by Dennis Crouch
Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., No. 2022-1889 (Fed. Cir. Nov. 6, 2023) [decision]
The Federal Circuit’s bread-and-butter over the years has been claim constructions that often surprise or confuse district court judges. Part of the issue here is that most Federal Circuit judges have construed thousands of patents and are deeply immersed in the law of claim construction — while most district court judges see claim construction as a small part of a patent case, which itself is a small part of their overall docket. The other part of the issue, of course, is that no deference is given to the district court’s claim construction on appeal. The ensuing appeal then regularly turns out like that law school class where students seemed to provide really good answers in the Socratic game, but the professor could never resist tweaking — “almost right.”
The Actelion case involves a common situation where the patent claims include a measurement but do not state the level of precision, and the court is forced to decide whether values slightly outside the claimed range might be covered.
Actelion’s U.S. Patent Nos. 8,318,802 and 8,598,227 are directed to a new formulation of epoprostenol, a substance that naturally occurs in the human body and that is useful for treating cardiovascular diseases. The claims appear directed to a product-by-process — a freeze dried powder (lyophilisate) formed from a solution that contains epoprostenol and that “has a pH of 13 or higher.” Mylan’s ANDA proposes a generic version that would have a pH made from a solution with pH slightly under 13.
The question for claim construction is whether the requirement of “13 or higher” pH encompasses something akin to a pH 12.6. For abstract mathematicians, it is quite clear that 12.6 is less than 13 — the opposite of what is claimed. But, experimental scientists understand that a measurement of 12.6 might often be properly rounded to 13. The district court adopted Actelion’s proposed construction that “a pH of 13” includes values that round to 13, such as 12.5 and concluded that Mylan’s approach was infringing. Mylan argued on appeal that the term requires an pH of “exactly” 13 — not values that are about or approximately 13.
The Federal Circuit opinion walked through various factors to help it understand the proper construction. As the court has held, the analysis begins with the claim language, as it is of primary importance. Additionally, “the specification is always highly relevant to the claim construction analysis” and is often “the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
Claim Language: The court examined whether the language setting a lower limit of “13” precludes rounding or not. The claim is written as a whole number, rather than in decimal form. The district court noted that this involved “two significant figures’ without implying any higher level of precision.” At oral arguments, the patentee’s counsel explained:
[The inventor] did not say 13.0, which is a figure that would have 10 times the greater precision, and certainly didn’t say ‘exactly 13’, which is not scientifically possible in the context of pH, because you’re talking about measurement of billions of ions in a liter of water of hydrogen ions and determining their concentration.
Oral args at 18:00. On the other side, in places the specification appeared to equate 13.0 to the whole number 13.
Lack of Approximation Terms: The court noted that the claim lacks words like “about” that would imply approximation and that are often included within patent claims. As the court explained, “Unlike other claim terms, the disputed claim term lacks approximation language like ‘about.'”
Nature of pH Measurements: The court considered whether pH values can be measured precisely or inherently require some margin of error. The court noted Actelion’s argument that “it is not practically possible to measure exact pH values” because it would require counting every hydrogen ion in solution.
Specification: The specification alternately uses approximation terms like “about” or lacks decimal points when describing pH values. For example, the specification states the pH is “preferably adjusted to about 12.5-13.5, most preferably 13.” This shows the inventor knew how to use “about” to imply approximation, but did not for the “13” value. The statement also suggests that 12.5 is different from 13. As the court summarized, “the specification is inconsistent, also describing pH values like ‘13.0’, ‘11.58’, and ’13’ without clear precision.”
Prosecution History: During patent prosecution, the patentee had distinguished its invention from a formulation with pH 12 — arguing that pH 13 exhibited substantially more stability. But the prosecution history did not compare pH 13 with values in between 12 and 13. As the court explained, the examiner “drew a distinction between the stability of a composition with a pH of 13 and that of 12” but this did not address whether pH 13 includes values rounding to 13.
With claim construction, the Federal Circuit has ruled that courts can quite often construe claims based solely upon intrinsic evidence. But, at times courts are permitted to go further and access extrinsic evidence like scientific texts. Here, the Federal Circuit concluded that this is a case where extrinsic evidence is necessary to understand how a skilled artisan would view the claim language in terms of pH precision and significant figures. As the court explained, “this case is one where the proper claim construction cannot be reached without the aid of extrinsic evidence.” The appellate panel thus vacated the claim construction and infringement judgment and remanded for the district court to consider the extrinsic evidence like scientific textbooks and perhaps expert testimony in the process of reconsidering the claim construction.
The panel consisted of Circuit Judges Reyna, Stoll, and Stark. Circuit Judge Stoll authored the opinion.
= = =
This case highlights an issue that has led to claim construction disputes in numerous cases involving measurements and precision with billions of dollars turning on so-called rounding errors. The lack of clarity stems from applicants not specifying the precision or margin of error for claim terms either in the original application or during prosecution. This ambiguity could be avoided if the USPTO were to put the onus on patent applicants to identify the precision and error margin for any measurements recited in the claims. For example, the USPTO examiner could reject the claims as ambiguous based upon the broadest reasonable interpretation and require the applicant to clarify whether “a pH of 13” allows for values that round to 13 and if so, the acceptable variance (e.g. ± 0.1, ± 0.01 pH units).
Requiring patent applicants to explicitly identify the precision and error margin for measurements during prosecution would prevent the need for courts to resort to extrinsic evidence to resolve ambiguity that should have been addressed before issuance. This would increase certainty around claim scope and reduce unnecessary litigation.
What do you think, should the USPTO consider more ways to have applicants clarify claim term precision when filing and prosecuting applications involving numerical measurements?