In a big victory for branded drugmakers, Canada's Supreme Court affirmed the validity of a Sanofi-Aventis patent on Plavix's active ingredient. Generics maker Apotex had challenged that patent, saying that it simply carved out one ingredient from a class that Sanofi patented years before.
But the high court said in its ruling that Sanofi had spent millions of dollars and several years developing Plavix as a "less toxic" and "better tolerated" alternative to the previously protected class of compounds. "The inventor selects only a bit of the subject matter of the original genus patent because that bit does something better than and different from what was claimed in the genus patent," Justice Marshall Rothstein wrote.
Apotex's concern about "evergreening," as the practice is called, is unjustified the court said--and here's where the decision stands to benefit other drugmakers. Rothstein said that it's important to allow "selection patents" because it encourages pharmaceutical innovation.
The ruling is "absolutely crucial," Patrick Kierans, a lawyer who argued for Canada's Research-Based Pharmaceutical Companies as a legal intervenor, told the Globe and Mail. "Selection patents are desperately important in the pharmaceutical industry," Kierans said. "Society wants [scientists] to go back to the well where we already believe there are potential winners."
Of course the ruling also is a big win for Sanofi and marketing partner Bristol-Myers Squibb, which have been fighting off Apotex's copycat Plavix since 2003. As you know, the generic maker briefly introduced its version in 2006, which cut into sales for months. According to a prepared statement, the companies "are pleased that the Supreme Court of Canada dismissed Apotex's appeal, which effectively prevents Apotex from marketing" Plavix there. "We are pleased that our intellectual property rights have been maintained."