Philippines – Case Notes:Phil Pharmawealth v. Pfizer

The Supreme Court of the Philippines was recently faced with an intriguing issue: Is it permissible to grant an injunction in respect of a patent post-expiration of the patent term? The Supreme Court also had the opportunity to opine on another interesting issue, that of forum shopping. Without jumping the gun by stating how the Supreme Court dealt with the issues, it may be pertinent to briefly dwell on what transpired and how the issues arose in Phil Pharmawealth, Inc v. Pfizer, Inc and Pfizer (Phil) Inc.

A Peek into How the Events Unfurled
The case involved Philippines Letters Patent No 21116, covering Ampicillin sodium/ Sulbactam sodium (Sulbactam Ampicillin)[SA], a substance which was marketed under the brand name Unasyn. The subject patent was issued on July 16, 1987, and under the old patents regime it had a term of protection of 17 years reckoned from the date of issuance, viz. until July 16, 2004.

Sometime in 2003, Pfizer came to know that Phil Pharmawealth (Pharmawealth) had submitted bids for the supply of SA to several hospitals without Pfizer’s consent. Following an unsuccessful attempt to prevent the hospitals from accepting Pharmawealth’s bids, Pfizer filed a complaint for patent infringement with the Bureau of Legal Affairs of the Intellectual Property Office (BLA-IPO). A preliminary injunction was issued for a period of 90 days.

Prior to the expiration, Pfizer filed a Motion for Extension of Writ of Preliminary Injunction, which was denied. Aggrieved, Pfizer filed a special civil action for certiorari with the Court of Appeals assailing the resolution of the BLA-IPO and praying for the issuance of a preliminary mandatory injunction for the reinstatement and extension of the writ of preliminary injunction issued by the BLA-IPO. Meanwhile, Pfizer filed a complaint before the Regional Trial Court of Makati City, alleging infringement and unfair competition and praying for the issuance of a temporary restraining order and preliminary injunction.

Pharmawealth then filed a Motion to Dismiss before the Court of Appeals on the ground of forum shopping, contending that the case filed with the Regional Trial Court had the same objective. On January 18, 2005, the Court of Appeals issued the questioned resolution directing the issuance of a temporary restraining order conditioned upon Pfizer’s filing of a bond. To which, Pharmawealth filed its Second Motion to Dismiss for being moot and academic, contending that Pfizer’s patent had already lapsed. The patent right sought to be protected by the temporary restraining order has been extinguished.

Determination by the Supreme Court
Pharmawealth brought this matter to the Supreme Court and questioned the propriety of the Court of Appeals Resolution dated January 18, 2005; the Supreme Court ruled that the patent owner’s exclusive rights can only be enforced during the patent’s term of protection.

Period of Monopoly granted by a Patent
Pfizer’s exclusive rights to monopolize the product subject of the Patent only exist within the term of the patent or until July 16, 2004. After this period, Pfizer no longer possess any right of monopoly, and as such, there is no more basis for the issuance of a restraining order or injunction. Since the patent, which was initially the basis of the BLA-IPO for issuing the injunction, was no longer valid, any issue as to the propriety of extending the life of the injunction was already moot and academic. Section 37 of RA 166 is clear that the exclusive right of a patentee to make, use and sell a patented product, article or process exist only during the term of the patent.

Forum Shopping?
Antecedent to the main issue, was the claim of forum shopping, to which the Supreme Court found Pfizer guilty for having instituted separate actions before the IPO and the Regional Trial Court, praying for the same relief.
It appears that the ultimate objective which Pfizer seeks to achieve in their separate complaints filed with IPO-BLA and then the Regional Trial Court Makati is to ask for damages for the alleged violation of their right to exclusively sell SA products and to permanently prevent Pharmawealth from selling said products.

Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]- 3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:
pharmawealth1

 

 

Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia 1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:
pharmawealth2

 

 

UNASYN, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0.