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Prior Art Clinical Study Protocol Anticipates Treatment Method Claims: Federal Circuit
Practical Law Legal Update 5-519-3802 (Approx. 4 pages)
Prior Art Clinical Study Protocol Anticipates Treatment Method Claims: Federal Circuit
by PLC Intellectual Property & Technology
| Published on 10 May 2012 • USA (National/Federal) |
In In re Montgomery, the US Court of Appeals for the Federal Circuit affirmed the Board of Patent Appeals and Interferences' (BPAI) decision rejecting certain patent claims covering administering certain drugs to patients to treat and prevent strokes. The Federal Circuit agreed that a particular prior art clinical study protocol inherently anticipated the claims.
Key Litigated Issues
The key issue before the US Court of Appeals for the Federal Circuit in In re Montgomery was whether the Board of Patent Appeals and Interferences (BPAI) erred in affirming an examiner's rejection of certain claims of US Patent Application No. 11/118,824 ('824 Application) as anticipated.
Background
Hugh Edward Montgomery, John Francis Martin and Jorge Daniel Erusalimsky filed the '824 Application in April 2005, which concerns renin-angiotensin system (RAS) inhibitors. The '824 Application specification notes that there are already known RAS inhibitors, such as ramipril, and that these inhibitors have been used to treat hypertension. The '824 Application specification is largely directed to treating wasting diseases and to improving cardiovascular fitness. However, both stroke treatment and prevention are mentioned as a potential object of the invention.
Three of the application claims (claims 42, 43 and 45) recite administering RAS inhibitors to patients who are diagnosed as needing stroke treatment or prevention. Specifically, the claims at issue concern the administration of ramipril:
- To a patient diagnosed as needing stroke treatment or prevention.
- For the treatment or prevention of stroke or its recurrence.
The examiner rejected these claims as anticipated by four prior art references that describe the administration of ramipril to patients at risk of having strokes. The BPAI affirmed the examiner's rejection of all three claims as anticipated by each of these prior art references. The BPAI found that each reference teaches administration of ramipril to patients prone to strokes.
One of the prior art references the examiner and the BPAI relied on was the HOPE (Heart Outcomes Prevention Evaluation) Study: The Design of a Large, Simple Randomized Trial of an Angiotensin-Converting Enzyme Inhibitor (Ramipril) and Vitamin E in Patients at High Risk of Cardiovascular Events (HOPE). This reference describes a clinical study protocol, which is the design of a large, simple randomized trial of ramipril and Vitamin E in the prevention of stroke, among other ailments. The results of the study were not published until after the priority date of the '824 Application and therefore the results themselves were irrelevant to the anticipation analysis.
Outcome
Anticipation
The Federal Circuit began its discussion by reiterating the two-step analysis for determining whether patent claims are anticipated under Title 35, Section 102(b) of the US Code:
- Claim Construction: The first step is claim construction of the patent at issue. On appeal, claim construction is a question of law reviewed de novo. During examination:
- claims should be given their broadest reasonable interpretation consistent with the specification; and
- claim language should be read in light of the specification as one of ordinary skill in the art would interpret it.
- Claim Comparison: The second step involves comparing the claims to the prior art. On appeal, anticipation is a question of fact reviewed for substantial evidence. A prior art reference anticipates a patent claim if:
- it discloses every claim limitation; or
- a claim limitation that is not expressly disclosed is necessarily present or inherent in the single anticipating reference and the inherent result inevitably results from the disclosed steps.
The Majority Holds that the Relevant Claims Are Anticipated
Applying the two-step analysis to the claims at issue, the majority opinion by the Federal Circuit held that the claims were anticipated by the HOPE reference. Because the court found that the HOPE reference anticipated these claims, it did not address the remaining three prior art references. The court also discussed only the elements of claim 45, since the appellants did not dispute that a prior art reference that anticipates claim 45 would necessarily anticipate the other two claims.
The Federal Circuit determined that the HOPE reference anticipates claim 45 because:
- It discloses a protocol for administering ramipril to stroke-prone patients, a fact that was uncontested by the appellants.
- There was no question that administering ramipril to stroke-prone patients inevitably treats or prevents stroke.
The Federal Circuit rejected the appellants' arguments that inherent anticipation requires that the claimed method was actually performed and that the HOPE reference does not disclose actual performance of the method. The court determined that:
- The HOPE reference does reveal the actual administration of ramipril for stroke treatment or prevention.
- Even if the HOPE reference merely proposed administration of ramipril for stroke treatment or prevention without actually doing it, it would still anticipate the claim because anticipation requires only an enabling disclosure, not actual creation or reduction to practice.
The court noted that the HOPE reference:
- Was a published protocol on an advanced stage of testing designed to secure regulatory approval.
- Was designed to obtain data for submission to regulatory agencies on the effect of ramipril on cardiovascular diseases including stroke.
- Could have been the basis for patent claims at issue by the HOPE reference's authors.
The majority concluded that the HOPE reference, in all relevant respects, is identical to the '824 Application and therefore cannot fail to anticipate the relevant claims.
Dissenting Opinion
The dissent acknowledged that "[i]nherency is a very tricky concept in patent law." For the dissent, the keystone of the inherency doctrine is inevitability. In other words, a later-claimed invention must have necessarily resulted from the practice of a prior art reference. Citing Metabolite Laboratories, Inc. v. Laboratory Corp. of America Holdings, the dissent noted that a mere proposal for further experimentation is not an inherent disclosure (370 F.3d 1354 (Fed. Cir. 2004)).
The dissent argued that the majority's conclusion that the conduct of the study outlined in the HOPE protocol would inherently treat or prevent stroke is not supported by the record. It pointed out that:
- The design of the study described in the HOPE reference provides specific criteria for early termination if the proposed treatment is ineffective.
- The results of the study were not preordained because they merited publication in a highly selective peer reviewed journal.
- The authors of the study acknowledged altering the prior art HOPE protocol demonstrating that it was a plan subject to modification.
- The HOPE reference is a description of what had not been carried out.
To the dissent:
- The HOPE reference merely describes a planned study and fails to describe any administration of ramipril at a dose and for a period of time that would inherently lower the risk of stroke.
- The results of a proposed study are neither predictable nor inevitable.
Practical Implications
Patent applicants should be mindful of inherent anticipation when drafting claims and be aware that published prior art clinical trial protocols may render claims unpatentable due to inherent anticipation where the protocol, if carried out, might yield the claimed result.