NEW DOSAGE REGIMES
experimental evidence that can demonstrate, without any doubt, that the new dosage regimen is responsible for an advantageous technical effect or
frequency of
(eg, reducing the length the treatment, enhancing
drug activity, lowering side effects, etc) in comparison with the effect obtained by following dosage regimes previously known from the state of the art.
Speaking of the challenges that the Mexican IP system has for a new dosage regimen invention, however, and considering that a change in Mexican law can hardly be seen as imminent, there is an immediate need for the Mexican authorities to fix more accurate criteria in order to construct a more solid base to evaluate the patentability of this type of invention.
Further, the current form of Article 29 of the IP law regulations specifically requires that the claim chapter must be draſted based on the technical features of
clearly represents a barrier for the introduction of purpose-limited product claims as they are used in many other jurisdictions to define the scope of this type of invention. However, the truth is that Mexican IP law does not provide any definition of the term ‘technical features’ and, therefore, the establishment of a definition is vital for the Mexican IP system in order to provide a higher degree of certainty to its users.
In the author’s opinion, it could be said that, globally speaking, the Mexican IP system is currently experiencing an evolution of the manner in which the inventions directed to protect novel dosage regimens are understood and evaluated, which despite being a slow process, is a promising sign for applicants that may be interested in obtaining protection in Mexico for these types of
inventions. the invention. Tis
provision has been interpreted by our authorities in the strictest sense: that the technical features of a product (a drug molecule in this case) can be provided only by its structural elements and not by any of its associated functions, which
Likewise, just as in any other naturally occurring processes, external factors will play a key role in determining the future of this type of
invention. The applicant’s capacity
to obtain and exhibit strong and convincing experimental evidence to demonstrate that a new dosage regimen is responsible for an advantageous technical effect will be the most important factor.
Pablo Fuentes is a senior attorney at Becerril, Coca & Becerril, SC. He can be contacted at:
pfuentes@bcb.com.mx
Pablo Fuentes holds a degree in food
chemistry the from the National
University of Mexico (UNAM). He joined Becerril, Coca & Becerril, SC in 2008. As department engineer of
patents technical area, Fuentes focuses his practice in the technical analysis and response of official actions issued by the IMPI regarding patent applications in the chemistry, pharmaceutical and biotechnological fields.
www.worldipreview.com
Life Sciences Intellectual Property Review 2012
37
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