May 12, 2011

Changes in Patent Office Practice Affect Pharmaceuticals

PReMA Life

The Thai Patent Office has recently implemented two changes in its practice that could have a significant impact on applicants for pharmaceutical patents. These changes include a revised interpretation of “Swiss-type” use claims and new transliteration requirements.

“Swiss-type” use claims

In January 2011, the Thai Patent Examiners in the Biotechnology and Pharmaceutical group began issuing Office Actions rejecting method of treatment claims that have been rewritten to “Swiss-type” use claims. A “Swiss-type” use claim is a claim using the wording “use of a compound […] in the manufacture of […]” instead of the wording “method of treatment” or “method of diagnosis,” which is forbidden under Section 9(4) of the Thai Patent Act. The basis of these rejections is that “Swiss-type” use claims are now considered to fall under Section 9(4) of the Thai Patent Act, which bars patentability of method of treatment. The Examiners have based these office actions on Decision No. 1/2553 of the Board of Patents relating to Thai Patent Application No. 0201003643 entitled “Method for Treatment of Hepatitis C Virus.” In that decision, the Board of Patents considered that the subject matter of the patent application concerned a method of treatment even if the claims were amended to use-type format in an attempt to steer clear of Section 9(4). This decision is contrary to past guidelines that have been issued by the Patent Office, and its expected impact is currently being debated among Examiners and relevant parties.

Transliteration requirements

A second change of practice at the Patent Office relates to transliteration requirements. For all patent applications in relation to the chemistry field, the Thai transliteration of a compound/composition/ active substance name must be accompanied by its English name in parentheses. This practice is based on an Announcement of the Department of Intellectual Property dated December 30, 2010. For applications that have been pending for quite some time, these instructions put an undue burden on the applicants and agents to review and revise the specification text as filed. The Announcement does not mention the filing periods of patent applications to comply with the new requirement. Therefore, many applicants have now received office actions for applications filed before this announcement came into effect, requiring the applicants to comply with this new requirement.

Impact on pharmaceutical innovators

As a result of these changes, many pharmaceutical patent applications—which already face very slow processing times—are likely to be further delayed. Pharmaceutical innovator companies should be concerned about these changes because clear guidelines on each issue have not been provided by the Patent Office. This lack of clarity leads to uncertainty for patent applicants. These valid concerns have now been brought to the attention of the Patent Office, as we seek further clarification on how each issue will be resolved.

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