E-News No.45

E-News No.45

New Regulation on Biotechnological Patent Applications by Ignacio Sanchez Echagüe (Marval, O’Farrell & Mairal – Argentina)

The Argentine Patent Office issued Regulation No. 283/2015 amending the Patentability Guidelines on biotechnological inventions.

In general terms, the regulation incorporates the current practice of the Argentine Patent Office regarding patentability of biotechnological inventions into the Patentability Guidelines.

The main amendments are as follows:

  1. Homology/Identity percentage: The regulation does not allow the definition of molecules based on homology/identity percentages, and requires that the claimed sequence be specifically disclosed and exemplified in the specification.
  2. Plants and animals: Consistent with the PTO’s practice heretofore, plants and animals are non-patentable subject matter irrespectively of whether they are modified or not.
  3. Plant parts (seeds, cells, flowers, etc.) and components (organelles, DNA molecules, etc.) as well as animal parts (organs, tissues and animal cells) and components (organelles and DNA molecules): These elements are patentable subject matter as long as they are modified, isolated and cannot regenerate into a complete organism.
  4. Transformation events: Event claims are allowed provided the following requirements are met:
    • The entire sequence of the insert is disclosed,
    • The flanking regions with at least 100 pairs of bases is disclosed, and
    • The certificate of deposit of the biological material is referenced.
  5. Isolated: The regulation provides a definition of the term “isolated” requiring the claimed element to be separated from any organism.

At first sight it appears that the Regulation runs counter to the TRIPs Agreement, the Argentine Constitution, and the Argentine Patent Law. The Regulation may be considered unconstitutional because it introduces limitations to the patentable subject matter and is sanctioned by an administrative body lacking jurisdiction to regulate this question.