The Hindu Business Line : US judge urges special courts for patent cases

"A LOT of concerns that people have (on drug companies extending the monopoly on their products through incremental developments) can be solved by a good court system," said Mr Randall R. Rader, Circuit Judge on the United States Court of Appeals for the Federal Circuit.

Judges have usually invalidated attempts by companies to extend the life of a patent beyond the statutory time, he observed, highlighting the significant role that law courts will increasingly play as the product patent regime now gets implemented on the ground in India. Judge Rader has dealt with cases involving Indian generic companies in the US.

Pointing out that a product patent regime is only as good as its enforcement, he underlined the need for specialised courts. India will profit from having trial courts with patent expertise, he said.

Citing Japan as a case in point, he said, there could be higher court of appeals with the expertise to handle complex cases. Or a division can be designated to handle patent-related cases, as is the experience in Russia.

Over the last five years, nations such as China, Taiwan, Japan, Korea and Thailand have been striving to improve their courts. European nations have intellectual property speciality courts and same is the case with the US, he said.

Given the strong reaction in the local industry over the definition of what is patentable, he said law courts have normally not entertained attempts by companies to prolong the exclusivity on their medicines, by merely changing a small detail.

Responding to how innovation can be protected, while keeping medicines affordable, he told Business Line that each case had to be taken individually. A legitimate product improvement should be allowed, he felt.

There is a nagging suspicion in the local industry that big pharma companies normally know that their proprietary medicine may be useful in two different applications, but they pull out the second use only when the patent on the first application is coming to a close.

"Once a certain indication on a drug is in public domain, researchers may stumble on the alternate indications too. So it would be in the interest of the pharma company to come out with all the data on a medicine," he countered.

Challenging an unethical patent is often more a financial issue than a legal one, points out Mr Mark Pohl of the Pharmaceutical Patent Attorneys. Litigation is expensive, at about $10 m-$15 million, and companies do not contest patents for that reason, he said. .

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