Center for Advanced Study & Research on Intellectual Property


CASRIP Newsletter - Summer 1999, Volume 6, Issue 1

Osaka District Court Found Infringement under the Doctrine of Equivalents

Pharmacia & Upjohn Aktiebolag v. Nippon Eli Lilly1

by Toshiko Takenaka

On May 27, the Osaka District Court's IP Special Division issued a decision applying the doctrine of equivalents and found infringement. Since the Japanese Supreme Court's endorsement of the doctrine in the Ball Spline case,2 lower courts have reviewed claims of infringement under the doctrine of equivalents, and have clarified five conditions for its application. The lower courts did not apply the doctrine of equivalents because they determined that the accused device did not meet one or more of these conditions.3 The courts' reluctance to utilize the doctrine was evident in their narrow analysis of the conditions. Reacting to this determination, the Japanese patent community began to doubt if Japanese courts were truly willing to apply the doctrine of equivalents. The Osaka District Court dispelled such doubt by employing the doctrine and finding infringement in Pharmacia & Upjohn.

The patents at issue concerned an injection apparatus and a method for preparing an injection solution for use with the device. The device was used for mixing a sensitive solid medicament with liquid. It included a dual-chamber cylinder ampoule, to separate the dry medicament from the liquid. Upjohn sued Eli Lilly, alleging that (1) Eli Lilly's injection device was infringing literally on the apparatus claims, and (2) Eli Lilly's device was indirectly infringing the method claims because it had no use other than the infringing use. The Osaka District Court did not find Upjohn's apparatus claims either literally or equivalently infringed, but found indirect infringement of the method claims by the sale of Eli Lilly's injection device under the doctrine of equivalents.

With respect to both the apparatus and the method claims, the parties' dispute centered on the claim limitations relating to the thread mechanism. The thread mechanism was used for slowly moving the movable wall member to mix the medicament and the liquid contained in separate chambers. The method claims recited generally "a thread mechanism," but did not include any structural limitations. In contrast, the apparatus claims specifically recited the structure of the thread mechanism as being two tubular members screwed together in order to secure a vessel attached inside of the tubes.

In the accused injection device, the vessel was not secured inside of the tubular members. Instead, the vessel was held in an open-ended holder. Further, the threads were provided on a guide to which a solution plunger and a body were integrally provided. These threads attached to other threads on the inner wall of an operation knob, so as to move the body relative to a movable member. The accused device obviously did not meet the structural limitations of the thread mechanism and the tubular members, and the Osaka Court found no literal infringement.

The court then examined whether the accused device infringed upon the apparatus claims under the doctrine of equivalents. First, the court examined whether the thread mechanism was essential to the patented invention. According to the court, the elements are found to be essential if they are necessary to the functions and to the results unique to the patented invention. In other words, essential elements are those elements the replacement of which results in a technical idea different from that of the patented invention.

Applying this standard to Upjohn's apparatus claims, the court first reviewed the discussions of the purpose of the invention. The specifications indicate that the invention was intended to provide a device to gradually prepare a solution for injection by using a multiple chamber cylinder ampoule secured by two tubular members. The court then investigated the prior art. Evidence showed that a multiple chamber cylinder ampoule apparatus and the use of a thread mechanism in an injection device were publicly known as of the time of the priority date of the patented invention. The method of mixing the medicament with liquid through a threaded mechanism in an injection device was also well-known. Referencing the prior art, the court concluded that the essence of the invention resided in the disclosure of a particular structure formulated to attain the function and result recited in the specification. In this instance, to slowly prepare the injection solution. This line of reasoning led to the conclusion that the structure of the thread mechanism was an essential element of the claim. Thus, the first condition of the Ball Spline decision, requiring a finding of a non-essential element was not met. Accordingly, the court found Eli Lilly's injection device infringed upon none of Upjohn's apparatus claims under the doctrine of equivalents.

With respect to the method claims, Eli Lilly tried to confine the broadly defined "through the thread mechanism" limitations to the two tubular members recited in the apparatus claims. The first argument was that the court should interpret the limitations in the context of the definition and usage of limitations relating the thread mechanisms in different claims, particularly the apparatus claims. However, the court refused to read the structural limitations of the thread mechanism into the method claims because patentees are entitled to include claims with different breadths of scope. Unless the scope of a generic claim is too broad to be understood by one skilled in the art, courts should not restrictively interpret the generic claims. Eli Lilly's second argument was that the broadly stated limitations defined the invention in context of function, the scope of which was overly broad and ambiguous. Thus, the scope of functional language should be limited to the structure disclosed in the specification. The court found this argument unpersuasive because the scope was clear to one skilled in the art from the specification, the prior art, and general knowledge. Thus, the court found that the "through a thread mechanism" limitations covered the mechanism used in the accused device.

Further, the independent method claim included limitations requiring holding the ampoule in the vertical position in preparing the injection solution. In contrast, evidence clearly indicated that the ampoule of the accused device was held in the horizontal position or upward position in preparing the solution. Thus, Eli Lilly argued that its injection device was used differently from the method recited in the patented claims. To establish indirect infringement, an owner of a method patent must show that the accused device has no commercial or practical use other than the patented use. In this case, the Osaka District Court found that the use of the Eli Lilly's device held horizontally or upwardly did not literally infringe the patented method. Because such use existed, the device had a commercial use other than the infringing use. Thus, the sale of the device did not constitute indirect infringement.

However, the Osaka District Court also examined whether Eli Lilly's injection device infringed Upjohn's method claims under the doctrine of equivalents. In determining whether the substituted holding position was essential to the invention, the court repeated the same analysis done with respect to the thread mechanism. The holding position was found not to be essential. No discussion in the limitations suggested that holding the ampoule in the vertical direction was an essential advantage of the invention. Further, the evidence clearly indicated that positioning the needle point of the injection device upward was a well-known technique to prevent solutions from leaking from the needle. These findings also supported the court's conclusion that "holding the ampoule in the vertical position" was not essential to the invention. Thus, the accused method met the first condition, which required a non-essential element.

The court also found that the accused method met the second condition of replacement capability. Eli Lilly's injection device could have been used for preparing injection solution regardless of whether the ampoule was in the vertical position or the horizontal position. Changing the holding position did not affect the effectiveness of preparing the medicament.

Additionally, the court found that one skilled in the art would have readily recognized the use of Eli Lilly's injection device as merely manipulating the position of the ampoule. Thus, the substituted element in the accused method met the third condition of obviousness.

In examining the conditions limiting the application of the doctrine of equivalents, the court found the fourth condition not applicable. No evidence was produced to show that the preparation method that used Eli Lilly's injection device was known or would have been obvious from the prior art as of the priority date.

With respect to the fifth condition of intentional removal during the prosecution, Eli Lilly argued that Upjohn surrendered all claims of equivalents with respect to the holding position limitation. Upjohn had amended its claim to limit to the vertical position in response to a notice of rejection during the prosecution. However, the court did not believe that the limitations were included for overcoming the reason of rejection, because holding the device in a vertical position for preparing injection solution was well known to those skilled in the art. Thus, the court found no basis to show the patentee's intentional exclusion of the scope with respect to the holding position. By meeting all five conditions, the accused method infringed the method claims under the doctrine of equivalents. Therefore, the court found that all uses of Eli Lilly's device infringed the method claims either literally or under the doctrine of equivalents. The sales of the device constituted indirect infringement.

The Upjohn case evidences the Japanese courts' patent friendly attitude in construing claim language by refusing to read limitations into the disputed claim element from other claims. The Osaka District Court adopted a theory similar to the claim differentiation theory developed by U.S. courts in assuming patentee's intent to give respective claims different scopes.4 The doctrine was once popular in U.S. courts, but has fallen into disuse. The Federal Circuit court often rejects arguments based on claim differentiation, stating that the language of the claim should be consistent with the usage of the language in different claims.

The Upjohn court also rejected the argument that the disputed claim element was defined by function and thus was ambiguous. This assertion was once a very effective argument, and gave Japanese courts an excuse to limit the scope to disclosed embodiments.5 The court's analysis relied on not only the specification, but also the prior art, and the general knowledge of one skilled in the art to determine whether the scope of the disputed element was clear. This practice shows a marked contrast to the Federal Circuit's reliance on claim language to limit the structure to the specifications and their equivalents when the language itself does not include sufficient structural limitations.

The Upjohn court's determination of infringement under the doctrine of equivalents also indicates an interesting contrast with the reasoning of the Federal Circuit. Similar to earlier decisions from Osaka and Tokyo District Court's special IP divisions, the focus of the court's analysis was on the first three conditions. Each of these conditions was an affirmative test for finding infringement under the doctrine of equivalents. Unlike the Federal Circuit, examination of the conditions to prevent the application of the doctrine of equivalents was very brief.

The Upjohn court included an extensive discussion regarding the process by which to decide essential elements, and justified such analysis in context of patent policy. The Upjohn court's analysis of essential element somewhat paralleled the Federal Court's all elements rule by examining the role of the substituted element in context of the purpose and advantages of the invention.6 However, in determining essential elements, the Upjohn court went beyond the specification, and looked into the state of the art to find which elements constitute the novel and inventive steps of the invention. This reevaluation of the purpose parallels the German Supreme Court's approach of objectively redefining the purpose and inventive concept in terms of the prior art found after the examination.

The Upjohn court's examination of the second condition was very brief. This is because the first condition requires the substitution by an equivalent producing no effect on the function and result of the invention, and thus the second condition is automatically met once the first condition is met.

Regarding the third condition, although an earlier decision compared the third condition with the inventive step test, the court did not follow any of the usual steps to apply the test. For example, the examination of the motivation to use the device horizontally or upwardly was abbreviated. The earlier decision emphasized the high degree standard of scrutiny for examining the substituted element by one skilled in the art. In contrast, the court found the condition met in the present instance by simply stating that the element is known to one skilled in the art.

The examinations of the negative conditions were also very brief. The court did not examine the fourth element because Eli Lilly, on whom the burden is imposed, did not introduce sufficient evidence to show that the accused method was obvious from the prior art. With respect to the fifth condition of intentional exclusion, Upjohn presented a similar factual setting to Sextant and Festo,7 in having no record why the patentee included the disputed element of the holding position. The Osaka District Court adopted patent friendly view, agreeing with Judge Newman's position in Festo, and found no basis to narrow the scope. This contrasts sharply with Japanese courts' traditional approach to the doctrine of intentional exclusion. Under that approach, Japanese courts applied the doctrine broadly to prevent patentees from recapturing scope surrendered during the prosecution. Particularly, if the element was introduced during the prosecution, courts rejected any argument based on the doctrine of equivalents regardless of the reason for the amendment.

In short, Upjohn gives a great relief to Japanese patent owners, and affirms the patent friendly attitude of the Japanese courts in interpreting the disputed claims broadly and applying the doctrine of equivalents. Because Upjohn was the first case for a Japanese court to find infringement meeting the first three conditions, the theoretical justification for analyzing the last two conditions is still underdeveloped. As recent Federal Circuit decisions dealing with the prosecution history estoppel and the prior art limitation8 indicate, the difficulties of applying the two conditions, Japanese courts will soon face similar problems.

1. Judgment of the Osaka District Court, May 27, 1999. The decision is available on line at < 56795007fb825/7da56 fc63308e18a492567a20013a5c8?OpenDocument>.
2. Judgment of the Supreme Court of Japan, Feb. 24, 1998. An English translation of the decision by this author is published in 5-1 CASRIP Newsletter 12 (Center for Advanced Study and Research in Intellectual Property, University of Washington School of Law, Seattle, Winter 1998), available on-line at < newsletter/ newsv5i1jp1.html.
3. Judgment of the Tokyo District Court, Oct. 7, 1998, 52 Minshu (No. 1) 113, Hanrei Jiho No. 1657, 122 (1999); Judgment of Osaka District Court, Sept. 17, 1998. A report on these cases by this author is published in 5-4 CASRIP Newsletter 6 (Center for Advanced Study and Research in Intellectual Property, University of Washington School of Law, Seattle, Winter 1998), available on-line at < newsv 5i4jp1.html.
4. Because Japanese Patent System has long followed its traditional single claim system, the claim differentiation theory did not exist until it introduced U.S. type multiple claim drafting system. For general discussion, seeToshiko Takenaka, Interpreting Patent Claims: The United States, Germany and Japan, 17 Int'l Industry. Prop. and Copyright Studies 230 (1995).
5. Id. at 216.
6. Vehicular Tech. Corp. v. Titan Wheel Inc.,141 F.3d 1084, 46 U.S.P.Q.2d 1257 (Fed. Cir. 1998).
7. Sextant Avionique, S.A. v. Analog Devices, Inc., 172 F.3d 817, 49 U.S.P.Q.2d 1865 (Fed. Cir. 1999); Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 72 F.3d 857, 864, 37 U.S.P.Q.2d 1161, (Fed. Cir. 1995). The report on Festo by this author in comparing it to Sextant is published in this issue at page 4.
8. A difficulty in examining the patentability of the accused embodiment is discussed in Streamfeeder, L.L.C. v. Sure-Feed Sys., Inc., 175 F.3d 974, 50 U.S.P.Q.2d 1515 (Fed. Cir. 1999). The report on Streamfeader by this author in comparing Sextant is published in this issue at page 5.

Last updated 4/27/2012