Marine Polymer Technologies, Inc. v. Hemcon, Inc.
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Full Opinion
dissenting in part,
in parts I — II.
The court took this case en banc to address when absolute intervening rights arise under 35 U.S.C. § 307(b) during reexamination. In particular, the question is whether intervening rights accrue when
Despite the importance of the issue of intervening rights, as evidenced by the amicus briefs filed by numerous companies and organizations, the court did not seek further briefing and argument by the parties. This approach to an important issue is in my view difficult to justify. Now, remarkably, the court having affirmed the district court’s judgment by an equally divided court, goes on to opine in dictum as to the issue of intervening rights even though that issue (as discussed below) has been resolved by the affirmance and also, in the majority’s view, “is not properly before us on appeal.” Maj. Op. at 1362. This is an unusual and unfortunate approach to an important issue. This issue is likely to become even more important under the new Leahy-Smith America Invents Act (“ALA”) because of the increased availability of reexamination. The majority’s interpretation of the statute is both incorrect and certain to encourage improper strategic behavior by patent applicants. I dissent.
I
The starting point for an intervening rights determination is the meaning of the original claim language. The district court construed the key claim limitation (“bio-compatible”) of the original patent claims to require “polymers ... with low variability, high purity, and no detectable biological reactivity as determined by biocompatibility tests.” Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-cv-100-JD, 2008 WL 1995454, at *10 (D.N.H. May 6, 2008) (emphasis added). Contrary to Judge Lourie’s opinion, it seems to me that the district court’s construction was palpably incorrect and inconsistent with our established claim construction jurisprudence.
Some background is essential to an understanding of the claim construction issue. Marine Polymer asserted seven claims of U.S. Patent No. 6,864,245 (“the 245 patent”), directed to p-GlcNAc polymers, against HemCon. Independent claim 6 is representative and claims: “A biocompatible [p-GlcNAc polymer] comprising up to about 150,000 N-acetylglucosamine monosaccharides covalently attached in a |3-l->4 conformation and having a molecular weight of up to about 30 million daltons in which at least one N-acetylglucosamine monosaccharide has been deaeetylated.” 245 Pat. col.72 ll.5-10 (emphasis added). Marine Polymer acknowledges that pGlcNAc polymers had been disclosed in the prior art. The polymer also exists in nature in chitin, the chief organic structural component in the cell walls of fungi or algae and the protective shells of insects and crustaceans, but had been difficult to isolate with high purity and low variability. The '245 patent purported to disclose for the first time a “biocompatible” polymer in a purified form, along with methods for its purification from microalgae. With sufficient purity, these polymers have a number of biomedical applications, including, inter alia, as a means for the rapid control of severe blood loss. A purified polymer provides “increased effectiveness, reduced toxicity and improved bioavailability” for its biomedical applications. Id. col.5 ll.3-4.
There are substantial questions as to whether the prior art disclosed the claimed invention. That depends in significant part on the construction of the term “bio-compatible,” a term existing in each of the asserted claims. As noted above, the district court construed “biocompatible” p
One might at the outset be somewhat skeptical of this construction because it was not proposed by either party and was indeed contrary to the patentee’s own proposed construction. In the district court, Marine Polymer conceded that “biocompatible p-GlcNAc” could exhibit some biological reactivity, arguing that the term should be interpreted to mean “biomedically pure [p-GlcNAc] that reproducibly exhibits acceptably low levels of adverse bioreactivity, as determined by biocompatibility tests.” Claim Construction Order, Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-cv-100-JD, slip. op. at 2, 2008 WL 1995454 (D.N.H. May 6, 2008) (emphasis added). Similarly, it argued in its memorandum that its sample p-GleNAc “showed acceptably low adverse reactions” to each of the biocompatibility tests and that this construction of “biocompatible p-GlcNAc” was “fully supported” by the claims and specification. Memorandum in Support of Plaintiffs Claim Construction, Marine Polymer Techs., Inc. v. HemCoñ, Inc., No. 06-cv-100-JD, at 7, 10-11 (D.N.H. Aug. 17, 2007), ECF No. 48-1.
Whether or not Marine Polymer’s own constructions are binding,
Here, the specification defines “biocompatible” in a manner directly contrary to the district court’s construction of “no detectable biological reactivity.” The specification first discusses the concept of bio-compatibility in the Detailed Description of the Invention, stating that “[t]he p-GlcNAc of the invention exhibits a high degree of biocompatibility.” '245 Pat. col.10 ll.49-50. The specification does not provide at this point what constitutes an acceptably high degree of biocompatibility, but it discloses that “[b]iocompatability may be determined by a variety of techniques, including, but not limited to such procedures as the elution test, intramuscular implantation, or intracutaneous or systemic injection into animal subjects.” Id. col.10 ll.50-53. Each of these four “biocompatibility tests” is later described in detail, including the particular materials, methods, and conditions to properly perform each test on a p-GleNAc sample. The specification also discusses the results of each of the four tests, and specifically defines what constitutes “meet[ingj” the requirements of the particular “biocompatibility test.” See id. col.42 31.42-43. Judge Lourie’s opinion itself concedes that the specification contemplates non-zero “passing” scores on the biocompatibility tests. See Lourie Op. at 1358-59.
Notably, for each of the four tests, the specification does not require that there be no biological reactivity but provides that the test is satisfied where at least some reactivity is present. For example, with respect to the elution test, the specification states that “[tjhe test article (i.e., p
If this description of biocompatibility in the specification were not enough, the presence of six independent claims in the original patent dictate that the “biocompatible” limitation allow some exhibition of reactivity. Six dependent claims in the original patent specifically required that the “biocompatible” p-GlcNAc have an elution test score of either one or two, which correspond to “slight” or “mild” reactivity respectively and is directly inconsistent with a construction requiring no reactivity. '245 Pat. col.42 ll.50-55. If “biocompatible” requires that there be no reactivity, but these dependent claims require slight or mild reactivity, they are nullified and become utterly meaningless. Marine Polymer itself concedes that these six claims were rendered meaningless by the district court’s construction, and that “the dependent claims requiring non-zero elution test scores conflict with [the district court’s] construction.” Appellee’s Br. 28.
Where a particular construction of an independent claim would nullify claims that depend from it, the doctrine of claim differentiation creates a presumption that such a construction is improper. See Liebelr-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed.Cir.2004). We adopt a construction of a term which renders claims invalid or meaningless when it is the “only claim construction that is consistent with the claim’s language and the written description.” Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed.Cir.1999) (emphasis added). In other words, this presumption can be overcome only where a contrary construction is “dictated” — i.e., compelled — by the written description or prosecution history. Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1369, 1370-72 (Fed.Cir.2005) (holding that the presumption established by claim differentiation was rebutted because the written description “consistently” referred to the claim term in a specific manner and arguments made during prosecution amounted to a clear and unambiguous disclaimer of claim scope). Here, there is an alternate claim construction, one construing “bio-compatible” to mean “little or no detectable reactivity,” which preserves the validity of these six dependent claims. Nothing in the written description or prosecution history overcomes the presumption by dictating or compelling the conclusion that “biocompatible” is limited to exhibiting “no detectable reactivity.”
In supporting the district court’s claim construction Judge Lourie’s opinion ignores or dismisses much of this compelling evidence. The opinion suggests that the examiner’s adoption of the district court’s construction supports the correctness of that construction. Lourie Op. at 1359 n. 5. Quite the contrary. During reexamination, Marine Polymer asked the examiner to adopt the district court’s construction of “biocompatible” in evaluating whether the
Apart from its reliance on the examiner, Judge Lourie’s opinion rests its conclusion as to the correctness of the district court’s construction almost exclusively on the fact that there are two instances in the entire specification where it refers to the pGlcNAc “of the invention.” See Lourie Op. at 1357-59. These two references, however, do not limit the scope of the term “biocompatible.” With respect to the first, discussed above, the specification simply notes that the “p-GlcNAc of the invention exhibits a high degree of biocompatibility.” '245 Pat. col.10 11.49-50 (emphasis added). There is no indication in the specification that a high degree of biocompatibility is achieved only where there is no reactivity. The passage suggests the opposite. With respect to the second, the specification’s description of the p-GlcNAc “of the invention” was made in the context of a specific example — one of eighteen in the specification. Judge Lourie’s opinion leaves out highly pertinent language in quoting this portion of the specification. The specification explicitly states that
[i]n this Example, ... the p-GleNAc of the invention exhibits no detectable biological reactivity.
Id. col.41 11.66-67 (emphasis added). Judge Lourie’s opinion leaves out the “in this Example” language. This reference does not suggest that the invention always “exhibits no detectable biological reactivity”; rather, that it does so “in this Example.”
The approach in Judge Lourie’s opinion of interpreting a claim limitation based solely on a single example from the specification is an approach we have repeatedly rejected. See, e.g., Silicon Graphics, Inc. v. ATI Techs., Inc., 607 F.3d 784, 792 (Fed.Cir.2010) (“A construing court’s reliance on the specification must not go so far as to import limitations into claims from examples or embodiments appearing only in a patent’s written description unless the specification makes clear that the patentee intends for the claims and the embodiments in the specification to be
Judge Lourie’s new approach to claim construction would enable patentees to eliminate questions of validity by narrowing claims in accordance with a preferred embodiment or single example, while also allowing alleged infringers to narrow claims beyond their valid scope to avoid infringement. That approach cannot be correct.
II
Under the correct claim construction, ignoring for a moment the issue of intervening rights, HemCon at a minimum would be entitled to a new trial on all issues related to the validity of the original patent claims. The jury was specifically instructed under the incorrect claim construction and answered questions on the jury verdict form directly related to this construction. J.A. 111 (asking jury whether prior art discloses “having no detectable biological reactivity as determined by biocompatibility tests”). Moreover, after trial, the district court denied HemCon’s motion for JMOL and/or a new trial on anticipation and obviousness because HemCon’s expert’s opinions about the pri- or art “were based on the wrong definition of biocompatibility,” Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-cv-100-JD, 2010 WL 2902258, at *3 (D.N.H. July 21, 2010), and because the disputed prior art “did not disclose p-GlcNAc with no detectable biological reactivity as determined by biocompatibility tests,” id. at *4. See also id. at *8 (“[Bjecause none of the cited prior art disclosed the properties of biocompatible p-GlcNAe, as claimed by the '245 patent, the evidence at trial did not support findings for obviousness.”). This reliance on this incorrect claim construction alone warrants a new trial on these issues, putting to one side the issue of intervening rights. HemCon should at a minimum be permitted to defend itself against claims of infringing the original patent by attacking its validity under a proper claim construction.
Ill
A
I turn then to the question of intervening rights. While the judgment of the district court is affirmed by an equally divided court, the district court rendered no judgment on the question of intervening rights, and therefore there is nothing to affirm in that respect. Nonetheless, I agree with Judge Lourie that the effect of the equally divided affirmance is that the district court’s claim construction is binding on the parties as if the district court’s decision had never been reviewed. Durant v. Essex Co., 7 Wall. 107, 74 U.S. 107,
In my view the issue is properly before us. Here, while the district court entered judgment on September 22, 2010, and HemCon filed its Notice of Appeal to this court on September 24, 2010, the examiner did not issue the Notice of Intent to Issue an Ex Parte Reexamination Certificate until November 3, 2010, well after the appeal to this court. The majority offers no reasons why we should not consider the changes to a patent effected by reexamination. Just as we are obligated to take account of intervening changes in law that affect an appeal, see Bradley v. Sch. Bd. of City of Richmond, 416 U.S. 696, 714-15, 94 S.Ct. 2006, 40 L.Ed.2d 476 (1974); Vandenbark v. Owens-Illinois Glass Co., 311 U.S. 538, 542-43, 61 S.Ct. 347, 85 L.Ed. 327 (1941), we are obligated to take account of changes to a patent that occur during the pendency of a case on appeal, see Watts, Watts & Co. v. Unione Austriaca Di Navigazione, 248 U.S. 9, 21, 39 S.Ct. 1, 63 L.Ed. 100 (1918) (holding that “eourt[s] must consider the changes in fact and in law which have supervened since the decree was entered below”). Ample authority, uncontradicted by the majority, supports the original panel’s approach of addressing the issue of intervening rights,
The majority, though believing that the issue is not properly before us and that the issue is resolved by the district court’s claim construction, excuses its discussion of intervening rights by the fact that the original panel opinion “dealt extensively
B
On the merits of the intervening rights issue, the majority is incorrect as a matter of statutory interpretation. Section 307(b) provides:
Any proposed amended or new claim determined to be patentable and incorporated into a patent following a reexamination proceeding mil have the same effect as that specified in section 252 of this title for reissued patents on the right of any person who made, purchased, or used within the United States, or imported into the United States, anything patented by such proposed amended or new claim, or who made substantial preparation for the same, prior to issuance of a certificate under the provisions of subsection (a) of this section.
35 U.S.C. § 307(b) (emphasis added). Section 307(b) thus specifically incorporates the intervening rights provisions of reissued patents found in section 252. Congress was explicit that section 307(b) should be interpreted to be identical in scope to section 252:
Subsection 307(b) provides intervening rights similar to those provided by patent law section 252 with respect to reissued patents. Thus, a person practicing a patented invention would not be considered an infringer for the period between issuance of an invalid patent and its conversion through reexamination to a valid patent.
H.R.Rep. No. 96-1307(1), at 8 (1980), 1980 U.S.C.C.A.N. 6460, 6467 (emphasis added).
A patentee of a reexamined patent is entitled to infringement damages, inter alia, for the period between the date of issuance of the original claims and the date of issuance of the reexamined claims if the original and reexamined claims are “identical.” Reexamined claims are “identical” to their original counterparts if they are “without substantive change.” Furthermore, in determining whether substantive changes have been made, we must discern whether the scope of the claims are identical, not merely whether different words are used.
Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1346 (Fed.Cir.1998) (internal citations omitted) (first and third emphases added).
Here, the original and new claims are not “substantially identical.” During reexamination the patentee agreed, by both argument and by amending the claims to cancel six dependent claims, that the term “biocompatible” should be construed to mean “no detectable biological reactivity.” In doing so, as discussed above, the patentee adopted a construction that was different than the correct construction of the original claims, namely that “biocompatible” meant, inter alia, “little or no detectable reactivity.” The effect was to narrow the claims and protect them from a finding of invalidity.
As the majority recognizes, see Maj. Op. at 1363-64, it is well established that statements during prosecution or reexamination of a patent, as well as additions or deletions of claims to overcome rejections, can change the meaning of a claim term that would ordinarily be construed otherwise. See Am. Piledriving Equip., Inc. v. Geoquip, Inc., 637 F.3d 1324, 1336 (Fed.Cir. 2011); CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1362-63 (Fed.Cir. 2007); C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 867-69 (Fed.Cir.2004); Cole v. Kimberly-Clark Corp., 102 F.3d 524, 532 (Fed.Cir.1996). Here, although identical in language, the claims of the patent after reexamination were not identical in scope for purposes of intervening rights because they were “substantively changed” during reexamination.
The majority makes much of the difference in language between sections 307(b) and 252, pointing out that section 307(b) includes the language “amended or new claims.” The majority limits an “amended” claim under section 307(b) to a situation in which the claim language itself is changed. This interpretation ignores the statute’s language, its purpose, and the history of intervening rights.
Because the statute does not define “amended,” this term is “assumed to bear [its] ‘ordinary, contemporary, common meaning.’ ” Walters v. Metro. Educ. Enters., Inc., 519 U.S. 202, 207, 117 S.Ct. 660, 136 L.Ed.2d 644 (1997) (quoting Pioneer Inv. Servs. Co. v. Brunswick Assocs. Ltd. P’ship, 507 U.S. 380, 388, 113 S.Ct. 1489, 123 L.Ed.2d 74 (1993)). While “amend” may often connote an actual change in language,
In many other contexts the word “amend” has been interpreted as not requiring an explicit language change. In the context of the Administrative Procedure Act, amending an interpretive rule can be considered “amending ... a rule” under section 551(5), thus requiring notice and comment, even if there is no alteration in the language of the rule itself. United States v. Magnesium Corp. of Am., 616 F.3d 1129, 1139 (10th Cir.2010). As the Tenth Circuit has held, “if an agency amends its interpretation of a rule, it is effectively amending the rule itself.” Id. (internal quotation marks omitted); see also Jerri’s Ceramic Arts, Inc. v. Consumer Prod. Safety Comm’n, 874 F.2d 205, 206 (4th Cir.1989) (finding that an agency “interpretation” was in fact a substantive “amendment” to the Small Parts Rule, and thus the agency violated the APA). Legal instruments can often be constructively or effectively amended without changing literal text. See, e.g., Chamberlain Group, Inc. v. Skylink Techs., Inc., 381 F.3d 1178, 1189 (Fed.Cir.2004) (“For the purpose of determining Federal Circuit jurisdiction, we do not differentiate between actual and constructive amendments [to the complaint].”); see also, e.g., Battoni v. IBEW Local Union No. 102 Emp. Pension Plan, 594 F.3d 230, 235 (3d Cir.2010) (constructive amendment to pension plan); United States v. Starr, 533 F.3d 985, 997 (8th Cir.2008) (constructive amendment to a criminal indictment); S. Colo. MRI, Ltd. v. Med-Alliance, Inc., 166 F.3d 1094, 1099 (10th Cir.1999) (“By expressing an intent to be bound on July 7, 1993, the parties implicitly ... amended any prior [written] agreement that an asset purchase document was necessary to complete the contract.”). A statute may also be amended without a change in language. See United States ex rel. Palmer v. Lapp, 244 F. 377 (6th Cir.1917) (finding that an act indepen
The history of intervening rights provisions themselves compel an interpretation of “amended” that does not require a change in the language of the claims. The doctrine of intervening rights with respect to reissued patents existed as a judicial construct since the 1800s. See generally P.J. Federico, Intervening Rights in Patent Reissues, 30 Geo. Wash. L. Rev. 603 (1961). Section 252 in the Patent Act of 1952 substantially adopted and clarified the doctrine of intervening rights as it had been interpreted and developed by the courts. See H.R.Rep. No. 82-1923, at 8 (1952); see also Federico, supra, at 629-30. Courts for years have understood that the specification and the claims together act to define an invention. The Supreme Court recognized that the scope of patents could be changed by an amendment to the specification where there is no formal amendment to the claim. See, e.g., Russell v. Dodge, 93 U.S. 460, 463, 23 L.Ed. 973 (1876) (noting that a specification might “be substantially changed, either by the addition of new matter or the omission of important particulars, so as to enlarge the scope of the invention as originally claimed”).
The Supreme Court made clear that a change in the specification broadening the scope of the patent, just as a change to claim language, could lead to intervening rights. For example, in Battin v. Taggert the Court noted that
[wjhether the defect be in the specifications or in the claim ..., the patentee may surrender his patent, and, by an amended specification or claim, cure the defect.... But where the specification or claim is made so vaguely as to be inoperative and invalid, yet an amendment may give to it validity, and protect the rights of the patentee against all subsequent infringements.
58 U.S. 74, 83, 17 How. 74, 15 L.Ed. 37 (1854) (emphasis added). Similarly, in a case where a patentee had amended the specification during reissue by, inter alia, inserting an additional figure, one court held that “[t]he law does not permit such an enlargement of the original specifications as will interfere with other inventors who have acquired intervening rights.” Ficklen v. Baker, 47 App. D.C. 587, 596 (D.C.Cir.1918) (quoting Manly v. Williams, 37 App. D.C. 194, 201 (D.C.Cir. 1911)). Thus, prior to Congress enacting the intervening rights provisions of section 252, courts understood that not having a change in claim language was not indispensible to creating intervening rights, and that a change in the specification could also lead to intervening rights. Contrary to the majority’s assertion, I do not claim that these cases directly control this case. They do, however, make clear that the Supreme Court, in developing the doctrine of intervening rights, concluded that the scope of the claims could change without formal amendments and still require the recognition of intervening rights. There is no indication in the legislative history of section 252 that Congress intended to overrule the courts’ understanding on this
Most important, we must interpret “amended” to effectuate the intent of Congress in enacting the intervening rights provisions of the reexamination statutes. See Reves v. Ernst & Young, 494 U.S. 56, 62-63,110 S.Ct. 945, 108 L.Ed.2d 47 (1990) (“Thus, the phrase ‘any note’ should not be interpreted to mean literally ‘any note,’ but must be understood against the backdrop of what Congress was attempting to accomplish in enacting the Securities Acts.”). If “amended” only refers to changes in the actual language of the claims, the purpose of intervening rights will be plainly and directly thwarted.
It is initially important to understand that the majority agrees that claim scope can be changed by arguments made by the patentee during reexamination.
Neither of these alternatives makes sense, and each directly contradicts the purpose of the statute, thus demonstrating