Case 2:13-cv-07248-MRP-JEM Document 382 Filed 03/05/15 Page 1 of 12 Page ID
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`WESTERN DIVISION
`
`ELI LILLY AND COMPANY, and
`IMCLONE SYSTEMS LLC
` Plaintiffs,
` v.
`GENENTECH, INC., and CITY OF
`HOPE,
` Defendants.
`
`Case No. 2:13-cv-07248-MRP-JEM
`
`ORDER DENYING PLAINTIFFS’
`MOTION FOR SUMMARY
`JUDGMENT ON
`DOUBLE PATENTING
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`Mylan v. Genentech
`IPR2016-00710
`Genentech Exhibit 2112
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`Case 2:13-cv-07248-MRP-JEM Document 382 Filed 03/05/15 Page 2 of 12 Page ID
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`Introduction
`I.
` Plaintiffs Eli Lilly and Company and Imclone Systems LLC (collectively, “Eli
`Lilly”) have filed for summary judgment on the invalidity of U.S. Patent Nos.
`6,331,415 (“Cabilly II”) and 7,923,221 (“Cabilly III”) against defendants
`Genentech, Inc. and City of Hope (collectively, “Genentech”). The basis of this
`motion is that Cabilly II and Cabilly III are invalid for double patenting. For the
`reasons set forth in this order, the Court denies Eli Lilly’s motion.
`II.
`Background
` The subject matter of Cabilly II and III has been described in past orders of
`
`this Court. See, e.g., Eli Lilly & Co. v. Genentech, No. 2:13-cv-07248-MRP-JEM
`(C.D. Cal. Apr. 18, 2014); Medimmune, Inc. v. Genentech, Inc., No. 2:03-cv-
`02567-MRP-CT, 2007 WL 5760839 (C.D. Cal. Aug. 16, 2007). Cabilly II and III
`are directed to methods, host cells, and vectors for making genetically engineered
`immunoglobulins. Immunoglobulins are proteins normally produced by cells of
`the immune system in response to an infection. Antibodies1 have a Y-shape that
`comprises two heavy chains and two light chains. Antibodies can bind to antigens
`like bacteria and viruses and destroy them.
` Cabilly II and III claim methods for producing antibodies by inserting DNA
`that codes for heavy and light chains into a host cell through the use of one or two
`vectors. The host cells then produce antibodies. Claim 33 of Cabilly II is
`representative of that patent and recites:
`A process for producing an immunoglobulin molecule or an immunologically
`functional immunoglobulin fragment comprising at least the variable domains
`of the immunoglobulin heavy and light chains, in a single host cell, comprising:
`independently expressing a first DNA sequence encoding at least the
`variable domain of the immunoglobulin heavy chain and a second DNA
`
`1 The parties have disputed the claim constructions of the terms “immunoglobulin” and
`“antibody.” The Court has taken no position on the constructions of these terms. For the
`purposes of this section, “antibody” means an immunoreactive immunoglobulin molecule.
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`sequence encoding at least the variable region of the immunoglobulin light
`chain so that said immunoglobulin heavy and light chains are produced as
`separate molecules in said single host cell transformed with said first and
`second DNA sequences.
`Claim 20 of Cabilly III is representative of that patent. Claim 20 depends from
`claim 15. Together, they recite:
`15. A method for making an antibody or antibody fragment capable of
`specifically binding a desired antigen, wherein the antibody or antibody
`fragment comprises (a) an antibody heavy chain or fragment thereof comprising
`a human constant region sequence and a variable region comprising non human
`mammalian variable region sequences and (b) an antibody light chain or
`fragment thereof comprising a human constant region sequence and a variable
`region comprising non human mammalian variable region sequences, the
`method comprising coexpressing the heavy chain or fragment thereof and light
`chain or fragment thereof in a recombinant host cell.
`20. The method of claim 15 which results in the production of an antibody.
`Significant to this motion, Cabilly II and III claim a process called “coexpression,”
`in which DNA that codes for both heavy and light chains may be inserted into a
`single host cell, so that the host cell may express both chains at the same time.
`Cabilly II and III include vector claims and host cell claims related to this process.
` Cabilly II and III were preceded by U.S. Patent No. 4,816,567 (“Cabilly I”). In
`contrast to the later patents, Cabilly I does not claim the coexpression of heavy and
`light chains in the same host cell. Instead, Cabilly I merely claims the expression
`of either a chimeric heavy chain or light chain in a host cell. Eli Lilly primarily
`relies on claim 2 of Cabilly I, which depends from claim 1. Claim 1 recites:
`A method comprising
`(a) preparing a DNA sequence encoding a chimeric immunoglobulin heavy
`or light chain having specificity for a particular known antigen wherein a
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`constant region is homologous to the corresponding constant region of an
`antibody of a first mammalian species and a variable region thereof is
`homologous to the variable region of an antibody derived from a second,
`different mammalian species;
`(b) inserting the sequence into a replicable expression vector operably linked
`to a suitable promoter compatible with a host cell;
`(c) transforming the host cell with the vector of (b);
`(d) culturing the host cell; and
`(e) recovering the chimeric heavy or light chain from the host cell culture.
`Claim 2 recites the “method of claim 1 wherein the first mammalian species is
`human.” Cabilly I also claims host cells and vectors related to the process of claim
`1. For all relevant claims, the crucial difference between the claims of Cabilly I
`and the claims of Cabilly II and III is that Cabilly II and III recite the coexpression
`of heavy and light chains while Cabilly I recites the expression of a heavy or light
`chain.
`
`
`Standard for Summary Judgment
`III.
` The Court shall grant summary judgment if there is no genuine dispute as to
`any material fact, as supported by facts on the record that would be admissible in
`evidence, and if the moving party is entitled to judgment as a matter of law. Fed.
`R. Civ. P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Anderson v.
`Liberty Lobby, Inc., 477 U.S. 242, 250 (1986). In order to grant summary
`judgment, the Court must identify material facts by reference to the governing
`substantive law, while disregarding irrelevant or unnecessary factual disputes.
`Anderson, 477 U.S. at 248. If there is any genuine dispute about a material fact
`such that a reasonable jury could return a verdict for the nonmoving party,
`summary judgment cannot be granted. Id. The Court must view facts and draw
`reasonable inferences in favor of the nonmoving party. Scott v. Harris, 550 U.S.
`372, 378 (2007). If the party moving for summary judgment does not bear the
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`burden of proof as to a particular material fact, the moving party need only give
`notice of the absence of a genuine issue of material fact so that the nonmoving
`party may come forward with all of its evidence. See Celotex, 477 U.S. at 325.
`IV. Law of Double Patenting
`The doctrine of double patenting originates in the text of § 101 of the Patent
`Act, which states that anyone “may obtain a patent” for an invention. Courts have
`read this text to prohibit an inventor from obtaining multiple patents for the same
`invention. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1384
`(Fed. Cir. 2010). Courts refer to § 101’s prohibition as statutory double patenting.
`Id. Courts have created another doctrine to pair with statutory double patenting.
`This doctrine is known as obviousness-type double patenting (“ODP”)—the type
`of double patenting alleged in this case. ODP forbids an inventor’s second, later-
`expiring patent on an invention when a person of ordinary skill would not view the
`second patent as containing a patentably distinct invention from the inventor’s first
`patent.2 Id. ODP must be proven by clear and convincing evidence. Procter &
`Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 999 (Fed. Cir. 2009).
`ODP rests on the policy reflected by § 101. A patent represents a bargain with
`the federal government. The government will give an inventor the right to exclude
`others from making his invention for a limited term, and in exchange, the inventor
`discloses the invention and dedicates it to the public after the patent term expires.
`Without an ODP restriction, an inventor could extend indefinitely the right to
`exclude by filing subsequent patents on obvious modifications of the invention,
`effectively nullifying the public’s right to practice the invention after the first
`patent expires. See Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of
`Rheumatology Trust, 764 F.3d 1366, 1372–73 (Fed. Cir. 2014).
`
`2 A patentee may overcome an ODP problem by filing a terminal disclaimer, which shortens a
`second patent’s term so that it expires at the same time as an earlier-expiring patent. In re
`Goodman, 11 F.3d 1046, 1052 (Fed. Cir. 1993). In this case, the patentee did not file a terminal
`disclaimer of Cabilly II or Cabilly III over Cabilly I.
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`Courts analyze ODP in two steps. “First, the court construes the claim[s] in the
`earlier patent and the claim[s] in the later patent and determines the differences.
`Second, the court determines whether those differences render the claims
`patentably distinct. A later claim that is not patentably distinct from, i.e., is
`obvious over[ ] or anticipated by, an earlier claim is invalid for obviousness-type
`double patenting.” Sun, 611 F.3d at 1385 (Fed. Cir. 2010) (internal quotation
`marks omitted) (citations omitted). “[ODP] is an issue of law premised on
`underlying factual inquiries.” Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689
`F.3d 1368, 1376 (Fed. Cir. 2012).
`Discussion
`V.
`Eli Lilly does not argue that Cabilly II and III are obvious over Cabilly I. Eli
`Lilly argues only that Cabilly I anticipates Cabilly II and III. At summary
`judgment, Eli Lilly has wholly failed to show, by clear and convincing evidence,
`that Cabilly I anticipates the claims of Cabilly II and III.3
` This motion’s resolution largely depends on the meaning of a single word in the
`claims: “or.” Eli Lilly argues that the phrase “heavy or light chain” means “heavy
`and/or light chain.” Under this construction, Eli Lilly argues, Cabilly I anticipates
`Cabilly II and III, which claim the coexpression of a heavy chain and light chain.
`Genentech counters that the phrase “heavy or light chain” does not claim the
`coexpression of a heavy and light chain. Instead, the phrase requires only the
`expression of either a heavy chain or a light chain.
` The Court finds that the claim term “heavy or light chain” requires only the
`expression of either a heavy chain or a light chain. Under this construction,
`Cabilly I does not anticipate Cabilly II or Cabilly III. Therefore, Eli Lilly has
`failed to prove that Cabilly II and III are invalid for double patenting.
`
`3 Indeed, the Court finds it unfathomable that Eli Lilly would present this theory of double
`patenting in light of the Cabilly patents’ prosecution histories.
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`A. Genentech Is Not Estopped From Arguing for Its Proposed
`Construction of “Heavy or Light Chain”
`Eli Lilly argues that Genentech is estopped from arguing against Eli Lilly’s
`proposed construction of “heavy or light chain” as “heavy and/or light chain”
`because Genentech adopted the “heavy and/or light chain” construction when
`Genentech licensed Cabilly I.
`Eli Lilly’s argument is meritless. Genentech never adopted the “heavy and/or
`light chain” construction when it licensed Cabilly I. Eli Lilly bases its argument on
`a faulty assumption: that two licensed products, ReoPro and Erbitux, would not
`have infringed Cabilly I unless “heavy or light chain” meant “heavy and/or light
`chain. This assumption is not true. It is true that the production of ReoPro and
`Erbitux involved the coexpression of chimeric heavy and light chains. But
`producing both a heavy chain and a light chain necessarily involves producing
`either a heavy chain or a light chain. Therefore, coexpression may also infringe
`Cabilly I.
`Thus, Genentech did not need to construe “or” as “and/or” in order to conclude
`that the production of Reopro and Erbitux infringed Cabilly I. Even under
`Genentech’s construction of “or,” Reopro and Erbitux would have met the “heavy
`or light chain” limitation. Therefore, Genentech is not estopped from arguing for
`its construction of “heavy or light chain.”
`B. Construction of “Heavy or Light Chain” in Cabilly I
`Eli Lilly relies almost entirely on the construction of the word “or” in
`supporting its theory of double patenting. Eli Lilly argues that “heavy or light
`chain,” as used in Cabilly I, means “heavy and/or light chain,” and therefore,
`Cabilly I covers coexpression. The problem with this argument is that Eli Lilly
`confuses two separate concepts: what a claim means and what infringes a claim.
`By Genentech’s admission, coexpression of heavy and light chains may infringe
`Cabilly I. This fact does not mean that Cabilly I explicitly recites coexpression.
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`The Court starts with the claim language. “The words of a claim are generally
`given their ordinary and customary meaning as understood by a person of ordinary
`skill in the art when read in the context of the specification and prosecution
`history.” Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed.
`Cir. 2012). The plain meaning of “heavy or light chain” is clear. The word “or” is
`not used in any technical sense. The use of “or” in this phrase indicates that heavy
`and light chains are alternative options, consistent with the use of “or” in everyday
`language. See Oxford English Dictionary, OED Online, http://www.oed.com
`/view/Entry/132129?rskey=qKuMUE&result=9 (last visited March 5, 2015).
`Given this ordinary use of “or,” the relevant Cabilly I claims require only the
`expression of either a heavy chain or a light chain. As such, the claims do not
`explicitly recite coexpression.
`Eli Lilly is able to support its “heavy and/or light chain” claim construction
`only by misunderstanding the law. Eli Lilly first notes that the relevant Cabilly I
`claims use the transition “comprising,” and the use of this transition allows the
`claims to encompass coexpression. Eli Lilly is partially correct. The transition
`“comprising” does expand the universe of potentially infringing activity.
`“‘[C]omprising’ means that the recited elements are only a part of the device . . .
`[and therefore] if the invention is claimed as ‘comprising’ elements X and Y, it
`may also ‘read on’ and cover a device with elements X, Y, and Z.” 3-8 Chisum on
`Patents § 8.06[1][b][ii][A]. The transition “comprising” permits accused products
`to infringe the claim, even if these accused products contain additional elements, as
`long as the accused products practice every recited claim limitation. Thus, the use
`of “comprising” in Cabilly I would have permitted infringing products to include
`both heavy and light chains, even though only one or the other was needed for
`infringement. But the transition does not change what the claim limitations mean.
`“Heavy or light chain” means exactly what it says, and that is all that is required
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`for infringement. The fact that coexpression could infringe Cabilly I is irrelevant
`to the construction of “heavy or light chain.”4
`Eli Lilly fares no better in arguing that the specification provides a special
`definition of “or.” The plain language of the claim requires either the expression
`of a heavy chain or a light chain, and the claims, not the specification, define the
`invention. Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111,
`1115 (Fed. Cir. 2004). The specification does not offer a clear redefinition of
`“heavy or light chain.” Therefore, the Court cannot override the plain language of
`the claims and read in limitations from the specification. See Thorner, 669 F.3d at
`1365 (“To act as its own lexicographer, a patentee must clearly set forth a
`definition of the disputed claim term other than its plain and ordinary meaning.”
`(internal quotation marks omitted)).
`Finally, Eli Lilly cannot support its argument using prosecution history. In fact,
`the prosecution history cuts against the construction of “heavy or light chain” as
`“heavy and/or light chain.” During prosecution, Genentech proposed claim
`language explicitly reciting a “heavy and/or light chain,” which the examiner
`rejected as being “unduly alternative.” After this, Genentech cancelled the claims
`with this language and was granted claims reciting only a “heavy or light chain.”
`Instead, the coexpression embodiments were submitted in a continuation
`application that became Cabilly II. Genentech’s Statement of Uncontroverted
`Facts at ¶¶ 75–76. At best, the prosecution history is ambiguous as to Eli Lilly’s
`argument and therefore should not override clear claim language. Phillips v. AWH
`Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (“[B]ecause the prosecution history
`represents an ongoing negotiation between the PTO and the applicant . . . it often
`
`4 Eli Lilly’s theory is that a claim’s meaning is defined by all the activity that infringes the claim.
`If the Court accepted Eli Lilly’s theory, inventors would be effectively unable to claim
`improvements on already patented processes under a theory of double patenting or anticipation.
`See 35 U.S.C. § 101 (“Whoever invents or discovers any new and useful process . . . or any new
`and useful improvement thereof, may obtain a patent therefor.” (emphasis added)).
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`lacks the clarity of the specification and thus is less useful for claim construction
`purposes.”).
`For these reasons, the Court concludes that “heavy or light chain” requires only
`the presence of either a light chain or heavy chain and does not recite coexpression.
`C. Double Patenting Analysis of Cabilly II and III
`Given this construction of “heavy or light chain,” Eli Lilly’s argument is
`fundamentally flawed. Eli Lilly confuses infringement and double patenting.
`Although a later-expiring patent may be a species of another patent’s genus, this
`relationship does not necessarily mean there is double patenting. In other words,
`even if activity that infringes the later patent necessarily infringes the earlier
`patent, the later patent is not always invalid for double patenting.
`It is true that if an infringer of the earlier patent would necessarily infringe the
`later patent, then there is double patenting. “That which infringes if later
`anticipates if earlier.” Brown v. 3M, 265 F.3d 1349, 1352 (Fed. Cir. 2001)
`(internal quotation marks omitted). This maxim does not apply to the case at hand.
`An infringer of Cabilly I would infringe Cabilly II and III only if he practiced
`coexpression. He would not infringe Cabilly II and III if he practiced only single-
`chain expression. Knowing Eli Lilly cannot rely on this maxim, Eli Lilly attempts
`to derive another: if an infringer of the later patent necessarily infringes the earlier
`patent, there is necessarily double patenting. This statement of law is contrary to
`Federal Circuit precedent. “It is well-settled that a narrow species can be non-
`obvious and patent eligible despite a patent on its genus.” Abbvie, 764 F.3d at
`1379. Of course, “not every species of a patented genus is separately patentable.”
`Id. “[W]hen a ‘genus is so limited that a person of ordinary skill in the art can “at
`once envisage each member of this limited class,” . . . a reference describing the
`genus anticipates every species within the genus.’” Id. (quoting In re Gleave, 560
`F.3d 1331, 1337–38 (Fed. Cir. 2009)).
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` The question here, then, is whether a person of ordinary skill would have
`envisaged the coexpression claims of Cabilly II and III based on Cabilly I. Eli
`Lilly has offered no significant evidence to prove this. Even assuming Eli Lilly
`could use Cabilly I’s disclosure to support a double patenting argument, Eli Lilly
`makes only bare references to the disclosure of Cabilly I without explaining clearly
`how the disclosure renders Cabilly II and III invalid. See Pls.’ Opening Br. at 5–6,
`21–23.
`Eli Lilly’s argument based on Application of Schneller, 397 F.2d 350 (C.C.P.A.
`1968), is likewise unpersuasive. Schneller’s guidance appears to contradict
`Abbvie’s guidance that a narrower species may be patentable, even if the genus is
`already patented. Indeed, the Manual of Patent Examining Procedure observes that
`“[t]he decision in In re Schneller did not establish a rule of general application and
`thus is limited to the particular set of facts set forth in that decision.” MPEP
`¶ 8.37. The best way to reconcile Abbvie and Schneller is to conclude that in
`Schneller, the previously granted patent provided the person of ordinary skill
`sufficient motivation to “envisage each member of [a] limited class.” Abbvie , 764
`F.3d at 1379. As discussed above, Eli Lilly has not shown that Cabilly I’s
`disclosure provided such a motivation to a person of ordinary skill.
`Eli Lilly’s argument regarding Sun Pharmaceutical Industries, Ltd. v. Eli Lilly
`& Co., 611 F.3d 1381 (Fed. Cir. 2010), is wrong because Sun applies only to later-
`claimed uses for patented compounds. See Teva, 689 F.3d at 1380. Cabilly II and
`III do not claim later and previously disclosed uses for the Cabilly I invention.
`Instead, Cabilly II and III claim inventions involving coexpression as opposed to
`single-chain expression. Sun does not apply to this situation.
`Finally, this Court notes that its reasoning is consistent with the reasoning of the
`Patent Office during the Cabilly II reexamination, which focused on the question
`of double patenting. Like the Patent Office, this Court finds all of these double
`patenting arguments meritless.
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`VI. Conclusion
`The Court finds Eli Lilly’s other arguments unpersuasive. Therefore, the Court
`denies Eli Lilly’s motion for summary judgment on invalidity for double patenting.
`
`IT IS SO ORDERED.
`
`DATED: March 5, 2015
`
`
`
` _________________________________
`Hon. Mariana R. Pfaelzer
`United States District Judge
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