FACTS: Roma drug was selling medicines which were imported directly from abroad and not purchased through the local SmithKline, the authorized Philippine distributor of these products. For this reason, Glaxo Smithkline filed a case against Roma Drug for a violation of Section 4 (in relation to Sections 3 and 5) of Republic Act No. 8203, also known as the Special Law on Counterfeit Drugs (SLCD). Section 3(b)(3), includes “an unregistered imported drug product.” The seized imported drugs are exactly the same as their Philippine-registered counterparts and there is no claim that they were adulterated or mislabeled. They alleged “counterfeit” for the reason that they were imported abroad and not purchased from a registered owner of the patent of trademark of the drugs.
Issue: Whether or not the seized imported drugs were counterfeit.
Held: With the passage of Republic Act No. 9502, also known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008”, Section 72 of the Intellectual Property Code has been effectively amended by Section 7 of Rep. Act No. 9502. R.A. No. 9502 unequivocally grants third persons the right to import drugs or medicines whose patent were registered in the Philippines by the owner of the product.
“Section 72 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows:
“Sec. 72. Limitations of Patent Rights. – The owner of a patent has no right to prevent third parties from performing, without his authorization, the acts referred to in Section 71 hereof in the following circumstances:
“72.1. Using a patented product which has been put on the market in the Philippines by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market: Provided, That, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided, further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party;
72.2. Where the act is done privately and on a non-commercial scale or for a non-commercial purpose: Provided, That it does not significantly prejudice the economic interests of the owner of the patent;
72.3. Where the act consists of making or using exclusively for experimental use of the invention for scientific purposes or educational purposes and such other activities directly related to such scientific or educational experimental use;
72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product: Provided, That, in order to protect the data submitted by the original patent holder from unfair commercial use provided in Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Intellectual Property Office, in consultation with the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than one hundred twenty (120) days after the enactment of this law;
72.5. Where the act consists of the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided, further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party; xxx7″
DANTE O. TINGA CONCUR: LEONARDO A. QUISUMBING, CONCHITA CARPIO MORALES, PRESBITERO J. VELASCO, JR., ARTURO D. BRION
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