Court Opinion

ID: 8408371
Source: CourtListenerOpinion
Date Created: 2022-11-02 16:42:34.35592+00
Date Added: 2024-06-11T16:47:34.138613
License: Public Domain

LOURIE, Circuit Judge,
dissenting from denial of petition for rehearing en banc.
I respectfully dissent from the court’s decision not to hear this case en banc. I do so because it is an extraordinary decision, effectively precluding virtually all patents on human metabolites of drugs. It thus qualifies as an issue of exceptional importance, justifying en banc consideration.
The holding of the panel, which the full court left standing, is that an issued patent on a pharmaceutical product provides an enabling disclosure of all of that product’s metabolites (i.e., compounds that are formed in a patient’s body upon ingestion of the pharmaceutical product), simply by disclosing that the product can be used by administration to a human. Because product patents covering pharmaceutical products generally issue before clinical trials on the product have revealed the identity or nature of any metabolites, this decision will *996preclude protection of those metabolites, as the issued patent will be effective prior art against such application.
I do not question that when a pharmaceutical product has been in actual public use prior to the filing of a patent application on its metabolite, the metabolite will also have been in public use and hence will be unpatentable. The holding of this case, however, goes much further, mandating that the mere issuance of the patent on the product — or any other publication of that product — inherently anticipates claims to the metabolite merely by disclosing that the product can be administered to a patient, on the theory that such administration would inevitably cause the human body to “make” the metabolite. The decision holds that an enabling disclosure of “how to make” metabolites is provided by the mere recitation that one can administer a prior art compound to humans.
If U.S. Patent 4,282,233 really taught how to make metabolites, it might be another story. However, that patent simply included a minimal, boilerplate statement of how to use the claimed products, sufficient to satisfy the requirements of 35 U.S.C. § 112, but far from the careful and thorough prescribing information required by the FDA. The disclosure of the patent, like similar disclosures in other such patents, merely stated:
The compounds of the present invention are useful as non-sedating antihistamines. These compounds act as anti-allergic agents in the treatment of such conditions as perennial and seasonal allergic rhinitis and chronic urticaria.
The compounds of the present invention are administered in pharmaceutical formulations comprising the compound in admixture with a pharmaceutical carrier suitable for enteral or parenteral administration. The formulations may be m solid form ... or in liquid form
Although the required dosage will be determined by such factors as the patient’s age, sex, weight and the severity of the allergic reaction to be treated, the preferred human dosage range is likely to be 4 to 50 mg of the effective compound 1 to 3 times per day. The preferred dosage ranges for other animals can readily be determined by using standard testing methods.
’233 patent, col. 4, II. 42-66. That is hardly an enabling disclosure of how to make any metabolites, whatever they might turn out to be, sufficient to anticipate them by inherency. The ’233 patent does not identify or even mention any of the claimed products’ metabolites. Yet the court here sweepingly holds that the patent anticipates those metabolites.
It may be asked why, if a developer of a new product has a patent on that product, does it also need a patent on its metabolite. However, that is not the patent law question before us. Moreover, another company might hold a patent on the metabolite, having independently invented it before the product patent issued and before the product went into public use. In any event, we deal here with issues of patent law, not policy or equity, and to hold that a patent on a product, with a minimal disclosure of administering it to a human or other subject, anticipates a later application on a metabolite, of which no mention appears whatsoever in the patent, cannot be correct.