MARY L. COOPER, District Judge.
PRELIMINARY STATEMENT
I. BACKGROUND
II. DISCUSSION
III. CONCLUSION
This is a consolidated action involving four patents listed as covering plaintiffs' marketed pharmaceutical product Aloxi®. Defendants have filed Abbreviated New Drug Applications ("ANDAs") with the Federal Food and Drug Administration ("FDA"), seeking to market generic versions of the product and challenging those patents as invalid or unenforceable, pursuant to Section 505(j) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j). This Court has jurisdiction under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2)(A), and 28 U.S.C. §§ 1331 and 1338(a). (
Aloxi® contains the active pharmaceutical ingredient palonosetron hydrochloride, and is FDA-approved to treat chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting. (Dkt. 178-2 at 3.) The four related patents-in-suit are United States Patents No. 7,947,724 ("`724 patent"), No. 7,947,725 ("`725 patent"), No. 7,960,424 ("`424 patent"), and No. 8,598,219 ("`219 patent"). (Dkt. 174 at 2.) Those are all composition patents. There are other patents in the same patent family history, including method patents.
This opinion addresses certain language that appears in the preamble portion of the two independent claims of the `219 patent, including asserted claim 1. The entire preamble of claim 1 reads: "A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapyinduced nausea and vomiting, [comprising. . . .]."
The parties agree that all of the words of that preamble up to and including "formulation" constitute claim limitations, because those words provide antecedent basis for the "said formulation" language that follows in the claim body. However, the parties dispute whether the balance of the preamble text, consisting of the phrases "for intravenous administration to a human to reduce the likelihood of cancer chemotherapyinduced nausea and vomiting," should be read as claim limitations. Plaintiffs argue that the language is limiting, and defendants argue to the contrary. (Dkt. 175 at 6-9 (joint claim construction chart).)
The Court has considered the written submissions of the parties and conducted oral argument on this issue. The evidence presented by the parties as relevant to this claim construction was all intrinsic evidence. That evidence included the claims, specification, and prosecution history of the `219 patent and related patents in the same family history, as well as some of the prior art references cited in those United States Patent and Trademark Office ("USPTO") filings. Based on the intrinsic evidence and the arguments of the parties presented in these claim construction proceedings, this Court concludes that the disputed preamble language in claim 1 of the `219 patent does constitute claim limitations of the patent.
Courts define the meaning and scope of patent claims by the process of claim construction.
The intrinsic record, which includes the claims, specification, and complete prosecution history, is the most significant source for the legally operative meaning of disputed claim language.
It is well settled that "[t]he determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case; there is no litmus test defining when a preamble limits the scope of a claim." Manual of Patent Examining Procedure § 2111.02 (Rev. Aug. 2012) (citing
"Whether a preamble stating the purpose and context of the invention constitutes a limitation of the claim[s] . . . is determined on the facts of each case in light of the overall form of the claim, and the invention as described in the specification and illuminated in the prosecution history."
The Federal Circuit in
289 F.3d at 808 (internal citations omitted).
Those are the general guiding principles in this discrete area of patent law.
The `219 patent shares essentially the same specification with the related patentsin-suit. (
Clearly, the primary focus of all four of these patents is shelf stability of the claimed palonosetron formulations.
The aspects of the `219 patent that are placed in issue in this
The parties make arguments addressed to each phrase separately, and to both phrases jointly.
The `219 patent, like all of its related patents in the same patent family, is entitled "Liquid Pharmaceutical Formulations of Palonosetron." It contains eight claims, of which independent claim 1 and dependent claims 2, 6, and 7 are asserted in this case.
There is preamble language in each of the other three patents-in-suit that is similar but not identical to the disputed preamble phrases in the `219 patent. Here, also in the margin, we quote the corresponding portions of the other patents-in-suit, the `724 patent,
As can be seen, all three of those patents contain preamble language directed to "reducing . . . the likelihood of emesis," similar to the `219 preamble directed to "reducing the likelihood of cancer chemotherapy-induced nausea and vomiting." Also, the `724 and `424 patents contain preamble language specifying an "intravenous solution", or an "isotonic intravenous solution."
An earlier claim construction proceeding in this consolidated case pertained to the term "pharmaceutically stable" in the preambles of the `724, `725, and `424 patents.
Defendants maintain their opposition here to interpreting the "reducing . . . the likelihood of emesis" in the `724, `725 and `424 preambles, and the "reducing the likelihood of cancer chemotherapy-induced nausea and vomiting," in disputed Phrase Two of the `219 preamble, as claim limitations. They also contend that the disputed Phrase One language — "for intravenous administration to a human" in the `219 preamble — is not to be equated with the "intravenous solution" form that they acknowledged as limiting in the `724 and `424 preambles. (
As previously noted, the four patents-in-suit share essentially the same specification, as do the other patents stemming from the same original provisional application. For purposes of the following summary of their specifications, we will quote the `219 specification, recognizing that the corresponding sections of the three other patents-in-suit are the same.
Most of the text of the `219 patent specification addresses the prior art stability problems with palonosetron in liquid formulations, and the new formulations claimed in this patent family to overcome those stability problems.
There are, however, significant references to the anti-emetic properties of palonosetron in the `219 and related patent specifications. There are also discussions of intravenous and other types of formulations in those same specifications. Here we quote some of those portions of the `219 specification.
The references to intravenous medicaments and the use of palonosetron to reduce emesis are found throughout the specification. As those are somewhat entwined in the text, we will quote them together where they appear together, highlighting those two topics in bold type.
The Abstract states:
(`219 patent, p.1.)
The Background of the Invention states:
(
The Summary of the Invention states:
(
The Discussion section repeats some of the above-quoted text. It also states:
. . . .
(
We will refer to this summary of the `219 claim language and specification, and the corresponding text in the `724, `725, and `424 patents, in Sections II.A and II.B,
The entire prosecution history of the `219 patent, and the relevant portions of its rather complicated patent family history, have been supplied to the Court in the parties'
Any patent file history includes both procedural and substantive aspects. First, we briefly summarize the pertinent procedural chronology relevant to the `219 file. The substantive aspects of these events are next described here, and discussed in Sections II.A and II.B,
The `219 patent is recent, having been issued on December 3, 2013. (`219 patent, p.1.) The actual prosecution file for the `219 patent is fairly simple, but the patent comes from a long and complicated family tree. The original provisional application, No. 60/444,351, was filed on January 30, 2003. (
As stated on the cover page of the `219 patent, its application number was Application No. 13/901,437. The preceding United States application data for the `219 patent, following the original `351 provisional application in January, 2003, is quoted in the margin.
This procedural history establishes that the `724 patent is a parent patent to the `219 patent, and the two other patents-in-suit, the `725 and `424 patents, came from continuation-in-part applications derived from the application for the `724 patent. Thus, all four prosecution histories are relevant to the claim construction issues here, while it is recognized that the specific claims of the individual patents do contain differences.
The `724, `725, and `424 patents, all stemming from the same original `351 provisional application and all issued prior to the `219 patent, had extensive prosecution histories. The patents were approved only after appeals in all three cases to the Commissioner for Patents. Much file history was accumulated in those prosecution files. Some of that file history is discussed by the parties as relevant here. The application file for the `219 patent itself, albeit not as extensive as those of its predecessor patents, also includes its share of dialogue with the USPTO. That too is referred to by the parties, insofar as now pertaining to this claim construction. Here we summarize those portions of the substantive file history relating to the disputed `219 patent preamble phrases.
There are several features in the substantive prosecution history that plaintiffs refer to in support of their position that the two disputed preamble phrases in the `219 patent are limiting. Those may be summarized as follows, with details provided in the margin:
The closest prior art Tang (Anesth Analg 1998 . . .) specifically teach that implications in administering palonosetron (i.e., RS-25259) was effective only at a higher dose (i.e., 30 µg/kg which is 2.1 mg when an average weight 70 kg of the patient is considered). This dose is far greater than that recited by the applicant. Yes Tang teaches a concentration of 3.0 µg/kg which is the closest to the dose recited [in this application], however Tang also teaches that it fails to provide [sic: prevent] or reduce the post-operative vomiting.
The arguments of the parties drawn from the above-cited prosecution history portions of the intrinsic evidence are discussed in Sections II.A and II.B,
The parties make several arguments going to both disputed preamble phrases, and they also argue several separate points directed to each phrase. As we have stated, the Court likewise considers the two phrases together, but also separately as Phrase One and Phrase Two.
The disputed Phrase One in claim 1 of the `219 patent, as we analyze the text, is "for intravenous administration to a human." (`219 patent, col. 10, lines 2-3.) That is actually two phrases, grammatically speaking, with the prepositional phrase "to a human" modifying the noun "administration." But we refer to all of those words as Phrase One.
The disputed Phrase Two in claim 1 of the `219 patent is "to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting." (`219 patent, col. 10, lines 3-4.) The parties and the Court commonly abbreviate the last six words of this phrase as "CINV," and we will do so in this discussion.
Most of the parties' arguments are based on the concepts articulated by the Federal Circuit in its 2002 decision,
Plaintiffs contend, by way of overview, that two of the recognized grounds for treating preamble language as limiting apply to all of the disputed text here. First, they say that all of that language modifies and provides antecedent basis for the words "said formulation" in the body of the claim, and that in the broader sense it is necessary to "give life, meaning, and vitality" to the claim.
Defendants contend that the
The discussion in this Section II.A is focused specifically on the parties' arguments directed to Phrase One, "for intravenous administration to a human." Section II.B,
The parties first look at the language of claim 1 and its dependent claims 2-7. Defendants say that "antecedent basis" only applies to the undisputed portion of the preamble, "[a] pharmaceutical single-use, unit dose formulation," because the reference in the body of claim 1 is only to "said formulation." (
Plaintiffs respond that all of Phrase One should be deemed to modify "formulation" in the preamble, because there is no reason why words appearing before and after "formulation" in the preamble should be so divided. "Just because some words come before and some come after" — plaintiffs argued during the
Defendants also contend, again looking just at the claim language, that the undisputed portion of the preamble, up to the term "formulation," is structural language defining that term. They say that in contrast, the disputed portion, including Phrase One, is functional and should not be deemed limiting. (Dkt. 182 at 7 (citing
Plaintiffs make two responses to this argument. First, they say that the preamble language immediately preceding "formulation," namely "single-use, unit-dose," is not just structural. That language also helps to define how the formulation is designed to be used; that is to be administered once, to one patient, and then discarded. (Dkt. 181 at 6; dkt. 220 at 13-14.) Second, they say that the Phrase One preamble language following "formulation," namely "for intravenous administration to a human," is not just functional but also conveys essential structure for the formulation, because intravenous products require a unique formulation strategy. The formulated product has to be not only sterile and isotonic, as required by the body of the claim, but also pyrogen free and free of particulate matter in order to qualify as an intravenous formulation, as opposed to an oral formulation. (Dkt. 177 at 9 & n.5; dkt. 181 at 7-8 & nn.5, 6 (citing prior art references listed in `219 patent disclosures).)
Thus, plaintiffs argue that comparing the language up to "formulation" with the Phrase One language following it in the `219 preamble, any attempt to distinguish between those groups of words as "structural" versus "functional" is unfounded. Another reason, according to plaintiffs, why the Phrase One preamble language conveys essential structure is to clarify that the claimed formulation is an intravenous composition rather than some other form of injectable formulation described in the specification, such as intramuscular or subcutaneous. (Dkt. 177 at 6-7.)
Plaintiffs also take issue with defendants' position that there is a difference between the "intravenous solution" or "intravenous isotonic solution" in the preambles of the `724 and `424 claims, and the "for intravenous administration" language in Phrase One of the `219 preamble. Defendants maintain that there is a substantive difference between using "intravenous" as an adjective positioned before the noun "solution," as in the `724 and `424 preambles where they stipulated the language was limiting, and using the prepositional phrase "for intravenous administration" after "formulation" in the `219 preamble. (Dkt. 182 at 10 & n.7; dkt. 220 at 61-64.) Plaintiffs reply that there is no material difference between "intravenous solution" and "formulation for intravenous administration"; that the terms mean the same thing and should be treated alike as limiting. (Dkt. 220 at 15-19.) As to that argument, the Court finds itself squarely in agreement with plaintiffs.
Defendants point out that the "intravenous" feature referred to in disputed Phrase One of the `219 preamble is not so limited in the specification of the patent. For example, none of the "objects of the invention" describe the invention as being "for intravenous administration," and the word "intravenous" is not found in the "summary of the invention." (Dkt. 182 at 16.) Instead, the specification lists a wide range of possible liquid formulations that could be made according to the invention, including oral and other injectable kinds. (
Turning to the prosecution history pertaining to the `219 patent, plaintiffs rely on several portions in support of their argument that the Phrase One preamble language is limiting. First, they point to the amendments in the applications for both the `724 and `424 patents, omitting "adapted for oral administration" in dependent claim language and inserting "intravenous" in the preambles of the independent claims. Those amendments were made to overcome obviousness objections based on prior art references to oral formulations.
This prosecution history, we find, fits squarely within the
This Court has considered the arguments of the parties, as summarized here, and the portions of the intrinsic evidence cited and discussed by them. We find that the points argued by plaintiffs regarding the claim text, specification, and prosecution history of the `219 patent and its related patents-in-suit support their position, and they have made a sufficient showing based on the intrinsic evidence that this preamble language is limiting. Accordingly, the Court construes Phrase One of the disputed preamble language, "for intravenous administration to a human," to be a limitation in asserted claim 1 of the `219 patent.
Defendants' arguments against treating Phrase Two as a claim limitation are stronger than as to Phrase One, but on balance the Court finds that plaintiffs' arguments prevail on that issue as well.
Defendants argue first that there is no structural aspect to the phrase, "to reduce the likelihood of CINV," and therefore this is purely a "use" description that should fall within the general rule that "a preamble is not limiting `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;'" and that "preambles describing the use of an invention generally do not limit the claims because the patentability of . . . composition claims depends on the claimed structure, not on the use or purpose of that structure."
Plaintiffs do not dispute that there is really no structural aspect to Phrase Two. Nevertheless, they claim antecedent basis tied to the undisputed preamble claim term "formulation," reasoning that Phrase Two should, like Phrase One, be interpreted to be an integral part of all the words modifying "formulation" in the preamble. (
Plaintiffs also argue, however, that the specification is replete with references to the pharmaceutical purposes of the drug palonosetron in general, and of the specific formulations of the drug claimed in the `219 patent and related patents-in-suit. In that sense, according to plaintiffs, the Phrase Two preamble language, read in light of the specification, will support a finding that although shelf stability of the formulations is the primary stated objective of the claimed inventive formulations, their use in treating emesis and specifically CINV is another claimed aspect of the invention. Thus, in plaintiffs' view, the specification supports the stated intended use of "reducing the likelihood of CINV" as a fundamental characteristic of the claimed invention.
Defendants emphasize the fact that the `219 patent claims and specification are devoid of support for the effective use of the claimed formulations, providing no information about whether the claimed amounts of palonosetron are effective or clinical trial data. For that reason as well, defendants argue, it would be improper to read Phrase Two of the preamble as limiting. (
It is sufficient for purposes of claim construction, plaintiffs contend, that if an apparatus or composition claim refers to a function or an intended use, that claim language would require the apparatus to be actually capable of performing as claimed. (
The parties next address the prosecution history pertaining to their dispute over Phrase Two, which is found in several locations. First, in the prosecution history of the parent `724 patent and related `725 and `424 patents, the examiners in each case rejected preamble language "for preventing emesis," under the Section 112 enablement requirements. In response, the applicants did not delete the reference to the therapeutic capability of the claimed formulations. Instead, they amended each application to substitute the phrase, "for reducing emesis or the likelihood of emesis," and thus overcame the Section 112 rejections.
Defendants contend that in any event, the
The dispositive aspect of the `219 prosecution history itself, as bearing on the Phrase Two claim construction dispute as we see it, was at the very end of the prosecution history when the examiner conducted the telephone interview with the applicants. The examiner documented that interview in the official notes preserved in the prosecution record. Furthermore, the examiner confirmed in the Notice of Allowability that the arguments by the applicants relying on that preamble language, in connection with dosage data in the body of the claim, overcame the examiner's prior art issue concerning the cited Tang reference.
We find that this intrinsic evidence clearly proves that: (1) the applicants for the `219 patent considered the preamble language "reducing the likelihood of CINV" to be a limitation of the claim; and (2) the examiner relied on the applicants' arguments about that preamble language, and their arguments distinguishing the prior art Tang reference, in allowing the patent to be approved. Whether the examiner made a correct decision that the language was limiting, and that the prior art was successfully distinguished, is not relevant to the claim construction issue presented here. The fact is conclusively shown by this intrinsic evidence that the applicant clearly relied on that preamble language to distinguish the claimed invention from the prior art.
For all of these reasons, including the frequent references in the specification to the claimed formulations to treat emesis and the specific reference there to treating CINV, and the prosecution histories of the related patents-in-suit and of the `219 patent itself, this Court construes Phrase Two of the disputed preamble language, "to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting," to be a limitation in asserted claim 1 of the `219 patent.
The parties submitted a Joint Claim Construction and Prehearing Statement identifying a dispute with respect to whether the preamble language "for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting" is a limitation of asserted claim 1 of the `219 patent (and dependent asserted claims 2, 6, and 7). (Dkt. 175 at 2.) The same Statement confirmed that the parties do not have any dispute about terms appearing in the asserted claims of the `219 patent, and they agree that plain and ordinary meaning of the claim terms should govern. (
The Court has considered the briefs and intrinsic evidence materials submitted by the parties, and conducted oral argument. No party requested an evidentiary hearing, and the Court has made its findings based on the intrinsic evidence pertaining to the `219 patent and asserted patents in the same patent family tree. A court's finding as to intrinsic evidence amounts "solely to a determination of law."
"Whether to treat a preamble as a limitation is a determination `resolved only on review of the entire[] . . . patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.'"
What is claimed is:
(`219 patent, col. 10, lines 1-38 (emphasis added).)
What is claimed is:
(`724 patent, col. 9, lines 27-35, col. 10, lines 1-33 (emphasis added).)
What is claimed is:
(`725 patent, col. 10, lines 3-19 (emphasis added).) Text in the body of the claims refers to "sterile injectable" and "a tonicifying effective amount of mannitol." (
What is claimed is:
(`424 patent, col. 10, lines 5-15 (emphasis added).)
(`219 patent, p.1 (emphasis added).)
The Court notes that the `724 patent did issue with a dependent claim 14, "The solution of claim
(Dkt. 220 at 32-33.)