Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) has been sued in the US District Court for the District of New Jersey on patent infringement charges by VIVUS, Inc. (NASDAQ:VVUS).
The lawsuit comes a month after Teva filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA), seeking permission to sell generic versions of VIVUS’ star obesity drug Qsymia. VIVUS, a small California-based biopharmaceutical company claims Teva’s proposed ANDA for generic Qsymia was filed prior to expiry of several US patents for the drug currently held by VIVUS including Patents 7,056,890, 7,553,818, 7,659,256, 7,674,776, 8,580,298, 8,580,299, 8,895,057 and 8,895,058. These are listed with the FDA in its Orange Book containing all patents for Approved Drug Products with Therapeutic Equivalence Evaluations.
As part of the Hatch-Waxman Act, a company is allowed to seek FDA approval to market generic version of a brand name drug prior to its patent expiry. The company that leads in ANDA filing for the purpose gains exclusive marketing rights for cheaper generic for 180 days. However, it is important for the generic applicant, in this case Teva, to include in its ANDA a “paragraph IV certification” that ensures the branded drug’s patent is not infringed upon or invalid, and to notify the same to the patent holder, in this case VIVUS. Teva met the said condition.
At the same time, since the infringement suit filed by VIVUS was within 45 days of Teva’s ANDA submission, generic Qsymia’s FDA approval gets automatically deferred for 30 months, unless the patent expires during the time or is found to be not infringed or invalid by the FDA. This clause, in favor of the patent holder, enables it to postpone generic entry of its patented drug by asserting its patent privileges in court.
VIVUS develops and markets drugs that treat unmet needs for sleep apnea, obesity, sexual health, and diabetes. Qsymia is a key drug under the small biotech’s umbrella, approved by the FDA for the treatment of obesity back in July 2012. The approved doses of Qsymia capsules CIV combine two FDA-approved medicines, phentermine and topiramate, in an extended-release formulation. It is designed for use alongside low-calorie diet and physical exercise in obese as well as overweight individuals with Body Mass Index (BMI) equal to or greater than 27, who suffer from at least one weight-related comorbidity. The drug is being further tested for sleep apnea as well as type 2 diabetes in mid-stage trials.
