and the separation matrix. At this
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`point, ideally, only the targeted proteins remain stuck to the separation matrix. An "elution"
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`solution is then applied to the separation matrix. This solution is designed to "un-stick" the target
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`proteins from the separation matrix and carry the target proteins out of the column. As this
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`solution flows out of the column, it is collected. This collected solution is the "elution pool," and
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`ideally it will contain the functional, correctly folded, target proteins without the contaminants.
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`Additional purification steps may be needed before the targeted proteins are suitably pure for
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`therapeutic use.
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`The '997 Patent, entitled "Capture Purification Processes for Proteins Expressed in a
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`Non-Mammalian System" issued on May 9, 2017. The '707 Patent, entitled "Process for
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`Purifying Proteins" issued on September 25, 2012. Amgen was the applicant, and is the current
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`assignee, of both patents.
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`Mylan produces generic versions of brand-name pharmaceuticals. Amgen accuses Mylan
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`of seeking FDA approval for a biosimilar version of the active ingredient in the Neulasta® family
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`of products, pegfilgrastim. The parties' current dispute centers around Mylan's allegedly
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`infringing purification processes. Mylan argues that its purification processes do not infringe the
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`claims of Amgen's asserted patents and has moved for a judgment on the pleadings pursuant to
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`Fed. R. Civ. P. 12(c). (ECF No. 79). 1 The parties have proposed five terms in the '997 Patent and
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`four terms in the '707 Patent for construction. 2
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`1 In the briefing directed to the Motion for Judgment of the Pleadings, both parties advanced arguments related to
`the construction of disputed terms of the '707 Patent. (ECF Nos. 80, 81, 86, 87, 95, 97). The resolution of these
`claim construction disputes could be, in the Court's estimation, dispositive of several considerations in that Motion.
`The Court thus determined that resolution of the Motion was inappropriate prior to the Court's construction of the
`disputed claim terms, and therefore dismissed the Motion without prejudice and subject to its reassertion following
`the Court's construction of the disputed terms. (ECF No. 170).
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`2 The parties had previously disputed an additional term in the '707 Patent but have since entered into a joint
`stipulation regarding the construction of that specific term. (ECF Nos. 158, 161 ). The Court, having concluded that
`the parties' joint position with respect to the jointly proposed construction was supported by the intrinsic evidence,
`approved and adopted the parties' joint stipulation. (ECF No. 162).
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`II.
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`LEGAL STANDARD
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`Claim construction is a matter of law that is to be exclusively determined by the Court.
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`Markman v. Westview Instruments, Inc., 517 U.S. 370, 384 (1996). A district court must construe
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`a claim term when the parties present a "fundamental dispute regarding the scope" of the term.
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`02 Micro Int'! Ltd. v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1361-63 (Fed. Cir.
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`2008). The purpose of claim construction is to "give meaning to the limitations actually
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`contained in the claims" and not to "obviate factual questions of infringement and validity" by
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`redefining claim language or reading in limitations. Am. Pile driving Equip. Inc. v. Geoquip, Inc.,
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`637 F.3d 1324, 1331 (Fed. Cir. 2011). But, though claim construction should not "obviate"
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`factual determinations related to infringement or validity, claim construction is always the first
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`step of any infringement or validity contention. See State Contracting & Eng 'g Corp. v.
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`Condotte Am., Inc., 346 F.3d 1057, 1068 (Fed. Cir. 2003).
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`Claim construction begins with an analysis of the claims themselves and their language.
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`Scanner Techs. Corp. v. !COS Vision Sys. Corp., 365 F.3d 1299, 1303 (Fed. Cir. 2004). The
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`words of a claim "are generally given their ordinary and customary meaning" which is "the
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`meaning that the term would have to a person of ordinary skill in the art in question at the time of
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`invention." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en bane). But
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`claim terms "must be construed in light of the specification and prosecution history, and cannot
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`be considered in isolation." GE Lighting Solutions, LLC v. AgiLight, Inc., 750 F.3d 1304, 1308-
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`09 (Fed. Cir. 2014) (citing Phillips, 415 F.3d at 1313). That is, "the person of ordinary skill in
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`the art is deemed to read the claim term not only in the context of the particular claim in which
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`the disputed term appears, but in the context of the entire patent, including the specification."
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`Phillips, 415 F.3d at 1313. At times, the ordinary meaning of the claim terms is so apparent that
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`detailed construction and analysis is unnecessary. Id at 1314. But, more often, this meaning is
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`"not immediately apparent" and thus courts "look[] to the sources available to the public that
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`show what a person of skill in the art would have understood disputed claim language to mean."
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`Id (quoting lnnova!Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116
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`(Fed. Cir. 2004)).
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`"The specification is the single best guide to the meaning of a disputed claim term and is,
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`thus, the primary basis for construing the claims." Trustees of Columbia Univ. in City of N. Y v.
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`Symantec Corp., 811 F.3d 1359, 1362 (Fed. Cir. 2016) (quoting Vitronics Corp. v. Conceptronic,
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`Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); Phillips, 415 F.3d at 1315) (internal quotation marks
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`omitted). But, limitations from the specification are generally not to be read into the claims. See,
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`e.g., Comark Commc 'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998); Intel Corp.
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`v. U.S. Int'! Trade Comm'n, 946 F.2d 821,836 (Fed. Cir. 1991) ("[W]here a specification does
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`not require a limitation, that limitation should not be read from the specification into the
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`claims.") (emphasis in original). And, though a specification will often describe particular and
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`specific embodiments of an invention, claims should generally not be construed to be limited to
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`those embodiments. See Nazomi Commc 'ns, Inc. v. ARM Holdings, PLC, 403 F.3d 1364, 1369
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`(Fed. Cir. 2005).
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`Finally, courts may consider extrinsic evidence, such as expert testimony, dictionaries,
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`and treatises, but "such evidence is generally of less significance than the intrinsic record."
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`VirnetX Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1316 (Fed. Cir. 2014) (citing Phillips, 415 F.3d
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`at 1317). Further, this extrinsic evidence cannot be "used to contradict claim meaning that is
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`unambiguous in light of the intrinsic evidence." Phillips, 415 F.3d at 1324.
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`III.
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`DISCUSSION
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`The '997 Patent
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`The '997 Patent is entitled "Capture Purification Processes for Proteins Expressed in a
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`Non-Mammalian System" and issued on May 9, 2017. Amgen was the applicant for the patent
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`and the current assignee. The '997 Patent generally discloses a simplified protein purification
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`process.'997 Patent at 1 :56-60. Non-mammalian cells, such as microbial cells, can be genetically
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`engineered to produce proteins. Id. at 3:65-67. These organisms will typically deposit the
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`proteins in large insoluble aggregates called inclusion bodies. Id. at 4:1-3. The expressed
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`proteins
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`in
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`these
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`inclusion bodies are
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`typically unfolded or misfolded, and thus not
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`therapeutically useful. Id. at 12:27-32. Accordingly, the proteins must be isolated from the cells
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`that produce them, purified, and refolded into their correct three-dimensional configuration
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`before they are viable for use as a pharmaceutical product or precursor. Id.
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`The '997 Patent teaches such a purification process that is purportedly more efficient than
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`processes that were known in the art. In one embodiment, the microbial cells are stimulated to
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`produce, or express, the proteins of interest. '997 Patent at 13 :9-20. These cells are then lysed to
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`break apart the cells and release the target proteins of interest ( often entangled in inclusion
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`bodies). Id. at 13:33-36. The protein is then separated from the lysis pool by employing
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`conventional methods, such as centrifugation, to isolate the protein of interest. Id. at 13 :48-56.
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`The expressed protein is then solubilized in solubilization solution. Id. at 13:65-14:3. The
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`function of the solubilization solution is to solubilize and denature the expressed protein so that it
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`can be later refolded into a suitable configuration. Id. This refolding is accomplished by forming
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`a refold solution, which comprises the solubilization solution, solubilized protein, and a refold
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`buffer that is chosen, based on the protein of interest, to shift the thermodynamics of the solution
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`to encourage proper protein folding. Id. at 14:27-40. The refold solution is then applied to a
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`separation matrix. Id. at 15 :23-30. The expressed protein interacts with the separation matrix,
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`and then a wash buffer is applied to the matrix to preserve these interactions and to wash away
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`contaminants and other impurities from the separation matrix. Id. at 16: 1-4. The target protein is
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`then eluted from the separation matrix by applying an elution solution, which promotes the
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`release of the protein from the separation matrix. Id. at 16:19-23. In contrast to prior art
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`methods, the '997 Patent teaches that the refold solution can be applied directly to the separation
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`matrix without intervening steps such as dilution of the refold solution or removing other
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`components of the refold solution that may reduce the ability of the expressed protein to
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`associate with the separation matrix. Id. at 15:50-67. According to the '997 Patent, this results in
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`a more efficient process that conserves time and resources. Id.
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`A patent in the same family as the '997 Patent was construed in the Northern District of
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`California by Judge Seeborg in Amgen Inc. v. Sandoz Inc., No. 14-cv-04741, 2016 WL 4137563
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`(N.D. Cal. Aug. 4, 2016). (construing U.S. Patent No. 8,940,878 (the '"878 Patent")). The '878
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`Patent shares a specification with the '997 Patent that is identical in all material aspects. The
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`Sandoz court construed two of the five terms disputed in this case, and also construed a term that
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`is nearly identical to one of the terms disputed in this case. Mylan asks this Court to adopt the
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`constructions of the Sandoz court of each such claim. Mylan offers several arguments as to why
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`Amgen should be precluded from challenging the constructions of the Sandoz court, namely, that
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`Amgen was a party to the previous action, that Amgen failed to appeal adverse constructions,
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`and that Amgen should not be allowed to now assert that certain terms require a construction
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`when they did not so assert in Sandoz. While the Court is mindful of the importance of
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`Case 2:17-cv-01235-MRH Document 171 Filed 11/20/18 Page 9 of 52
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`uniformity in patent claim term interpretation, see Markman, 517 U.S. at 390, the Court does not
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`agree with Mylan's arguments.
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`A. Amgen is not collaterally estopped from asserting the claim construction
`arguments that they present in this case.
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`The Federal Circuit applies the law of the regional circuit in determining whether
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`collateral estoppel applies to another district court's claim construction. See RF Del., Inc. v. Pac.
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`Keystone Techs., Inc., 326 F.3d 1255, 1261 (Fed. Cir. 2003). Under Third Circuit law, in order
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`for collateral estoppel to apply, a party must demonstrate that "(1) the identical issue was
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`previously adjudicated; (2) the issue was actually litigated; (3) the previous determination was
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`necessary to the decision; and ( 4) the party being precluded from re litigating the issue was fully
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`represented in the prior action." Jean Alexander Cosmetics, Inc. v. L 'Orea! USA, Inc., 458 F.3d
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`244, 249 (3d Cir. 2006) (internal quotations omitted). The Third Circuit also considers whether
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`the party being precluded "had a full and fair opportunity to litigate the issue in question in the
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`prior action" and "whether the issue was determined by a final and valid judgment." Id. (quoting
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`Sebrowski v. Pittsburgh Press Co., 188 F.3d 163, 169 (3d Cir. 1999); Nat'! R.R. Passenger Corp.
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`v. Pa. Pub. Utility Comm 'n, 288 F.3d 519, 525 (3d Cir. 2002)).
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`Following the Northern District of California's Markman claim construction Order, the
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`defendant Sandoz moved for, and was granted, summary judgment of non-infringement. Amgen
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`Inc. v. Sandoz Inc., 295 F. Supp. 3d 1062, 1071 (N.D. Cal. 2017). Amgen filed an appeal with
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`the Court of Appeals for the Federal Circuit on February 12, 2018, currently pending on the
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`Federal Circuit's docket as No. 18-1551. Amgen appealed the construction of the "washing" and
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`"eluting" elements of Claim 7 of the '878 Patent, (Amgen Appeal Br. at 3, ECF No. 111-12),
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`because these terms were essential to the Sandoz court's grant of summary judgment. Mylan
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`contends that Amgen 's decision to only appeal these claim construction rulings from the Sandoz
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`order effectively operates as a waiver of any claim construction arguments that Amgen now
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`advances as to non-appealed constructions.
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`As a preliminary matter, the claim construction rulings that Amgen appealed are not final
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`judgments and are thus not preclusive in this Court. See Phil-Insul Corp. v. Airlite Plastics Co.,
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`854 F.3d 1344, 1357-58 (Fed. Cir. 2017) (explaining that "the claim constructions became final
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`when we affirmed them on appeal.") (emphasis added). By implication, claim constructions that
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`are subject to a pending appeal are not final. 3 For this reason, see Nat'! R.R. Passenger Corp.,
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`288 F.3d at 525, the Court will treat the Sandoz court's constructions of the "washing" and
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`"eluting" terms as persuasive, but not binding, authority.
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`B. Amgen is not precluded from asserting, nor has it waived, arguments relating to
`the construction of "under conditions suitable for the protein to associate with the
`matrix."
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`The Court concludes that Amgen's "decision" to not appeal the construction of "under
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`conditions suitable for the protein to associate with the matrix" is also not preclusive, nor does it
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`operate as a waiver, because this construction was not "necessary to" the summary judgment
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`decision. See L 'Orea!, 458 F.3d at 239. The final judgment in the Sandoz case was grounded in
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`the determination that the washing and eluting steps must be distinct and sequential in the
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`process claimed by the '878 Patent, and that Sandoz's accused process did not meet these
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`limitations. Sandoz, 295 F. Supp. 3d at 1069. And, at any rate, Amgen could not have appealed
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`this construction because, as discussed, it was not necessary to the Sandoz court's summary
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`judgment decision. See Personalized User Model, LLP v. Google Inc., 797 F.3d 1341, 1350 (Fed.
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`3 Mylan cites to Nestle USA, Inc. v. Steuben Foods, Inc., 884 F.3d 1350 (Fed. Cir. 2018) and Sightsound Techs, LLC
`v. Apple Inc., 809 F.3d 1307, 1316 (Fed. Cir. 2015) to assert that Amgen has waived its opportunity to argue for
`claim constructions contrary to what was construed by the Sandoz court. In the Court's estimation, these cases are
`inapposite because the Sandoz appeal is still pending. Nestle held that a party was estopped from raising arguments
`in an appeal after the Federal Circuit had already rejected those arguments in a related patent in an earlier appeal.
`Nestle, 884 F.3d at 1351-52. Sightsound dealt with the construction of two related patents in the same pending
`appeal. 809 F.3d at 1316. It makes sense that the Federal Circuit would want to decide the issues consistently within
`the same action.
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`Cir. 2015) (holding that the Federal Circuit lacked jurisdiction to review a district court's claim
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`construction that did not affect the merits of the infringement controversy between the two
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`parties in the appeal).
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`Mylan also cites TM Patents, L.P. v. International Business Machines Corporation, for
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`the proposition that a party that "cuts off his right to review" a claim construction "cannot
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`complain that the question was never reviewed on appeal" and that said construction remains
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`preclusive. 72 F. Supp. 2d 370, 378 (S.D.N.Y. 1999). To the extent that this case is persuasive
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`authority, the Court does not believe it governs the disposition of this matter. First, TM Patents
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`dealt with a situation wherein a party to the previous action settled the case, and in this sense,
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`chose to forego further review of the court's claim construction. Id. Here, several claim
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`constructions from the Sandoz matter have been appealed, but by choosing to appeal these and
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`not others, Amgen has not "cut off' its right to appellate review. As explained, this was not a
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`true "choice" by Amgen, as it could not have appealed constructions that were not necessary to
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`the Sandoz court's summary judgment decision. Second, TM Patents is not binding on this
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`Court, and its conclusions and reasoning have been criticized by other district courts.4 Finally,
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`the Federal Circuit later ruled in RF Delaware that collateral estoppel did not apply in a case
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`where another district court issued a claim construction order and that case settled prior to the
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`court ruling on a pending summary judgment motion. 326 F.3d at 1260-61 ("We conclude that
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`collateral estoppel does not apply in the present case because judgment, much less final
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`judgment, was ever entered[.]"). This undercuts one of the TM Patents court's justifications for
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`granting the prior court's claim construction order preclusive effect, and further calls into
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`question whether TM Patents remains good law. Cf TM Patents, 72 F. Supp. 2d at 379
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`4 See, e.g., Powervip, Inc. v. Static Control Components, Inc., No. 1 :08-CV-382, 2011 WL 2669059, at *6 (W.D.
`Mich. July 6, 2011); Kollmorgen Corp. v. Yaskawa Elec. Corp., 147 F. Supp. 2d 464,467 (W.D. Va. 2001); Graco
`Children's Prods., Inc. v. Rega/a Int'/, LLC, 77 F. Supp. 2d 660, 663 (E.D. Pa. 1999).
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`(concluding that claim construction orders were effectively "final" judgments such that collateral
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`estoppel could apply).
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`As the Court sees it, Mylan is asking the Court to find that Amgen has "waived" any
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`arguments for the construction of "under conditions suitable for the protein to associate with the
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`matrix" based on another district court's construction of the term in a related (but different)
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`patent in an unrelated infringement litigation. The final judgment in that case is currently on
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`appeal, and Amgen could not have appealed this particular claim construction. The Court
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`concludes that waiver is not appropriate here. This is not, as Mylan argues, giving Amgen a
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`"second bite at the apple." (Mylan Br. at 10). While Amgen is proposing the same constructions
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`before this Court as it advanced before the Sandoz court, 2016 WL 4137563 at *15-*16, the
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`reality is that Amgen had not finished the first bite of the apple.
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`C. Amgen has not waived its opportunity to argue for the construction of certain
`claim terms based on its decision to not submit constructions for those terms in
`the Sandoz matter.
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`Neither party in the Sandoz matter sought a construction for the term "forming a refold
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`solution comprising the solubilization solution and a refold buffer." And, in the Sandoz matter,
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`Amgen did not identify the following terms for construction: "solubilization solution;"
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`"separation matrix;"5 and "buffer." Citing Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d
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`1420, 1423 (Fed. Cir. 1997), Mylan argues that Amgen cannot now argue that these terms
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`require a construction in this case. (Mylan Resp. Br. at 10). In the Court's estimation, Sage
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`Products does not provide support for the proposition that Mylan advances. That case appears to
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`stand for the rather uncontroversial position that, absent some indication from the patentee to the
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`contrary, the plain and ordinary meaning of claim terms control. Sage Prods., 126 F.3d at 1423.
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`And, that case was a direct appeal from a district court's judgment. The Federal Circuit held only
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`5 This term is likewise not in dispute here.
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`that it would not review novel claim constructions on appeal that were not presented to the trial
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`court. Id. at 1426. It did not hold that a party could not present constructions for terms that were
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`not construed in an earlier, unrelated action in another district court. Further, there are different
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`accused processes at issue here. In the Sandoz matter, the terms above were not in dispute and
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`thus did not require a construction. As the Federal Circuit has stated:
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`Claim construction is a matter of resolution of disputed meanings
`and technical scope, to clarify and when necessary to explain what
`the patentee covered by the claims, for use in the determination of
`infringement. It is not an obligatory exercise in redundancy.
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`U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). The
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`implication from this pronouncement is that neither litigants nor the courts are expected or
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`required to identify claim terms for construction that are not in dispute or not material to an
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`infringement determination. See also 02 Micro, 521 F.3d at 1362 ("[D]istrict courts are not (and
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`should not be) required to construe every limitation present in a patent's asserted claims."); Vivid
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`Techs., Inc. v. Am. Sci. & Eng 'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) ("[O]nly those terms
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`need be construed that are in controversy, and only to the extent necessary to resolve the
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`controversy."). Amgen is thus not precluded from seeking construction for these terms in this
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`action. In light of a different accused process, 6 certain claim terms may now be material to the
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`infringement determination where before they were not. Amgen is not prejudiced here for its not
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`raising every possibly disputed claim term in the Sandoz case in light of all possibly infringing
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`processes in a prior action involving only one such process.
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`6 Mylan suggests in its briefing that this would run afoul of the Federal Circuit pronouncement that claims are to be
`construed "without reference to the accused device." See Mylan Surreply Br. at 2, ECF No. 130 (citing SRI Int'/ v.
`Mitsushita Elec. Corp. of Am., 775 F.2d 1107, 1118 (Fed. Cir. 1985)). This is incorrect. SRI teaches that the accused
`device is not to be considered or consulted when determining the meaning of the claims; it does not state that the
`accused device/process cannot influence the determination of what claims are material and/or disputed in a
`particular infringement determination. It appears plain to the Court that the specific features of a particular allegedly
`infringing product or process would set the contours of the disputes for litigation, including which claim terms are in
`dispute and require construction. The Court is aware of no rule of law that holds, or even suggests, that this is
`improper.
`
`- 13-
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`

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`Case 2:17-cv-01235-MRH Document 171 Filed 11/20/18 Page 14 of 52
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`For the foregoing reasons, the Court will not treat the Sandoz court's claim constructions
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`as binding and/or preclusive. The Court also holds that Amgen has not waived any arguments
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`based upon its decision to not propose constructions for certain terms in the Sandoz action, or its
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`decision to not appeal certain claim constructions from the Sandoz case. However, the Court
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`recognizes the importance of uniformity in the interpretation of claim terms across related
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`patents. Nestle, 884 F.3d at 1352; see also Markman, 517 U.S. at 390. Accordingly, the Sandoz
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`court's claim construction order will be treated "as persuasive authority" and the Court will
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`"provide [it] the deference provided any legal holding by a respected colleague." See CoStar
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`Realty Info., Inc. v. CIVIX-DDI, LLC, No. 12 C 4968, 2013 U.S. Dist. LEXIS 135448, at *24
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`(N.D. Ill. Sept. 23, 2013).
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`1. "forming a refold solution comprising the solubilization solution and a refold
`buffer"
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`Amgen's Proposed Construction: mixing the solution comprising
`the solubilized protein and one or more of a denaturant, a
`reductant, and a surfactant with a pH-buffered solution comprising
`one or more of a denaturant, an aggregation suppressor, a protein
`stabilizer, and a redox component providing the conditions for the
`protein to refold into its biologically active form
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`Mylan's Proposed Construction: plain and ordinary meaning, no
`construction necessary
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`This disputed term appears in Step (b) of Claim 9 of the '997 Patent. The Court disagrees
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`with Mylan's contention that construction of this term is not necessary because the scope of the
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`term is fundamentally in dispute. 02 Micro, 521 F.3d at 1362-63. The fundamental disputes are
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`the composition and identity of the solubilization solution, as well as the composition of the
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`refold buffer. The scope of this claim may be substantially broader or narrower depending on
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`how "the solubilization solution" and the "refold buffer" are defined. The breadth of these terms
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`will likely be material to an infringement analysis.
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`- 14-
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`

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`Case 2:17-cv-01235-MRH Document 171 Filed 11/20/18 Page 15 of 52
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`a. Solubilization Solution
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`Parties disagree whether "the solubilization solution" in the disputed term refers to the
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`solubilization solution that is formed in Step (a) of Claim 9. 7 Amgen, in its reply brief,
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`recognizes that "a solubilization solution" in Step (a) provides the antecedent basis for "the
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`solubilization solution" in Step (b). (Amgen Reply Br. at 12, ECF No. 114). The parties disagree
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`about whether a strict identity of the two solutions is required. Amgen argues that additional
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`components (notably, the "expressed protein" that is solubilized in the solution) may be added to
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`the solubilization between Step (a) and Step (b), and also that certain components of the solution
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`may be diluted or removed. In Amgen's view, because the "solubilization solution" is introduced
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`in Step (a) as "comprising one or more" of a denaturant, reductant, and surfactant, '997 Patent at
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`22:39-43, as long as the solution continues to comprise at least one of those components, it is
`
`t