As specified by Article 26-1 of the Patent Act, the patent specification shall fully disclose the invention in a manner clear and sufficient for it to be understood and carried out by a person having ordinary skill in the art (“PHOSITA”). In other words, the patent specification shall comply with “enablement” requirement, or it may otherwise constitute the cause for invalidation. Although the extent to which the patent specification shall be disclosed to comply with enablement requirement has been particularly problematic for biotech-pharma patent practitioners, the Supreme Administrative Court’s 2011-Pan-No.278 judgement dated June 8, 2017 provided a few guidelines.
In this case, the Taiwan No.I342772 invention patent titled “Drug For Treating or Alleviating Allergy Diseases” (“Patent in dispute”) was claimed to be invalid. The Taiwan Intellectual Property Office (“TIPO”) determined that the Patent in dispute does not meet the enablement requirement and thus the Patent in dispute is invalidated. The Administrative Appeals Committee of Ministry of Economic Affairs and the Intellectual Property Court both upheld the TIPO’s decision. The patentee appealed the case to the Supreme Administrative Court.
After reviewing the case, the Supreme Administrative Court first clarified that whether the patent specification has been fully disclosed for enablement shall be determined by the specification’s description of the invention, the scope of the claim(s) and the drawing(s) as a whole based on the PHOSITA’s view on the filing date or the priority date. The judgment is based on whether the patent specification can be understood and carried out by such PHOSITA. If it can be carried out, the patent specification shall be deemed to have explicitly and sufficiently disclosed the content of the invention. In principle, the evidence proffered by the patentee in this regard should focus on whether the PHOSITA can reproduce the content of the invention according to the patent specification but without multiple trials and errors. It should not focus on whether the PHOSITA on the filing date considers the feasibility of patent content and its room for improvement as this can only be used to determine the non-obviousness requirement but not the enablement requirement.
In this case, the Supreme Administrative Court found that the Patent in dispute is deficient in experimental data, therefore lacking explanation of the relevance between the causes of the allergy diseases, the varying degrees of the diseases and the claimed compositions. The Patent in dispute is also deficient in data concerning the validity and reliability. For example, the Patent in dispute not only fails to offer data comparing the control group and the test group in its experiment design, it also fails to reveal the physiology, pathology and/or toxicity reports of the lab rats. Thus, the Supreme Administrative Court determined that the Patent in dispute indeed fails to comply with the enablement requirement.
Therefore, although the Taiwan Patent Act does not require the patent specification to disclose every experimental step to comply with the enablement requirement, referring to the foregoing opinions provided by the Supreme Administrative Court, patentee shall still disclose or provide experiment design, valid and reliable data that conform to scientific principles. This allows the PHOSITA to deduce the technical content and function of the invention without repeated experiments. This case is a valuable reference for drafting patent specification.