Pharmaceutical Products Patent Applications filed before January 1, 1995

On May 21, 2002 the Argentine Supreme Court rendered a decision in re: “Pfizer” that has settled the issue of the applicability of Article 70.7 of the TRIPS Agreement to pharmaceutical products patent applications filed before January 1, 1995.

The issue to resolve was whether a patent application filed before January 1, 1995, and invoking a priority document dating before January 1, 1994, could be upgraded so as to claim also the pharmaceutical products that had been disclosed, but not claimed, in the original application.

Usually pharmaceutical products were not claimed because the old Patent Law 111 forbade patentability of said products. Therefore, only the process to obtain the product was claimed.

The decision of the Federal Court of Appeals in re: “Pfizer” had been favorable to applicant on the grounds of Article 70.7 of the TRIPS Agreement. Unfortunately, the Supreme Court reversed such decision and rejected the Bill of Complaint.

The Supreme Court ruled that although Paragraph 7 of Article 70 of the TRIPS Agreement appeared to be favorable to plaintiff’s position, said paragraph could not be interpreted separately from Paragraph 8 of the same Article. The conclusion of the Supreme Court was that a joint interpretation of Paragraphs 7 and 8 of Article 70 implicated that a pharmaceutical product patent application filed before January 1, 1995, or invoking a priority date prior to January 1, 1994, could not be granted.

The decision is certainly debatable because the wording of Paragraph 7 of Article 70 was clearly favorable to applicant, and said Paragraph 7 is, in our view, in no manner limited by Paragraph 8 in the TRIPS Agreement. Unfortunately, the Supreme Court is the highest tribunal in Argentina, and therefore this holding will surely be repeated in all similar cases.

In addition, decisions of the Supreme Court are only mandatory for lower courts in the same case decided by such tribunal (i.e., they are not mandatory in other similar cases), although lower courts usually follow the criteria established by the Supreme Court to avoid unnecessary litigation.

Finally, the Argentine Patent Office also follows the decisions of the Supreme Court, and therefore the holding of the Pfizer case will in all probability be applied to pending patent applications.