It is often the case that an inventor identifies a new biochemical target and obtains knock-out/knock-down data to demonstrate the target’s involvement in a metabolic pathway.

From a scientific perspective, such a discovery could be highly significant; but from a patent perspective, consideration needs to be given to what will eventually be commercialised − because the patents will need to cover such commercial products or methods.

It must first be recognised that the main commercial interest in such inventions is unlikely to be the target − it will be the compounds (e.g. agonists or antagonists) which bind to the target. Ultimately, it will be those compounds which are sold as medicaments.

In terms of patenting such inventions, there are two main strategies, depending on whether the invention has been made in a commercial or an academic context.

Inventions made by commercial companies

If the invention has been made by a commercial company, the general strategy is to keep all information about the target confidential and only to patent the compounds which interact with the target.

Keeping the target as a trade secret provides the company with a commercial advantage − no one else knows what their compounds are interacting with. (This can be done because the patent system requires the identification of the compounds and some evidence that they are efficacious, but it is does not require the target to be identified.)

Therefore, for as long as the target remains out of the public domain, the company can continue to benefit from this commercial advantage.

Inventions made by academics

If the invention has been made by an academic, then keeping the target confidential for any length of time is unlikely to be an option; there will probably be a strong pressure to publish details of the invention.

Under such circumstances, it is generally recommended to direct the patent application to all new compounds which have been found to bind to that target, and to antibodies; uses of those compounds/antibodies (and ones which are known to bind to that target) can also be claimed for the treatment of diseases associated with that target.

Even after publication of the identity of the target, it will still generally be possible to obtain patent protection to new compounds which bind to that target (unless the identification of the target makes all such compounds obvious); but this option will be open to all parties after the publication of the target.

Claims

Screening method claims

It might also be possible to obtain patent protection for methods of screening for agonists/antagonists which bind to the target, but such claims can be of limited value due to the difficulty of enforcing them (i.e. how do you find evidence of people using such methods?).

Reach-through claims

As mentioned above, the commercial aim of such ‘target’ inventions is to find compounds which bind to the target and which can block or enhance its activity. Therefore, claims of the following scope are highly desirable:

1. An agonist or antagonist which binds to [target X].

Unfortunately, such claims are generally not obtainable, primarily because the claim does not adequately identify the agonists/antagonists (and hence how can the Patent Examiners determine whether such claims are novel or inventive?).

On the other hand, claims of the following format might be allowable in some countries, if sufficient agonists/antagonists are known or described in the patent application:

2. Use of an agonist/antagonist of [target X] for the treatment of [disease/disorder associated with target X].

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