2.11.7.10A Support Required for Pharmaceutical Inventions and Methods of Treatment

Date Published

Note: The information in this part only applies to:

  • standard patent applications with an examination request filed on or after 15 April 2013.
  • innovation patents with an examination request filed on or after 15 April 2013.
  • innovation patents where the Commissioner had not decided before 15 April 2013 to examine the patent.  

Overlap Between Support and Usefulness

In the context of pharmaceutical inventions and methods of treatment, there is a considerable degree of overlap between the requirements of sec 40(3) and sec 18(1)(c) and sec 18(1A)(c) (useful).  In some cases, where the claims are not supported for the purposes of sec 40(3), the claimed invention will not meet the usefulness requirements, and vice versa.   

Where objections under both grounds apply, whether an objection is raised as lack of support or lack of usefulness, is not important. Examiners are to use their judgement and may take either objection or both.

Where both objections are raised, examiners may take separate objections, or simply note in a fully reasoned objection under one ground (or in a separate objection) that the reasons provided would also form the basis for an objection under the other ground. Where the reasons in an objection under sec 40(3) would also support an objection under sec 40(2)(a) (clear enough and complete enough disclosure), the same approach may be followed. (This is consistent with the strategy used where objections on the grounds of novelty and inventive step both apply).

Note: Where the claims are not supported for the purposes of sec 40(3) as outlined below, examiners should also consider whether a lack of usefulness objection applies (see 2.9.3.4.3A Therapeutic or Pharmacological Use).

Support

Claims to the use of known pharmaceutical compounds for a new therapeutic use will lack support in the absence of any evidence of the idea working for the new use (Prendergast’s Applications [2000] RPC 446).  Similarly, even where a pharmaceutical compound per se is new, a claim to the therapeutic use of the compound will lack support in the absence of evidence of the therapy working over the whole scope of the use as claimed.  In the absence of any such evidence, there will not be a basis in the disclosure for any reasonable expectation that the treatment will work.

Where an application claims methods of treatment, the description should not only identify a condition that may be treated, but also demonstrate by reference to tests that the treatment is a reality and not just a possibility (Hoerrmann's Application [1996] RPC 341, Consultant Suppliers Ltd's Application [1996] RPC 348).  Rudimentary tests will suffice, and full, detailed, rigorous and conclusive testing of a drug for its ability to treat a condition is not necessary (Prendergast’s Applications [2000] RPC 446).   

Where the treatment of a number of different medical conditions is claimed, the description should demonstrate by relevant in vivo or in vitro tests that the specified compounds are indeed effective against each of the claimed conditions (Hoerrmann's Application [1996] RPC 341).  Relevant in silico tests may also provide support in some circumstances.

The tests that must be disclosed in order to support a claim to a therapeutic method depend on the nature of the invention.  The question of support in each case should be considered on its merits.  However, ‘rudimentary’ tests may include in vivo tests, or in silico modelling, that credibly and plausibly demonstrate that the specified compounds possess an activity that could lead to the treatment of a given disorder.

A mere assertion in the specification that a pharmaceutical composition or medicament will treat a medical condition does not provide adequate support for claims to a method of treatment (Prendergast’s Applications [2000] RPC 446).  Furthermore, a mere statement in the specification that the claimed invention has been tested will not provide adequate support where no details of the tests are provided (Consultant Suppliers Ltd's Application [1996] RPC 348).  

Where there is a well-established link between a physiological process (such as a molecular interaction or biochemical pathway in the body) and a particular disease, tests demonstrating a relevant activity may support claims to the use of a compound for the treatment of diseases associated with the interaction or pathway.  For example, disclosure in the body of the specification of in vitro tests demonstrating that a compound restores p53 function will adequately support claims to the use of the compound to treat specified p53-mediated cancer conditions.  Similarly, support for the use of a compound to treat diseases caused by harmful prions will be provided by in silico tests that credibly and plausibly demonstrate that a specified compound binds a cavity in a prion protein, thereby stabilising its normal conformation and reducing the amount of harmful prion.

Example

In Consultant Suppliers Ltd's Application [1996] RPC 348, claim 1 was to the:

“Use of a benzoic acid derivative of [a specified general formula] for the treatment of disease by inhibition of nuclear ADP-ribosyl and similar transferase enzymes.”  

A dependant claim specified particular diseases to be treated.  

The description referred to the medical use and provided some statements indicating that certain compounds had been tested and found to exhibit the specified enzyme inhibiting activity, but no data or details of the testing procedures were provided.  In the absence of even rudimentary data regarding the testing done and the results obtained, showing that the claimed therapeutic activity was a reality for each disease falling within the scope of the claims, the claims were not supported.

As a separate issue, the description contained suggestions that not all derivatives falling within the scope of the claims had the specified enzyme-inhibiting activity.  In this situation, the term ‘benzoic acid derivative’ in the claims could not represent a principle of general application, because given the statements in the description, it was not reasonable to expect that everything falling within the term had the relevant activity.  Since only some of the compounds within the scope of the claims had the activity, and the specification provided no testing procedure to identify the derivatives with the relevant activity (and a procedure was not apparent from the common general knowledge in the art), the claims were not enabled over their full scope and for this reason did not comply with the requirements of sec 40(3) (or sec 40(2)(a)).