Abstract
In 2013, the US Court of Appeals for the Federal Circuit (Federal Circuit) and the US Supreme Court together issued a large number of opinions related to questions of patent law, many of which are relevant to the biotechnology industry. One of the important and controversial issues that the Supreme Court addressed was the patent eligibility of isolated DNA in Association for Molecular Pathology v. Myriad Genetics, Inc. 1 Other important issues addressed by the Federal Circuit in 2013 were written description, indefiniteness, and anticipatory public use. In this article, we discuss some of the significant decisions relating to these issues, with the exception of the Supreme Court's Myriad decision, which was reviewed at length in previous articles in this journal. 2,3
Written Description
In Novozymes v. DuPont, the Federal Circuit held that Novozymes' (Bagsvaerd, Denmark) patent on specific mutant alpha-amylase enzymes with improved thermal stability was invalid because it did not sufficiently describe the claimed mutant enzymes. 4 While all of the claim elements were described separately in the patent, the claimed combination of those elements was not disclosed anywhere in the patent. Novozymes had done significant research to alter the protein sequences of various wild-type alpha-amylase enzymes to identify mutant enzymes with enhanced thermal stability. This work led to the discovery of numerous different mutant enzymes and Novozymes filed a patent application that covered these mutants and described the methods by which they could be made and tested. In addition to listing seven specific wild-type enzymes that could be mutated, the patent application also disclosed 33 specific amino acid positions in these enzymes that could be altered to provide improved thermal stability, as well as test data for 16 of these locations. As is typical, the patent application noted that mutations at any one or more of these locations should provide the desired results. However, the patent application did not indicate which locations or types of mutations were preferred.
DuPont (Wilmington, DE), through its own extensive research, tested 1,500 different alpha-amylase mutants and developed a specific mutant enzyme with improved thermal stability, for which DuPont received its own patent. As it turned out, DuPont's mutant enzyme was based on one of the seven wild-type enzymes and included an amino acid substitution in one of the 33 locations noted in Novozymes' patent application. However, Novozymes' patent application did not actually list DuPont's specific mutation. Nevertheless, when Novozymes found out about DuPont's new mutant enzyme, it did what many patent owners do; it filed a continuation application that included claims carefully drafted to cover DuPont's mutant enzyme. The claims recited three elements: DuPont's specific wild-type enzyme; the specific amino acid location of DuPont's mutation; and improved thermal stability. Thus, the claims, while seemingly narrow, were broad enough to cover DuPont's mutant, and Novozymes sued DuPont the day the patent issued.
Novozymes initially won at trial, because the jury held that the patent was valid and infringed, and it awarded $18 million to Novozymes. However, in response to a motion filed by DuPont, the District Court held that as a matter of law the jury had made a mistake, and that Novozymes' patent was invalid for lack of written description. The Federal Circuit affirmed the decision, because the patent fails to disclose any of the species covered by the issued claims.
At trial, DuPont had demonstrated that 13 of 19 different amino acid substitutions (including Novozymes' example of a tryptophan substitution) at the specific location of DuPont's mutant failed to provide a mutant with increased thermal stability. In contrast, DuPont's glutamine substitution worked very well. This data cast doubt on Novozymes' statements in its patent that any substitutions at any of the specified 33 locations would produce mutants with increased thermal stability.
The Federal Circuit carefully considered Novozymes' claims and acknowledged that the three elements recited in the claims were individually supported in the patent, but found that they were never described anywhere in the patent in combination. Furthermore, the patent failed to list even a single mutant enzyme that met all three of the required claim elements. Thus, the court concluded that Novozymes' application provided nothing more than a “roadmap,” which left the actual inventive work to industry to finish an unfinished invention. The court held that nothing in the patent indicates that Novozymes possessed at the original filing date what it ultimately claimed in the patent, and thus the patent is invalid for lack of written description under 35 U.S.C. §112, first paragraph.
The Novozymes case is a clear indication that the US courts are taking a more restrictive view of the common practice of filing continuation applications with claims crafted to cover either a competitor's product or improvements by the patentee that may have been made well after an original patent application is filed. The European Patent Office has been quite strict on such support issues for many years, and perhaps the US courts are now starting to follow a similar approach. As a result, one should carefully consider continuation claims to ensure they are adequately supported both generally and specifically in the application, and when drafting original applications it is important to describe many different combinations and sub-combinations of the essential elements of the invention that might be useful to support future claims.
Indefiniteness
The Federal Circuit dealt with the issue of indefiniteness in many decisions in 2013, but two decisions of particular relevance are Teva v. Sandoz and Biosig v. Nautilus.
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In Teva v. Sandoz, the Federal Circuit reversed the Southern District Court of New York's holding that the term “molecular weight” was not indefinite under § 112, second paragraph. The claims at issue in Teva v. Sandoz were split into two different groups. Claim 1 of US Patent No. 5,981,589 (‘589 patent) is representative of the Group I claims asserted by Teva (Petah Tikvah, Israel; emphasis added)
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: 1. Copolymer-1 having a reacting protected copolymer-1 with hydrobromic acid to form trifluoroacetyl copolymer-1,…and purifying said copolymer-1, to result in copolymer-1 having a molecular weight of about 5 to 9 kilodaltons.
Claim 1 of US Patent No. 6,054,430 (‘430 patent) is representative of the Group II claims asserted by Teva (emphasis added)
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: 1. Copolymer-1 having over
In the District Court, the judge denied Sandoz's motion for summary judgment that the claims were invalid for indefiniteness. 9 Sandoz appealed the finding that the claims were not indefinite based on two main arguments: that the term “molecular weight” can refer to different measures including peak (Mp), weight-average (Mw), and number-average (Mn) molecular weight 10 ; and Teva inconsistently defined “molecular weight” as Mw and Mp during prosecution of two of the familial patents. 11 Teva countered by arguing that the term “molecular weight” in their claims should be construed as “Mp” and that the specification resolves any ambiguity in the meaning of the term as the specification refers to size exclusion chromatography, which is relevant for determining “Mp.” 12
The Federal Circuit held that the Group I claims that only specify “molecular weight” are invalid as being indefinite, because “their plain language does not indicate which average molecular weight is intended” and “Teva's attempt to resolve the ambiguity hinges in part on the prosecution history….but two of its prosecution statements directly contradict each other and render the ambiguity insoluble.” 13 The Federal Circuit also held that the description of size exclusion chromatography methods in the specification did not solve the ambiguity of the term “molecular weight” as based on testimony by an expert during trial: “[size exclusion chromatography] does not exclusively provide Mp – both Mn and Mw can also be obtained from the data generated by the…[size exclusion chromatography] method after some calculations.” 14
In contrast, the Federal Circuit held that the Group II claims that referred to “the percentage of copolymer-1 molecules in a sample falling within an arbitrarily set molecular weight range” were not indefinite. 15 The Federal Circuit reasoned that “the numbers that set the boundaries of that range…[such as 2 kDa and 20 kDa in claim 1 of the ‘430 patent above], refer to precise points on the ‘Molecular Weight’ axis, rather than to statistical properties of the molecular weight curves….and therefore, the scope…is thus readily ascertainable.” 16
Teva v. Sandoz stresses the importance of making consistent arguments and statements during prosecution of a patent application, and even within different applications in the same patent family. In addition, Teva v. Sandoz highlights the importance of consistently using and clearly defining specific terms recited in the claims of a patent, especially if the term can have different meanings within the field.
Biosig v. Nautilus is another 2013 Federal Circuit decision relating to the issue of indefiniteness. In this decision, the Federal Circuit held that the phrase “spaced relationship” was not indefinite under 35 U.S.C. § 112, second paragraph. US Patent No. 5,337,753 (‘753 patent) at issue in this case has claims directed to a heart rate monitor associated with an exercise apparatus.
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Claim 1 is representative (emphasis added): 1. A heart rate monitor for use by a user in association with exercise apparatus and/or exercise procedures, comprising: an elongate member;… said elongate member comprising a first half and a second half; a first live electrode and a first common electrode mounted on said first half in a a second live electrode and a second common electrode mounted on said second half in
This case was appealed to the Federal Circuit by Biosig (Champlain, NY) after the District Court held the claims invalid as being indefinite under § 112, second paragraph. 18 The District Court found that the term “spaced relationship” was indefinite, because “a spaced relationship did not tell me or anyone precisely what the space should be….[n]or whether the spaced relationship on the left side [the first half] should be the same as on the right side [the second half].” 19
As an initial matter, the Federal Circuit reiterated the standard that “if reasonable efforts at claim construction result in a definition that does not provide sufficient particularity and clarity to inform skilled artisans to the bounds of the claim, the claim is insolubly ambiguous and invalid for indefiniteness.” 20 The Federal Circuit also noted that in determining the indefiniteness of a claim term, a court can review the claim language, the specification, and the prosecution history of the corresponding patent application, as well as extrinsic evidence. 21 Upon reviewing the specification and figures of the patent and the knowledge of those in the field, the Federal Circuit reversed the District Court and held that the term “spaced relationship” was not indefinite.
As the basis for this decision, the Federal Circuit stated that based on the figures and the description in the patent, “it is not feasible that the distance between the live and common electrodes be infinitesimally small, effectively merging the live and common electrodes into a single electrode with one detection point,” while on the other hand “the distance between the live electrode and the common electrode cannot be greater than the width of the user's hands because claim 1 requires the live and common electrodes to independently detect electrical signals at two distinct points of a hand.” 22 In addition, the Federal Circuit considered that the recitation of the function of the claims in the specification was “highly relevant in ascertaining the proper bounds of the ‘spaced relationship’ between the live and common electrodes.” 23 The Federal Circuit also considered the level of knowledge in the art, noting that “a skilled artisan could apply a test and determine the ‘spaced relationship’ as pertaining to the function…” and that “the fact that some experimentation may be necessary to determine the scope of the claims does not render the claims indefinite…” 24
Biosig v. Nautilus indicates that courts will review the function of the patent claims as well as extrinsic evidence to determine whether a claim term is “insolubly ambiguous” and invalid under §112, second paragraph. Nautilus (Vancouver, WA) appealed the Federal Circuit decision, and the Supreme Court granted certiorari on two issues: whether the Federal Circuit's acceptance of ambiguous patent claims with multiple reasonable interpretations, so long as the ambiguity is not “insoluble” by a court, defeats the statutory requirement of particular and distinct patent claiming under §112, second paragraph; and whether the presumption of validity dilutes the requirement of particular and distinct patent claiming under §112, second paragraph. 25 If the Supreme Court reverses the Federal Circuit's standard for proving indefiniteness, many patent claims may be more vulnerable to invalidity challenges under §112, second paragraph, at the claim construction stage.
Anticipatory Public Use
In Pronova v. Teva, the Federal Circuit held that the submission of samples of a patented fish oil supplement by the patent owner to a third party before filing a patent application without any restrictions on use constituted a “public use” of the claimed invention, thus invalidating the patent. 26
Pronova (Oslo, Norway) owns a patent covering a prescription fish oil product that it sells under the Lovaza® name. Pronova had FDA approval to market Lovaza® as a treatment to reduce triglyceride levels. Teva wanted to get into this lucrative market and so filed an ANDA with the FDA to obtain permission to market a generic version of Lovaza®. Based on this ANDA filing, Pronova filed suit against Teva for patent infringement. Teva countered that a prior public use should invalidate the patent. The District Court found that all prior uses were experimental and thus not barring “public uses,” and further that for a use to be a “public use” it had to be for the purpose identified in the patent, and no such use occurred in this case. Thus, the court held that the patent was not invalid and would be infringed if Teva commenced sales of a generic product.
Teva appealed the decision to the Federal Circuit, asserting that Pronova's predecessor had submitted samples of the claimed fish oil product to a professor for analysis well before the patent application had been filed. Teva further argued that the samples met all the claim limitations and that the professor had no restrictions on his use of the samples. In fact, the professor had actually analyzed the samples and so, according to Teva, his testing was a prior public use that invalidated the patent even though he had not tested whether the samples could reduce triglyceride levels.
The Federal Circuit first confirmed the law that a barring public use under 35 U.S.C. §102(b) exists where before the earliest effective filing date of a patent the invention is (1) in public use by either public access or commercial exploitation, and (2) is “ready for patenting,” which means that the invention was either reduced to practice or sufficiently described and/or illustrated to enable others of skill in the relevant field to practice the invention. Next, the court found that the invention was clearly ready for patenting, and that the samples were sent to the professor with no confidentiality or other restrictions. In addition, the samples were sent with a detailed analysis of the components of the fish oil product, and the professor did in fact analyze the samples. Thus, the submissions put the complete invention into public use and it did not matter that the professor did not make the same use recited in the patent. As a result, the patent was invalid under § 102(b).
The lesson to be learned from this case is simple–before you file a patent application be very careful with any submissions of your invention to third parties and maintain confidentiality and control over any uses, not just uses defined or described in your patent application. Better yet, file your patent application before any public uses of your invention. In specific cases in which testing of a product may be done by a third party before you file your patent application, make sure that a representative of the third party signs a confidentiality agreement and reports the results back to you, and also that no one involved in the testing receives any details of the invention if they are not also required to sign a confidentiality agreement.
Take-Away Lessons
The cases discussed above provide several lessons to those filing and prosecuting biotechnology patent applications in the US. It is important to avoid making inconsistent comments during prosecution to help preclude an indefiniteness challenge in court. Another strategy to address an indefiniteness rejection/challenge of a composition claim, at least in part, is to point to a description of the function of the composition in the specification.
To avoid a future written description rejection, it can be beneficial not only to ensure that your claims are adequately supported in the patent, but to provide specific, explicit support in the patent specification for both combinations and sub-combinations when drafting new applications. Finally, to avoid a non-intentional anticipatory public use by third party collaborators, one should take steps to maintain confidentiality and control over the activities of any such collaborators.