PATENT PROTECTION
HOW TO DEVELOP A WINNING STRATEGY
The history of Viagra and the battle to enforce its patents against attack from generic manufacturers offers good lessons for devising a plan of defence.
In 1989, British scientists at Pfizer created a truly ‘blockbuster’ drug. Known as silendafil citrate, the drug was supposed to treat heart problems and, by 1991, Pfizer had obtained a UK patent for this purpose. But as the scientists began testing the drug, they soon realised its desired impact was minimal. Surprisingly, they found, the drug had a notable side effect—it stimulated penile erection. In the five years that followed, Pfizer rigorously studied and tested the drug before, in 1996, it successfully applied for a US patent covering erectile dysfunction. Only two years later,
the US Food and Drug Administration
(FDA) approved Pfizer’s application to sell the drug. Viagra was born.
From these humble beginnings at a research facility in Kent, Viagra soon dominated the market and generated revenues of more than $1 billion a year. It is perhaps unsurprising, then, that Pfizer’s success brings an array of challenges when enforcing its patents and protecting its market share worldwide. Faced with a determined attack by generic companies wishing to sell its drugs more cheaply, a pharmaceutical company must employ a carefully craſted litigation strategy. And although such an attack can always be expected, winning in the courts is an altogether different matter.
“Each day can mean millions of dollars or more,” says litigation specialist Bill Zimmermann, pointing towards the importance of winning in the lucrative US market. Zimmermann, partner at law firm Knobbe Martens in Washington DC, says brands typically take two approaches when facing assault from generic companies: pursue them aggressively and try to beat them, or delay their entry to market if they are likely to succeed.
Developing a winning strategy—the primary aim for any brand—first depends on a solid and diverse portfolio of patents, built over a number of years. “If you have six or seven different patents, you look at the strength of each one relative to what the generic is doing and then put forward your best case,” he says. Te “best case” typically requires a patent covering the drug’s molecule, seen as the strongest patent and one which sets the foundations for an aggressive approach to litigation.
“Generally speaking, claims covering a new chemical compound (molecule) are very simple and precise, and usually there is no debate about infringement,” says James Monroe, partner at law firm Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, in the US. “Te primary debate concerns validity, and it’s harder to invalidate a new chemical compound patent
than a composition or a method of use patent,” he says.
www.worldipreview.com World Intellectual Property Review July/August 2012 29
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