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.


The United States Patent and Trademark Office released its FY 2014 Performance and Accountability Report and reported that 50.9% of the patent applications filed at the office in 2014 came from non-U.S. Residents. This is consistent with the prior year trend of increases in the percentage of foreign patent applicants.

A total of 295,051 patent applications were filed by non-U.S. residents, with the patent applicants from the following countries representing the top-ten countries of origin:

  • Japan (87,369)
  • South Korea (34,795)
  • Germany (31,537)
  • Taiwan (21,949)
  • China (15,496)
  • Canada (14,730; %)
  • United Kingdom (13,680)
  • France (11,972)
  • Israel (7,230)
  • India (6,411)

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The continued increase in foreign origin patent applications is an indication of the overall health of the United States patent system.  Foreign investment in our patent system represents confidence in both our patent system and in our court system to enforce the patents issued by the United States Patent and Trademark Office.  The increase in foreign origin patent applications in the United States is consistent with the overall trend of increased patent application filings by foreign origin applicants at the European Patent Office, the Japan Patent Office, the Korean Intellectual Property Office and the Chinese Intellectual Property Office (SIPO).  In combination with patent law harmonization efforts that have progressed over the past twenty years, the global nature of these increases indicates confidence in the major national and regional patenting authorities and legal systems to enforce the ensuing patent rights.

Disclaimer: This content is provided for general informational purposes only.  Any information contained in this post should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter. No recipient of content in this post (whether clients or otherwise) should act or refrain from acting on the basis of this content without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.

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.

Commil v. Cisco: Whether a good-faith belief of invalidity negates the intent requirement for induced infringement

On December 5, 2014, the Supreme Court granted certiorari in Commil USA v. Cisco Systems to decide whether a defendant’s good-faith belief of patent invalidity is a defense to induced infringement under 35 U.S.C. §271(b).  A ruling is due by the end of June and could prove significant for patent litigation involving intent or knowledge standards as a defense to liability.

Commil holds a method patent for implementing short-range wireless networks (“hand-offs”).  These hand-offs result when a mobile device changes wireless access points on a network. Commil’s patent provides a method for faster and more reliable hand-offs.  Commil sued Cisco for direct infringement and induced infringement. Commil alleged that Cisco prompted its customers to infringe Commil’s patent through the use of networking equipment that Cisco manufactured. Under 35 U.S.C. § 271(b), to induce infringement, a defendant must ““knowingly induce[] infringement and possess[] specific intent to encourage [another party’s direct] infringement.”  Prior to trial, Cisco provided evidence demonstrating its good-faith belief that Commil’s patent was invalid.  However, the district court excluded the evidence and provided jury instructions imposing liability for inducers that were at least negligent to the fact that their actions would induce infringement. Consequently, the jury found Cisco liable for induced infringement.

On appeal, Cisco argued that (1) the district court improperly excluded evidence of its good-faith belief of invalidity and (2) the jury instruction on induced infringement was erroneous because it allowed the jury to find inducement based on mere negligence. The U.S. Court of Appeals for the Federal Circuit agreed with Cisco’s arguments, holding that: (1) the jury should have been allowed to consider the evidence of Cisco’s good-faith belief of invalidity and (2) the jury instruction on induced infringement was erroneous as a matter of law and prejudiced the outcome.  The Federal Circuit relied on the standard for induced infringement set forth by the Supreme Court in Global-Tech v. SEB which requires “knowledge that the induced acts constitute patent infringement,” a requirement that can be satisfied through actual knowledge or willful blindness. Under this standard, the Federal Circuit reasoned that induced infringement liability is precluded when the facts only support recklessness or negligence on the part of the inducer.  Because the district court’s jury instruction erroneously allowed a finding of liability based on mere negligence rather than actual knowledge or willful blindness, the Federal Circuit found that the outcome was prejudiced. Consequently, the Federal Circuit vacated the district court’s holding on induced infringement and remanded for a new trial.

On January 23, 2014 Commil filed a petition for a writ of certiorari, challenging the Federal Circuit’s approval of Cisco’s good-faith belief of invalidity as a defense and the jury instruction regarding inducement. In response, the Court requested the Solicitor General to file an amicus brief on whether certiorari should be granted.  The Solicitor General’s brief supported the grant of certiorari and argued that a defense based on the accused inducer’s good-faith belief in the patent’s invalidity may undermine Section 271(b)’s efficacy in deterring and remedying infringement.

The Supreme Court’s decision may be significant for future cases involving intent or knowledge standards as they relate to induced infringement.  If the Court affirms the Federal Circuit decision, alleged infringers accused of inducing others to infringe will have a new defense to induced infringement based on their own analysis of the validity of patent claims.  Critics of the Federal Circuit decision contend that an actual knowledge standard would drastically weaken the Patent Act’s provision of liability for inducing infringement and provide infringer’s with an escape hatch from liability. Further, opponents of the Federal Circuit decision argue that disproving a good faith belief would be very difficult to refute, since alleged infringers produce self-serving evidence.  On the other hand, supporters of the decision assert that actual knowledge is the appropriate standard and that a good-faith belief is just one piece of evidence to consider.