This is part of a series of articles discussing recent orders of interest issued in patent cases by the United States District Court for the District of Massachusetts.
In Videray Technologies Inc., et al. v. Viken Detection Corp., No. 1:23-cv-13035, Magistrate Judge Boal granted in part Plaintiffs' motion to compel supplemental interrogatory responses. In relevant part, the Court found:
- Interrogatory responses relying on Federal Rule of Civil Procedure 33(d) must actually "identif[y] the documents from which the answer can be derived";
- Facts underlying a patentee's determination that an individual is an inventor on a provisional application but not an inventor on the patents-in-suit are not privileged;
- A request for information about conception "on a claim-by-claim and element-by-element" basis is not "nonsensical" and must be answered at least as to conception of the claims.
The Court ordered supplementation as to these topics within two weeks and declined to award sanctions.
In Radius Health, Inc., et al. v. Orbicular Pharmaceutical Technologies Pvt. Ltd., No. 22-11546-RGS, following a ten-day bench trial, Judge Stearns found two claims of one patent invalid as obvious, and the remaining asserted claims of that and four other patents valid over Defendant's allegations of obviousness and invalidity under 35 U.S.C. § 112.
The case is a Hatch-Waxman litigation arising from Defendant's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Radius's osteoporosis drug, Tymlos. Plaintiffs co-developed the drug and alleged infringement of five patents covering various aspects of the Tymlos dosage and formulation.
Two issues were tried: (1) whether disputed claims of the '382, '333, and '444 patents were invalid as obvious; and (2) whether disputed claims of the '208 and '041 patents were invalid for lack of enablement or written description.
Obviousness
The Court found two claims of the '333 patent invalid as obvious.
- Claim 2 of the '333 patent is directed to a storage stable abaloparatide formulation with a pH of 5.1. The Court agreed with Defendant that prior art references and general knowledge would lead a skilled artisan to reasonably expect stability at this pH. The Court considered several types of objective evidence of nonobviousness presented by Plaintiff, but rejected all except long-felt need for lacking a nexus to the claim. Ultimately the Court concluded the claim was obvious despite Plaintiff's evidence of long-felt need.
- Claim 11 of the '333 patent is directed to the use of 5 mg/mL of phenol as a preservative in an abaloparatide formulation. The Court found that phenol was a widely used antimicrobial, and that the prior art recommended its use at similar concentrations. Further, Plaintiff's evidence of secondary considerations did not show nonobviousness. It was not unexpected that 5 mg/mL of phenol would work (i.e., no unexpected results), and with respect to the remaining secondary considerations evidence Plaintiff again failed to establish a nexus to the invention.
The remaining challenged claim of the '333 patent, as well as all disputed claims of the '382 and '444 patents, were found valid over Defendant's obviousness challenge.
- Claim 13 of the '333 patent covers a storage stable abaloparatide formulation without a chemical stabilizer. Abaloparatide is a PTHrP analog, and Defendant's obviousness challenge relied on a prior art patent disclosing a generic formulation for a PTHrP analog that does not contain a chemical stabilizer. The Court rejected Defendant's obviousness challenge finding that a skilled artisan would not reasonably expect stability without a chemical stabilizer at least in part because the prior art patent did not disclose stability data for the recited formulation or mention abaloparatide.
- Claim 7 of the '382 patent and claims 20, 34, and 57 of the '444 patent relate to a dosage of 75-80 µg of abaloparatide. Defendant argued that doubling the 40-µg maximum dosage of teriparatide disclosed in a prior art drug label would be obvious in light of a prior art abstract, which reported a twofold potency benefit of abaloparatide over teriparatide based on animal studies. The Court disagreed, citing several reasons including that teriparatide and abaloparatide share only 40% sequence similarity and animal studies are not always predictive of human outcomes. Further, the Court pointed out that the authors of the prior art abstract had elsewhere concluded that higher potency might allow for lower dosages, not higher. The Court thus found that Defendant failed to show that the claimed dosage was obvious.
Section 112
Defendant challenged claims of the '208 and '041 patents, arguing that the patents fail to enable a skilled artisan to practice the invention without undue experimentation because they do not disclose how to formulate abaloparatide API with the requisite purity levels. The Court rejected this argument, finding that the challenged claims could be practiced without knowing how to formulate. The Court noted that the claims are directed to a formulated drug product whose suitability was established by quantifying the beta-Asp10 impurity, and that the specification expressly describes two methods for doing so. Further, the specification teaches storage conditions to minimize formation of the beta-Asp10 impurity.
Defendant's written description challenge mirrored its enablement argument. The Court found that the specification adequately described the claimed invention and rejected the challenge for the same reasons.
Accordingly, the Court ruled that claims 2 and 11 of the '333 patent were invalid as obvious, but upheld the remaining asserted claims.
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