Patently a problem

As pharma companies face the prospect of patents expiring, companies will go to great lengths to hold off the threat of generic competition, often by attempting to repurpose a drug.

Last week, it was revealed that Bristol-Myers Squibb (BMS) spent over USD 2.8m in H1 2007 to lobby the US Federal government over patent protection.

As generics companies attempt to cash in on impending expiries, many lawsuits are arising. Last week, Teva Pharmaceutical sued Apotex to prevent the generic rival from selling a copy of GlaxoSmithKline's (GSK) antihypertensive drug, Coreg (carvedilol).

Servier vs Apotex
Apotex was involved in another lawsuit earlier in 2007 when French pharma company Servier sued it for infringement of its patent for the alpha crystalline form of its ACE inhibitor drug perindopril, sold under the brand name Coversyl.

Eventually the judge ruled that Servier's patent was invalid and that Apotex was free to produce and market generic versions. Until the judge ruled in the case, Servier had an interim injunction imposed stopping Apotex's production. As a result, Servier retained its monopoly for nearly 12 months, despite eventually losing the case.

The perindopril market is an important one: Servier's turnover in the UK was around GBP 70m per year and Apotex made GBP 4m in sales from its generic equivalent before the injunction was put into place.

The judge ruled in July 2007 that Servier's patent was invalid on the grounds of lack of novelty and obviousness, as the new drug was not any different to the alpha form of the drug that the original patent covered.

Pozzoli vs BDMO precident aids appeal
Before the Judgment was made public, the Court granted Servier permission to appeal, even though it believed there was no real chance of success. However, the Judge felt bound to do so because of a precedent set by the Court of Appeal in Pozzoli SPA v BDMO, which said Öunless the case is very clear on the facts and can be understood sufficiently readily in an hour or so, the better course of action is normally for the trial judge to give permission.

The court then agreed to maintain the injunction over the weekend to allow Servier to ask for permission to appeal, which was then refused. The Court of Appeal then expressed surprise that the court felt bound by the court's decision in Pozzoli.

However, despite that no clear guidance has been issued on how to interpret Pozzoli.

According to Matthew Royle, IP associate at Taylor Wessing, at a hearing on leave to appeal last week, the judge in the case, Pumfrey, indicated he would continue to apply his interpretation of Pozzoli.

There is every chance that Pozzoli could be used again to grant leave to appeal in a case that has little or no chance on appeal, particularly in pharmaceutical cases, which are often complex and will require more than an hour's reading by the Court of Appeal.  That being said, it is relatively rare for a case to have no prospects of success on appeal so I am not sure how often Pozzoli might apply, explained Royle.

Generics held at bay
Although the Servier case was unusual in the fact the original patent was ruled invalid, the stalling tactics employed by the company are not. Whichever way the case goes, whether in favour of the pharma or generics company, it looks likely that an interim injunction might now be granted pending appeal even when a patent has been held to be invalid at first instance. This potentially will increase the patentee's monopoly on an invalid patent for a further nine months or so.

As a result, generic companies will be kept off the market longer, the price for the drugs will stay high and the patentee will continue to make a lot of money. This is the first time that this situation has been brought before the court because the assumption was always that you could not enforce an invalid patent.  Until it comes before the court again it is not possible to say what effect this judgment will have but it will certainly encourage patentees to try to extend the injunction pending appeal, concluded Royle.