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Tuesday 15 May 2012

Patricia Covarrubia

Argentina: examination of patentability

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As posted early today, credit to Felix Rozanski from CEDIFICA (Study Centre for the development of the chemical and pharmaceutical Industry, Argentina) who made the iptango aware of the approved guidelines for the examination of patentability of certain chemical-pharmaceutical inventions.

The full Official Bulletin can be accessed here (in Spanish) and for those of you who are scanning through the document there were certain issues that caught my attention:
  • Under number 1 subtitled “considering the molecular structure” and it continues (i)Polymorphs, and explaining what it is. Once the definition is explained as ‘an inherent property from the solid state that is present in drugs which are use in the pharmaceutical industry’ it concludes that polymorphs are not inventions because they are not man-made but on the contrary they are a natural property of the substance. It then adds that the substance may be in different forms: solid or crystalline depending on different arrangements of molecules in their internal structure-- depending on environment conditions and independent of human action. Due to the above said, it is declared that (1) when a polychromes result from mere identification and/or characterization of a new crystalline form know in the prior art, even if they have pharmacokinetic differences or stability in relation to the solid forms ( amorphous and/or crystalline) which are known substance, such application are not admissible. (2)The process of obtaining polymorphs constitutes a customary testing in the preparation of drugs; they are not patentable because it is obvious to try to get the more suitable polymorph pharmaceutically, using methods that are conventional.
A discovery is not patentable; however we understand that it is possible to patent a natural substance. For example, isolating a substance found in nature gives it sufficient technical character to avoid being a mere discovery – i.e. to patent the process of obtaining the substance. This fact is regulated by the Biotechnology Directive in Europe (EU).
  • Same subtitle and numbered as (iii) Enantiomers. It starts by defining it and then explaining that when a molecular structure reveals a racemic compound (which has both enantiomers in a ratio 1:1), the novelty is lost since the known molecular formula (written or not in a three-dimensional way) is revealed/disclose to the skilled man in the art. Therefore, it is not patentable even if the patent application does describe different properties. Yet, process to obtain a single enantiomers can be patentable is they are new, have an inventive step and are clearly described and the result is well characterized –through spectroscopy data.
  • Under number 3 subtitle ‘whereas chemically related elements’ (iv) salts, esters and other derivatives of known substances: new salts of known active ingredients, known alcohol esters and other derivatives of known substances (such as amides and composite) are considered the same substance already known to the state of the art and are not patentable.
 I believe that it is crystal clear here: the substance if already known in the art, novelty is destroyed.
  • Same subtitled and numbered (vi) we found active metabolites: “ in some cases, pharmaceutical compounds generate, upon administration to the patient, an active metabolite, which is the product of the process of metabolism in response to the compound. Metabolites are by-product of active ingredients used. It cannot be considered to be ‘created’ or ‘fabricated’. Metabolites are not separately patentable from the active ingredient.”
No comments.
  • Numbered 4 and subtitled ‘whereas pharmaco-techniques features’ and under (ix) formulations and compositions, it covers the issue of patent applications for composition or formulation using principles which are active substances and carriers of suitable pharmaceutical matters such as: diluents, binders, separators, lubricants, colorants and flavourings. In this regards it follows to explain that these are not patentable due to public policy – they may affect bioavailability.

  • Same subtitle and numbered (xi) we encounter dosage/dose. It refers to the fact that some patent applications claiming inventions consisting on dosages are equivalent to methods of medical treatment, since the product is neither a process nor a product – thus, non-patentable.
This is the practice in the EU, New Zealand, the Philippines, Chine, Japan, Israel and Canada for example. However, methods of medical treatment of humans are patentable in the US and Australia for example.
  • Finally, same subtitle and under (xii) second medical use (new medical use) we read the following: “application for the use a product, including a second medical indication (or any other medical use) of compounds known, are not admissible. Frequently, applications are restricted to describe essays of pharmacological activity in order to confirm the detection of another possible use. The patent applications for second medical indication (or any other use) are equivalent to a method of treatment and do not have industrial applicability. This rule applies even where the application is made under the ‘Swiss formula’ that is ‘use of substance x for the in the manufacture of a medicament for the treatment of condition Y" or variant thereof.”
This final one, I am speechless!! Moreover, I wonder whether a known compound for a new purpose (non-medical) can still be patentable --as it is for example in the US and in the EU. I ask this because the reason given for non-patentability of second medical use is based on the fact that it is equivalent to a method of treatment – but, no based on anticipation for instance.

There were of course many other issues covered in the Official Bulletin but these were the few that got my attention. Feel free to read it and comment in this new Argentina’s guidelines.

Patricia Covarrubia

Patricia Covarrubia