Method of dispensing thalidomide deemed not to be patentable subject matter

Method of dispensing thalidomide deemed not to be patentable subject matter

Method of dispensing thalidomide deemed not to be patentable subject matter

Celgene Corporation [2012] APO 12.

In a recent decision relating to an innovation patent, the Australian Patent Office has held that claims directed to a method of dispensing the drug thalidomide do not define a “manner of manufacture” and are therefore not capable of patent protection. The method was also found to lack novelty and an innovative step.

The decision provides clarification in relation to the scope of patentable subject matter and highlights the importance of selecting features for inclusion in dependent claims of innovation patents that provide a contribution to the working of the invention.

The thalidomide distribution patent

The patent at issue was innovation patent number 2011100687, which related to an improved method for dispensing drugs such as thalidomide to patients in order to reduce the risk of known adverse side effects. The method improved the monitoring and control of drug distribution by requiring a “prescription approval code” to be communicated to pharmacies by a risk management centre before prescriptions are filled.

The essential features of the method are:

  • the registration of the prescriber, pharmacist and patient in a computer readable storage medium;
  • the assessment of acceptable risk; and
  • communication of a prescription approval code.

When examination of the patent ultimately reached an impasse an oral hearing was held.

Key issues of patentability, novelty and sufficient innovation

Based on examination of the patent the Hearing Officer identified the following key issues for determination:

  1. whether reference to a method of treatment in the claims could render the method patentable subject matter;
  2. whether the manner of manufacture objection could be overcome by including reference to an explicit treatment step in the claims;
  3. whether there is any difference between a prescription approval and a prescription approval code; and
  4. whether selection of a prescription approval code from a stored list amounts to an innovative step.

Did reference to a method of treatment in the claims render the method patentable subject matter?

Under Australian patent law the manner of manufacture requirement necessitates that an invention be a proper subject matter for the grant of a patent.

During examination the Examiner contended that the method merely represented a scheme for dispensing a drug and could not therefore be considered patentable subject matter. In response the patentee amended the first claim of its patent so that the preamble of the claim referred to a method of treating a patient with thalidomide. The patentee asserted that the claim was not a scheme, but rather a specific series of steps which define an improved treatment method, the outcome of which is a tangible product to treat patients with a serious disease.

The Hearing Officer noted that the first claim does not include an explicit step requiring administration of thalidomide to a patient, and as a result is more properly construed as a method of dispensing thalidomide as opposed to a method of actually treating a patient. The Hearing Officer went on to state that the method of dispensing thalidomide represents mere possession or non-possession of the drug by a patient that causes no change in the patient. Having regard to an earlier decision of the Full Federal Court1 it was held that possession and transfer of property is not an effect that is capable of patent protection. The claims were therefore found to define non-patentable subject matter.

Could the manner of manufacture objection be overcome by including reference to an explicit treatment step in the claims?

The Hearing Officer recognised that the patentee could amend the first claim so as to include an explicit method of treatment step, and with this in mind considered whether such an amendment would overcome the manner of manufacture objection.

The Hearing Officer noted that the hypothetical claimed method relates to checking risk during the dispensing of thalidomide, which is analogous to a process of treating a patient whereby the patient double checks the instructions on the container prior to taking a tablet. It was found that whilst this was a sensible approach, “the essence of the method does not lie in the useful arts, or the field of economic endeavour”. On this basis it was held that the addition of an explicit treatment step would not be sufficient to render the method a manner of manufacture.

Novelty – Is there any difference between a prescription approval and a prescription approval code?

During examination the Examiner alleged that four of the patent’s claims lacked novelty in light of a pre-existing US patent application (“the Maetzold patent”). The question of whether the Maetzold patent was novelty-defeating turned primarily on whether the prescription approval disclosed therein was the same as the prescription approval code required by the first claim of the thalidomide distribution patent. The patentee submitted that a “prescription approval” could be a simple YES or NO, whereas a “prescription approval code” is something different. The Hearing Officer understood this submission to mean “that a code is a symbol or sign that represents a message, whereas the word YES is the message”.

In noting that the specification does not contain a definition of the term “prescription approval code”, the Hearing Officer expressed difficulty in accepting that a word such as YES is not properly viewed as a code, and thus held that a YES or NO response could be regarded as a prescription approval code.

Does selection of a prescription approval code from a stored list amount to an innovative step?

Having dealt with novelty, the Hearing Officer considered whether the patent’s second claim involved an “innovative step”. A claim will involve an innovative step unless the invention defined therein would only vary from the prior art information in ways that make no substantial contribution to the working of the invention.

The patent’s second claim requires that the prescription approval code is generated from a list stored in the computer readable storage medium. Whilst the specification did not provide any explanation in relation to the contribution made by this feature, the patentee submitted that the use of a list to generate the prescription approval code can promote record keeping and tracking, and in view of the consequences of improper administration of the drugs, such benefits are important contributions to the working of the method.

The Hearing Officer did not accept this submission and stated that the benefit of promoting record keeping and tracking flows from the use of the prescription approval code itself. In deciding that the patent’s second claim lacks an innovative step the Hearing Officer remarked that locating a list in the computer storage medium is merely a matter of convenience that does not make a substantial contribution to the working of the invention. 

Implications of the decision

In cases where a specification considered as a whole discloses subject matter that does not meet the manner of manufacture requirement, it may not be possible to convert the subject matter into a manner of manufacture by insertion of a feature into a claim which in itself would be regarded as patentable subject matter. In the present case, the feature was the actual taking of thalidomide by the patient.

As it relates to innovative step, patentees would be well served by giving careful consideration to the features included in the dependent claims (of which only four may be included – innovation patents may only have five claims). In order to provide the best chance of surviving an attack on validity each dependent claim should ideally include a feature that makes a substantial contribution to the working of the invention.

On 6 February 2012 the patentee lodged an appeal against the decision in the Federal Court of Australia.

Endnotes

  1. Grant v Commissioner of Patents [2006] FCAFC 120.