GlaxoSmithKline, which has sued Ranbaxy Laboratories Ltd, Novartis AG, Geneva and Biochemie in connection with the manufacture of generic Augmentin on the ground of stolen trade secret, might well be holding a weak case.
Should GSK demand an injunction on the sale of the generic in the US market, it can affect the prospects of RLL's product. But patent expert, Dr Gopakumar G Nair says, grant of such an injunction is very unlikely.
Ranbaxy, which has denied the theft charge, has been planning to launch the generic version in the US market in December after taking FDA approval. A ruling in the case is not expected before 12 months and can even be delayed upto18 months. Highly placed industry sources here said that the case will have no impact on RLL's launch plans.
These companies are generic manufacturers of Augmentin which is a non-addictive prescription penicillin medicine widely used to treat bacterial infections by killing bacteria or preventing their growth. The US market is witnessing a mad rush of generic manufacturers, all trying to eat into established brand sales with heavy price competition.
GSK's second-largest product, Augmentin had a global turnover in excess of $2 billion last year. The US annual sales of the brand account for £912m. It is very important for GSK to stop the generic manufacturers from hitting the US market, the most profitable in the world, if it wants to maintain its sales. The company lost patent protection for the product in the US in May this year, and GSK shares have tumbled over 20 per cent ever since.
The lawsuits have been filed by GSK on August 9, 2002 against Geneva, Biochemie and Novartis with the District Court, City and County of Broomfield Colorado, and against Ranbaxy Pharmaceuticals and Teva Pharmaceuticals in the Court of Common Pleas in Philadelphia County.
Tests on generic versions of Augmentin carried out by GSK recently suggested that the crucial ingredient had been made using a strain of bacteria developed at GlaxoSmithKline.
Siobhán Lavelle, Director, UK Corporate Media, GlaxoSmithKline, told Pharmabiz.com from London that following GSK's tests on the finished products, they believe that there is a high probability that a key ingredient in these finished products was made using a trade secret of GSK - a bacterial production strain.
"GSK believes that it has a responsibility to safeguard all information and property owned by the company and we are taking these actions to protect our important trade secret assets," Lavelle added.
But the GSK case appears to be weak. Says Dr Nair, "There should be no right to claim protection under trade secrets for strains of microorganisms which have already been the subject matter of patents and public use. How can anyone claim a product which has been commercially marketed for years bringing billions of dollars worth of sales income to be a trade secret. If the existing laws of any country permits such protection it is an "unfair perennial protection" and this anomaly need to be corrected forthwith."
"We are not in a position to speculate on timings for the outcome of these lawsuits. There is always uncertainty in litigation and we will now await legal responses from these companies," Lavelle said.
According to "In spite of the Best Mode" requirements by USPTO, or the "Best Method" under Indian Patent Act, it is a well-known secret that patents, by and large, especially the cleverly drafted ones, disclose not more than what the Titanic iceberg did, notes Dr Nair. However, as regards microorganism patenting is concerned, the requirements of Budapest Treaty can be overlooked only at the cost of protection claimed.
Dr Nair says deposit of the microorganism and claim to the microorganism from the depository are irrebutable. Patents primarily deal with protection in return for disclosure. What is not disclosed is not protected. As long as the subject matter of a patent is a microorganism the disclosure norms should include open access to the microorganism once the patent (covering the microorganisms) expires.
He says there is ground for reviewing the "perennial patenting". "Every extreme will attract equal and opposite extreme reaction. The institution of patents must be protected from excessive greed, exploitation and abuse."
Not allowing a microorganism to be in public domain after the expiry of a patent covering the same, amounts to "Perennial Patenting." Indian Patents (Amendment) Act, 2002 while extending the patent protection period to 20 years uniformly (Section 53), has also extended the protection to all patents which are valid on the date of the Act covering into force, also for upto 20 years (including period already enjoyed). The 2002 Act also [under section 10(d)] makes it mandatory for all microorganism patent applicants, to deposit the relevant microorganism with authorized depository under the Budapest Treaty. It therefore, should be mandatory for all biological or microorganism patents (already granted) whose remaining life term get extended to 20 years to deposit the relevant microorganism with the depository, to be eligible to claim the right of extended 20 year life term.
The international patent regimes like USPTO, EPO, JPO etc. must also take note of such a disclosure and disclaimer for microorganism patents after expiry of a patent covering the same, Dr Nair added.