Government told to restrict import of anti-hypertension drug (BusinessWorld)

Published in the August 18, 2006 issue of BusinessWorld

BY JENNEE GRACE U. RUBRICO, Sub-Editor

Government told to restrict import of anti-hypertension drug

Pfizer Philippines, Inc. yesterday got the upper hand in an infringement case it filed against government agencies after a court order effectively upheld the firm’s patent for anti-hypertension drug amlodipine besylate until its expiration next year.
In an order issued in open court, Makati Regional Trial Court Branch 149 Judge Cesar Untalan directed the board of directors of government-owned and -controlled Philippine International Tradin Corp. (PITC) to issue a resolution that states it will not import the patented drug, which is sold under the brand Norvasc in the Philippines, until the expiration of its patent in June 2007.
At the same time, the order also asked the Bureau of Food and Drugs (BFAD) to make sure any certificate of product registration it issues on the said drug’s efficacy and safety would have an effectivity date that falls after expiration of the drug’s patent to protect the patent holder.
In return, Pfizer will consider dropping the infringement case it filed against the government agencies.
Last March, Pizer sued the PITC, the BFAD and BFAD director Leticia Barbara B. Gutierez and Officer-In-Charge Emilio L. Polig, Jr. for patent infringement, damages, and injunction after the BFAD issued a certificate of registration to PITC for the patented drug.
PITC had imported 80 samples from Pakistan to submit these to BFAD for testing and evaluation to find out if these drugs, which are priced at around P10 apiece in Pakistan, are the same as the drugs that are sold as Norvasc in the country for over P40.
Following the test, which showed the Norvasc in Pakistan were the same as those being sold in the country, BFAD issued PITC a certificate of product registration by issuing a parallel import drug registration.
Under parallel importation of drugs, the government is allowed to source from other countries cheaper drugs that have expired patents.
Pfizer contends that the registration effectively threatens the patent it has for the drug in the country. PITC, however, maintains that it has no intention of importing the product before the expiration of the patent.
“The board of directors of the PITC is hereby ordered to issue a resolution to the effect that they shall now make importations of[amlodipine besylate] until the expiration  of its patent... The BFAD,
through its counsel, will coordinate with its principals that from now on, if it will issue a certificate of registration on items, goods and articles, they shall state that it shall be effective after the expiration of the patented item,” Mr. Untalan said.
He noted that while PITC President Roberto Pagdanganan already issued an undertaking to Pfizer that his firm will not, as a matter of policy import the drug while the patent is still effective, this was not enough as the Corporation Code provides that “policy is made by the board of directors.”
Mr. Pagdanganan, who was at the witness stand for cross-examination, tried to prevent the order from being issued, saying that getting the backing of the PITC board for his undertaking was “unnecessary.”
“This is policy, and we have not violated the Intellectual Property Law,” he said.
He also said that instead of forcing the issue of getting board approval for his undertaking, Pfizer should be made to explain instead why Norvasc costs five times more in the Philippines than it does in Pakistan.
“It’s the Filipinos who suffer,” he said as he noted that cardiovascular disease, which accounts for 30% of the deaths in the country, is one of the most prevalent ailments in the Philippines.
Mr. Pagdanganan also said that Norvasc accounts for P1 billion of the yearly sales of Pfizer in the Philippines.
Pfizer legal counsel Ramon S. Esguerra, however, said Pfizer does not need to explain its pricing structure in the country. “We are operating on a free market. If the government wants to regulate the prices, let them pass a law,” he said.
BFAD counsel Thomas M. Laragan, for his part, said that the government agency may be able to do what the court asked, but added that he would need to discuss with his principals on the matter.
Mr. Esguerra told BusinessWorld after the hearing that Pfizer may drop the charges against the government agencies if they comply with the two orders of the court.
He said that Pfizer wants board approval for Mr. Pagdanganan’s undertaking because “we believe that he does not have board authority.”
“The charter of the PITC requires that policy is done by the board,” he said.
Parties were given 35 days to discuss the proceedings of yesterday’s hearing with their principals.
The court will resume proceedings on Sept. 28 through a chamber meeting to discuss the possiblity of resolving the prayer for injunction as well as the dropping of the case.