Kalen Lumsden is a JD candidate at Osgoode Hall Law School.
On June 1, 2011, Pfizer, manufacturer of the erectile dysfunction drug Viagra, filed suit against rival Watson Pharmaceuticals to frustrate its attempts to produce a generic version of the drug. The next day Watson confirmed that it had applied to the US Food and Drug Administration (FDA) for approval to market the generic Sildenafil Citrate tablets.
The suit brought by Pfizer will delay final approval of Watson’s Abbreviated New Drug Application (ANDA) by the FDA until November 6, 2013 or earlier if settlement is reached. As it stands, Pfizer’s patent (US Patent No. 6,469,012) is due to expire in November 2013. This delay allows Pfizer to protect its yearly Viagra sales of more than $1 billion from generic competition for another two years.
Pfizer lost its monopoly on the Viagra patent in the United Kingdom in 2000 when it was found “invalid for obviousness,” which opened up the market to generic competition. Putting off the day when Viagra has to face competition within the United States is obviously in Pfizer’s best interests and legal delay tactics are perfectly suited to the task.
Pfizer’s fight to protect Viagra is an interesting case study in the larger debate on the role of intellectual property law and generic drugs. Here, the action occurs entirely within the US and concerns a drug for erectile dysfunction. At the other end of the spectrum are countries that lack strong intellectual property laws and use this to manufacture generic drugs for HIV and AIDS treatment that would otherwise be unaffordable. The tightening of intellectual property laws in conjunction with bilateral trade agreements with developing countries is a trend many are critical of specifically because it reduces the availability of generic drugs.
Juxtaposing Viagra with HIV medication highlights many of the values that underpin a strict patent regime that values protection of assets above all else. After all, isn’t cheaper Viagra clearly the best outcome in this scuffle between two massive drug companies?