Title
Smith Kline and French Laboratories, Ltd. vs. Court of Appeals
Case
G.R. No. 121267
Decision Date
Oct 23, 2001
Pharmaceutical patent dispute over compulsory licensing for Cimetidine, upheld to promote public health, prevent monopolies, with 2.5% royalty deemed reasonable.
A

Case Summary (G.R. No. 121267)

Key Dates

Patent issued: November 29, 1978.
Compulsory license petition filed with BPTTT by Danlex: August 21, 1989.
Court of Appeals decision affirming BPTTT: January 27, 1995.
Supreme Court decision (G.R. No. 121267): October 23, 2001.

Applicable Law and Legal Framework

Primary statutory framework applied: Republic Act No. 165 (the Patent Law, 1947, as amended), particularly Section 34 (grounds for compulsory licensing), Section 35 (grant of license), and Section 35-B (terms and conditions of compulsory license, including royalty ceilings).
International treaty cited: Paris Convention for the Protection of Industrial Property, Article 5 provisions invoked by petitioner.
Constitutional context: Because the Supreme Court decision date is after 1990, the analysis is situated within the framework of the 1987 Philippine Constitution (the prompt does not attribute specific constitutional provisions to the Court’s reasoning).

Procedural History

Danlex filed a compulsory license petition before the BPTTT in 1989 under Section 34(1)(e) of RA 165, asserting that cimetidine is a medicinal product and that Danlex was capable of using the patented product in manufacture. The BPTTT granted a compulsory license allowing Danlex to use, manufacture and sell its own brand of cimetidine-containing pharmaceuticals and fixed royalties at 2.5% of net sales in Philippine currency. Smith Kline & French appealed to the Court of Appeals, which affirmed the BPTTT decision on January 27, 1995. Petitioner’s motions for reconsideration and for injunctive relief were denied by the Court of Appeals. Petitioner then filed a petition for review on certiorari with the Supreme Court.

Facts Found by the BPTTT and Accepted on Review

  • The patented product is medicinal in nature (cimetidine, useful as an antihistamine and in the treatment of ulcers).
  • More than ten years had elapsed since issuance of the patent, and the petition for a compulsory license sought to allow manufacture and sale of a medicinal product.
  • Danlex demonstrated capability to work the patented product or to employ it in manufacturing a useful product.
  • Publication requirements under the Patent Law were found by the BPTTT and the Court of Appeals to have been satisfied (petitioner later contested the adequacy of proof of publication).

Issues Presented to the Supreme Court

  1. Whether the grant of the compulsory license by the BPTTT under Section 34 constituted a valid exercise of police power and was supported by law and fact.
  2. Whether Section 34 (and the BPTTT’s exercise under it) violated the Paris Convention by providing grounds for compulsory licensing beyond those enumerated in the Convention.
  3. Whether the royalty fixed by the BPTTT at 2.5% of net sales amounted to an uncompensated taking or otherwise was unreasonable.
  4. Whether the BPTTT acquired jurisdiction over Danlex’s petition given alleged noncompliance with publication requirements under the Patent Law.

Supreme Court’s Analysis — Validity of Compulsory License

The Court affirmed the BPTTT and Court of Appeals holdings that the grant complied with Section 34 of RA 165. Section 34 permits applications for compulsory licenses after two years from the grant of a patent where the patented invention relates to food or medicine or is necessary for public health or safety (Section 34(1)(e)). The Court emphasized that the statutory prerequisites were met: the patent had been issued over ten years previously and the application concerned a medicinal article; Danlex had shown capability to work the invention or to use it in manufacture, satisfying Section 34(2). The Court recognized that compulsory licensing under the statute is intended both to ensure public supply and to prevent the building up of patent monopolies.

Supreme Court’s Analysis — Paris Convention Issue

The Court rejected petitioner’s contention that Section 34 of RA 165 contravenes the Paris Convention. It relied on Article 5, Section A(2) of the Paris Convention, which permits member countries to adopt measures providing for compulsory licenses to prevent abuses that might result from the exercise of patent rights (failure to work being an illustrative example). The Court held that the Convention allows national legislative measures addressing abuses beyond the specific example of failure to work; therefore Section 34’s enumerated grounds, including public health grounds, are consistent with the Convention. The Court referenced prior case law reaching the same conclusion.

Supreme Court’s Analysis — Potential Confusion Over Source of Invention

Petitioner argued that a compulsory license would confuse the public into believing Danlex was the originator of cimetidine. The Court found this concern unfounded, noting that the licensee expressly acknowledges the patentee as the source of the patented product. Even if some confusion were possible, the Court concluded the public benefit (increased supply and lower prices) outweighed such disadvantages.

Supreme Court’s Analysis — Royalties and Expropriation Argument

Petitioner asserted that the 2.5% royalty was grossly inadequate and constituted an uncompensated taking. The Court held there was no deprivation of property without just compensation because the patentee had already enjoyed exclusive rights for at least two years from the patent grant, and the statutory scheme provides for remuneration to the patentee in the form of royalties under compulsory licensing. The Court pointed to Section 35-B(3), which caps royalties at 5% of the net wholesale price (and

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