Tuesday, April 18, 2017

More on The Medicines Company v. Mylan, 2017 U.S. App. LEXIS 5947. Reverse doctrine of equivalents?

The case The Medicines Company v. Mylan, 2017 U.S. App. LEXIS 5947, is unusual in several respects. Although a counterclaim of invalidity had been lodged, the question of invalidity was not reached, even though there were significant questions of indefiniteness and functional claiming.

For example claim 1 of the '727 patent had a "wherein" clause, which amounted to claiming a result, without utilizing means for language:

1. Pharmaceutical batches of a drug product comprising bivalirudin . . . wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

Of functional, result-defined claiming, the CAFC wrote:

Although functional limitations in patent claims are not per se objectionable even when the means-plus-function format is not invoked,6 they cannot be "so broad that [they] cause[] the claim to have a potential scope of protection beyond that which is justified by the specification disclosure." In re Swinehart, 439 F.2d 210, 213, 58 C.C.P.A. 1027 (C.C.P.A. 1971). Here, Medicines' construction would [*23] expand the scope of "efficient mixing" to cover any way of mixing that achieves a compounding solution having an Asp9 level of less than 0.6 percent. The patentee's construction of "efficient mixing" thus attempts to claim all solutions to the identified "impurities" problem, without describing the entire range of solutions to that problem. Medicines' construction is therefore not permissible. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352-53 (Fed. Cir. 2010) (en banc) ("Such claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any [solution] later actually invented and determined to fall within the claim's functional boundaries—leaving it to [others] to complete an unfinished invention."); see also Bayer Crop Science AG v. Dow AgroSciences LLC, 728 F.3d 1324, 1330-31 (Fed. Cir. 2013). Rather, efficient mixing must be defined in terms of the particular process or processes identified in the specification.

Footnote 6 is not about case law on functional claiming without means plus function language, but RATHER:

There is no contention here that the claims are means-plus-function claims governed by 35 U.S.C. § 112(f) (formerly 35 U.S.C. § 112 ¶ 6).

** A law review by KEVIN EMERSON COLLINS in 90 Wash. U. L. Rev. 1399 (2013) suggests that the discussion of the CAFC on functional claiming might not be completely accurate:

In the first half of the twentieth century, the Supreme Court made explicit its objection to functional claims. The Court invalidated a series of patent claims on the grounds that the claims were overbroad because they only recited the functional properties of technology that an inventor had produced and thus were not limited to an inventor's actual invention. n109 As [*1428] a mid-twentieth-century patent treatise noted: "It is possible that a claim for all means of arriving at a desired result would be broad enough to cover later discovered means wholly independent of the first means for arriving at the same final result. In that case, the inventor would be over-protected." n110 In this passage, "means" is code for a technology with particular structural properties, and "a desired result" is a functional property.

In Holland Furniture Co. v. Perkins Glue Co., n111 an inventor developed a starch-based glue that was useful for wood veneering because, among its properties, it had the low water content that previously had only been attainable in glue made from animal substances. n112 The inventor obtained a functional claim to any starch-based glue "having substantially the properties of animal glue." n113 Claim scope was thus delineated "not in terms of [the invention's] own physical characteristics or chemical properties ... but wholly in terms of the manner of use of the product." n114 The Su-preme Court invalidated the claim because it employed only functional limitations. "A claim so broad, if allowed, would operate to enable the inventor who has discovered that a defined type of starch answers the required purpose to exclude others from all other types of starch" with different chemical compositions. n115

In General Electric Co. v. Wabash Appliance Corp., n116 an inventor obtained a functional claim that encompassed tungsten filaments "made up mainly of a number of comparatively large grains of such size and contour as to prevent substantial sagging and offsetting during a normal or commercially useful life for ... a lamp or other device." n117 The Supreme Court held the claim "invalid on its face" because of its functional language. n118 "The claim ... falls within the condemnation of the doctrine that a patentee may not broaden his product claims by describing the [*1429] product in terms of function" and "vividly illustrates the vice of a description in terms of function" in a claim. n119
Similarly, in Halliburton Oil Well Cementing Co. v. Walker, an inventor made an improvement in a device that records the echoes of sound waves sent into an oil well in order to measure well depth. n120 The inventor limited the scope of his claim with reference to a "means ... for tuning [an echo-recording device] to the frequency of echoes ... to clearly distinguish the echoes ... from ... each other." n121 The Court invalidated the claim, noting that the claim de-scribed the invention "in terms of what it will do rather than in terms of its own physical characteristics" and opining that the claim illustrated the "overhanging threat of the functional claim." n122

The Supreme Court cases barring purely functional claims because of overbreadth remain good law today, but Congress has softened their impact. Describing the full scope of an invention without using functional limitations is sometimes difficult, and invalidating any claim with a functional limitation might leave inventors without effective patent protection. Therefore, Congress responded to Halliburton by enacting what is now section 112(f) as part of the 1952 Patent Act:
[p. 1430]

An element in a claim ... may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. n123

** As to Cardinal Chemical, the latitude for not entertaining invalidity questions is narrow, and not consistent with the facts of Mylan, wherein invalidity was the bigger issue.

In Liebel Flarsheim, the district court [2002 U.S. Dist. LEXIS 8891, later reversed in 358 F.3d 898 ] wrote of Cardinal Chemical:

Having found non-infringement in favor of Medrad, L-F argues that the Court should dismiss Medrad's invalidity and unenforceability counterclaims as moot. (Doc. No. 276, p.9). Medrad, on the other hand, argues that this Court does not have the authority to dismiss its invalidity and unenforceability counterclaims as moot because, according to Medrad, the United States Supreme Court has held that a finding of non-infringement does not moot an invalidity counterclaim. See Cardinal Chemical Co. v. Morton Int'l., Inc., 508 U.S. 83, 124 L. Ed. 2d 1, 113 S. Ct. 1967 (1993). (Doc. No. 274).
In Cardinal Chemical, the Supreme Court rejected the Federal Circuit's practice of routinely vacating declaratory judgments of invalidity as moot when it affirmed a district court's determination of non-infringement. 508 U.S. at 102-03. The Court concluded that an appellate court's affirmation of a district court's non-infringement ruling did not affect the appellate court's power to review the invalidity issue. 508 U.S. at 98. Furthermore, the Court observed that there were strong public policy and practical reasons for addressing the issue of invalidity regardless of the outcome of the question of infringement. 508 U.S. at 102-01. Thus, the Court ruled that HN1Go to this Headnote in the case.the Federal Circuit should not automatically vacate a district court's ruling of invalidity as moot based solely on a finding of non-infringement. 508 U.S. at 103-04.
While Cardinal Chemical is instructive, it is not dispositive of the issue currently before this Court -- whether a district court has the discretion to dismiss an invalidity counterclaim as moot in light of a finding of non-infringement. The Cardinal Chemical court specifically limited its holding to "the jurisdiction of an intermediate appellate court -- not the jurisdiction of either a trial court or [the Supreme] Court"). 508 U.S. at 95. Furthermore, while indicating a preference for resolving validity questions, the Cardinal Chemical court did not establish a per se rule that an invalidity counterclaim could never be mooted by a finding of non-infringement. Rather, the Court held that declaring an invalidity counterclaim moot based solely on a finding of non-infringement was an abuse of discretion on the part of an appellate court:
In rejecting the Federal Circuit's practice we acknowledge that factors in an unusual case might justify that court's refusal to reach the merits of a validity determination -- a determination which it might therefore be appropriate to vacate. A finding of non-infringement alone, however, does not justify such a result. Nor does anything else in the record of this case. The two patents at issue here have been the subject of three separate lawsuits, and both parties have urged the Federal Circuit to resolve their ongoing dispute over the issue of validity; it would be an abuse of discretion not to decide that question in this case.
508 U.S. at 102-03 (emphasis added). Thus, the Court left open the possibility that even an appellate court could refuse to reach to merits of an invalidity [*8] question if other factors, in addition to a finding of non-infringement, weighed in favor of finding the invalidity question moot. 3

Footnote 3

3 Confusion over the ultimate holding of Cardinal Chemical stems, in part, from the following statement that appears in the case: "[the invalidity counterclaim] did not become moot when [the appellate] court affirmed the finding of non-infringement". Cardinal Chemical, 508 U.S. 98, 124 L. Ed. 2d 1, 113 S. Ct. 1967. This statement's meaning, however, is only apparent when read in the context of the entire opinion. The statement appears in the section of the opinion in which the Court concludes that a controversy continues to exist for the purpose of establishing jurisdiction until a court is made aware of a change in circumstances that eliminates the controversy. Id. Because no such change of circumstances had occurred in Cardinal Chemical, the Court concluded that the appellate court had the power (i.e., jurisdiction) to review the invalidity issue. Id. The statement's inclusion in a discussion of jurisdiction indicates that the Court was referring to jurisdictional mootness. See Morton Int'l, Inc. v. Cardinal Chemical Co., 967 F.2d 1571, 1574 (Fed. Cir. 1992)(Nies, C.J. dissenting)("'Mootness' is jurisdictional when the dispute between the parties, or at least an issue in the case, no longer exists. That is, the issue no longer presents an actual case or controversy. If an issue is moot in this sense, a court has no discretion but must dismiss for lack of jurisdiction. (citations omitted)").

The ultimate holding of the Cardinal Chemical case was that in the case.dismissing an invalidity counterclaim as moot based a finding of non-infringement alone and in the absence of any other factors justifying the refusal to reach the merits of a validity determination was an abuse of discretion, implying that if appropriate factors exist, an invalidity counterclaim may be moot. Cardinal Chemical, 508 U.S. at 102-03. This type of mootness is referred to as prudential mootness. See Morton, 967 F.2d at 1574. ("An issue is also said to be 'mooted' when a court, having decided one dispositive issue, chooses not to address another equally dispositive issue. In this sense, mootness means only that a decision on another issue would have no practical significance. This type of mootness results from prudential, not jurisdictional, considerations." (citations omitted)).

End Footnote 3 here

The issue of whether a district court, versus an appellate court, may dismiss an invalidity counterclaim as moot following a finding of non-infringement was addressed in Phonometrics, Inc. v. Northern Telecom Inc., 133 F.3d 1459 (Fed. Cir. 1998). In that case, the plaintiff patent owner brought an action against various manufacturers and sellers of telephone equipment alleging infringement of its patent. Id. at 1461-63. The defendants counterclaimed seeking a declaratory judgment for non-infringement, invalidity, and unenforceability of the patent. Id. The district court ruled in favor of the defendants on the issue of non-infringement and dismissed their invalidity and unenforceability counterclaims as moot. The plaintiff appealed both the finding of non-infringement and the dismissal of the defendants' counterclaims, arguing it had a "general interest in a judicial determination of its patent's validity." Id. at 1468.
With respect to the dismissal of the counterclaim for invalidity, the appellate court concluded that it was within a district court's discretion to dismiss the counterclaims as moot where it makes a finding of [*10] non-infringement:
We have previously held that a district court has discretion to dismiss a counterclaim alleging that a patent is invalid as moot where it finds no infringement. See Nestier Corp. v. Menasha Corp.-Lewisystems Div., 739 F.2d 1576, 1580-81, 222 USPQ 747, 751 (Fed. Cir. 1984)("There was no reversible error or abuse of discretion . . . in the District Court's withholding of judgment on the issues related to the . . . patent's validity -- despite the jury's having found the patent not invalid -- in light of the jury's finding of non-infringement."); see also Leesona Corp. v. United States, 208 Ct.Cl. 871, 530 F.2d 896, 906 n. 9, 185 USPQ 156, 163 n. 9 (adopted as opinion of Court of Claims at 208 Ct.Cl. 871, 530 F.2d 896, 192 USPQ 672 (1976))("While the better practice is to treat both the validity and infringement issues . . . it is not always necessary to do so. Where, as here, noninfringement is clear and invalidity is not plainly evident it is appropriate to treat only the infringement issue." (citations omitted)).
Id. The court concluded that the Cardinal Chemical case was distinguishable because [*11] it involved the authority of an intermediate appellate court rather than a district court:

The Supreme Court's decision in Cardinal Chemical Co. v. Morton International, 508 U.S. 83, 113 S. Ct. 1967, 124 L. Ed. 2d 1, 26 USPQ2d 1721 (1993), does not preclude this discretionary action by the district court. Cardinal Chemical simply prohibits us, as an intermediate appellate court, from vacating a judgment of invalidity when we conclude that a patent has not been infringed, and therefore has no bearing on the district court's actions in this case.
Id. 4

Footnote 1 of The Medicines Company v. Mylan, 2017 U.S. App. LEXIS 5947, includes the text:

Under Cardinal Chemical Co. v. Morton Int'l, Inc., 508 U.S. 83, 99, 113 S. Ct. 1967, 124 L. Ed. 2d 1 (1993), a finding of noninfringement cannot moot a counterclaim of invalidity, but we retain the discretion to limit the grounds upon which appeals are decided. Here, because Mylan has agreed that a judgment of noninfringement with respect to both patents in suit "would be tantamount to the relief sought on the merits" and that we need not reach the invalidity issues, we decline to reach the merits of Mylan's invalidity contentions. See Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d 1309, 1318 n.2 (Fed. Cir. 2006).

In the Mylan case, the CAFC discussed INVALIDITY issues, and even cited a CAFC decision in Cardinal Chemical:

A claim is indefinite if its legal scope is not clear enough that a person of ordinary skill in the art could determine whether a particular composition infringes or not."); Morton Int'l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993) ("[C]laims. . . [must be] sufficiently precise to permit a [*16] potential competitor to determine whether or not he is infringing.").

But the Mylan case is manifestly about infringement/not validity.

The Mylan decision talks about the written description of the '727 patent:

We conclude that one of ordinary skill in the art would rely on Example 5 to ascertain the metes and bounds of "efficiently mixing." As the only embodiment of efficient mixing, Example 5 is "highly indicative of the scope of the claims." Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1355 (Fed. Cir. 1998).8 Example 5, however, is not merely the only disclosed embodiment of efficient mixing—it is the only description of efficient mixing in the patents in suit that casts light on what efficient mixing is and that enables one of ordinary skill in the art to achieve the objects of the claimed invention. Although the specification provides that Example 5 is "non-limiting," e.g., '727 patent, col. 16 l. 6, no other part of the patents' written description sufficiently teaches the affirmative steps that constitute efficient mixing. In this circumstance, we think it entirely appropriate to limit the term "efficiently mixing" to the sole portion of the specification that adequately discloses "efficient mixing" to the public. See Alloc, Inc. v. ITC, 342 F.3d 1361, 1370 (Fed. Cir. 2003); SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344-45 (Fed. Cir. 2001).

The cited Alloc case had noted:

this court recognizes that in the case.it must interpret the claims in light of the specification, Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370, 134 L. Ed. 2d 577, 116 S. Ct. 1384 (1996), yet avoid impermissibly importing limitations from the specification. Comark Communications v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998). That balance turns on how the specification characterizes the claimed invention. Sunrace Roots Enter. Co., LTD v. SRAM Corp., 336 F.3d 1298, 1305 (Fed. Cir. 2003). In this respect, this court looks to whether the specification refers to a limitation only as a part of less than all possible embodiments or whether the specification read as a whole suggests that the very character of the invention requires the limitation be a part of every embodiment. For example, it is impermissible to read the one and only disclosed embodiment into a claim without other indicia that the patentee so intended to limit the invention. [**20] Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002). On the other hand, where the specification makes clear at various points that the claimed invention is narrower than the claim language might imply, it is entirely permissible and proper to limit the claims. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1345 (Fed. Cir. 2001).

After a lengthy discussion of what "efficient mixing" is limited to, the CAFC quickly disposes of infringement issues:

The net effect of our claim construction is that to infringe either the '727 patent or the '343 patent, infringing batches must be compounded using a process that employs the efficient mixing conditions of Example 5. See Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1291-95 (Fed. Cir. 2009) (en banc). Under this claim construction, Mylan's ANDA does not infringe the asserted claims since is undisputed that, for example, Mylan does not use multiple mixing devices as required by Example 5.

One wonders if what happened in the Mylan case, as referenced to the Alloc case, is simply the "reverse doctrine of equivalents" masquerading under a different name. Without invoking the narrowed claim construction, one says simply that Mylan obtained the Asp9-bivalirudin level in a different way than taught by the patentee.

Separately, lurking in the background, is the problem that it might seem the CAFC limited the '727 claim to preserve its validity as to a written description/enablement attack. BUT the court will not re-write claims in order to preserve their validity. See Pfizer, Inc. v. Ranbaxy Laboratories Ltd., 457 F.3d 1284, 1292 (Fed. Cir. 2006).
"Preserving validity" does not permit the Court to re-write the claims in a manner inconsistent with the intrinsic record in order to preserve validity of the claims. McCarty v. Lehigh Valley R.R. Co., 160 U.S. 110, 116, 40 L. Ed. 358, 16 S. Ct. 240, 1895 Dec. Comm'r Pat. 721 (1895); Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357 (Fed. Cir. 1999) ("We must construe the claims based on the patentee's version of the claim as he himself drafted it."); Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1584 (Fed. Cir. 1995) ("Although we construe claims, if possible, so as to sustain their validity, it is well settled that no matter how great the temptations of fairness or policy making, courts do not redraft claims."); Becton Dickinson & Co. v. C.R. Bard Inc., 922 F.2d 792, 799 n.6 (Fed. Cir. 1990) ("Nothing in any precedent permits judicial redrafting of claims. At most there are admonitions to construe words in claims narrowly, if possible, so as to sustain their validity.")

On the record, it might seem patentee intended a broad scope for "efficient mixing." And, validity was not at issue in the Mylan case, as decided.

**In passing, see also

**And from blawgsearch, on 18 April 2017:


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