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Mumbai: The Indian Patent Office (IPO) has issued new draft guidelines for pharmaceutical patents aimed at minimizing the risk of patent litigations of the kind that Swiss drugmaker Novartis AG fought for seven years over its cancer drug Glivec.

The patent office, which put out the norms to help its officials enforce uniform standards of patent examination and grant, has for the first time included the phrase “enhanced therapeutic efficacy" as the criteria to allow new patents for a previously known drug substance.

The Glivec case was one of the most controversial and lengthy patent cases in India, running for seven years from 2006 to 2013. Pursued by Novartis against the government of India, it challenged the IPO’s rejection of its patent application for the blood cancer drug and a crystal form of a previously known drug called imatinib mesylate.

The patent office had rejected the application in 2006 on grounds the original molecule imatinib was in public domain before 1995—the cut-off year for grant of drug patents in India—and that the crystal form did not demonstrate any enhanced efficacy to treat the disease.

The draft norms for deciding patentability of drugs make it clear that “enhanced therapeutic efficacy" is the only criteria for grant of a new patent for drug substances, which are the modified forms of a known drug.

The draft norms, which stress provisions under Section 3 (d) of the Indian Patent Law 1970 that denies patent grant for incremental innovations or modified forms of known drugs, have been put out for public comments till 21 March. They have been reviewed by Mint.

The norms, which replace the earlier phrase “enhanced efficacy", are in line with rulings by both Madras high court in 2006 and the apex court in April 2013.

The courts, while passing judgments in the case, had ruled that an incremental innovation in case of a drug product is patentable only if it demonstrates “enhanced therapeutic efficacy".

The norms may not please foreign firms banking on incremental innovation because their new chemical entity research has shrunk in the last few years, an intellectual property law expert and a corporate consultant who did not want to be named said.

Ranjana Smetacek, director general, Organisation of Pharmaceutical Producers of India, which represents foreign drug makers in India, said: “The said norms do not have the force of law and are merely supplemental to the practices and procedures followed by the patent office."

In fact, the norms mention that in case of any conflict between the norms and the Patents Act of 1970 and its rules, the Act and rules will prevail, she said.

The Patent Act 1970, that was amended in 2005, didn’t have the restrictive clause of Section 3 (d) till amendment. The guideline is a procedural guide to help examiners.

But a senior official at IPO said the draft norms are in conformity with the law. “This sectoral guideline was drafted to standardize the method of pharmaceutical patent examination across the four regional offices and will help avoid confused views on patent claims among examiners and controllers within IPO, as it has been the case earlier," said this official, who did not want to be identified.

The apex court, by holding that the test of efficacy in the case of medicine could only be “therapeutic efficacy", had apparently raised the bar with regard to requirements of Section 3(d), according to Smetacek.

Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, a domestic industry lobby, said, “The draft guideline is to address criticism by foreign companies and their trade bodies that India’s patent system lacks consistent adherence to patent rules and procedures between regional patent offices."

“BIO, a trade body of US biotech firms, had alleged from time to time, including in its recent submission to the US Trade Representative, about the lack of consistent adherence to patent rules and procedures between the regional patent offices and the need for increased training on patentability criteria," Shah said.

To address such criticism, IPO is making efforts to improve the quality of examination of pharmaceutical patents, in consultation with the industry and other stakeholders, Shah said in an email.

In 2006, when Novartis sued the patent office and government of India in the Madras high court, the drug maker had argued that the crystal form of imatinib mesylate enhances bioavailability and, thus, meets the criteria of enhanced efficacy. But the court defined “enhanced efficacy" as therapeutic enhancement, rather than bioavailability.

Bioavailability is the availability of drug ingredient in a patient’s body.

The Supreme Court, while giving its judgement on Novartis’s appeal on the Madras high court order seven years later, also upheld this definition.

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