SpicyIP Tidbits

The Eco Times reports that:

“The Tea Board of India filed an application here Monday to register Darjeeling as a Geographical Indication (GI) in the European Union (EU). GI is a sign used on products, which have a specific geographical origin. The use of a GI often acts as a certification that the product possesses certain qualities, or enjoys a certain reputation, due to its geographical origin. Darjeeling was the first GI to be registered in India and is the first application for registration of a tea in Europe.

The distinctive characteristics of Darjeeling tea are due to both its geographic origin and the way in which the tea is processed in Darjeeling. A major portion of the annual production of Darjeeling tea is exported, the key markets being Japan, Russia, the US and the EU countries.”

2. Government issues Circular on border enforcement of IPRs

Thanks to Nihas Basheer of Wadia Gandhy Associates for referring me to this recent news on IP rules in relation to customs:

“In its Circular dated October 29, 2007 (“Circular”), the Central Board of Excise & Customs under the Ministry of Finance, India, has issued instructions to the relevant customs and excise authorities, for implementation of the Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007 (“IPR Rules”) dated May 8, 2007.

The IPR Rules emanate from Section 11 of the Customs Act, 1952 which empowers the Central Government to prohibit import or export of goods infringing intellectual property rights. Before the notification of the IPR Rules, the notification of January 18, 1964, prohibited import of goods infringing trademarks and design.

These new IPR Rules prohibit import of goods infringing patent, copyright and geographical indications as well. The implementation of IPR Rules was preceded by a series of representations by industry players to the Government.

Another reason behind this change cited by the Government of India is its obligations under Articles 51 to 60 of TRIPs. While the mandatory obligations under Articles 51 to 60 of TRIPS dealing with border measures are restricted to Copyright and trade Marks infringement only, the Indian Government has taken a proactive step to include other IPRs.”

3. Makali Ber, a promising “herbal” drug

Pharmabiz reports that CFTRI researchers have identified extracts of ‘Makali ber’ having promising stomach ulcer control properties.

Central Food and Technological Institute (CFTRI) has identified extracts of ‘Makali Ber’ (swallow root), a widely available root in Karnataka and used in the making of pickles, as having property to block the stomach ulcer-related complications and provide relief.

….The team of researchers found that ‘Makali ber’ prevented the bacterial growth of Helicobacter pylori, which causes severe acidity leading to ulcers in the stomach in lab conditions This confirmed its ability to inhibit various steps of gastric ulceration directly.

Another feature of ‘Makali Ber’ is that it is known to be non-toxic. The root has also emerged as an ideal anti ulcerant alternative over the existing allopathic drugs, which have known to cause serious side-effects. Further, ‘Makali Ber’ is also known to lower the drug burden on patients.

The extract was also found to protect against alcohol stress induced ulcers in experimental animal models. The study also provided details about normalizing damage to stomach tissue by preventing the entry of an ulcero-genic such as Helicobacter pylori.“

What is the government doing to incentivise more research into herbal drugs? We’ve been focusing too much on our traditional generic strength.

There needs to be more of a focus on herbal medicines. This could be an excellent way to not only decrease our health care cost, but also to lead to more innovation around our ancient medicinal systems. The Chinese are leading here, having already devised a 15 year plan to boost more innovation in Chinese traditional medicine.

4. Indian Government Seeks to Spur More Creativity and Innovation

A. Creativity Institute for India

The Hindu Reports on the establishment of the Rajiv Gandhi Institute of Creativity in Hyderbad.

“The institute will foster creativity by imparting education, nurturing cutting edge research driven by industry and societal requirements. To be set up by the Ministry of Science & Technology, it will render professional services to demonstrate the creativity application potential by developing relationship with prominent institutions and organisations across the world. The institute will be a global leader focused on enhancing the creative quotient in children, entrepreneurs and professionals while enabling the application of creative ideas for the industry, thus making India a hotbed for innovative solutions.”

B. Rs 75-cr fund to promote tech start-ups

The Hindu Business Line reports:

“A Rs 75-crore fund to promote start-ups involved in product development in the areas of information and communication technology’s (ICT), will be launched soon by the Centre. The Department of Scientific and Industrial Research (DSIR) will operate the fund with the active involvement of the Indian School of Business (ISB), TiE (The Indus Entrepreneurs) and the Indian Institute of Science (IISc).

According to Mr A.S. Rao, Advisor, DSIR, the fund will focus on helping start-ups to convert intellectual property into product developments. As there are not many funds for technology start-up, the idea of the Government is to promote core product development, he told newspersons on the sidelines of the TiE-ISB meet, here. Mr Rao said the Government will take the help of the ISB and TiE in examining the viability of the business models proposed by the start-ups, while the IISc, Bangalore would validate the technological competencies.

5. Indian companies hiving off their R&D Units

The Economic Times Reports:

“Risk and reward don’t come unstuck. That’s what top Indian pharma companies are realising as they step out to leverage the expertise gained in reverse engineering of patented molecules, and build capabilities in original research targeting new chemical entities (NCE) and novel drug delivery systems (NDDS).

In fact, understanding this mix of opportunities and threats, many pharma majors are now de-merging their NCE operations into separate companies to scale-up their R&D activities, achieve better focus and hedge against risks.

The trend is catching up fast and already deep-pocket pharma majors such as Dr Reddy’s Laboratories, Ranbaxy Laboratories, Nicholas Piramal India, Sun Pharmaceutical Industries have hived off their NCE activities into separate companies.

Experts feel it’s the logical extension for the R&D activities ever since India recognised the product patent regime since 2005. “The R&D operations of Indian pharma companies have reached an inflexion point that could catapult them into the big league globally.

Their expertise in early discovery phase I & II clinical trials is most useful, especially when combined with the late discovery competencies of international pharma majors. R&D for drug discovery is a capital-intensive activity.“

Readers will recollect an earlier post asking the question: now that Indian companies have increased R&D spending and more collaborations with MNC’s, what role will the Indian patent regime pay in incentivising such R&D? In other words, since most of our big R&D spenders (Ranbaxy and Dr Reddy’s) focus more on the Western markets, will the Indian patent regime really make a difference to their R&D incentives.

6. Fewer Drug Approvals

Pharmalot, the leading pharma blog reports:

“New drug approvals by the FDA have fallen further behind last year’s levels, with just 59 NDA approvals through October, down 29 percent year-over-year from last year’s 83, and 13 percent below the 10-year average of 68 NDAs, writes Jim Kumpel, an analyst at Friedman Billings Ramsey, in an investor note this morning.

More importantly, the 14 new molecular entity (NME) approvals through October represent an 18 percent drop year-over-year and is 22 percent below the 10-year average of 18 NMEs. That said, the four NME approvals in October represent the high water mark for NMEs in 2007, although that’s still down 20 percent from the prior October, he notes. Biologics approvals have fallen off a cliff in 2007, he adds, with just one so far this year, compared with four at this time in 2006.

The “NDA approval ratio appears to be on track for the lowest level since 1994,” Kumpel writes. “We have reviewed 40 years worth of NDA submission and approval data to put 2007 into perspective. While some pundits have argued that the pipeline of NDAs submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims.

“Since 1986, only three years have featured NDA submissions above 126, while the rest of the period has stayed remarkably steady in the range of 98 to 125. The number of NDAs approved each year has been much less predictable, resulting in the ratio of NDAs approved to NDAs submitted ranging from 49 percent in 1987 to 109 percent in 1996. The approval ratio has only dropped below 60 percent in two years since 1989. However, with NDA approvals down nearly 30 percent year to date in 2007, the NDA approval ratio could come down from the 76 percent level of 2006 to something less than 60 percent, would represent the lowest level since 1994.”

Intererstingly, FDA deputy commish Janet Woodcock recently blamed the slow rate of approvals on pharma, which insists the problem is because the FDA is more cautious. “I know the CEOs think we have become extremely conservative, but the standard for getting a drug approved has not changed,” she said. “The number of new drug approvals is directly proportional to the number of applications we receive. It’s because we’re getting fewer submissions.”