The Supreme Court on Monday issued an unprecedented ruling that cancels the Merck & Co. patent that protected the exclusivity of the active ingredient in its best-selling osteoporosis drug Fosalan (known in the US as Fosamax).
The lawsuit was filed by Ramat Gan-based generic drug maker Unipharm, which in 1998 discovered that the patent application registered in Israel by Merck for the active ingredient monosodium alendronate trihydrate was not legally in effect.
Unipharm then presented a series of requests for cancellation of the patent application and prepared to market generic alendronate under the commercial name Maxibone. But when this Israeli product was marketed in 2000, Merck filed suit in the Tel Aviv district court against Unipharm for alleged patent violation, and Unipharm was not allowed to market it for two years.
The court, headed by Judge Gavriel Kling, rejected the Merck claim, but Merck appealed and at the end of 2002 the Supreme Court sent the file back to the district court for completion. When the file returned to Kling, Merck asked him to declare that he could not handle the case; the judge acceded to this request.
But Unipharm appealed and then-Supreme Court president Justice Aharon Barak returned the case to Kelling. In 2003, the district court cancelled Merck's patent application, but the international pharmaceutical company appealed this, too. The two sides presented their claims in December 2004 with Unipharm arguing that a few months before Merck registered the active ingredient, it mistakenly publicized it. As a patent is granted only for novelty and inventiveness, the fact that it was publicized meant it could not be protected by a patent, Unipharm argued.
Finally, Supreme Court Justices Edna Arbel, Miriam Naor and Ayala Procaccia rejected the Merck claim on Monday. Merck was ordered to pay NIS 60,000 in lawyers fees and court costs.
Adi Levit, who represented Unipharm, told The Jerusalem Post that Merck charged exorbitant amounts for its osteoporosis treatment and that many patients were prevented from taking it until Fosalan was added to the basket of health services about five or six years ago.
Unipharm has "liberated the public from the chains of unfair monopoly," said Levit. "Patents are not things that can't be discussed. The opposite is true. Many multinational companies make cynical use of the patent system to steal public property from the general public and get rich at the public's expense... Patent registration brings about the limitation of competition and the raising of prices, and sometimes the failure to include drugs in the basket of health services because of the high price," Levit said.
Levit noted that after the original Unipharm appeal in 2002, England, the US and Hungary cancelled the Merck patent for Fosalan (Fosamax) and allowed generic products to be marketed.
He added that Unipharm's Maxibone is based on "the exact molecule that Fosalan is. Teva's Alendronate Teva osteoporosis pill has a different amount of water in the crystal."
As a result of the lawsuit and the release of generic drugs, Merck reduced its price for Fosalan from about NIS 300 a packet to about one-tenth of the original, making the drug highly accessible.
Levit said he is currently conducting similar patent suits against GlaxoSmithKline and Pfizer.