GJE argument leads EPO Technical Board of Appeal to revoke key pharmaceutical patent

Radically different argument persuades the Board that the claims of the patent lack an inventive step

May 3rd 2011
Gill Jennings & Every LLP partner, Arnie Clarke, achieved the revocation of a key patent protecting Spiriva® (tiotropium bromide) today. The drug is the gold standard for treating chronic obstructive pulmonary disease (COPD), a common and debilitating lung condition.

The patent in question, European patent no. EP 1475379, was one of Boehringer Ingelheim’s key “secondary” patents which are commonly used as part of a manufacturer’s “Evergreening” strategy. This is an approach used by brand-name manufacturers to extend the monopoly on a drug by obtaining separate 20-year patents on multiple attributes of a single product. Such practices are increasingly viewed as being anti-competitive because they create unjustifiable legal barriers and can lead to the maintenance of inflated branded pharmaceutical prices.

Spiriva was launched in the US, Japan, France, Germany, Italy, Spain and the UK between 2002 and 2004. In 2010, Boehringer Ingelheim reported sales of the drug reached $4.1bn (€2.9bn). The drug is the only long-acting bronchodilator specifically marketed for COPD and is the only long-acting anticholinergic on the market.

The initial opposition to the grant of the patent had proved unsuccessful, but with the transfer of the case to GJE, a radically different strategic approach was adopted for the appeal (no. T1097/09). This succeeded in persuading the EPO Technical Board of Appeal that the claims of the patent lacked an inventive step.

Arnie comments that “The patent was of importance because it covered all routes to the production of tiotropium bromide, starting with a broadly defined starting material which covered the most desirable synthetic reagents. This was monopolizing the most commercially viable routes for producing Spiriva®, effectively providing the Patentee with extended protection of the product, not just the synthetic process.”

The revocation of the patent will open the way for generic manufacturers of tiotropium bromide to manufacture it in Europe via any (otherwise unpatented) synthetic route.

Arnie’s approach was to undermine the patent by focusing on discrepancies between its contribution to the state of the art and the manner in which the invention was claimed. The patent described a new synthetic route to tiotropium bromide. However, Boehringer Ingelheim had instead claimed a starting material and all conceivable routes to tiotropium bromide. Arnie argued that this would cover a pair of prior art documents, the first which used the starting material to produce compound X, and the second which used compound X to produce tiotropium bromide. As the patent theoretically covered this combination, the Patentee could not claim that there was any technical advantage over it, even though it advocated an alternative route which did not use intermediate X. Without an advantage, the claim was considered to lack an inventive step.