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BOEHRINGER INGELHEIM ANIMAL HEALTH, INC. v. SCHERI

October 6, 1997

BOEHRINGER INGELHEIM ANIMAL HEALTH, INC., Plaintiff,
v.
SCHERING-PLOUGH CORPORATION and SCHERING CORPORATION, Defendants.



The opinion of the court was delivered by: ACKERMAN

 Ackerman, D.J.

 This matter comes before the court on plaintiff's motion for a preliminary injunction in its patent infringement action. *fn1" For the reasons detailed below, plaintiff's motion is DENIED.

 I. Background

 This patent litigation arises from two company's endeavors to develop a vaccine for a disease known as Porcine Reproductive Respiratory Syndrome ("PRRS") -- "the most challenging infectious disease facing the [swine] industry today." Hays Declaration P 6, Ex. 5 (copy of Schering letter to Swine Industry Professionals from Robert J. Young, Product Director. Large Animal Business Unit). This disease, PRRS, also known as Mystery Swine Disease ("MSD") and Swine Infertility and Respiratory Syndrome ("SIRS"), infects pigs and causes them to give birth to dead or sickly piglets. In addition, it causes reproductive failure, respiratory disease, and other symptoms such as anorexia, fever, dyspnea, and neurological impairment.

 A Basic Principles of Virology

 Before one can begin to analyze the issues involved in this case, it is important to outline the some general principles of virology. Viruses, such as PRRS, are parasitic organisms that grow and multiply within "host cells." A virus depends on the host cell's "machinery" for survival and uses that machinery to reproduce. It will use this machinery to produce its own proteins and nucleic acids -- the blueprint of all genetic information in living organisms. When a higher organism such as an animal or human is exposed to a virus and its cells become viral hosts, the animal or human develops a natural immunity. This immune response operates at two levels: first, at the initial stage of the infection before the virus has invaded the host and second, after the virus has invaded. When the virus stimulates certain specialized cells, these cells produce antibodies which prevent future infection. But this exposure still produces disease symptoms. Thus, the universal objective of virologists is to develop a vaccine which produces an immune response without the attending sickness.

 There are two common types of vaccines -- killed virus vaccines and modified-live virus vaccines. Both Boehringer and Schering's vaccines are derived from modified live viruses. A modified-live virus is made by obtaining a strain of the virus and putting it through the process of "attenuation." To "attenuate" a virus, like PRRS, means to repeatedly pass it through an appropriate in vitro culture system. In very crude terms, this means taking a tissue sample from a diseased animal and putting it into some kind of a vessel, like a bottle, with a host cell. When placed in a favorable medium, the tissue simple and cells interact in such a way as to facilitate the growth of the virus. That is the first passage. Then, the fluid or material containing the virus is transferred to another vessel with the host cell and passaged through a similar process. That is the second passage. Ultimately, the attenuation process alters the virus enough so that it produces the immune response and thereby protects against any subsequent infection without causing the disease. To be sufficiently attenuated, a virus may be passaged several times. The number of passages varies with each vaccine. For example, Schering has developed a PRRS vaccine which has been passaged ninety-four times.

 In the early 1990's, Boehringer initiated an "extensive research program to study PRRS and develop a vaccine." Plaintiff's Br. at 4. First, Boehringer focused its energies on the task of "finding a suitable host cell" in which to grow and replicate the causative virus. See Gorcyca Declaration P 12; Plaintiff's Br. at 4. In 1990, at the Conference of Research Workers in Annual Diseases, Joseph Harris, a Boehringer research assistance met Dr. James Collins and Dr. David Benfield, two scientists from the University of Minnesota and South Dakota State University scientist, respectively. Collins and Benfield had been working together on the cause of PRRS. They had successfully collected specimens from various organs of diseased pigs, reduced the organs to a tissue homogenate from which an inoculum could be prepared, and inoculated the inoculum into gnotobiotic pigs. *fn2" See Defendant's Br. at 5. As a result of their work, they could reproduce the symptoms of PRRS in the pigs. However, they were unable to observe CPE on cell lines. Id. at 6. CPE refers to "cytopathic effect" which the plaintiff has defined as a "change in the microscopic appearance of a cell after infection with a virus" or some observable effect shown on the simian cells. As the defendant has explained, this observable effect is the killing of inoculated cells. The court will elaborate on the significance of CPE below, (see infra at 22), but for now, it is sufficient to know that one needs to observe CPE to be able to grow the virus on a cell line. Thus, Collins and Benfield could not grow the virus.

 At some point, Boehringer agreed to work with Collins and Benfield on PRRS. Thereafter, Harris sent Collins a number of cell lines, but Collins did not try them. Collins sent his inoculum samples to Harris at the Boehringer lab so that Harris could try the inoculum on his own cell lines. On April 25, 1991, Harris observed CPE on the partial cell line derived from a monkey kidney, MA-104.

 To confirm that it has been able to recover the PRRS virus, Boehringer need to perform what is known as "Koch's Postulates." In the instant case, this entailed sending the third passage of the virus to Benfield. Dr. Benfield took the viral agent recovered by Harris and introduced it into gnotobiotic pigs who then exhibited symptoms of the disease. Benfield took tissue samples from the diseased pigs and sent them back to Dr. Collins and then to Harris. Using the same method described above, Harris inoculated and incubated the sample and observed CPE. This satisfied Koch's Postulates and confirmed that Boehringer had been successful in recovering the PRRS virus.

 After it "discovered that PRRS viruses could be grown and isolated on a full or partial sheet of simian monkey cells," specifically MA-104, Boehringer filed a patent application on August 26, 1991. On December 19, 1995 the Patent Office issued as Boehringer Patent No. 5,476,778 ("the '778 Patent"). The '778 Patent made the following five claims:

 
1. A method of growing and isolating swine infertility and respiratory syndrome virus, ATCC-VR2332, which comprises inoculating the virus on a full or partial sheet of simian cells in the presence of serum in a suitable growth medium and incubating the inoculated cell sheet at about 34 [degrees] C. to 37 [degrees] C. until CPE is observed.
 
2. The method as recited in claim 1 wherein the simian cell line is MA-104.
 
3. A method of attenuating swine infertility and respiratory syndrome virus, ATCC-VR2332, which comprises passaging the virus through simian cell line on maintenance medium in the presence of serum at pH about 7.6 about twenty-five time at about 35 [degrees] - 37 [degrees] C without carbon dioxide, and then passaging the resulting virus through a simian cell line on maintenance medium in the presence of serum at pH about 7.6 about twelve times at about 31 [degrees] C.
 
4. The method as recited in claim 3 wherein the simian cell line is MA-104.

 In the instant action, only claims 1 and 2 are at issue. Notably, these two claims do not cover a vaccine. Rather, Boehringer believes that its patent covers a method which is instrumental in developing a vaccine for PRRS. After the patent issued, Boehringer obtained two licenses for modified-live vaccines -- RespPRRS TM and RespPRRS/Repro TM -- which prevent the respiratory form of PRRS. Boehringer alleges that these vaccines were made using patented methods at issue in this litigation.

 C. Schering's Alleged Infringement

 Like Boehringer, the defendant in this case Schering-Plough and Schering Corp. (collectively "Schering") was interested in the PRRS disease. In October 1991, Schering isolated its own strain of the PRRS virus using porcine alveolar macrophages as a host cell. Then, Schering created its "Master Seed Virus" by putting the virus through an attenuation process comprising ninety-four passages. It then developed a vaccine production process whereby it produced more of the virus using MA-104, a simian cell line, as a host cell line. According to the plaintiff, on August 20, 1996, Schering-Plough and Schering Corp. (collectively "Schering") "commenced sales of a swine vaccine for the prevention of PRRS that is made by a method that infringes the '778 Patent." Plaintiff's Br. at 1. As a result, the plaintiff alleges that Schering has infringed upon claims 1 and 2 of its '778 Patent, both literally and under the doctrine of equivalents.

 II. Motion for Preliminary Injunction

 A party seeking a preliminary injunction must establish four factors:

 
1. a reasonable likelihood of success on the merits
 
2. an irreparable harm
 
3. the balance of hardships tipping in its favor; and
 
4. a tolerable effect on the public interest.
 
Sofamor Danek Group v. DePuy-Motech, 74 F.3d 1216, 1219 (Fed. Cir. 1996).

 The court "must balance these factors against one another and against the extent of the relief sought." Id. The movant bears the burden of proving entitlement to relief. See Id. However, irrespective of how the court resolves the third and fourth factors, the movant must demonstrate the existence of the first two before this court grants a motion for a preliminary injunction. See Reebok Int'l v. J. Baker, Inc., 32 F.3d 1552, 1556 (Fed. Cir. 1994). The court may deny the motion based upon a plaintiff's failure to establish either of the first two factors. See Id. Moreover, where the plaintiff has not established either of the first two factors, the court need not articulate findings regarding the others. Id.

 A. Reasonable Likelihood of Success

 At the preliminary injunction stage, a patentee must establish a likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement. See Nutrition 21 v. United States, 930 F.2d 867, 869 (Fed. Cir. 1991). There are two steps in a patent infringement analysis: the first being the construction of the claim and the second being the determination as to whether the accused method infringes the asserted claim as properly construed. Markman v. Westview, 52 F.3d 967 (Fed Cir. 1995) (en banc), affirmed, 517 U.S. 370, 134 L. Ed. 2d 577, 116 S. Ct. 1384 (1996). Under Markman, as a matter of law, the court must construe the claim.

 In a preliminary injunction context, a court may, in exercising its discretion, decide to interpret the claim conclusively. See Sofamor Danek, supra, at 1221 (Although "the trial court has no obligation to interpret [a claim] conclusively and finally during a preliminary injunction proceeding . . . . [It] may exercise its discretion to interpret claims at a time when the parties have presented a full picture of the claimed invention."). Since the Supreme Court decided Markman, many courts have held a "Markman hearing" before trial in order to construe the claims involved. In the instant proceeding, I conducted a Markman hearing in conjunction with the preliminary injunction hearing.

 a. General Principles

 In interpreting an asserted claim, the court looks at "the intrinsic evidence of record, i.e. the patent itself, including the claims, the specification, if in evidence, the prosecution history . . . " because it is the "most significant source of the legally operative meaning of disputed claim language. Vitronics v. Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996) (citing Markman, supra). First, the court must examine the words of the claim itself, both asserted and nonasserted, to define the scope of the patented invention. When interpreting technical terms used in a patent, the court must construe those terms as "having the meaning that it would be given by persons experienced in the field of the invention, unless it is apparent from the patent and the prosecution history that the inventor used the term with a different meaning." Id. at 1582 (citing Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir.), cert. denied, 136 L. Ed. 2d 198, 117 S. Ct. 275 (1996)). That means that while patent terms should generally be construed to have their ordinary meaning, at the time of the patent application, a patentee is still entitled to "choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history." Id. Under those circumstances where the patentee's meaning is clear, the court must adopt the special definition of the term.

 Therefore, the court's second step in construction of a claim must be to review the specification "to determine whether the inventor has used any terms in a manner inconsistent with their ordinary meaning." Id. As I have already indicated, the Federal Circuit has noted, "the specification acts as a dictionary when it expressly defines terms or when it defines terms by implication." Id. It is "the single best guide to the meaning of a disputed term" but it "must be clear and complete enough to enable those of ordinary skill in the art to make and use it." Id. Nevertheless, if the specification does not use a term in a "special" or "unique" way, "its ordinary meaning to one skilled in the art controls." Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1303 (Fed. Cir. 1997).

 As a third step in claim construction, the court may consider the prosecution history of a patent in interpreting claims. This history may include a "complete record of all the proceeding before the Patent and Trademark Office, including any express representations made by the applicant regarding the scope of its claims," and in some circumstances becomes critically significant. Vitronics, supra, at 1582.

 Finally, although the court generally does not consider extrinsic evidence in addition to the intrinsic evidence already mentioned, it may do so in limited circumstances. While it is improper to consider extrinsic evidence where an "analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term" ( Id. at 1583), the court may do so where necessary to resolve any persisting ambiguities. Thus, a court may not rely on any extrinsic evidence "where the public record unambiguously describes the scope to the patented invention, reliance on any extrinsic evidence is improper." Id. In the event that a court does look to extrinsic evidence such as expert testimony, it may do so only to the extent that such evidence does not contradict the specification and file history. Id.

 The Federal Circuit's reticence regarding extrinsic evidence is rooted in its understanding of the purposes of the patent system. Excessive use of extrinsic evidence could undermines the public's right to rely upon the public record. See Id. As the Federal Circuit has noted, "competitors are entitled to review the public record, apply the established rules of claim construction, ascertain the scope of the patentee's claimed invention and thus, design around [it]." Id.

 Notwithstanding the discussion above, there exists one small exception to the rule disfavoring extrinsic evidence: a court may consult technical treatises and dictionaries, notwithstanding the fact that they fall within the category of extrinsic evidence, in order to "better understand the underlying technology." Id. at 1584 n.6. It may rely on dictionary definitions to construe claim terms "so long as [the definition] does not contradict any definition found in or ascertained by a reading of the patent documents." Id. at 1584 n.6.

 b. Construing the '778 Patent

 The parties have three fundamental disagreements over the construction of Claim 1. They have vigorously disputed: first, the meaning and significance of the term "isolating" located in the preamble, second, the significance of the phrase "swine infertility and respiratory syndrome virus, ATCC-VR2332," and third, the meaning of "until CPE is observed."

 i Isolating

 The preamble to Claim 1 describes the patent as a "method of growing and isolating . . " Neither side disputes that "growing" means "propagation or cultivation of the virus, whereby the virus increases in number," but there is fervent debate over the term "isolating". Initially, Boehringer argues the position that as a general rule, preamble language never serves as a limitation. The preamble is that portion of the claim preceding the word "comprising." See Judin v. United States, 27 Fed. Cl. 759, 775 (Fed.Cl. 1993). While the significance of preamble language is a vexing issue for federal courts interpreting patent claims, Boehringer's position is untenable.

 A "claim preamble has the import that the claim as a whole suggests for it" and when the drafter uses "both the preamble and the body to define the subject matter of the claimed invention, the invention so defined, and not some other, is the one the patent protects." Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). In other words, where the preamble language is "necessary to give life, meaning and vitality to the claim" or it is deemed "essential to point out the invention defined by the claim," the Federal Circuit has found that the language effectively limits the scope of the claim. Bell, supra, at 620-21. Conversely, "where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation." Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997).

 In Bell Communications, the court clarified that the construction of preamble language does not present some "deep[] mystery." See Bell Communications, supra, at 621. Bell Communications dictates that the mechanics of preamble construction are the same as those for general claim construction. See Id. Therefore, this court must employ the interpretive principles elucidated in Markman and Vitronics, cited supra. First, I must look to the preamble language itself and then to the specification to further clarify the scope of the claim. See Bell Communications, supra, at 619-20. The court should also consider the prosecution history and when necessary, any extrinsic evidence. See Vitronics, supra.

 The entire record in this case makes clear that Boehringer was working on the problem of both "growing" and "isolating" the PRRS virus. Boehringer has argued that "isolating" does not limit the scope of the claim because the body of the claim does not contain an isolation step. To some extent, that is true. When the claim language talks about "inoculating the virus . . . and incubating the inoculated cell sheet," that defines how to grow the virus and not necessarily how to isolate it. Nevertheless, to construe the claim as not involving "isolation" "would be divorced from reality." See Corning Glass Works, supra, at 1257. The specification makes clear that "isolation" is an integral part of the process which cannot be separated from the growing component. There is no question that steps involved in the body of claim 1 facilitate isolation. As will be discussed below, the specification anticipates that the claimed method will be repeated in several passages and while there are no isolation steps in the body of the claim, the elements of the claim facilitate isolation and the isolation step is necessary to be able to repeat the method. By introducing its claim as a "method of growing and isolating," Boehringer has defined the environment in which its process takes place. Once we understand that the term "isolating" impacts upon the scope of the claim, the construction of the term "isolating" becomes the more important task.

 According to Schering, the clear meaning of the word "isolating" is recovering the causative (viral) agent from the tissue homogenate. Under that interpretation, the patent would cover the initial isolation of PRRS, but it would not cover "subsequent passages." In response. Boehringer argues that the term should be construed much broader. Boehringer posits that "isolation" is the "separation of the virus from its surroundings" -- a construction which encompasses "the initial recovery from a tissue sample [or homogenate] or separating or harvesting the virus from a cell culture system." Plaintiff's Finding No. 117. Certainly, the latter definition comports more with the common definition of isolation meaning: "to set or place apart, detach or separate. See RANDOM HOUSE COLLAGE DICTIONARY (1980). Moreover, nothing in the claim, specification, or prosecution history supports Schering's interpretation.

 First and most importantly, when the claim refers to isolating the virus, it does not indicate whether the source of isolation is either the tissue homogenate from the diseased pig or the virus recovered from a previous passage. Second, under the heading, "Isolation," the specification discusses "initial isolation" and "subsequent passages." In that section, which discusses the use of serum in the process, the patent states that:

 
The presence of serum may be helpful for the initial isolation of the viral agent. Subsequent passages of the viral agent in the MA 104 cell line will produce the CPE without the presence of serum. However, more pronounced CPE is observed with the use of serum in the growth medium for the MA-104 cell line. See '778 Patent, Col. 3, lines 37-42 (emphasis added).

 The specification language anticipates that there will be an "initial isolation" and other isolations "in subsequent passages." Schering does not believe that this is a valuable distinction because the specification does not mention "other isolations," just "subsequent passages." If the patent covered "other isolations," Schering intimates, the specification would need to distinguish between "initial isolation" and "subsequent" isolations, not just passages. However, such a degree of precision is not necessary. The language assumes that other isolations occur and therefore, the term "isolating" should not be limited to the initial isolation from the tissue homogenate. Finally, because the prosecution history does not suggest anything to the contrary, I find that the term "isolating" references the recovery of the virus from either the tissue homogenate or a previous passage.

 A question remains as to how isolation is performed. In its post-trial briefs, Boehringer has argued that isolation means to recover the virus from its surroundings. At the hearing, Boehringer argued that isolation meant to "decant fluids containing virus and separate out debris." See Plaintiff's Ex. 10 (copy of chart demonstrating "Passaging PRRS Virus According to claim 1"). Looking at the specification. which is the most relevant indicator -- isolation is effected when, after incubation, the "fluid [containing the virus] is separated from the bottle, and passed into a new bottle." Although the differences between these definitions may be insignificant, the court will use the language of the specification because apart from the claim language itself, it is "the single best guide to the meaning of a disputed term." Vitronics, supra, at 1582

 ii. Swine infertility and respiratory syndrome virus, ATCC-VR2332

 The parties also dispute the significance of the term "swine infertility and respiratory syndrome virus, ATCC-VR2332" located in the preamble of claim 1. In July 1991, made a deposit with the American Type Culture Collection in Rockville, Maryland. That deposit contained a strain of the PRRS virus. ATCC-VR2332 refers to the accession number assigned to the deposit. At the hearing, the court learned that the actual deposit was a strain of PRRS after its eighth passage. This particular isolate was the first PRRS virus to be deposited and Boehringer has described it as "'prototype' PRRS virus." Boehringer Finding No. 61.

 Initially, Boehringer argues that as a matter of law, preamble language has no limiting effect. But, for reasons which I have already stated, Boehringer is wrong. See Bell Communications, supra. In what has become the seminal case on the import of preamble language, Bell Communications, the court interpreted a claim of a patent which recited in the preamble "a method for transmitting a packet over a system comprising a plurality of networks said packet including a source address and a destination address." Id. at 621. The claim then recited the steps of "assigning, by said source device, one of said trees to broadcast said packet and associating with said packet an identifier indicative one of said trees." Id. The court found that because the two steps of the claimed method referred to "said packet" and thereby "expressly incorporated by reference the preamble phrase 'said packet including a source address and a destination address," the claim should be limited to a method for transmitting packets that have both source and destination addresses. Id. While use of the word "said" does not have a "talismanic effect," Bell Communications typifies a situation where the court found that a preamble clearly defined an element of the claim. See ADC Telecommunications, Inc. v. Siecor, 954 F. Supp. 820, 829 (D. Del. 1997).

 In the instant case, the claim speaks of a "a method of growing and isolating swine infertility and respiratory syndrome virus, ATCC-VR2332, which comprises inoculating the virus . . . ." Schering posits that the term, "the virus," refers to the "swine infertility and respiratory syndrome virus, ATCC-VR2332" because the only "antecedent" in the claim for the words "the virus" is that which is mentioned in the preamble. According to Schering, the claim drafter used both the preamble and the body of the claim to define its subject matter and therefore, Bell Communications compels this court to treat the preamble as a limitation.

 There is no question that the preamble language "swine infertility and respiratory syndrome virus, ATCC-VR2332" "breathes life" into the body of the claim. A contrary conclusion would be incredible because without the preamble language, the claim would refer to any virus. Claim 1 clearly denotes "swine infertility and respiratory syndrome virus, ATCC-VR2332" as the virus upon which it focuses its attention. ...


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