Technology Information Law Blog by Charles Gideon Korrell

Tag: Enablement

  • Federal Circuit Overturns ITC’s Patent Ineligibility Ruling in US Synthetic v. ITC

    On February 13, 2025, the United States Court of Appeals for the Federal Circuit issued its opinion in US Synthetic Corp. v. International Trade Commission, a case involving key issues in intellectual property law, particularly the eligibility of patent claims under 35 U.S.C. § 101 and the requirements for enablement under § 112. The Federal Circuit reversed the ITC’s conclusion that certain patent claims were directed to an abstract idea and, therefore, ineligible for patent protection, marking a significant decision for patent law concerning material compositions.

    Case Background

    US Synthetic Corp. (USS) filed a complaint with the International Trade Commission (ITC) alleging that several companies had violated Section 337 of the Tariff Act (19 U.S.C. § 1337) by importing and selling products that infringed its U.S. Patent No. 10,508,502 (the ’502 patent). The patent in question covers a polycrystalline diamond compact (PDC), a material used in drilling and machining applications.

    After an investigation, the ITC determined that the asserted claims of the ’502 patent were directed to an abstract idea and were thus patent-ineligible under § 101. The ITC’s ruling was based on its conclusion that the patent claims were primarily focused on certain magnetic properties of the PDCs, which it considered to be merely the result of the manufacturing process rather than structural limitations of the claimed composition.

    USS appealed this determination, arguing that the ITC had misapplied the Supreme Court’s Alice test and that the patent claims were not abstract but instead directed to a specific, novel composition of matter.

    Federal Circuit’s Analysis and Ruling

    The Federal Circuit reversed the ITC’s finding of patent ineligibility and ruled in favor of USS. The court applied the Alice two-step test for determining patent eligibility:

    1. Step One: Are the Claims Directed to an Abstract Idea? The Federal Circuit found that the claims were not directed to an abstract idea but rather to a specific composition of matter. The court emphasized that the patent defines the PDC by its material composition, including diamond grains, catalyst properties, grain size, and certain magnetic properties. Because these characteristics inform a skilled artisan about the structure and physical properties of the PDC, the claims were not abstract.
    2. Step Two: Do the Claims Contain an Inventive Concept? Since the claims were not abstract under step one, the court did not need to proceed to step two. However, it noted that even if step two had been necessary, the claimed composition involved specific manufacturing parameters that resulted in improved material properties, which could qualify as an inventive concept.

    Enablement Under § 112

    In addition to patent eligibility, the intervenors argued that the claims were not enabled under § 112 because the patent did not adequately describe how to achieve the claimed properties without undue experimentation. However, the Federal Circuit upheld the ITC’s conclusion that the claims were enabled. The court found that the patent specification contained sufficient details on the manufacturing process and provided working examples that a skilled artisan could follow without undue experimentation.

    Key Takeaways for Intellectual Property Law

    1. Clarification on Patent Eligibility for Material Compositions
      • The ruling reinforces that claims defining specific material compositions—especially when tied to measurable properties—are not abstract ideas under § 101.
      • The decision pushes back against an overly restrictive view of patent eligibility that might otherwise exclude innovations in material science.
    2. Reaffirmation of the Enablement Standard
      • The Federal Circuit reiterated that the burden of proving non-enablement is on the party challenging the patent.
      • The court emphasized that some level of experimentation is permissible as long as it is not unduly extensive.

    Conclusion

    The US Synthetic v. ITC decision is a significant win for patent holders in the field of material science. It demonstrates that courts are willing to take a nuanced approach when assessing whether a patent is directed to an abstract idea, particularly in cases involving compositions of matter. Moreover, the ruling affirms that patents must provide enough information to enable a skilled artisan to practice the invention without undue experimentation, but they do not need to be exhaustive in their disclosures. This decision is likely to influence future litigation involving patent eligibility and enablement in the chemical and material sciences industries.

    By Charles Gideon Korrell

  • Federal Circuit Reverses Invalidity Finding for Novartis’ Entresto Patent

    On January 10, 2025, the Federal Circuit issued a significant decision in In re Entresto (Sacubitril/Valsartan) Patent Litigation, reversing a district court ruling that had found claims of Novartis’ U.S. Patent 8,101,659 (“the ’659 patent”) invalid for lack of written description. The appellate court affirmed the district court’s rulings that the patent was not invalid for obviousness or lack of enablement, solidifying Novartis’ ability to protect its blockbuster drug, Entresto®.

    This decision highlights several key patent law principles, particularly in the areas of written description, enablement, and obviousness. Here’s a breakdown of the major issues addressed by the court.

    1. Written Description – The Core Issue on Appeal

    The Federal Circuit reversed the district court’s finding that the ’659 patent lacked an adequate written description. The lower court had ruled that because the patent did not describe a valsartan-sacubitril complex, it failed the written description requirement. However, the Federal Circuit clarified that the claims did not specifically require such a complex—they covered valsartan and sacubitril administered in combination, not in a bound form.

    Key Takeaway:

    A patent’s written description must support what is actually claimed, not an unclaimed feature of the accused product. The court found that the patent sufficiently described the claimed combination therapy, even though it did not describe the later-developed valsartan-sacubitril complex.

    2. Enablement – The Patent Need Only Enable the Claimed Invention

    The district court had found that the ’659 patent enabled the claimed invention, and the Federal Circuit affirmed this conclusion. The court held that because valsartan-sacubitril complexes were unknown at the time of filing, Novartis was not required to enable them in its patent.

    Key Takeaway:

    Later-developed technologies cannot be used to argue that an earlier patent lacks enablement. If the claimed invention was enabled based on the state of the art at the time of filing, the patent remains valid.

    3. Obviousness – No Clear Motivation to Combine

    The court also upheld the district court’s ruling that the asserted claims were not obvious. The defendants (generic pharmaceutical manufacturers) argued that a person of ordinary skill in the art would have been motivated to combine an ARB (valsartan) and an NEP inhibitor (sacubitril) based on prior studies of similar drug combinations.

    However, the court found:

    • The prior art did not directly suggest combining valsartan with sacubitril.
    • Sacubitril was one of over 100 known NEP inhibitors in 2002, and it had never been tested in humans or animals for hypertension or heart failure.
    • The available studies on other NEP inhibitors showed discouraging results.

    Key Takeaway:

    Obviousness cannot be based on hindsight—just because an invention later proves effective does not mean it was obvious at the time of the patent filing.

    Conclusion: A Win for Novartis and Strong Patent Protection

    This decision strengthens Novartis’ patent protection for Entresto®, a drug with annual U.S. sales exceeding $3 billion. It reinforces the principle that:

    1. The written description requirement applies to what is actually claimed, not later-developed variants of the product.
    2. Enablement is judged based on what was known at the time of filing, not what was developed later.
    3. Obviousness must be based on clear motivation and reasonable expectation of success from the prior art.

    For pharmaceutical innovators, this case underscores the importance of careful patent drafting and robust litigation strategies. Meanwhile, for generic manufacturers, it highlights the challenges of proving invalidity when prior art does not clearly suggest the patented invention.

    By Charles Gideon Korrell