The world’s largest pharmaceutical company, Pfizer, is suing the Philippine government for having imported and registered – but not marketed – a product that is still under patent. At the same time, industry is said to be lobbying against a bill under consideration in the Philippines that would introduce more flexibilities into the country’s intellectual property law, according to sources.

Philippine sources fear that if Pfizer wins the case, it may continue using this strategy to hinder the entering of cheaper generic versions of other medicines into the Philippine market immediately upon patent expiry.

The product in question, Pfizer’s Norvasc (amlodipine besylate) for high blood pressure, does not have any cheaper versions available in the Philippines, while it is being sold for nearly half the price in Indonesia and Thailand, according to an internal working paper of an alliance which will address this issue along with other access to medicines issues in the Philippines, a Philippine lawyer said. The Philippine price for the equivalent product in India, Amlogard, is 650 percent higher (for 5mg), according to the paper.

On 1 March 2006, Pfizer (Pfizer, Ltd. UK and Pfizer, Inc. Philippines) filed a case against the government-owned Philippine International Trading Corporation (PITC), the Bureau of Food and Drugs (BFAD) and two of the employees at the BFAD for having imported samples of Norvasc from India, sources say.

BFAD Director Leticia Barbara Gutierrez and Emilio Polig, BFAD officer in charge of the legal, information and compliance division, have been asked to pay damages to Pfizer, the Philippine lawyer said.

Some 200 tablets were imported and submitted to the BFAD for registration, according to the paper. BFAD granted the products approval in the form of a parallel import drug registration, and a government source said the country’s rules required this registration even though it is not intended to be sold in the market until after patent expiry. The PITC has “repeatedly informed Pfizer in writing that it will not market its amlodipine besylate product until after the Pfizer patent expires,” the paper said.

But Pfizer argued that this infringed its patent on Norvasc, which runs until 13 June 2007.

The Philippines has implemented the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which allows countries flexibilities from the agreement such as parallel importation. The Philippines does not have a clear policy agreement and “no general law that governs parallel imports,” according to a government source. But there are a number of bills pending on the issue, and parallel import of pharmaceuticals from countries such as India is allowed in the Philippines under the Administrative Order 85 (series 2000) issued by the Department of Health, he said.

Parallel importation is purchase of a patented drug from an approved source in an exporting country where it is sold more cheaply, without seeking the consent of the patent holder, as defined by a recent World Health Organization report. The TRIPS agreement, reinforced by the 2001 Doha Declaration, leaves it to national governments to decide for themselves when a patent may be exhausted, such as with parallel imports.

This practice of early registration is in many IP regulations referred to as the “Bolar provision,” and allows a company to import samples of a product and develop and test it in order to prepare for an early registration while the product is still under patent. This ensures that the product can hit the market immediately upon patent expiry.

The Bolar provision is found in Argentina, Canada, the United States and some European countries, but it is not explicitly expressed in the Philippine law, the paper said. But the Consumer Project on Technology (CPTech) said that this “has been part of Philippine regulatory practice for several years, and it has never been challenged before.”

As a result of the lawsuit, Pfizer is now demanding that the registration granted to the PITC be revoked, according to the paper. But it said that without early registration it would take at least 18 months after the patent has expired before a cheaper version could be marketed. This is the time it takes BFAD to handle a drug registration application from a company such as PITC, it said, adding that this would effectively extend Pfizer’s monopoly.

The PITC has filed a countersuit against Pfizer, according to the US publication Salon.

Pfizer’s Reaction

A Pfizer spokesperson told Intellectual Property Watch that the case had been filed “following several attempts to remedy the situation with the government and the PITC.”

The spokesperson said the move was a matter of protecting its patent for amlodipine besylate until it expires in June 2007. “There was no legal assurance provided to Pfizer that our patent would not be infringed by the importation of an unauthorized amlodipine besylate product,” the spokesperson said, adding that the company was also concerned about patient safety as it was unknown from which manufacturing source the product would be imported to the Philippines.

The company also disagreed that this case involves parallel importation. “Pfizer doesn’t consider this a parallel importation issue because we don’t believe the product in question is from a Pfizer-authorised source,” the spokesperson said.

Pfizer sued two individuals as well, according to the spokesperson, because, “The two government representatives are named in the suit in their respective official capacities as director of the BFAD and officer in charge of the legal, information and compliance division of the BFAD,” the spokesperson said.

It was perhaps not a good week for Pfizer, as company CEO Henry McKinnell personally met with resistance for his recent salary hike and reported $83 million retirement arrangement, as well as for the Philippine case. Stanford alumni and graduate students in the United States have initiated a signatory campaign to “kick McKinnell off a Stanford advisory board over Pfizer’s bullying of Philippine government drug regulators,” according to CPTech’s Judit Rius, one of the initiators of the campaign.

There were also protests at Pfizer’s annual shareholder meeting on 27 April regarding executives’ pay packages, according to reports. According to one report, McKinnell has called for a review of the Philippines case.

The case was filed in the Republic of the Philippines Regional Trial Court, Makati City Branch, Pfizer said, which added that at the moment “the parties are working to resolve the issue as expeditiously as possible.”

The Philippine source said that the hearing that was scheduled for 25 April was reset as the judge was on leave. But he said that this was “the usual thing” in the Philippine courts.

Pfizer Influencing News Coverage of the Case?

CPTech said that Pfizer also has attempted to “block negative articles in the newspapers” through a “multiple print ads campaign.” The activist group argues that this has led to critical coverage only by columnists and tabloid newspapers where Pfizer has not yet run its ads.

A Philippine source told Intellectual Property Watch that just prior to a scheduled 25 April hearing of the case, “groups working on the issue made a press release and circulated it to national media organisations and not one bit of it came out,” despite it being a high profile news issue.

An editor at The Manila Times told Intellectual Property Watch that there had been a “very wide coverage” of the issue in the Philippine media. Most newspapers have been “sort of siding with the general good,” but, he said, there may be some that ran the Pfizer ads that have sided with the company.

The editor held the view that it would be good for a poor country such as the Philippines to have more generic medicines available. He said The Manila Times had not been pressured by Pfizer not to run articles on the issue, and had published editorials as well as critical articles.

As for the case, he said that Pfizer does not want anyone in the Philippines to do anything until the patent has expired, but the PITC has never said it wanted to manufacture but to prepare itself for when the patent would expire. He said that the price if Norvasc was very high in the Philippines as the product was available only from Pfizer.

Pfizer said that “there is no advertising campaign underway as a result of this lawsuit. In fact, direct-to-consumer advertising is not permitted in the Philippines.” The spokesperson also said that Pfizer was “absolutely not” attempting to block negative news coverage of the issue.

Flexibilities Bill Awaiting Action

CPTech says that the pharmaceutical industry in the Philippines, including Pfizer and the business group called the Pharmaceutical and Healthcare Association of the Philippines, is lobbying against the bill that would change Philippine IP law.

Senate bill 2139, introduced by Senator Mar Roxas, would introduce flexibilities enjoyed under TRIPS into the intellectual property law in the Philippines, CPTech says.

This would help lower the cost of medicines, according to a 22 March press release from 3CPNet, a coalition of non-governmental organisations. “The bill has already had several hearings and the committee report will be filed soon,” the release said.

The bill was introduced on 13 October 2005 and referred to a Senate Committee on Trade and Commerce and the Senate Committee on Health on 24 October 2005. The committees are supposed to carry out consultations with stakeholders, one informed source said.

The 3CPNet cited a speech by Roxas in which he said that more and more Philippine families had problems paying their medicine bills, and the intellectual property code should be amended to “promote fair and healthy competition in the pharmaceutical industry.”

“We need to level the playing field on drug importation and manufacturing for our people’s benefit,” Roxas said.