In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic (PK) properties were recited. The opinion supports the court’s summary judgement of invalidity of the patents.
The VIMOVO® Patents At Issue
The VIMOV® patents at issue in this decision were U.S. Patent Nos. 9,220,698 and 9,393,208, which claim methods of treating, e.g., osteoarthritis or rheumatoid arthritis, by administering “AM” and “PM” unit dose forms comprising naproxen and esomeprazole, wherein the AM and PM unit dose forms “target” certain pharmacokinetic profiles, such as certain Cmax, Tmax, and mean plasma concentration AUC levels.
Indefiniteness Of “Target” PK Values
The court first considered whether the “target” clauses were limiting or merely recited intended results of the claimed methods. On this issue, the court determined that the Applicant’s reliance on these features during examination to distinguish prior art required that they be given weight.
Turning to the indefiniteness issue, the court applied its construction of the term “target” as meaning “set as a goal,” and found the claims indefinite. Indeed, reading the opinion begs the question whether that claim construction doomed the claims from the outset.
The court reasoned:
The fundamental difficulty is that both key phrases here are incomprehensible: “the AM and PM unit dose forms target:” and “the AM and PM unit dose forms further target.” It is not possible to comprehend what these phrases mean, because pills cannot be said to set goals. In ordinary usage, we understand a goal to be something that people, or perhaps living creatures, set; inanimate objects set no goals.
According to Judge Chesler, because target” was construed to mean “set as a goal,” and because the claims recite that the dosage forms “target” the recited PK parameters, the claims are “incomprehensible” because dosage forms cannot set goals.
Even putting that particular conundrum aside, the court noted, “The problem here is that the target clauses fail to draw clear boundaries.” That is, the court could “see no way that defining the goals for a method can, without more, inform the public of how to act to avoid infringement.”
The court found that the Patentee’s arguments treated “target” as meaning “produce,” which was inconsistent with the claim construction and therefore unhelpful (or, in the court’s words, “defective”).
Thus, the court concluded that the claims, “read in light of the specification delineating the patents, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention,” and therefore are invalid as indefinite.
Why “Target” PK Values?
The “target” language at issue in this case is found in the original claims, and appears throughout the patent specifications without express definition or direct explanation. It is possible that this terminology was chosen with the knowledge that not every administration of the claimed AM and PM dose units would achieve the recited PK parameters in every patient. Unfortunately for the Patentees here, the court rejected their argument that “target” should be construed as “produce,” which also foreclosed their arguments that the recited PK parameters were average values obtained across a group of patients.
In parallel Inter Partes Review proceedings, the USPTO Patent Trial and Appeal Board constructed “target” as “have or set the goal of obtaining.” Would the “have” aspect of that construction left room for a different result here?