Merck Sharp & Dohme LLC, MSD International GmbH, MSD International Business GmbH, and AIC246 AG & Co. KG v. DUS Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited

Summary

The United States District Court for the District of New Jersey construes disputed terms in U.S. Reissued Patent No. RE 46,791, relating to letermovir and antiviral treatment of cytomegalovirus. The court adopts Plaintiffs’ proposed constructions for terms concerning stereoisomeric forms, methods for treating, antivirally effective amounts, and enantiomeric excess, rejecting Defendants’ indefiniteness and racemic-mixture arguments. The court reserves any remaining indefiniteness arguments concerning the amount of an antivirally effective compound for summary judgment or trial.

Holdings

1. Claim 1 is not limited to racemic compounds; it encompasses a compound existing in a stereoisomeric form or a mixture of stereoisomeric forms, consistent with the claim's plain and ordinary meaning.
2. Claims 29 and 30 encompass a compound existing in a stereoisomeric form or a mixture of stereoisomeric forms and are not limited to racemic mixtures.
3. Claims 21, 26, 27, and 32 are not limited to racemic compounds and have their plain and ordinary meaning encompassing stereoisomeric forms or mixtures of stereoisomeric forms.
4. The term "method for treating" includes both prophylactic or preventative treatment and curative treatment; it is not limited to treatment of an existing disease or injury.
5. The term "an antivirally effective amount" is not indefinite at the claim-construction stage and means an amount that provides an antiviral effect or activity. Any remaining dispute concerning the amount effective under particular circumstances is reserved for summary judgment or trial.
6. The term is not indefinite and means, within the limits of detection, having more than 95% of one enantiomer and less than 5% of the second enantiomer, such that the enantiomeric excess is greater than 90%.

Questions Presented

1. Whether claim 1 is limited to racemic compounds or encompasses compounds existing in a stereoisomeric form or a mixture of stereoisomeric forms.
2. Whether claims 29 and 30 are limited to racemic compounds or encompass compounds existing in a stereoisomeric form or a mixture of stereoisomeric forms.
3. Whether claims 21, 26, 27, and 32 are limited to racemic compounds.
4. Whether the term "method for treating" in claims 18 and 21 includes prophylactic as well as curative treatment.
5. Whether the term "an antivirally effective amount" in claims 18 and 21 is indefinite and how it should be construed.
6. Whether the term "having an enantiomeric excess of more than 90%" in claims 41 and 42 is indefinite and how it should be construed.

Disposition

other