Prosecution history estoppel applies to narrowing amendment for a purpose, but not for all purposes
| September 25, 2020
Bio-Rad Laboratories, Inc., Et Al. v. 10X Genomics Inc.
August 3, 2020
Newman, O’Malley (Opinion author), and Taranto
Summary
The Federal Circuit held that 10X infringes Bio-Rad’s ‘083 patent under the doctrine of equivalents because a tangential exception to the prosecution history estoppel applies in this case.
Details
Bio-Rad Laboratories, Inc. and the University of Chicago (collectively, “Bio-Rad”) accused 10X Genomics Inc. (“10X”) of infringing three patents: U.S. Patent Nos. 8,888,083 (“083 patent”); 8,304,193 (“193 patent”); and 8,329,407 (“407 patent”). The United States District Court for the District of Delaware held that 10X willfully infringed all three patents and awarded damages in an amount of $23,930,716.
The patents-in-suit are directed to systems and methods for forming microscopic droplets (also called “plugs”) of fluids to perform biochemical reactions. Claim 1 of the ‘083 patent, as below, is representative:
A microfluidic system comprising:
a non-fluorinated microchannel;
a carrier fluid comprising a fluorinated oil and a fluorinated surfactant comprising a hydrophilic head group in the microchannel;
at least one plug comprising an aqueous plug-fluid in the microchannel and substantially encased by the carrier-fluid, wherein the fluorinated surfactant is present at a concentration such that surface tension at the plug-fluid/microchannel wall interface is higher than surface tension at the plug-fluid/carrier fluid interface.
During prosecution, the inventors amended the claims, as underlined above, to distinguish from a prior art, U.S. Patent No. 7,294,503 (“Quake”). Quake disclosed microchannels formed or coated with Teflon (a fluorinated polymer) or other fluorinated oils. Furthermore, the inventors argued that their invention attempts to prevent droplets from sticking to the walls of microchannels and requires that the “surfactant should be chemically similar to the carrier fluid and chemically different from the channel walls.” That is, the non-fluorinated microchannels and the fluorinated surfactant are required not to react with each other. This is the purpose of the amendment. In contrast, Quake did not teach that microchannels and carriers fluids were chemically distinct, and the fluorinated microchannels and surfactants could, therefore, react with each other.
After the litigation was filed, 10X modified its products to add 0.02% Kynar-a non-reactive amount of a fluorine-containing resin-to its microchannels. 10X concedes that the addition of this amount of Kynar is irrelevant to the functioning of its products. In the District Court, the jury found that 10X’s accused products, as modified, do not literally satisfy the “non-fluorinated microchannels” limitation, but meet the limitation under the doctrine of equivalents. On appeal, among other issues, 10X argued that prosecution history estoppel and claim vitiation barred Bio-Rad’s theory of equivalence. The District Court held that prosecution history estoppel does not apply in this case because the amendment at issue was only tangentially related to the accused equivalent.
On appeal, 10X continued to argue that prosecution history estoppel applies because the inventors’ amendment narrowed the claims to recite a “non-fluorinated microchannel” to overcome Quake, which taught “fluorinated” microchannels. As such, the inventors surrendered the right to expand their monopoly to cover microchannels containing fluorine, “for whatever purpose.” In response, Bio-Rad counter argued that the reason for narrowing the claims was peripheral, or not directly relevant to the alleged equivalent. Bio-Rad contends that the patentees amended the claims to make clear that the carrier fluid and the microchannel wall should be chemically distinct, which bears no more than a tangential relation to the alleged equivalent-microchannel walls containing a nominal amount of fluorine that is not chemically distinct from the carrier fluid. The Federal Circuit agreed with Bio-Rad, and reasoned that inventors surrendered microchannels coated with fluorine that reacted with carrier fluids, not those containing de minimis amounts of fluorine that have no effect on how the microchannel functions in the system. The narrowing amendment can only be said to have a tangential relation to the equivalent at issue-negligibly fluorinated microchannels, or microchannels with non-fluorinated properties. That is, the inventors surrendered microchannels coated with fluorine for a purpose, but not for all purposes.
Take away
- During prosecution, inventors should also explain in detail the purpose of the amendment of claims in order to narrow the scope surrendered by the amendment.
Tags: doctrine of equivalents > prosecution history estoppel > tangential exception
Be careful in translating foreign applications into English, particularly with respect to uncommon terms
| September 18, 2020
IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc. v. Teva Pharmaceuticals USA, Inc.
July 31, 2020
Prost (Chief Judge), Reyna, and Hughes. Opinion by Prost.
Summary
In a U.S. application claiming priority to an Italian application, the term “semiliquido” was translated as “half-liquid.” This term was found to be indefinite, in view of a lack of a clear meaning in the art, as well as the statements of the prosecution history and specification. Further, attempts to argue that the term “half-liquid” should be interpreted as “semi-liquid” failed due to inconsistencies with the specification.
Details
IBSA is the owner of U.S. Patent No. 7,723,390, which claims priority to an Italian application. Claim 1 of the ‘390 patent is as follows:
1. A pharmaceutical composition comprising thyroid hormones or their sodium salts in the form of either:
a) a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said inner phase, dissolved in gelatin and/or glycerol, and optionally ethanol, said liquid or half-liquid inner phase being in direct contact with said shell without any interposed layers, or
b) a swallowable uniform soft-gel matrix comprising glycerol and said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said matrix.
Teva filed an ANDA with a Paragraph IV certification asserting that the patent is invalid. In particular, Teva asserted that claim 1 is invalid as being indefinite. Upon filing of the ANDA, IBSA filed suit against Teva.
The key issue in this case is the meaning of the term “half-liquid.” IBSA asserted that this term should mean “semi-liquid, i.e., having a thick consistency between solid and liquid.” Meanwhile, Teva argued that the term is either invalid, or should be interpreted as a “non-solid, non-paste, non-gel, non-slurry, non-gas substance.”
District Court
At the district court, all parties agreed that the intrinsic record does not define the term “half-liquid.” However, IBSA asserted that its construction is supported by intrinsic evidence, including the Italian priority application. The Italian priority application used the term “semiliquido” at all places where the ‘390 patent used the term “half-liquid.” In 2019, IBSA obtained a certified translation in which “semiliquido” was translated as “semi-liquid.” IBSA asserted that “semi-liquid” and “half-liquid” would be understood as synonyms.
However, the district court noted that there were other differences between the Italian priority application and the ‘390 patent specification, beyond the “semiliquido”/“half-liquid” difference. These differences included the “Field of Invention” and “Prior Art” sections. Because of these other differences, the district court concluded that the terminology in the U.S. specification reflected the Applicant’s intent, and that any difference was deliberate.
Furthermore, the district court noted that during prosecution, there was at one point a dependent claim using the term “semi-liquid” which was dependent on an independent claim using the term “half-liquid.” Even though the term “semi-liquid” was eventually deleted, this was interpreted as evidence that the terms are not synonymous.
Additionally, the specification cited to pharmaceutical references that used the term “semi-liquid.” According to the district court, this shows that the Applicant knew of the term “semi-liquid,” but chose to use the term “half-liquid” instead.
Finally, all extrinsic evidence was considered by the district court to be unpersuasive. The extrinsic evidence used the term “half-liquid” in a different context than the present application. As such, the district court concluded that the term “half-liquid” was “exceedingly unlikely” to be a term of art at the time of filing.
Next, the district court analyzed whether a skilled artisan would nevertheless be able to determine the meaning of the term “half-liquid.” First, the court noted that the claims do not clarify what qualifies as a half liquid, other than the fact that it is neither liquid nor solid. The district court concluded that one skilled in the art would only understand “half-liquid” to be something that is not a gel or paste. This conclusion was based on a passage in the specification that stated:
In particular, said soft capsule contains an inner phase consisting of a liquid, half-liquid, a paste, a gel, an emulsion, or a suspension comprising the liquid (or half-liquid) vehicle and the thyroid hormones together with possible excipients in suspension or solution.
Additionally, during prosecution, the Applicant responded to an obviousness rejection by including the statement that the claimed invention “is not a macromolecular gel-lattice matrix” or a “high concentration slurry.” As such, the Applicant disclaimed these from the scope of “half-liquid.”
Finally, the district court commented on the expert testimony. IBSA’s expert had “difficulty articulating the boundaries of ‘half-liquid’” during his deposition. Meanwhile, Teva’s expert stated that “half-liquid is not a well-known term in the art.”
Based on the above, the district court concluded that one having ordinary skill in the art would find it impossible to know “whether they are dealing with a half-liquid within the meaning of the claim,” and concluded that the claims are invalid as being indefinite.
CAFC
The CAFC agreed with the district court on all points. First, the CAFC agreed that the claim language does not clarify the issue. Rather, the claim language only clarifies that “half-liquid” is not the same as liquid.
As to the specification, the CAFC agreed with the district court that the portion of the specification noted above clarifies that “half-liquid” cannot mean a gel or paste. Moreover, the CAFC cited another passage, which refers to “soft capsules (SEC) with liquid, half-liquid, paste-like or gel-like inner phase.” The CAFC concluded that the use of the word “or” in these passages shows that “half-liquid” is an alternative to the other members of the list, such as pastes and gels. Meanwhile, since gels and pastes have a thick consistency, IBSA’s proposed claim construction is in contradiction with these passages of the specification.
Additionally, the CAFC refuted IBSA’s argument that the specification includes passages that are at odds with the description of “half-liquid” as an alternative to pastes and gels. These passages include:
…an SEC capsule containing an inner phase consisting of a paste or gel comprising gelatin and thyroid hormones or pharmaceutically acceptable salts thereof…in a liquid or half liquid.
However, this argument conflates the inner phase and the vehicle within the inner phase, and does not explain why these are the same.
Additionally, the CAFC noted that the specification includes a list of examples of liquid or half-liquid vehicles, and a reference to a primer on making “semi-liquids.” However, even if some portions of the specification could support the position that “half-liquid” and “semi-liquid” are synonyms, the specification fails to describe the boundaries of “half-liquid.”
Next, the CAFC discussed the prosecution history. As in the district court, IBSA asserted that “half-liquid” means “semi-liquid.” This was because the term “half-liquid” was used in all places where “semiliquido” was used, and a certified translation showed that “semiliquido” is translated as “semi-liquid.”
The CAFC agreed the use of “half-liquid” was intentional, relying on not only the differences between the Italian application and the U.S. application noted by the district court, but others as well. In particular, claim 1 of the U.S. application differed from claim 1 of the Italian application, and incorporated an embodiment not found in the Italian application. Further, the Italian application does not use the term “gel” in the first passage noted above.
The CAFC also agreed with the district court that the temporary presence of a claim reciting “semi-liquid” dependent on a claim reciting “half-liquid” further demonstrates that these terms are not synonymous.
Finally, the CAFC reviewed the extrinsic evidence. The CAFC noted the IBSA’s expert’s inability to explain the boundaries of the term “half-liquid.” The CAFC also pointed out that only one dictionary of record had a definition including the term “half liquid,” and this was a non-scientific dictionary. This dictionary defined “semi-liquid” as “Half liquid; semifluid.” But, IBSA’s expert stated that “semifluid” and “half-liquid” are not necessarily the same.
Further, although other patents using the term “half-liquid” were cited, these patents used the term in a different context, and thus were not helpful to define the term in the context of the ‘390 patent. IBSA’s expert acknowledged the lack of any other literature such a textbook or a peer-reviewed journal using the term “half-liquid.” Additionally, IBSA’s expert stated that he was uncertain about whether his construction of “half-liquid” would exclude gels or slurries.
Based on the above, the CAFC concluded that the term “half-liquid” does not have a definite meaning. As such, the claim is invalid as failing to comply with §112.
Takeaways
-When translating a specification from a foreign language to English, it is preferable that the specifications are as close to identical as possible.
-If there are differences between a foreign language specification and the U.S. specification, these differences should ideally be limited to non-technical portions of the specification.
-If using a term that is not widely used, it is recommended to clearly define this term in the record. Failure to do so may result in the term being interpreted in an unintended manner, or worse, the term being considered indefinite.
-Where there are discrepancies between a foreign priority application and a US application, such differences may be interpreted as intentional.
In a patent infringement action involving standard essential patents, standard-essentiality is to be determined by judges in bench trials and juries in jury trials
| September 11, 2020
Godo Kaisha IP Bridge 1 v. TCL Communication Technology Holdings Ltd. (Fed. Cir. 2020) (Case No. 2019-2215)
August 4, 2020
Prost (Chief Judge), Newman and O’Malley. Court opinion by O’Malley
Summary
The Federal Circuit unanimously affirmed all aspects of the district court’s rulings and the verdict predicated thereon in favor of a patentee in a patent infringement action involving standard essential patents. In Fujitsu, the Court endorsed standard compliance as a way of proving infringement, holding that, if a district court construes the claims and finds that the reach of the claims includes any device that practices a standard, then this can be sufficient for a finding of infringement. In this case, the Court moved on to hold that standard-essentiality is a question for the factfinder (meaning judges in bench trials and juries in jury trials), rejecting the defendant’s argument that, under Fujitsu, the court must first make a threshold determination as part of claim construction that all implementations of a standard infringe the claims.
Details
I. background
In a patent infringement action for U.S. Patent Nos. 8,385,239 and 8,351,538 in the U.S. District Court for the District of Delaware filed by Godo Kaisha IP Bridge 1 (“IP Bridge”) against TCL Communication Technology Holdings Ltd. et al. (“TCL”), asserted claims are directed to the Long-Term Evolution (“LTE”) standard, a standard for wireless broadband communication for mobile devices and data terminals, and IP Bridge’s infringement theory relied on Fujitsu Ltd. v. Netgear Inc., 620 F.3d 1321 (Fed. Cir. 2010), holding, on appeal from a summary judgment decision, that a district court may rely on an industry standard in analyzing infringement. Specifically, the Federal Circuit stated:
“We hold that a district court may rely on an industry standard in analyzing infringement. If a district court construes the claims and finds that the reach of the claims includes any device that practices a standard, then this can be sufficient for a finding of infringement. We agree that claims should be compared to the accused product to determine infringement. However, if an accused product operates in accordance with a standard, then comparing the claims to that standard is the same as comparing the claims to the accused product. We accepted this approach in [Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263 (Fed.Cir.2004)] where the court held a claim not infringed by comparing it to an industry standard rather than an accused product. An accused infringer is free to either prove that the claims do not cover all implementations of the standard or to prove that it does not practice the standard.” Fujitsu, 620 F.3d at 1327.
IP Bridge presented evidence to show that (1) the asserted claims are essential to mandatory sections of the LTE standard; and (2) the accused products comply with the LTE standard. In contrast, TCL did not present any evidence to counter that showing.
After a jury trial in 2018, the jury found that TCL was liable for infringement of the asserted claims by its sale of LTE standard-compliant devices such as mobile phones and tablets. The jury also awarded IP Bridge damages in the amount of $950,000.
Following the verdict, TCL filed a motion for judgment as a matter of law (“JMOL”), contending that IP Bridge’s theory of infringement was flawed because the Fujitsu “narrow exception” to proving infringement in the standard way, and IP Bridge filed a motion to amend the judgment under Federal Rule of Civil Procedure 59(e), seeking supplemental damages and an accounting of infringing sales of all adjudicated products through the date of the verdict, and ongoing royalties for TCL’s LTE standard-compliant products, “both adjudicated and non-adjudicated.”
The district court denied TCL’s JMOL motion, concluding that substantial evidence supported the jury’s infringement verdict. In contrast, the district court awarded the requested pre-verdict supplemental damages, and awarded on-going royalties in that amount for both the adjudicated products and certain unadjudicated products, with finding that the jury’s award represented a FRAND (Fair, Reasonable And Non-Discriminatory) royalty rate of $0.04 per patent per infringing product. The district court reasoned that, because IP Bridge demonstrated at trial that LTE standard-compliant devices do not operate on the LTE network without infringing the asserted claims, the unaccused, unadjudicated products “are not colorably different tha[n] the accused products.”
TCL timely appealed the district court’s infringement finding and its rulings regarding royalties.
II. The Federal Circuit
The Federal Circuit unanimously affirmed all aspects of the district court’s rulings and the verdict predicated thereon in favor of a patentee in a patent infringement action involving standard essential patents.
The issue in the appeal was a question not expressly answered by its case law including Fujitsu: who determines the standard-essentiality of the patent claims at issue—the court, as part of claim construction, or the jury, as part of its infringement analysis? The Court agreed with IP Bridge that standard-essentiality is a question for the factfinder.
TCL’s entire appeal rested on a single statement from Fujitsu, 620 F.3d at 1327: “If a district court construes the claims and finds that the reach of the claims includes any device that practices a standard, then this can be sufficient for a finding of infringement” (emphasis added). In TCL’s view, the statement mandates that a district court must first determine, as a matter of law and as part of claim construction, that the scope of the claims includes any device that practices the standard at issue.
The Court rejected TCL’s contention for three reasons below.
First, the Court pointed out that the statement in Fujitsu assumed the absence of genuine disputes of fact on the two steps of that analysis, which would be necessary to resolve the question at the summary judgment stage. The passing reference in Fujitsu to claim construction is simply a recognition of the fact that the first step in any infringement analysis is claim construction.
Second, the Court stated that its reading of Fujitsu is buttressed by that decision’s reference to Dynacore where the Court affirmed the summary judgment of non-infringement because the patentee did not show that a particular claim limitation was mandatory in the standard. The Court read Dynacore such that: “Although we referenced the claim construction by which the patentee was bound, Dynacore considered the possibility of the dispute going to the jury and rejected it based on undisputed facts.” Based on this, the Court concluded that, under Dynacore, which Fujitsu referenced in its holding, standard-essentiality of patent claims is a fact issue. The Court noted that the standard-essentiality may be amenable to resolution on summary judgment in appropriate cases like any other fact issue, but that it does not mean it becomes a question of law.
Finally, the Court expressed a view that determining standard-essentiality of patent claims during claim construction hardly makes sense from a practical point of view. Essentiality is, after all, a fact question about whether the claim elements read onto mandatory portions of a standard that standard-compliant devices must incorporate. In the Court’s view, this inquiry is more akin to an infringement analysis (comparing claim elements to an accused product) than to a claim construction analysis (focusing, to a large degree, on intrinsic evidence and saying what the claims mean).
From the foregoing, the Court found that substantial evidence fully supports the jury’s infringement verdict.
Further, the Court saw no reason to disturb the district court’s conclusions after carefully considering TCL’s remaining arguments—including its argument that the district court abused its discretion in awarding on-going royalties in this case.
In conclusion, the Court unanimously affirmed all aspects of the district court’s rulings and the verdict predicated thereon in favor of a patentee in a patent infringement action involving standard essential patents.
Takeaway
· In a patent infringement action involving standard essential patents, standard-essentiality is to be determined by judges in bench trials and juries in jury trials.
