The Indefinite Peril Of Claim Drafting

20 January 2021 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

As a non-precedential decision on claim construction, Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc., may not be relevant to any other case, but it caught my attention as an example of the perils of claim drafting. Claim language mirroring language in the specification that the examiner considered without difficulty during prosecution was held indefinite as being “nonsensical.”

The Claim Language At Issue

The claim language at issue is found in claim 1 of U.S. Patent No. 9,220,698, which is partially reproduced below with emphasis added:

1. A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis comprising orally administering to a patient in need thereof an AM unit dose form and … a PM unit dose form, wherein:

the AM and PM unit dose forms each comprises: naproxen, or a pharmaceutically acceptable salt thereof, in an amount to provide 500 mg of naproxen, and esomeprazole, or a pharmaceutically acceptable salt thereof, in an amount to provide 20 mg of esomeprazole; …
the AM and PM unit dose forms target:

i) a pharmacokinetic (pK) profile for naproxen where: a) for the AM dose of naproxen, the mean Cmax is … and the median Tmax is … and b) for the PM dose of naproxen, the mean Cmax is … and the median Tmax is …
ii) a pharmacokinetic (pK) profile for esomeprazole where: a) for the AM dose of esomeprazole, the mean area under the plasma concentration-time curve … is … b) for the PM dose of esomeprazole, the mean area under the plasma concentration-time curve … is … and c) the total mean area under the plasma concentration-time curve … is ….

The Claim Construction Issue

The claim construction issue on appeal focused on the highlighted clause, and what it meant for a “dose form” to “target” the recited pK profiles. As summarized in the Federal Circuit decision, both the patent owner and the accused infringers argued that it “has its ordinary meaning,” but the patent owner asserted that to be “produce,” while the accused infringers asserted that to be “with the goal of obtaining.”

The district court agreed with the accused infringers and found the meaning “‘set as a goal’ fit with the court’s understanding of what ‘target’ ordinarily means, with several dictionary definitions, and with claim 1 and the patent as a whole.” The district court then held the claims indefinite because, “pills cannot be said to set goals.” 

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Hughes and joined by Judges Moore and O’Malley.

The Federal Circuit reviewed the claim construction de novo, but agreed with the district court’s plain and ordinary mean of “target.” The court turned to the indefiniteness holding, and upheld that as well (with emphasis added and internal citations omitted):

One circumstance in which claims are indefinite is where the claims, as properly construed, are nonsensical. …. We agree with the district court that the “target” clauses of claim 1 render the claim indefinite because “[t]he fact that a goal is clearly defined does not mean that the act of targeting that goal is clearly defined, and this is the crux of the definiteness problem here.” …. As the district court explained, both clauses are incomprehensible. …. Reading the claim literally, a dose form, which is an inanimate object, cannot set a goal. That the proper construction of the claims is nonsensical does not warrant judicial redrafting of the claims.

Couldn’t a “nonsensical” claim construction be a sign that it’s the claim construction that’s invalid, not the claim?

The Perils of Claim Drafting

The claim language at issue, a dose form that “targets” the recited pK profiles, is used throughout the original specification without definition or explanation in the same context as the claims. Skimming the prosecution history, both the examiner and the applicant appear to have understood and applied the term as meaning “produces,” which also is used in the original specification a few times. Instead of accepting the patent owner’s argument that the parallel usage indicated “target” means “produce,” the Federal Circuit reached a contrary conclusion:

If anything, this suggests that the patent applicants were aware of their separate meanings and chose to use “target” in the patent claims instead of “produce.”

I think what bothers me most about this decision is that it appears both the applicant and the examiner applied the same meaning consistently during prosecution without difficulty (e.g., “produces” or “results in”). The richness* of the English language means most words have multiple “plain and ordinary meanings.” Any word may have a meaning that would be nonsensical in a given situation. To invalidate patent rights on this basis seems nonsensical.

*rich (adjective):
1. having a great deal of money or assets; wealthy.
2. plentiful; abundant.
3. producing a large quantity of something.
4. pleasantly deep or strong.
5. interesting because full of diversity or complexity.
6. causing ironic amusement or indignation.

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