The US based pharmaceutical company Pfizer was celebrating its victory after receiving a long awaited judgement in the High Court. The decision prevents generics companies from copying its successful cholesterol-lowering drug ÂLipitorÂ until at least 2011.
This did not come as good news to the defeated Indian generics manufacturer Ranbaxy Laboratories. Nevertheless all is not lost as it could still win a parallel case against Pfizer in the US. Â
However, Ranbaxy is claiming partial victory against Pfizer as the judge did rule that the IsomerÂ patent was valid which may (if upheld on appeal) have an affect on large pharmaceutical companies. Â
The Judge, Justice Pumfrey had to rule on two separate points, the first of which was broughtÂ jointly by Arrow Generics (as UK generics supplier) and Ranbaxy.
RanbaxyÂs claim for a declaration of non infringement on the Pfizer patent Liptor was dismissed by the judge. If the judge found in favour of Ranbaxy this would have allowed it to make copies of the drug.
Many legal practitioners have criticised RanbaxyÂs approach to seek a declaration of the basic patent rather than challenging the weaker patents covering the drug.Â
The second approach taken by Ranbaxy and Arrow was to attack the validity of another Pfizer patentÂ which covered a particular isomer of LiptorÂs active ingredient, known as the ÂatorvastatinÂÂ molecule.
Justice Pumfrey did question the inventive step in the isomer patent, and found that it was an obvious development from the first patent which covers the atorvastatin molecule. Pumfrey ruled that the isomer patent was anticipated by one of PfizerÂs earlier PCT patents.Â
The basic patent guarantees protection against generics until 2011. However, much will depend onÂ RanbaxyÂs appeal.
Pfizer released a statement saying that it would appeal the decision concerning the second patent:Â
ÂThe courtÂs decision was based entirely on British law and has no bearing on Liptor patent litigation between Pfizer and Ranbaxy in he US or other countries.Â
According to reports LiptorÂs sales for the prescribed cholesterol-lowering drug was estimated at $12 billion from this year alone.