GR 211850 Gesmundo (Digest)
G.R. No. 211850 , September 8, 2020
ZUNECA PHARMACEUTICAL, AKRAM ARAIN AND/OR VENUS ARAIN, M.D., AND STYLE OF ZUNECA PHARMACEUTICAL, PETITIONERS, VS. NATRAPHARM, INC., RESPONDENT.
FACTS
This case involves a trademark dispute between two pharmaceutical companies over the brand names “Zynapse” (citicoline, for stroke) and “Zynaps” (carbamazepine, an anti-convulsant). The ponencia, with which Justice Gesmundo concurs, is compelled by the clear letter of Section 159.1 of the Intellectual Property Code (IPC) to rule that a registered mark shall have no effect against any person who was using the mark in good faith for his business before the filing date. This legal provision results in the unfortunate outcome of allowing two different drugs with confusingly similar brand names to coexist in the market.
ISSUE
Whether, beyond resolving the legal dispute, the Supreme Court should address the public health implications of allowing confusingly similar medication names to be sold concurrently, and suggest legislative or regulatory measures to prevent such risks.
RULING
Justice Gesmundo, in a Separate Concurring Opinion, agrees with the ponencia’s legal conclusion but emphasizes the Court’s duty to address the grave public health and safety risks posed by the decision. The coexistence of “Zynapse” and “Zynaps” poses a significant threat of medication errors, as empirical data from studies in the Philippines show that look-alike or sound-alike medication names are a common cause of such errors. For instance, a stroke patient mistakenly taking Zynaps (carbamazepine) instead of Zynapse (citicoline) could suffer serious harm, including Stevens-Johnson syndrome.
The opinion traces the regulatory history, noting that the Bureau of Food and Drugs (BFAD) Regulation No. 2 (1986) previously required brand name clearance to prevent similarity with already registered drugs. However, Bureau Circular No. 17, s. 1999 transferred the processing of brand name clearance for pharmaceutical products to the Intellectual Property Office (IPO), effectively removing the FDA’s direct regulatory oversight over medication brand names to prevent confusion.
To fulfill the State’s constitutional mandate to protect and promote the right to health and to maintain an effective food and drug regulatory system, Justice Gesmundo urges legislative and executive action. He recommends: (1) amending or supplementing existing laws and regulations to empower the FDA to strictly monitor and register medication brand names, ensuring they are not confusingly similar; and (2) adopting best practices from other jurisdictions, such as Canada and the European Union, where health regulatory bodies play a role in assessing trademark applications for pharmaceuticals to prevent name confusion. The Court’s role is to interpret the law as written, but it can and should sound a clarion call for other branches of government to act in the paramount public interest of safeguarding patient safety.
