Intrinsic Evidence Trumps Plain and Ordinary Meaning
In Astrazeneca Ab v. Mylan Pharmaceuticals Inc., Appeal No. 21-1729, the Federal Circuit held that for purposes of claim construction, intrinsic evidence can trump the plain and ordinary meaning of scientific conventions such as significant figures.
AstraZeneca AB and AstraZeneca Pharmaceuticals LP (collectively, “AstraZeneca”) sued Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. (collectively, “Mylan”) for infringement of patents directed to a pressurized metered-dose inhaler that administers a stable formoterol/budesonide pharmaceutical. The district court construed the term “0.001%” in the limitation “PVP K25 is present at a concentration of 0.001% w/w” according to its “plain and ordinary meaning, that is, expressed with one significant digit” (i.e., encompassing a concentration of PVP K25 in the range of 0.0005% to 0.0014%). Mylan then stipulated to infringement and the district court entered final judgment of infringement.
The Federal Circuit held the district court erred in its claim construction and vacated and remanded the infringement holding. The Federal Circuit stated that while the plain and ordinary meaning was based on scientific convention, the intrinsic evidence (i.e., written description and prosecution history) placed considerable emphasis on formulation stability and thus supported the narrower construction of “‘0.001%’ as [a] precise number, with only minor variations, i.e., 0.00095% to 0.00104%.” For example, the written description showed the inventors understood that a formulation comprising 0.001% w/w PVP K25 is more stable than a formulation with even a slight difference in the concentration (e.g., 0.0005% w/w PVP K25). Furthermore, over the course of the prosecution history, the patentees narrowed the concentration of PVP K25 to 0.001% w/w from a broader range without using the qualifier “about” in order to “emphasiz[e] to the Examiner that 0.001% w/w PVP K25—not concentrations slightly more or less than 0.001% w/w—was critical to stability of the formulation.”
Judge Taranto dissented in part, arguing that, “0.001%” should be construed to have its significant figure meaning with one “possible interval-shrinking change” that ultimately would not disturb the previous finding of infringement.
(Pharmaceuticals, Claim Construction, Invalidity; Prepared by Alexander Zeng)
Limitations in Claim Language Frame Reasonable Expectation of Success Analysis
In Teva Pharmaceuticals USA, Inc., v. Corcept Therapeutics, Inc., Appeal No. 21-1360, the Federal Circuit held that limitations, such as specific drug doses, in claim language can impact the application of the reasonable expectation of success analysis for obviousness.
Teva sought a post-grant review of the claims of Corcept’s patent. The claims were generally directed to a method of treating Cushing’s syndrome that involved a co-administration of drugs. Teva argued that the claims were obvious. The prior art materials disclosed information related to drug-drug interaction. The PTAB found that Teva failed to show that the claims would have been obvious because Teva failed to show that a skilled artisan would have had a reasonable expectation of success for safe co-administration of the drugs. Teva appealed and argued that the PTAB misapplied the law relating to obviousness. Teva argued that the PTAB required precise predictability, rather than a reasonable expectation of success.
The Federal Circuit affirmed the PTAB’s decision. The Federal Circuit stated that “[t]he reasonable expectation of success analysis must be tied to the scope of the claimed invention.” In the present case, the claim was construed to require safe administration of a specific amount of mifepristone, and thus, the PTAB was required to frame its reasonable-expectation-of-success analysis around that specific dosage. The Federal Circuit found that Teva had failed to prove that a skilled artisan would have expected co-administration of the claimed dosage of mifepristone with a strong inhibitor to be safe, and that the PTAB had not required precise predictability.
(Pharmaceuticals; Obviousness; Prepared by Paige Cappelli)