Pfizer Inc. (PFE) recently received a favorable ruling in its patent infringement case against Teva Pharmaceuticals (TEVA). Teva had filed an abbreviated new drug application with the US Food and Drug Administration (FDA) seeking approval for its generic version of Viagra.
Teva had challenged the validity of the Viagra use patent, which expires in 2019. The United States District Court for the Eastern District of Virginia ruled that the Viagra patent for the treatment of erectile dysfunction is valid and enforceable.
This means that Teva will not be able to gain approval for its generic version of Viagra until Oct 2019. Teva, however, has the option to appeal the court’s ruling. Meanwhile, several other generic companies are also seeking approval for their generic versions of Viagra. Pfizer said that no trials are scheduled for these cases.
The court’s decision comes as a relief for Pfizer, which is facing a major patent cliff. Pfizer’s biggest drug, Lipitor, which posted sales of $10.7 billion in 2010, is slated to lose exclusivity in the US later this year.
The delay in the entry of generic versions of Viagra would help Pfizer offset some of the impact of genericization of other products. Viagra sales came in at $1.9 billion in 2010.
We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). While near-term earnings growth will come in the form of cost cutting and share repurchases, longer-term growth will be dependent on the success of drug development. Pfizer expects to present phase III data on several candidates in 2011.
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