US Patent Ruling On Teva's Copaxone A Big Win For India

US Patent and Trade Mark Office’s decision to reject the patent claims of Teva Pharmaceutical Industries on its 40-milligram dosage of multiple sclerosis drug Copaxone is undoubtedly a booster dose for the generic drug industry and the Indian drug makers in particular. The US patent office ruling, which was out on Wednesday, had lifted share price of India drug maker Natco Pharma, which has partnered the US generic drug maker Mylan to supply this drug for the US market, to a record high on Thursday (25 August).

The rejection of Teva’s claims on the Copaxone patent is an important milestone in the US drug market as it discourages the practice of evergreening of patents. This practice, which blocks the entry of cheaper generics in the market, also costs the patients heavily. India being the largest generic drug supplier to the US market, the local drug makers are obviously the biggest beneficiaries of not only this decision but of more such decisions in future.

Evergreening of patent is a practice by which the patent holders try to retain their exclusivity on patented drugs even after the expiry of the patent by making frivolous additional patent claims on the same molecule. Such practices mostly followed by Big Pharma (large research based drug makers of the world) often get passed easily in the US as the country has a comparatively liberal patent law.

Although Teva is the world’s largest generic drug maker, it currently holds three patents on this drug and it earns almost 20 per cent of its overall sales from this drug alone. Teva’s first patent on the original molecule of the drug has already started facing generic competition in the US after its expiry.

The share price of the Israeli drug maker fell about 3 per cent on Wednesday after US patent office invalidated two of the patents. These two patents are among the three being challenged by generic drug makers, including Mylan at the US Patent Trial and Appeal Board (PTAB) at present.

PTAB is expected to issue a final decision on Teva’s third patent on this drug by next week.

However, Teva had said that it will challenge the Wednesday decision of the US patent office.

While PTAB has already rejected a Mylan petition to invalidate a fourth patent application from Teva on the same drug, the three patents under review at present will otherwise expire only in 2030.

The US patent office’s decision to reject Teva’s additional patents on the drug gains significance as US is one country, which has been critical about India’s strong stand against evergreening of patents.

India’s Natco Pharma will immensely benefit from this latest US patent office ruling in favour of its partner Mylan. The current sales of Teva’s 40-milligramd osage of Copaxone were around $3.2 billion in 2015. Hence, the Mylan-Natco combine will be able to grab a significant portion of these sales by introducing their generic version in the US once it is outside of the patent protection.

More importantly, since Mylan was the first generic company to challenge Teva patent on this drug, it may get a six-month market exclusivity also. Apart from Natco, many more Indian generic drug makers are also currently targeting Copaxone market in the US.