EVERGREENING Lies – Biocon 1000 Patents Didn’t Make India Rich & Healthy

April19, 2013

It is a confirmed fact that just 1% of Patented Drugs are manufactured in India in $18b Indian Market (World $800b) and this also confirms that India had been filing Bogus Process patents for many decades. India is Barren Land where no Invention Is Produced. Patent filings are less than 0.1% of the World - mostly bogus Process Patents and most of them also don’t get funds to commercialize them.

Biocon’s 1000 Patents all bogus process patents didn’t make India rich and healthy – CSIR DSIR always filed bogus or useless patents this includes patents by Mashelkar or Brahamchari.

R&D and Inventing is an Evolving Process. When I started filing patents – I used to prepare for collecting Information, Study, Experiments, Drawings, Drafting, Disclosing to Patent Attorney etc within hours of filing I was thinking of newer ideas to further improve the product. But when over several thousand R&D persons are permanently engaged in an organization developing improving Patenting Inventions there are improvements made every day – some big research based companies file well over thousand patents in a year and these are largely improvements and few Breakthrough Molecules. There is long and complicated process of validation and certification – this process itself demand improvements to the originally disclosed in first patent. Obviously USFDA would approve ‘Latest Version Cleared For Public Use’ – So concept of EVERGREEING is malicious and deliberate mischief.

Patents, Patent of Additions, Division of Patents, Utility Patents

EVERGREENING MISCHIEF is creation of weird minds who have ABUSED science and technology and who have generally not filed any patent or filed bogus patents.

Ø      Improvements in Inventions are permissible by filing More Patents, Patents of Additions and Division of Patents. Patent of Additions are minor improvements while Division Patents are meant for Multiple Big Inventions in a Patent – Inventors are allowed to file more than one Division Patent based on disclosure in first patent.

Ø      In addition Utility Patents also provide IPR for improvements in Most Industrial Countries. THUS INDIA WAS NEITHER PROTECTING BIG INVENTIONS NOR SMALL INVENTIONS.

Ø      It is unfortunate Inexperience Attorneys on both sides didn’t CORRECTLY placed facts before the Supreme Court. [Foreign Lawyers are not licensed to work in India]

Ø      When Patents were granted in all countries North America and Europe before 2000, denying Novartis a Patent in 2013 is not the best JUDGMENT.

In Novartis case first patent was filed in 1994 and India agreed in 1995 to grant patents from 2005 and all the Drug Patents Filings were put in Drop Box to be opened in 2005.

USFDA approved Novartis patented drug for Medical Prescriptions in 2001. It obviously had improvements made to 1994 Patent in the intervening period.

India cannot be Developed and World Leader until it proactively introduces Latest Technologies.

Technologies flow seamlessly in Developed Countries and properly protected.

All Developed Countries invest in R&D and creating Intellectual Property – even small countries Switzerland or Israel have created substantial Intellectual Property mainly for Exports – India a big country has its own Captive Market as well as potent to serve rest of the world market.

Progress of India depends on how much of New Technologies India can Create and Patent for World Market than how many are denied Patents in India and in doing so crippling Indian Patent Office.

Biocon article halfheartedly support this when drastic action is called for.

Ravinder Singh

Inventor & Consultant

KNOWLEDGE, MARKETS, CAPITALISM, PEOPLE

Keep the Doors Open for World Pharma

After setting the bar on repetitive patenting, India now has to move fast to ensure that it is both innovation and investment friendly

    Weeks after the Supreme Court ruling on Novartis AG’s cancer drug, Glivec, one thing is clear: India is now in the position of a thought leader on pharmaceutical patents. But the country cannot afford to lose the moral high ground. Therefore, just as India has set the bar on repetitive patenting, it cannot be seen as being guilty of condoning patent law violations. India should ensure that it does not violate any multilateral trade agreements when invoking tools like compulsory licensing for ensuring affordability of patented innovator drugs. Moreover, the judicial system should also be alert to local generic drug makers trying to exploit loopholes in existing regulations to bring their products into the market in flagrant violation of the spirit of these rules.

FREEZING EFFECT

Already, large overseas pharma innovators are threatening to reduce their investment on drug research and development in India following multiple concerns that include the Glivec ruling, the spate of compulsory licensing cases as well as the recent Merck vs Glenmark case on a patented diabetes drug. There could be a freezing effect on the entry of cutting edge pharma products from overseas innovators into India, which will deprive patients here access to the most recent medical advances. A competitive cost base and a strong scientific talent pool have helped India emerge as a preferred innovation partner for contract research and clinical development services for large pharma innovators. But a weak IP regime could push these companies away from doing business with local players. We simply cannot afford to lose our competitive position as a preferred destination for innovation.

REDRESS QUICKLY

To prevent lasting damage to its image of an investment-friendly destination, India needs to move quickly to demonstrate that it is a credible signatory of the TRIPS agreement and takes its obligations on intellectual property rights seriously. So, if a large pharma innovator makes a strong case of its patent rights being compromised, India should move to redress it quickly. The government will also have to base its decisions on patent issues on evidence-based data and not be compelled by activists’ pressure. Laws should also be strengthened to make patent prosecution severe enough to deter future violations. Let’s be very clear: India needs patented drugs. We should be mindful of spurious arguments in certain media reports against the need of a strict IP regime in India, considering only 1% of the domestic pharma market comprises patented drugs. One must understand that it is through these patented drugs that Indians can access treatments for unmet medical needs. And this access does not come cheap, there is a big difference between the cost of innovation vis-avis the cost of imitation. This begs the question: who should pay for the high cost of drug innovation?

AFFORDABLE INNOVATION

It is an important question in India, where affordable health care is a critical issue and requires the government to play a much bigger role. However, the government seems to have abdicated its responsibility in this regard. In such a scenario, regulatory authorities need to define a smarter regulatory pathway that cuts the cost of development and enables affordable drug innovation, benefiting consumers by improving access to affordable drugs. For example, drugs that have already obtained approval from the US or European drug regulator, should be granted a waiver on conducting clinical trials in India. The regulator should give such drugs a “conditional approval” and give them a year’s time to collect “safety and efficacy” data post marketing. The final approval should be given after submission of this data. This will ensure that local regulatory requirements don’t add to the cost of innovation, forcing innovator companies to price their products at a premium. Smart regulations and a strong patents regime can help India build an ecosystem that fosters cheaper drug innovation and gives pharma innovators the impetus to pass on the benefits to patients, without having to take a hit to their bottom lines. India needs inventive solutions to meet the health care needs of millions through affordable medicines. But affordability and access can’t come at the cost of disrespecting IP rights.

India must clearly enunciate the rules governing patentability, demonstrating their compatibility with the TRIPS agreement. Such a move is crucial as pending judgments on various patent cases will be closely watched by the world to determine where India stands on the key issue of intellectual property rights.