Balancing patent protection with generic medicines

Loopholes in the 1984 US Hatch–Waxman Act have allowed innovator drug companies to extend their patents far too long. So said the group Business for Affordable Medicine (BAM) at a press conference to Congress earlier this year. BAM, which consists of politicians, employers and labour organizations, is pushing for changes to facilitate faster availability of generics, which would reduce the cost of medicines. The Hatch–Waxman Act was designed to make it easier for generics manufacturers to enter the market by changing the patent rules and FDA testing procedures for generic drugs. One incentive offered to generics companies is the 180-day market exclusivity to the first manufacturer to market a drug previously supplied only as a brand-name drug. However, BAM maintains that brand-name drug companies routinely claim that a generic drug approval infringes the patented drug, which triggers a statutory 30-month delay in the final approval of the generic. No damages are awarded to the generics company should the claim be found groundless. Whereas BAM urges Congress to close the loopholes to prevent these kind of abuses, the Pharmaceutical Research and Manufacturers of America contend that changes to the Hatch–Waxman Act would stifle research and development.

AstraZeneca Losec patent ruled invalid in UK court

The anti-ulcer drug Losec, one of the world's top-selling drugs, accounted for 35% of AstraZeneca's total sales in 2001. Each day that generic competition is delayed, the company earns around US $2.5 million in profits. In March, the Patents Court of the High Court of Justice's Chancery Division ruled in favour of two UK-based pharmaceuticals firms, Cairnstores and Generics, in their challenge to two of the omeprazole (the active ingredient of Losec) formulation patents of AstraZeneca. However, AstraZeneca was given leave to appeal against the decision. Although the main patent on the drug expired last October, several other patents are still in force, which is providing the mainstay of AstraZeneca's defence against the generics companies. The company maintains that the UK decision does not have any implications for a similar case that is now underway in New York. WEB SITES European patent database Lovegren, K. I. et al., Haessle AB, EP 247983 Lovegren, K. I. et al., Haessle AB, EP 496437

Generics companies should challenge patents in court

Interim injunctions, those granted before a dispute is settled, are not often issued by the UK High Court. Last year, an interim injunction was granted on behalf of GlaxoSmithKline (GSK) against Generic UK over the production of a generic version of a GSK drug. The granting of the interim injunction in this case indicates that the Court will not look favourably on those who wait for legal action to come to them as a practical matter, rather than challenging the patent validity in court. The judge took into account that Generic UK had known that legal proceedings were likely if it went ahead with the product in question, but failed to take steps to challenge the validity of the patent that it considered invalid. The GSK patent-infringement case against Generic UK is underway in the High Court.