Summary
The United States District Court for the Eastern District of Virginia considers La Jolla Pharma LLC’s challenge under 35 U.S.C. § 145 to Patent Trial and Appeal Board decisions rejecting patent applications concerning angiotensin II dosage forms and treatment methods for distributive shock. The court addresses claim construction and the prior art, including anticipation and obviousness, and grants the USPTO Director’s motion for summary judgment while denying La Jolla’s motion for partial summary judgment.
Topics
Practice areas
Questions Presented
- Whether the preamble of claim 1 of the '901 application limits that claim and its dependent claims to treatment of distributive shock in human patients.
- How the term dosage form should be construed in the applications.
- Whether angiotensin II refers only to human angiotensin II or also includes mammalian and modified forms.
- Whether the claims in the '901 and '943 applications were anticipated by the prior art.
- Whether the claims not anticipated were obvious under 35 U.S.C. § 103.
- Whether La Jolla's motion to exclude the Director's expert should be granted.
- Whether either party was entitled to summary judgment.
Holdings
- The preamble of claim 1 of the '901 application is limiting and restricts claim 1 and its dependent claims to a dosage form for treating distributive shock in a human patient. The preamble does not limit independent claim 7 or claim 10.
- The term dosage form encompasses both the form in which angiotensin II is distributed by a manufacturer and the liquid form in which it is administered intravenously to a patient.
- Angiotensin II, as used in the applications, includes human and nonhuman mammalian forms, including bovine-derived and modified forms.
- All claims in the '901 and '943 applications except claim 14 of the '901 application and claims 35 and 36 of the '943 application were anticipated by the prior art, principally the 1969 Physician's Desk Reference.
- Claim 14 of the '901 application and claims 35 and 36 of the '943 application were obvious to a person having ordinary skill in the art based on the PDR and Tidmarsh.
- La Jolla's motion to exclude Dr. Laird Forrest's opinions was denied because he qualified as a person of ordinary skill in the art under the parties' agreed definition.
Key quotations
“Having reviewed the record, the Court finds that La Jolla’s claimed inventions were either anticipated by, or obvious to, a person having ordinary skill in the art at the time that the applications were filed.”
“Accordingly, the Court finds that “dosage form” as used in the patent applications refers to both the forms in which the Ang II product is distributed by a manufacturer—whether in freeze-dried or liquid form—and to the liquid forms of the product that are administered to patients intravenously.”
Factual background
La Jolla sought patents on dosage forms and administration methods involving angiotensin II for treating distributive shock. The applications claimed, among other things, sterile angiotensin II dosage forms containing approximately 0.5 to 20 mg, aqueous formulations, lyophilizates, kits, and continuous intravenous infusion methods. The court found that publicly available prior art, particularly the 1969 Physician's Desk Reference description of Hypertensin and later references, disclosed most of the claimed features and rendered the remaining claims obvious.
Procedural history
The USPTO examiner rejected the '901 application as obvious and under 35 U.S.C. § 101, and rejected the '943 application as obvious. The PTAB reversed the § 101 rejection of the '901 application but affirmed the obviousness rejections for both applications. La Jolla filed two § 145 actions, which the court consolidated. After claim-construction and summary-judgment briefing and oral argument, the court denied La Jolla's motions, denied its motion to exclude the expert, and granted the Director's motion for summary judgment.