Questions Related To Chemical Process Applications

A. Patentability of intermediate compounds
Question 1
Where an inventive chemical process (which may consist of one or more chemical steps) is concerned, are claims directed to novel intermediates thereof automatically considered inventive?

Answer 1
NO, not necessarily so.

Question 2
If the answer to question 1 is NO, how is the inventiveness of an intermediate compound, which is part of an inventive chemical processes, considered?

Answer 2
The inventiveness will be examined based on, if the intermediate compound provides a solution to a technical problem, which have been sought by others but have not been successfully resolved. Additionally, the intermediate compound should involve a series of steps to achieve or arrive at the desired result and is not merely one step away from a prior art. If above requirements is met, then the intermediate compound shall satisfy the inventiveness requirement.
On the contrary, the intermediate compound cannot be considered inventive if it is just a mere modification of an existing product or process or a mere substitution of an existing equivalent which is commonly known.

Question 3
If the answer to question 1 is NO, what is the state of the art to be considered for judging the inventiveness of the intermediates?
(a) Is it the “close-to-the-intermediate” state of the art, namely state of the art relating to compounds identified from their chemical composition as lying close to the intermediates?
or
(b) Is it the close-to-the-product” state of the art, namely the state of the art relating to compounds identified from their chemical composition as lying close to the product onto which the intermediate is converted to?

Answer 3
The answer is (a) due to the fact that the protection is sought for the intermediate (and not the product itself which might have been disclosed in prior art).

Question 4
If the answer to question 1 is NO, would the intermediate be seen to contribute to the inventiveness of the process because its “structural difference” provides an “effect” (e.g. increased yield, decrease in the number of chemical steps) without which the advantageous complete process is inconceivable?

Answer 4
Yes, the intermediate should be “structurally different” from the prior art and the difference should provide the desired effect, and such inventive step would not have been obvious to a person having ordinary skill in the art.

Question 5
If the answer to question 1 is NO, would the intermediate be patentable because it opens the way to a new and inventive process for preparing the known end product?

Answer 5
YES.

Question 6
If the PCT publication of the application in question contains independent process claims directed to a chemical process and also independent compound claims directed to intermediates of the chemical process, and at national phase entry or when filing the request for examination, the Applicant omits all of the process claims (e.g. in an attempt to reduce the claims fees, or the examination fee), can the independent compound claims directed to the intermediates be granted in the absence of any process claim? In other words, can the inventiveness of the independent compound claims directed to the intermediates be acknowledged in the absence of evaluating the inventiveness of any claims directed to the chemical process where such intermediates are part of? Please consider this question in particular, in the context of a situation where the inventiveness of the intermediates is to be supported on the basis to their contribution to the inventiveness of the process, which will not be evaluated if there are no process claims.

Answer 6
It is advisable to claim both the intermediate and the process claims. In the event that the applicant would like to reduce the number of claims due to reducing the claim fee, then the applicant should consider claiming the process.
If the patent is granted in respect to a process, the patentee receives exclusive right to (i) use the process; and (ii) doing any of the acts referred in above paragraph in respect to of a product obtained directly by of the granted process. Therefore, the process claims provides wider coverage in terms of its protection.
Based on your question above, the inventiveness of the claims relating to the intermediate can still be examined by the Examiner and if the requirement of novelty, inventiveness and industrial applicability is met, the claims relating to the intermediate will be granted, but as mentioned in our opinion above, the protection is rather limited.

B. Disclosure requirement for chemical process patents

Question 1
When is the subject matter of a claim to a chemical process considered to be sufficiently disclosed?

Answer 1
The subject matter is considered to have been sufficiently disclosed if it can be understood and in a manner sufficiently clear and complete for the invention to be evaluated and to be carried out by a person having ordinary skill in the art and it shall state any advantageous effects of the invention with reference to the prior art. The matter must also be claimed.
For a process claim, it shall find support in the description by means of examples, and all the process parameters shall be disclosed in a manner that the process can be performed by the person having ordinary skill in the art.

Question 2
Is it necessary to include process parameters (e.g., molar proportion, solvent, temperature, reaction time) in the claim to the chemical process?

Answer 2
YES.

Question 3
Is there a need to restrict the meanings of the radicals (e.g. R, R1 and R2 in starting materials, intermediates or products) on the basis of the particular examples provided as experimental support?

Answer 3
YES.

C. Patent term extensions of process patents

Question 1
Is it possible to extend the term of a patent covering a chemical process for preparing a pharmaceutical product?

Answer 1
In Malaysia, there is no provision for patent term extension.