IVAX v Chugai
This month, I want to talk about added matter, and the IVAX v Chugai judgment. IVAX claimed that Chugai’s patent on the formulation of Nicorandil was obvious and invalid, and Chugai sought to amend its claims. IVAX argued that the amendment constituted added matter and should not be permitted. Obviousness was considered on Windsurfer principles and I will not write about the arguments – simply, the judge considered that the patent was obvious, and would have been infringed, if valid.
And - this is the part that I think is interesting - he found that the amendments requested should not be permitted because they were “added matter”.
It may be worth reminding you, at this point, that patent claims can be amended provided that the specification includes the subject matter of the amendment – if not, this is regarded as ‘added matter’, and cannot be included.
The patent claimed a process for producing stable Nicorandil preparations. The proposed amended claim 1 read as follows:
“A process for producing a stable Nicorandil-containing pharmaceutical preparation which comprises mixing Nicorandil with palmitic or stearic acid present in an amount of at least 3% of the total weight of the Nicorandil-containing preparation and formulating the mixture in a suitable dosage form” (new words underlined) The original claim referred to a ‘saturated higher aliphatic acid or saturated higher alcohol both of which are solid at ordinary temperatures’".
Palmitic and stearic acid are both solid at ordinary temperatures.
Thus, there were two aspects to the amendment: the substitution of a “saturated higher aliphatic acid or a saturated higher alcohol, both of which are solid at ordinary temperatures” by “palmitic or stearic acid”, and the inclusion of the limiting words “in an amount of at least 3% of the total weight of the Nicorandil-containing preparation”. The first amendment was accepted as a simple narrowing of the claim, but the latter amendment was claimed to be invalid, as added matter. Reducing an already envisaged range - ie making a quantitative rather than qualitative change can be permitted, and Chugai argued that this was the effect of their amendment.
In working out whether matter has been added, the following has to be taken into account.
‘The decision as to whether there was an extension of disclosure must be made on a comparison of the two documents read through the eyes of a skilled addressee. The task of the court is threefold:
a. To ascertain through the eyes of the skilled addressee what is disclosed, both explicitly and implicitly in the application.
b. To do the same in respect of the patent as granted.
c. To compare the two disclosures and decide whether any subject matter relevant to the invention has been added whether by deletion or addition.
The comparison is strict in the sense that subject matter will be added unless such matter is clearly and unambiguously disclosed in the application either explicitly or implicitly”[2].
It is notable that the test is not obviousness. The matter will be additional unless it is clearly and unambiguously disclosed in the application as filed – although disclosure may be implicit.
The same approach is adopted in the EPO.
“If such added feature, although limiting the scope of protection confirmed by the patent, has to be considered as providing a technical contribution to the subject matter of the claimed invention, it would, in the view of the Enlarged Board, give an unwarranted advantage to the patentee, contrary to the …purpose of Article 123 (2) EPC [and would] constitute added subject-matter within the meaning of that provision.
A typical example of this seems to be the case, where the limiting feature is creating an inventive selection not disclosed in the application as filed….[3] ” .
The Judge decided that Chugai’s proposed amendment was not just a quantitative change, (i.e. one which simply reduced the selection), but was also a qualitative change. The reader was “being taught by the proposed amended specification something about an invention which is not disclosed in the un-amended specification”. Whilst, based on the original specification, “the skilled person [could have believed] that palmitic acid and stearic acid might behave in the same way as stabilising agents, he simply would not know without carrying out further research”.
The Judge concluded:
“This evidence, considered as a whole, does not come near to establishing that there was a clear and unambiguous disclosure that palmitic acid and stearic acid were, for practical purposes, inter-changeable or of the efficacy of a 3% concentration of stearic acid as a stabiliser”.
Patentees want to make their patent as broad as possible to catch maximum numbers of potentially competing products, and the need to make sure that they doesn’t claim things which are obvious or in the public domain, otherwise the claims will not be valid. A patentee can narrow patent claims, based on disclosure, but can’t add matter. This case shows how important it is for patentees to ensure that disclosures cover what they want. I suspect that Chugai could have worded their original patent in the form of the proposed amended claims, and had they done so, they would have been able to prevent IVAX from making this particular formulation. But they couldn’t use the process of amending patents in order to make a qualitative change.
If you have any questions on any of these matters please contact me.
Anna McKay
July 2005
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