"wherein" the Money: Limiting, Inherent, or Aspirational?

• Publication year: 2019
• Author: D. Benjamin Borson

"Wherein" the Money: Limiting, Inherent, or Aspirational?

D. Benjamin Borson

Borson Law Group PC.

INTRODUCTION

Patent practitioners often draft claims containing "wherein" (or "whereby") clauses. Under USPTO practice, such clauses have been challenged by Examiners, requesting such phrases to be deleted from the claims. This has led to uncertainty about the usefulness of such clauses, and some practitioners have attempted to draft such clauses in ways that do not incur an objection.

In the case, Allergan Sales, LLC, Allergan, Inc. (Allergan), v. Sandoz Inc., Alcon Laboratories, Inc. (Sandoz), Slip Op. 2018-2207 (Fed. Cir. 29 August 2019), the issue has been somewhat clarified.

Allergan is the owner of U.S. Patent No. 9,770,453 (the '453 patent) entitled "Combination of Brimonidine and Timolol for Topical Ophthalmic Use," which claims ophthalmic treatments for glaucoma or ocular hypertension, under the trade name Combigan®. Allergan also owns U.S. Patent No. 9,907,801, and 9,907,802. All three of Al-lergan's patents share the same specification. For simplicity, this article will address the '435 patent, although the holdings are similar for the other two patents.

Claim 1 of the '435 patent recites:

1. A method of treating a patient with glaucoma or ophthalmic hypertension comprising topically administering twice daily to an effected eye a single composition comprising 0.2% w/v brimoni-dine tartrate and 0.68% w/v timolol maleate, wherein the method is as effective as the administration of 0.2% w/v brimonidine tar-trate monotherapy three times per day and wherein the method reduces the incidence of one or more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily. Slip. Op. at page 4; italics in original.

Sandoz filed an Abbreviated New Drug Application (ANDA) to market a generic version of Allergan's composition, thereby infringing the patents in suit, including the '435 patent. Sandoz asserted that the "wherein" clauses did not constitute claim limitations, but rather represented only "intended uses" and that the recited results are not "material to patentability," and therefore, the claims were invalid as obvious. Id. at 6.

DISTRICT COURT DECISION

Senior Judge William H. Walls, writing for the District Court for the District of New Jersey (No. 2:17-cv-10129-WHW-CLW), "found that the 'wherein' clauses are limiting because they are material to patentability and express the inventive aspect of the claimed invention," viz., "Combigan*'s ability to reduce daily administrations from TID [three times daily] to BID [twice daily] without a loss of efficacy, and with reduced adverse events." Id.

As a result, Judge Walls held the claims not invalid and issued a preliminary injunction stopping Sandoz from selling its competing composition.

APPEAL: MAJORITY OPINION

On appeal, Sandoz disputed the District Court's construction, arguing that: "(1) the 'wherein' clauses 'merely state the intended results of administering Combigan® twice daily,' and (2) the recited results are not 'material to patentability.'" Id.

Writing for the panel (Prost, Newman, and Wallach), Judge Wal-lach agreed with the District Court's decision, based in part on the specification of the '435 patent.

The specification explains that the combination is preferably formulated as 0.01 to 0.5 percent by weight brimonidine and 0.1 to 1.0 percent by weight timolol solution in water at a pH of 4.5 to 8.0, e.g., about 6.9.... The specification states, however...