Tag Archives: Intellectual Property

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.

USPTO Issues New & Revised Guidance on Patent Eligibility Under 35 USC § 101

The United States Patent and Trademark Office (USPTO) has issued revised guidance to its examiners relating to determination of patent eligibility under 35 U.S.C. §101. This “Interim Guidance” provides more specific advice for evaluating claims directed to any technical field, but is of particular relevance to patent applications includes “nature-based” and biotechnology technologies. The previously issued guidelines included a multifactor approach which resulted in a great deal of uncertainty about the appropriate standard for examination of “nature-based” products.  While no bright line rule yet exists, the newly issued Interim Guidance does provide a simpler two-step analysis framework for consideration of issues related to patent eligibility.

In 2014, the USPTO has issued to its examination corps two sets of examination instructions relating to patent eligibility under §101. First, on March 4, 2014, the USPTO issued a “Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” (the “Myriad-Mayo Guidance”).  Earlier this week, on December 16, 2014, the USPTO issued new Guidance on Patent Subject Matter Eligibility (the “Interim Guidance”) that supersedes the Myriad-Mayo Guidance.

The Myriad-Mayo Guidance received overwhelming public criticism and the USPTO itself admitted that that it raised several controversial issues while being unnecessarily broad. The Interim Guidance was long-anticipated by practitioners in the biological and pharmaceutical arts, as the complicated framework of the Myriad-Mayo Guidance is now replaced by a more straightforward analysis.  According to the Interim Guidance, patent eligibility of a claim including a nature-based product is determined under a two-step test.

1st step

First, an examiner determines whether the claim is directed to “a product of nature” exception (e.g., a law of nature or a naturally occurring phenomenon). This analysis requires comparing the nature-based product in the claim to its naturally occurring counterpart (or a closest naturally occurring counterpart) in its natural state to identify “markedly different” characteristics based on structure, function, and/or properties. Even a small change can render the claimed nature-based product “markedly different.” The Interim Guidance notes that “[c]are should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not nature-based” and directs examiners to utilize a streamlined analysis approach “[f]or claims that recite a nature-based product limitation (which may or may not be a ‘product of nature’ exception) but are directed to inventions that clearly do not seek to tie up any judicial exception. In such cases, it would not be necessary to conduct a markedly different characteristics analysis.”

Functional Differences May Avoid 2nd Step

The Interim Guidance addresses some difficulties identified in public comments regarding the “markedly different” analysis. In particular, the Interim Guidance specifies that “functional characteristics and other non-structural properties can evidence markedly different characteristics.” In the prior Mayo-Myriad Guidance, “only structural changes were sufficient to show a marked difference.” Now, a claim directed to a “nature-based product” can avoid the “significantly more” analysis of the 2nd step if the claimed product has any “markedly different” characteristics from the naturally occurring product, where “structure, function, and/or other properties” are to be considered when making the “markedly different” determination.

One example presents a purified protein as being patent eligible because there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart. Moreover, the Interim Guidance states that “[w]hen the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination rather than its component parts.” Thus, a combination of nature-based products may be patent-eligible if it has markedly different characteristics than any naturally occurring counterparts of the combination or the individual components.

Process Claims

Moreover, the Interim Guidance excludes a process claim from the markedly different analysis for nature-based products used in the process, “except in the limited situation where a process claim is drafted in such a way that there is no difference in substance from a product claim (e.g., ‘a method of providing an apple.’).”  This is a welcome change from the previous guidance such that that process claims usually will not raise eligibility issues for reciting nature-based products.

2nd Step

Only if no “markedly different” characteristics are found, the analysis proceeds to the second step of determining if the claim recites additional elements that amount to “significantly more” than the judicial exception when the elements of the claim, considered both individually and as an ordered combination. The “significantly more” finding is based on what has been termed as an “inventive concept” based on the Supreme Court’s Alice decision.  The guidance emphasizes that “[i]ndividual elements viewed on their own may not appear to add significantly more … but when combined may amount to significantly more than the exception.”

Furthermore, when rejecting a claim during examination, the Examiner is asked to “identify the exception by referring to where it is recited . . . in the claim and explain why it is considered an exception. Then, if the claim includes additional elements, identify the elements in the rejection and explain why they do not add significantly more to the exception.” Thus, the Interim Guidelines provide that “[i]f there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible.”

Conclusion

While the additional examples in the Interim Guidance of limitations provide a simpler scheme, it does not provide a bright line test for what is and is not patent eligible. Such a bright line rule appears unlikely to be forthcoming from the courts in the near future. Patent practitioners and applicants can take some comfort, however, in the broader base of potential arguments available for rebutting a rejection based on alleged lack of patent eligibility. A study on patent applications released this summer by BIO and Bloomberg BNA found that roughly 40% of reviewed claims similar to the ones under scrutiny in Mayo and Myriad received a Section 101 rejection.  However, under the Revised Guidance, some of these rejected claims would be patentable subject matter.

The take away for practitioners and applicants is to present claims that highlight such features and/or that truly add meaningful limitations recited in a manner that does not give the appearance of precluding any way of practicing a concept that is amenable to characterization as one of the judicial exceptions. The new analysis focuses on the claims as a whole and on the “markedly different” properties of the claimed subject matter as compared to the natural counterpart product. However, the Interim Guidance provides what appears to be a more workable framework. While the Interim Guidance may be helpful to many applicants with claims involving natural products, it does not provide much discussion of diagnostic or personalized medicine method claims. The USPTO may be waiting for further guidance from the Federal Circuit on these types of claims, and until then includes only the Prometheus claims in its examples.