The guidelines were released on December 11 2013 with a public comment period until January 11. The Patent Office received comments from Indian biotechnology firms, patent law firms, and groups such as the Organisation of Pharmaceuticals Producers of India (OPPO), the Biotechnology Industry Organization (BIO) and even the Japan Intellectual Property Association.
The Spicy IP blog described the publication as a “welcome development”.
The introduction to the draft guidelines state that they are intended to address serious concerns concerning “novelty, obviousness, industrial applicability, extent of disclosure and clarity in claims” which often arise in biotechnology patents. The guidelines also note that there are issues unique to biotechnology, “such as those relating to moral and ethical concerns, environmental safety, issues relating to patenting of ESTs (expressed sequence tags) of partial gene sequences, cloning of farm animals, stem cells, [and] gene diagnostics”.
Representatives of rights holders have expressed concern that the guidelines take too strict a view on patentability. OPPI, the industry group for large international pharmaceutical companies, said in its submission that the guidelines used an overly broad definition of obviousness. It also said that some of the provisions lacked clarity, that some limitations such as the prohibition of patenting methods of treatment appear to be broader in the guidelines’ examples than in the guideline text.
Similarly, Anand & Anand, who represents a number of large international pharmaceutical companies, stressed in its comments that the draft outlines do not have the force of law and argue that some of the illustrations are inconsistent with Patent Office practice.