BRPTO extends deadline to submit comments to new uses of known products proposed guidelines: October 27

The BRPTO published on the Federal Register of July 29 the intention to approve a new chapter of the Chemistry guidelines addressing the examination of patent applications related to new uses of known products. In sum, the guidelines establish additional restrictions for use claims (see below a summary).

The BRPTO published on September 23 a notice that is extending the deadline to October 27 to receive comments to the new guidelines.

Background

The updated guidelines would be applicable when the primary invention is the new use of a known product and not merely a secondary use of a new product. Although it may seem like a logical conclusion, such definition will help address/reduce objections in which the examiners mistakenly considered the provisions on new uses on the examination of accessory use inventions. The document emphasizes that the product itself must already be known, and the novelty resides solely in its new purpose of application. Accordingly, the BRPTO emphasizes that use claims should be treated as process claims.

Summary of the proposed updated chapter:

- Novelty and inventive step are evaluated based on the new purpose/use and whether it was previously disclosed or would be obvious to a skilled practitioner.

- A new therapeutic application must differ significantly from the prior use. Features of claims that do not confer novelty: 1) Dosage regimen, route of administration, patient group, or treatment schedule. Using a known product for a subset of patients (e.g., diabetics or children) is not novel. The new chapter provides several examples of situations considered as referring to a dosage regimen or group of patients, which are only generically mentioned in the current guidelines.

- Proposed claims would likely be obvious when: 1) The mechanism of action of the compound whose new use is claimed is the same as the known mechanism of action for treating the new condition; 2) The mechanism of action of the compound is known in the state of the art and also relates to treatment of the new condition; 3) There is structural similarity to known compounds used for the same purpose; 4) The new use is based on known side effects or symptom management already described in the art; and 5) The etiology of the new and previous indications is the same. In contrast to the current guidelines, the updated chapter sheds light on how the mechanism of action could be a hint towards the new use.

- Patent application must describe the new use clearly and completely, with in vivo evidence at the time of filing.

- In vivo studies are required for enablement. Data solely from in vitro, ex vivo, or in silico studies are insufficient. The proposed updated chapter leaves no room for the acceptance of new data.

- Support is only recognized for the exact compounds tested and, contrary to support of compounds per se, extrapolations on structural similarities are unacceptable.

- Key changes vis-à-vis the current guidelines:

• Explanation on why patient groups are unacceptable contradicts the concept of selection inventions established in the General Patent Applications Examination Guidelines and disregard relevant technical aspects (e.g., physiological differences between children, adults and elders) which impact the therapeutic effect.
• More rigorous criteria for enablement, demanding at least in vivo data from validated animal models.
• No room for supplemental data, even if aimed at corroborating information already disclosed in the specification, contrary to what is established in the General Patent Applications Examination Guidelines for inventive step, and removing the excerpt indicating that in vitro data could be substantiated by supplemental information.

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