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“Second Medical Use” Patents in Biotechnology and Pharmaceutical Areas

  • 18 November 2014
  • Articles

The trend that started with the decision of the EPO-Enlarged Board of Appeal G0005/83 of 5 December 1984, in relation to grant the title to a patent application containing claims only using the Swiss-style format, wherein the object of protection is the “use” of a composition “X ” for the manufacture of a medicament for the treatment of a therapeutic application “Y” (novel and inventive), which was later adopted by the Mexican Institute of Industrial Property.

However, as this trend became a local practice it actually, not then neither now, was properly fundamented or incorporated to the Mexican Law of Industrial Property, creating subjectivity as to how to carry out the substantive examination in areas such as Biotechnology and Pharmaceutical, which lead to different criterias for the same type of claims; as well as creating an uncertainty regarding the protection itself conferred by a patent of second medical use.

So, the linkage that started as a trend, then installed as local practice of this particular type of claims, leaved an uncertainty as to not find a specific figure of protection for “a use” under the Mexican law of Industrial Property.

My proposal to support and try to clarify the uncertainty that causes the lack of guidances or legal precedents, in our domestic legislation and local legal practice with respect to the figure of protection “Use”, in Mexico, is to use the “Guidelines Of International Search and the PCT International Preliminary Examination”, reported by the World Intellectual Property Organisation, dated March 11, 2004, which came into force on 25th of the same month and year.

In Chapter 5, Section 5.12 of the Guidelines is defined clearly and concisely the types or categories of claims that exists, which states that there are two fundamental types of claim: claims dealing with a material object (product, apparatus) and claims relating to an activity (process, use). Hence, is clearly distinguished the figure for protection “Use”, encompassed in the claims relating to an activity.

As such, the figure of protection for a “use” would be based on Article 45 of the Law on Industrial Property, where the types of claims that a single patent application may contain are determined, and the fraction II of said Article which reads, wherein describing a claim of the type of a process, and therefore on an activity, should be sufficient to recognize a “Use” as relative to the activity. This, reinforced by adding that Mexico is a Contracting State of the Patent Cooperation Treaty (PCT ), which obliged Mexico to observe the guidelines and obligations that arises from said Treaty.

Therefore, in light of the above referred, the fact that a patent claim related to a “product or composition”, has become even more attractive with the new resolution of the EPO-Enlarged Board of Appeal G0002/08, which reported at the time, that from January 28th 2011, the European Patent Office would failed to accept the second use application format or Swiss style type of claims. This has obviously caused that in Mexico a new trend has emerged requiring from the Mexican Examiners, during the substantive examination, the rephrasing of claims in accordance with the new format now accepted at the European Patent Office: “substance X for use in the treatment of a disease Y”.

Thus, in view of the above, and although it has submitted a proposal to base Patents second medical use, the Mexican Law of Industrial Property currently only recognizes claims of a “product” or a “process” which requires them the same conditions of novelty, inventive step and industrial application; so regardless if the object of protection is the second application or product (pharmaceutical composition), becomes more attractive the option of claiming a patent involving “a product” as the object of protection.

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“Second Medical Use” Patents in Biotechnology and Pharmaceutical Areas