GSK gives way on Paxil patents
pharmafile | October 29, 2003 | News story | |
New measures by the FDA to speed up patient access to generic medicines have claimed their first scalp after GlaxoSmithKline withdrew three patents related to its blockbuster Paxil.
The FDA announced last month that it would close legislative loopholes allowing pharma companies to delay the introduction of cheaper alternatives to their products by introducing frivolous patent extensions.
GSK said it voluntarily withdrew the three product-by-process patents to bring itself into line with the new rules, although they won come into force until August and do not specifically apply to existing patents.
The patents were withdrawn from the FDA's Orange Book listing of newer patents for existing drugs. Under the new FDA rules pharma companies are not allowed to file multiple patents in the Orange Book for a single drug.
Pharma companies could previously automatically gain 30 months' extra exclusivity by citing each patent listed in the Orange Book and GSK's move may allow generic competition for Paxil to come to market quicker.
The company said de-listing the patents did not affect their validity and it would continue its legal claims against Apotex and other generic companies over infringements of these and other patents.
The withdrawal of one of the three patents removes a legal stay on approval for Apotex's generic Paxil, but this was due to expire in September and continues to be bound up in ongoing litigation.
GSK remained cautious on when it expects to face generic competition for Paxil in the US and refused to upgrade its earnings for this year from the previously stated high single digit growth.
The company recently received a boost in the UK, where Paxil is marketed as Seroxat, when its patent on the drug was ruled "partially valid" by the Court of Appeal.
The court upheld a decision against BASF and also reversed an earlier ruling for Dutch generics company Synthon, which had challenged one of GSK's patents on the drug.
Paxil generated sales of $820 million in the first quarter of the year.
