Pa(per)tent Pitfalls

Pitfalls of paper anticipation in South African patent law 

When attempting to patent an invention in South Africa, two main requirements must be met, the invention must be both novel and inventive. These two requirements are universal, albeit defined differently in different jurisdictions.

When the validity of a patent is being tested, the above two requirements are formed into questions, i.e.

1. is the invention novel; and

2. provided the answer to 1 is a yes, then is that invention inventive?

The second question, inventiveness, is subjective, and is generally determined as to whether the invention is as a result of a logical step in the development or advancement within a particular industry. Stated another way: “could a person skilled in the art easily have taken that step?” If the invention is obvious to a person skilled in the art, the invention will not sustain a valid patent. Both questions must be answered in the affirmative to obtain a valid patent.

However, despite this, the Australia Federal Court of Appeal decided that a valid patent would be sustained in the absence of novelty when it dealt with this exact question in 2011 in Albany Molecular Research Inc v Alphapharm Pty Ltd (2011) FCA 120.

The case deals with chemical molecules and involves regioisomers, which are a type of isomer. Isomers are groups of chemical compounds that have exactly the same chemical formula, but different geometric structures.

Relevantly, it is often the case that a synthesis reaction intended to produce a particular compound which exists in the form of different isomers will necessarily result in a mixture of the different isomers, not all of which will be useful or desirable.

Therefore the question put to the court was as follows;

Albany Molecular Research Inc (‘AMR’) is the patentee of Australian patent no. 699799, which essentially claims fexofenadine compounds, and more particularly one specific pharmaceutically-effective regioisomer of those compounds.  Alphapharm Pty Ltd, the respondent), manufacture and sell generic pharmaceutical products in which the active ingredient is fexofenadine hydrochloride.  It was not disputed that if the claims of AMR’s patent were valid, then the respondent’s products would infringe.

The AMR patent specification discloses, and claims, methods to prepare the desired fexofenadine regioisomer in a substantially pure form.

The claims to the methods were not in dispute, but the patent also includes claims directed to the resulting substantially pure compounds themselves (‘compound claims’).

The ultimate question in the case was whether a claim to a compound can be deemed valid when the compound is theorised in the prior art, but not known to exist, or have been produced, in an isolated form?

The court found that the claims, while not being novel, were indeed inventive, which resulted in the patent being deemed valid.

The reason for the apparent loop hole is the anticipation concept, stated differently the disclosure of a concept or the presence of an idea or the explanation of a theory.

The existence of the particular isomer had previously only been a theory. The laws of chemistry state that if a particular isomer has a central carbon atom connected to four different molecules, there will be a non-superposable mirror image, and hence each compound is therefore designated as either the L-isomer or the R-isomer. Whether any person had ever been able to isolate or recover or physically create a particular R or L isomer is irrelevant, the theory states that if one exists, so should the other.

What it all means, is that the novelty is anticipated by a theory, based on the relevant laws. The novelty is not destroyed by the actual physical presence of the isomer, it is destroyed by its theorised existence, the ‘paper anticipation’. A ‘paper anticipation’ of this nature will affect the drafting of specifications for patents of the molecular kind. More specifically, a ‘patent application’ of this nature should highlight the distinction that it is not the product to which a claim is made, but the method to obtain that product.

It is yet to be seen whether the decision of the full bench appeal in the Australian courts will be supported elsewhere. What may be said however is that a patent application dealing with chemistry, molecules, microbes, bio-molecules or the like, should identify where the novelty actually lies in the invention and what may or may not be claimed.

Monty Rademeyer – Partner
monty@rademeyer.co.za