Tag Archives: Claim Construction

Related to issues and practice tips involving claim construction.

Teva v. Sandoz: The New Standard of Review In Claim Construction

CAFC-150x150In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court addressed the question of what the standard of review should be for patent claim construction. In its decision on January 20, 2015, the Court held that a federal appellate court could only overturn a district court’s factual findings if those findings were determined to be clearly erroneous. This holding modifies the longstanding de novo standard used by the Federal Circuit when reviewing claim construction.  While trying to generate certainty for district court claim construction decisions and decrease the reversal rate of claim construction decision by the Federal Circuit, the Federal Circuit may focus on the legal analysis and intrinsic evidence to keep claim construction de novo.

The case involves a patent dispute over the multiple-sclerosis drug Copaxone. Teva Pharmaceuticals owns several patents directed to copolymer-1, which is the active ingredient found in Copaxone. Teva sued Mylan and Sandoz for infringement based on their applications seeking FDA approval to produce and market generic versions of Copaxone.

At issue before the district court was how to construe the term “molecular weight.”  Sandoz argued that the term “molecular weight” in the claims at issue was indefinite because it was unclear how the molecular weight was calculated. In support of this indefiniteness argument, Sandoz proposed three different definitions for “molecular weight.”  However, based on the specification, prosecution history, and testimony from Teva’s expert, the District Court construed the term to mean peak average molecular weight and therefore found no ambiguity based on what a person having skill in the art would understand “molecular weight” to mean. Consequently, the district court held that the Sandoz and Mylan products infringed on Teva’s patents.  On appeal, the Federal Circuit applied a de novo standard of review and reversed, reasoning that the term “molecular weight” is indefinite because the claims do not indicate which molecular weight measure is intended.

The Supreme Court granted Teva’s petition for writ of certiorari to address whether a district court’s finding of fact in the construction of a patent claim should be reviewed de novo, as the Federal Circuit requires, or for clear error, as Federal Rule of Civil Procedure 52(a) requires. Teva argued that Federal Rule of Civil Procedure 52(a) requires deferential review of fact-findings, even when a question of law rests on these fact-findings. Further, Teva argued that fact-findings regarding the state of the art are entitled to deference. On the other hand, Sandoz argued that since claim construction is a “purely legal” question, Federal Rule of Civil Procedure 52(a) does not apply.

In a 7-2 majority, the Supreme Court reversed the Federal Circuit’s holding and remanded the case for further proceedings. The Court held that “when reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review.”  In the opinion penned by Justice Breyer, the Court reasoned that Federal Rule of Civil Procedure 52(a)(6) mandates that an appellate court give substantial deference to district court fact finding and to contravene the lower court’s factual determinations only if there was “clear error.”  In addition, the Court asserted, “A district court judge who has presided over, and listened to, the entirety of a proceeding has a comparatively greater opportunity to gain that familiarity than an appeals court judge.”

The decision is significant because claim construction has become such a major component of patent litigation and because the Court of Appeals for the Federal Circuit (CAFC) has a propensity of reversing a large number of claim construction decisions.  Under this ruling, determinations regarding evidence “intrinsic to the patent” will continue to be reviewed de novo on appeal.  However, determinations regarding “extrinsic evidence” will now be reviewed with deference on appeal. The act of consulting a dictionary – which is how a court might determine “the meaning of a term in the relevant art during the relevant time period” – seems entitled to deference.  However, this decision will serve to generate endless disputes over what is extrinsic vs. intrinsic evidence and what are isolated boundaries vs. contextual boundaries.  The legal analysis is still required for claim construction which will be reviewed de novo by the CAFC.  And intrinsic evidence may be viewed as determinative in claim construction by the CAFC as to retain de novo review… thus the CAFC may still have a high reversal rate for claim construction decisions and less certainty for district court decisions.

Promega v. Life Technologies: A Higher Enablement Standard for “Comprising” Not within the Preamble of the Claim

On December 15, 2014, the U.S. Court of Appeals for the Federal Circuit in Promega Corp. v. Life Technologies Corp.,” reversed the district court’s decision and held that U.S. Patents 5,843,660; 6,221,598; 6,479,235; and 7,008,771, which are owned by Promega Corp., are invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement. On appeal, the Federal Circuit held that by using the word “comprising” outside of the preamble there was no limitation to the set of loci and the claims included undisclosed embodiments that would have allowed a person skilled in the art to add new loci to the set of loci. Therefore, the Federal Circuit held that the Promega patents did not enable a person skilled in the art to practice the full breadth of this claim scope without undue experimentation.

Prior to the suit, Promega Corporation entered into limited licenses with Life Technologies under several patents directed to systems for using fluorescent tags to label pieces of DNA, systems to compare DNA samples in paternity tests, to monitor bone marrow transplants, and for cancer testing. Promega later sued LifeTech. Promega later sued LifeTech, alleging that LifeTech was selling its kits for uses that fell outside of the terms of the license, thereby infringing Promega’s patents. The district court denied LifeTech’s motion for summary judgment of invalidity of the four Promega patents for lack of enablement and granted Promega’s motion for summary judgment of infringement. On appeal, the Federal Circuit reversed the district court’s decision.

Generally, the enablement requirement under 35 U.S.C. § 112, first paragraph requires that the written description of the invention enable a person skilled in the art to which it pertains to make and use the claimed invention. The issue of enablement in the Promega case involved Promega’s use of the term “comprising,” which was used after the preamble, and in the claim limitations before the set of loci.  By way of example, Claim 23 reads:

“A kit for simultaneously analyzing short tandem repeat sequences in a set of short tandem repeat loci from one or more DNA samples, comprising: A single container containing oligonucleotide primers for each locus in a set of   short tandem repeat loci which can be co-amplified, comprising HUMCSF1PO, HUMTPOX, and HUMTH01.”

The word “comprising” is a term typically used to connect the preamble of a claim to the specific elements set forth in the claim, which define what the invention itself actually is. The use of the term “comprising” typically acts as a limitation on the claim, indicating whether a similar device, method, or composition infringes the patent if it contains more or fewer elements than the claim in the patent.  In this case, the use of “comprising” meant that the claims encompassed both “products that use no loci other than those listed in the claims” as well as “any other loci combination containing those three recited loci–whether that combination includes 13, 1,1300 or 13,000 STR loci.”[1]  Life Tech moved for summary judgment, which the district court denied because “the asserted claims need not enable ‘un-recited elements.’”[2]

On appeal, the Federal Circuit reversed, reasoning that by using the word “comprising” outside of the preamble there was no limitation to the set of loci. Further, the claims included undisclosed embodiments that would have allowed a person skilled in the art to add new loci to the set of loci. Therefore, the Federal Circuit held that the Promega patents did not enable a person skilled in the art to practice the full breadth of this claim scope without undue experimentation.

While use of the term “comprising” led to an invalidity ruling in this case, the Federal Circuit noted in dicta that it does not necessarily follow that every claim in which this phrase “comprising” is used will be considered invalid.  According to the Federal Circuit, “as we stated in Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1371 (Fed. Cir. 2005) open claims “embrace technology that may add features to devices otherwise within the claim definition.”  What is of particular importance in the Promega case is that the use of the term “comprising” is not in the preamble.  While the term “comprising” in a claim preamble may create an assumption that a list of claim elements is nonexclusive, it “does not reach into each [limitation] to render every word and phrase therein open-ended.”  Promega’s claims differ from customary “open-ended” claims in that Promega’s use of “comprising” in its “open loci set” limitation expands the claims in order to cover future advances in this unpredictable field.

Interestingly, during the prosecution of the claims-in-suit, Promega itself repeatedly argued the unpredictability point to the patent office to support their patentability over the prior art and during the litigation itself in defense of their nonobviousness.  “Promega explained that without a preexisting publication or teaching, a skilled artisan ‘could not predict with any certainty whether a given set of loci would co-amplify successfully together.’” [3]  These arguments were held against Promega and shows that statements made during prosecution may have a fatal effect to the broad scope of claims.

[1] Slip Op. at 7.

[2] Id. at 14.

[3] Slip Op. at 17.

In re Cuozzo Speed Technologies, LLC: Is BRI the correct standard for IPR claim construction?

On November 3, 2014, the Federal Circuit heard oral arguments in the appeal of the first inter partes review decided under the America Invents Act. In the case, In re Cuozzo Speed Technologies, LLC, Fed. Cir. 14-1301, the Federal Circuit has been asked to review the procedures of the new inter partes review proceedings, especially the standard of claim construction and the availability of appeals for IPR institution decisions.

In re Cuozzo Speed Technologies was the first inter partes review instituted by the PTAB after the AIA went into effect in September 2012. Since that time, the IPR procedure has been highly popular with accused infringers. The USPTO reported that, as of September 25, 2014, a total of 1,821 petitions for IPR had been filed. The PTAB has reached a decision on whether to institute review for 938 of those petitions. In 731 of those decisions, the PTAB instituted an IPR. At this time, the first appeals out of the IPR proceedings are beginning to reach the Federal Circuit, with various challenges to the PTAB’s rules and regulations.

One of the primary concerns raised by patent owners is that the standard relied upon during an instituted IPR, the “broadest reasonable interpretation,” in contrast to the “ordinary and customary meaning” construction standard relied upon during court proceedings.

During the oral arguments, the judges appeared largely supportive of the overall IPR procedure, although they also noted concerns about some of the IPR rules. As asked by Judge Pauline Newman, “So after the patent has issued, why should the result be different in the office than in the court, based on how the claims are construed?” Under the BRI standard, a broader swath of prior art is available to patent challengers and/or accused infringers. The primary justification raised for using the BRI standard is that patentees can amend their claims during the IPR proceeding in response to the PTAB’s construction of the claims. Judge Newman also pushed back on this claim, noting that “It’s not so easy.”

As noted by attorneys for Cuozzo Speed Technologies, in the two years of AIA IPR proceedings, no opposed motion to amend has been granted. Previously, former Federal Circuit Chief Judge Randall Rader even referred to the IPR proceedings as “death squads.”

The other main issue raised by In re Cuozzo Speed Technologies, LLC is whether “non-discretionary” jurisdictional requirements of the IPR proceedings may be appealed. According to briefs filed by Cuozzo, the “non-discretionary” requirements encompass: 1) “the petition must be filed by a person who is not the patent owner (35 U.S.C. § 311(a))”; 2) “the grounds of un-patentability must be limited to 35 U.S.C. § 102 or 103 and only based on patents or printed publications (35 U.S.C. § 311(b))”; 3) “the petitioner or real party in interest cannot have filed a civil action challenging the validity of a claim of the patent (35 U.S.C. § 315(a))”; and 4) “the petitioner, real party in interest or privy of the petitioner cannot have been served with a complaint alleging infringement of the patent more than 1 year before the date on which the petition is filed (35 U.S.C. § 315(b)).” See Reply Brief of Appellant, In re Cuozzo Speed Techs., LLC, No. 2014-1301, 2014 WL 3055159, at *2-3 (Fed. Cir. June 23, 2014). The issues raised by Cuozzo are relevant, because under 35 U.S.C. § 314(d) “The determination by the Director whether to institute an inter partes review under this section shall be final and non-appealable.”

The decision of the Federal Circuit in In re Cuozzo Speed Technologies, LLC will impact the IPR decisions that are just beginning to reach the courts, and potentially alter the course of the IPR proceedings if the Federal Circuit agrees that the BRI standard is inappropriate.

Regardless of the decision, the IPR proceedings remain an attractive option for accused patent infringers, given the substantially lower cost of the IPR proceedings versus litigation, as well as the accelerated timeline of IPRs. But for patent owners, the decision could signal an attempt to balance the IPR proceedings from thus far being heavily in favor of the patent challenger.

By: Matt Remissong