Utility For A Pharmaceutical Patent Must Relate To How It Is Used, Not Simply to Its Properties

Utility For A Pharmaceutical Patent Must Relate To How It Is Used, Not Simply to Its Properties

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Re Canadian Patent Application 2,389,321

This Patent Appeal Board (“PAB”) decision reminds pharmaceutical patent filers that if a pharmaceutical patent is construed to make a promise, then that promise must relate to how the invention will ultimately be used – not simply to the properties of the pharmaceutical itself. This therefore suggests that the right time to file for patent protection on a pharmaceutical is when it is known how the invention is intended to be used, and when the promise of the patent can be supported by evidence of utility that points toward that intended use. It was with this in mind that the Canadian Patent No. 2,389,321 (the ‘321 application) entitled “Neisserial Antigenic Peptides” was ultimately refused after the PAB determined several claims of the ‘321 application were invalid for lack of utility.

Background

Novartis Vaccines and Diagnostics (the Applicant) owns the ‘321 application, which was filed on October 20, 2000. The focus of the ‘321 application was on the identification, through genome sequencing, of new antigens that may be useful in the diagnosis, treatment or prevention of Neisseria meningitides, specifically serogroup B Neisseria meningitides (“mensB”). Neisseria meningitides is a bacteria that causes meningitis. Several different serogroups of neisseria meningitidis have been identified, and while some vaccines have been developed against some serogroups, no existing vaccines at the time of filing were effective against mensB. [4]

The ‘321 application was transferred to the PAB after being rejected based upon defects identified with respect to utility by the Examiner in a Final Action.

Issue: Do claims 1, 2, 4 and 5 lack utility?

“Claims 1, 2, 4 and 5 read as follows.

  1. A recombinant polypeptide comprising a Neisserial antigenic epitope and having at least 95% sequence identity to SEQ ID NO: 11076, wherein SEQ ID NO: 11076 and said recombinant polypeptide comprise a Neisserial antigenic determinant.
  2. The recombinant polypeptide of claim 1 comprising amino acid sequence SEQ ID NO: 11076.
  3. A purified polypeptide comprising a Neisserial antigenic epitope and having at least 95% sequence identity to SEQ ID NO: 11076, wherein SEQ ID NO: 11076 and said purified polypeptide comprise a Neisserial antigenic determinant.
  4. The purified polypeptide of claim 4 comprising amino acid sequence SEQ ID NO: 11076.” [40]

Utility

Utility is a statutory requirement for patentability. Pursuant to Apotex Inc v Sanofi-Aventis Canada Inc, 2013 FCA 186 a Court is required to construe a patent to determine whether a person skilled in the art would understand it to contain an explicit promise that the invention will achieve a specific result. In regard to a compound, the promise of utility must be related to how the patent will ultimately be used, not to the property of the compound. For example, the patent in AstraZeneca Canada Inc v Apotex, 2014 FC 638 was found to be useful as a pharmaceutical drug in therapy, not for possessing the chemical property of being stable against racemization. It is important and necessary to distinguish the utility promised by the patent and the particular property that makes it possible. The former is required and may be determinative of patent applications, while the latter may be helpful, but cannot alone satisfy the utility requirement.

A claimed invention must satisfy the utility requirement on the basis of either demonstrated or soundly predicted utility. Since the promised utility was not demonstrated here, it needed to have been soundly predicted. The PAB restated the three requirement for soundly predicted utility from Apotex Inc v Wellcome Foundation, 2002 SCC 77:

  • There must be a factual basis for the prediction;
  • There must be an articulable and “sound” line of reasoning from which the desired result can be inferred from the factual basis; and
  • There must be proper disclosure.

Promise of Utility

The PAB determined that the problem and solution of the ‘321 application were related to the search for a new therapeutic agent/vaccine against mensB. However, the PAB was unable to find an explicit promise of therapeutic utility in the ‘321 application, despite a broad discussion of its potential embodiments. Discussion of the use of the ‘321 application as a vaccine was prefaced with the term “may”, which the PAB held that the skilled person would interpret to denote a possible alternative embodiment, instead of an explicit promise of therapeutic utility.

“A broad discussion of potential embodiments spanning pages 2-4 of the description is reflected in the statement that the polypeptides ‘may be suitable as vaccines, for instance, or as diagnostic reagents, or as immunogenic compositions’ … Because these uses are all presented as possible alternative embodiments, and because the term ‘may’ is used, the skilled person would not consider these explicit promises of a therapeutic utility or any other utility.”[47]

The PAB found that the skilled person would construe the claims to explicitly promise that the polypeptide, chains of amino acids that are generally antigenic, comprises an antigenic determinant from a Neisserial protein. The PAB rejected the Applicant’s submission that the promised utility was that the claimed polypeptide is antigenic. The PAB found that the Applicant’s position was inconsistent with the claim language, which clearly stated that the claimed polypeptide comprises “a Neisserial antigenic determinant”, not simply that it be antigenic. [49]

The PAB also noted that antigenicity alone cannot define the utility of a protein or polypeptide. [51] If antigenicity alone could satisfy the utility requirement for proteins and polypeptides then almost no protein or polypeptide could ever be found to lack utility.

Sound Prediction of Utility

The PAB found that the while the Applicant’s prediction had a factual basis, there was no sound line of reasoning and therefore failed to establish soundly predicted utility. [70] The common general knowledge related to antigenic prediction algorithms that the Applicant utilized were contentious at the time of filing. The panel provided the Applicant two references that criticized antigen prediction algorithms in general, and that specifically criticized the accuracy rating of an algorithm that the Applicant relied on. [61-63]

In finding that the ‘321 application lacked utility, it therefore failed to comply with section 2 of the Patent Act.

Commentary

The present case illustrates the importance of utility as a requirement for patentability and the need to clearly communicate it. This case succinctly outlines the requirements needed to establish utility and it should be used as a reminder to patent applicants to be clear in their applications about what their patent is promising, and to ensure that the promise be either demonstrated or soundly predicted. The language used in patent applications is very important, as a patent may be rejected for lack of utility if the promise of the patent is not clearly communicated. Of particular importance is that when the patent in question is for a compound, the utility of the compound must be related to how the patent will ultimately be used.