WESTERN BUREAU:
INTERNATIONAL DRUG house Pfizer could pay millions of dollars in cost and compensation to local distributors Medimpex and LASCO if it loses an appeal to quash a ruling made by the Supreme Court that its patented medication Amlodipine (Norvasc) is invalid.
Amlodopine (Norvasc) is used to treat high blood pressure, protecting patients from the devastating complications of severe congestive heart failure, stroke, renal failure and other vascular complications due to hypertension.
The three companies have been in the courts since 2002. An injunction was granted against Medimpex and LASCO, which were forced to take the drug off the market in 2005.
In a landmark ruling on April 29, Justice Roy Jones ruled that the Letters of Patent 3247 issued in Jamaica in respect to Salts of Amlodipine to Maurice Courtenay Robinson (an attorney who applied on his own behalf under the Patents Act 1857) are not valid and subsisting for the reason that Letters of Patent 18266 for the same substance filed in Egypt on March 31, 1987, expired on March 31, 1997.
However, the judgment was stayed until the case was heard in the Court of Appeal, according to the attorney representing LASCO, Vincent Chen of Chen, Green and Company.
Hope for successful appeal
Chen told The Sunday Gleaner he was very pleased with the order that the judge made and hoped to be successful at the appeal.
One of his counterparts representing Medimpex described the ruling as historic as this was the first time a case under the Patent Act interpreting Section 29 has been tried in Jamaica.
Section 29 of the patent law states that once a patent is granted for a product in Jamaica, if it expires in the rest of the world, then the Jamaican patent automatically expires. In the case of Pfizer, the drug expired in Egypt in 1997 and in 2005, though its attorney, Maurice Courtenay Robinson, was able to get an injunction against the two Jamaican companies.
Court papers received by The Sunday Gleaner states that patents for Salts of Amlodipine/ Amlodipine Besylate have expired in several countries including the Dominican Republic, Argentina, New Zealand, Australia, Canada, Spain, Bangladesh, Poland and Germany prior to the grant of the Jamaican Patent No. 3247.
market share loss
Research has shown that Medimpex, which was the leading brand both in price and quality, lost an estimated market share of approximately J$5 million (US$85,000) per month as a result of the injunction. This means that since 2005 when the injunction was brought, the company lost about US$3.5 to $4 million in sales of Amlodipine.
And while LASCO prices were half, their share of the market and loss amount to approximately US$3 million.
Pfizer, which gave an undertaking four years ago that they would pay any losses incurred if they lost the case, may end up paying J$528 million to J$616 million in cost and J$5 million to $6 million in compensation for legal expenses to each defendant.
However, if Pfizer's lawyers, Grant, Stewart, Phillips and Company have their way, they will fight tooth and nail to have the ruling overturned when they return to court.
Efforts to get a comment from that firm proved futile as The Sunday Gleaner was told the team of partners was in a meeting.
Pfizer's battle in the courts took prominence in March when The Sunday Gleaner carried an exclusive on the high cost of high blood pressure medications to the country's poor and local pharmaceutical company, Indies Pharma promising to fight Pfizer so that hypertension sufferers could access the cheaper generic brand Amlocor (Amlodipine).
Checks made with a number of pharmacies showed that one month's supply of 5mg Norvasc (30 tablets) and 10mg (30 tablets) cost approximately J$3,120 and J$5,220, respectively, whereas the generic brand Amlocor will cost the patient J$924 for a month supply of 5mg tablets and J$1824 for 10mg (30 tablets) saving hypertensive patients in excess of 400 per cent.
Impact for NHF patients
The same drug from Pfizer upon applying the National Health Fund (NHF) benefits will cost the patient $1,950 for 30 tabs of 5mg and $2,910 for 10mg (30 tabs). When compared to the generic brand, patients will pay $48.96 for a month's supply 5mg AMLOCOR and $97.92 for a month's supply of 10mg tablets, stated Indies Pharma's managing director, Dr Guna Muppuri.
At this cost, hypertension sufferers would save 40 times more if the drug is NHF approved.
"There are too many people with severe hypertension ending up with heart attacks and strokes and if we can give this drug to the public at under $50 and under $100 a month supply on NHF, then it is really a great boon to our people and will save the country and its people from spending over $15 million dollars a month," argued Dr Muppuri.
He has called the ruling a most revolutionary and historic verdict in the pharmaceutical field, "It is going to be considered as a remarkable precedent for all future cases."
Janet.silvera@gleanerjm.com