USA - TEXAS Trends and Developments Contributed by: Danielle Healey and Matthew David, Spencer Fane LLP
because it addresses whether lump sum licenc- es covering multiple patents can be disaggre- gated into per-patent royalty rates for damages calculations and the standards damages experts must meet. The case arises from a long-running dispute over smart thermostat technology. EcoFactor alleged that Google’s Nest thermostats infringed its pat- ents. At trial, EcoFactor’s expert presented a damages model that derived a per-unit royalty from three broad licensing agreements, which included the asserted patent. Google chal- lenged the damages methodology, arguing that the expert’s approach lacked proper apportion- ment and failed to account for the value of non- asserted patents covered by the same licences. The Federal Circuit will determine whether dis- trict courts should treat the reliability of expert testimony as a threshold issue of admissibility under Daubert or leave it to the jury to assess its weight. The Intellectual Property Owners Asso- ciation (IPO), in its amicus brief, argued that the reliability of expert testimony should be treated as an issue of admissibility and not leave reli - ability to the weight of the testimony for the jury. Key takeaways: • The decision may raise the standard for expert testimony and necessitate the use of more exacting procedures when calculating royalties from similar licences. • If the Federal Circuit strengthens the Daubert gatekeeping function, expect an increase in pretrial challenges to damages experts. • To prevent issues in litigation later, companies involved in licensing negotiations may need to make sure that licence agreements specify patent-by-patent valuation.
With oral arguments scheduled for early 2025, EcoFactor could become one of the defining cases of patent damages in the coming years. Problems for pharma patent disclosures: Amgen Inc. v Sanofi In the case of Amgen Inc. v Sanofi, the Supreme Court reaffirmed the principle that broad claims necessitate equally broad disclosures. Amgen sought to protect a genus of antibodies while disclosing only a handful of examples, relying on a roadmap approach to permit skilled artisans to figure out the rest. But the Court was unper- suaded. It held that the enablement requirement demands more than just a conceptual roadmap – patentees must enable the full breadth of their claims. The Federal Circuit wasted no time in apply- ing this ruling to Baxalta Inc. v Genentech, Inc. There, the panel invalidated claims in another antibody patent, reasoning that the so-called roadmap approach left skilled artisans no bet- ter equipped to practise the full scope of the invention than the original inventors had been. The decision in Baxalta heightens the challenge for biotech companies seeking broad antibody claims, demanding a shift toward more precise and well-supported disclosures. Key takeaways: • Broad genus claims are increasingly risky without correspondingly detailed support in the disclosure. • Patent drafters should focus on experimental data and comprehensive, detailed disclosures to better withstand enablement challenges. Patent term adjustments and double patenting: Allergan v MSN Labs In Allergan v MSN Labs, the Federal Circuit expressed that a first-filed, first-issued, later-
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