Generic drug companies the world over, including Indian companies, are beginning to see greater opportunities, by way of increased market share, into the €300-billion European pharma market.
Generic makers believe that they could win easier access to the European markets as hundreds of patents on leading brands will expire by 2012.
Patents on 90 molecules in medicines with European sales worth nearly €60 million will expire in 2009. Another 110 molecules worth more than €90 billion will lose their patent protection in 2012.
If brand-name manufacturers are prevented from resorting to frivolous defenses by a pincer movement by Kroes and Brimelow, the generic share of the European medicines market could leap from its current €30 billion, according to generic companies.
Generic drug makers’ optimism has a bearing upon the possible outcome of a sector inquiry report to confirm if the brand-name companies have been obstructing the introduction of legitimate generic rivals.
Neelie Kroes, the European commissioner for competition, who is conducting the enquiry, is expected to present the final report probably in late June or early July 2009.
“I’m confident that there will be conclusions that will respond to some of our own recommendations,” stated Greg Perry, director-general of the European Generic Medicines Association (EGA).
Mr Perry believes that when Neelie Kroes submits her final report she can’t help but confirm that brand-name companies have been obstructing the introduction of legitimate generic rivals.
The inquiry was a lever for long-overdue change in the way that Europe awards and protects innovation, he commented.
The European Patent Office (EPO) has been awarding “weak patents that should never have been granted”. Its patent assessors lack “proper guidance” and have “neither the professionalism nor the time” to look at all the data submitted.
Consequently, they erroneously assume the patent applicant’s data are correct.
Also, while patents are often granted in 18 months, it can take up to five years for an opposition to a patent application to be heard.
This is how the brand-name companies are exploiting the system so as to frustrate the launch of competing products, Mr Perry argued in an interview given to European Voice.
Generic drug manufacturers feel that the sector inquiry will give an impetus to a general tightening up of the European patenting system.
However, associations representing brand-name companies are of the view that while swift generic entry is welcome as long as they do not infringe valid patents, the patent system should continue to safeguard Europe’s current attractions as “a location for high-risk R&D pharmaceutical investment.”
The European Federation of Pharmaceutical Industries and Associations, which predominantly represents brand-name companies, said it too supports proposals to strengthen and streamline the patent system.
“The European patent system is the bedrock of all innovative sectors. The sector inquiry’s final report must not undermine this,” stated, Brian Ager, director-general, the European Federation of Pharmaceutical Industries and Associations.
The generic companies should also invest back the savings generated into the health care system, Mr Ager added.
A number of Indian generic companies have already made deep forays in the European markets. Dr Reddy’s Laboratories, which acquired Betapharm of Germany for Rs 2,550 crore in 2006, remains one of the biggest Indian players in in the European market.
Ranbaxy Laboratories acquired Ethimed of Belgium, Terapia of Romania, and GlaxoSmithkline’s generics business in Italy in March 2006. Wockhardt Laboratories acquired Pinewood Laboratories in Ireland in 2006.
Aurobindo Pharma bought Pharmacin international BV of the Netherlands and French company Negma Laboratories for $265 million in 2007.