AFFORDABILITY OF LIFE SAVING DRUGS AND INTELLECTUAL PROPERTY RIGHTS

A furore has been created by a recent Supreme Court Ruling on a patent application by NOVARTIS in India which was rejected by the court.

Evidence in a widely cited study by the National National Institute of Health Care Management in USA on Changing Patterns Of Pharmaceutical Innovation is telling between 1989 and 2000 the US food and Drug Authority approved 1,035 new drug applications - of these -

65% contained ingredients that were already active in the market (ie .incrementally modified drugs)

11% were Identical 

15% were considered "highly innovative drug".

                      Now what we have to note is that  mischief like this results in a patent thicket around a single molecule to delay generic entry . Indi is the leading global drug supplier of bulk drugs ,formulations and generic Anti retrovirals (ARV),more than that domestic worry of affordability of drugs was a main factor . Further it was stated that "the efficacy is  a pharmacological idea associated with the ability of a drug to produce a desired therauepetic effect independent of potency ie."healing of diesease" again changing the making something more soluble or changing its properties (ie.flow properties, thermodynamic stability ) would not qualify it as an improvement . and the learned Court further says "there is absolutely nothing on this score (ie increased healing ) apart from the adroit submissions of the counsel".

Now please read the following link if interested

http://in.reuters.com/article/2013/04/01/india-drugs-patent-novarti...

Any for and against opinions are welcome - was this a fair ruling or not ?

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Moderator
Comment by John on April 8, 2013 at 8:59am

Thank You for the article on the R&D Myth.

I have had issues with "trials" for a long time. An Independent company actually should be used. Otherwise it appears as a conflict of interest for the Drug company to do their own trials.

Comment by Capt. Anand Kumar on April 8, 2013 at 3:36am

The Times of India in an article titled, "Busting The R & D Myth" quoted a 2011 London School of Economics paper exposing the high cost of new drug development as claimed by the pharmaceutical companies when arguing for patents. Even more interesting is the breakdown of funding for the cancer drug Glivec, for which Novartis lost the battle in Indian Supreme Court:

WHO PAID FOR GLIVEC R&D?

Funding source for Brian Druker's lab 50% National Cancer Institute — public 30% Leukaemia and Lymphoma Society — public 10% Oregon Health and Science University — public 10% Novartis — private Novartis bore cost of three Phase II trials with 1,028 patients Estimated cost of these trials — $38mn to $96mn The $96mn includes hefty overheads and the cost of capital Novartis sales for Glivec in 2012 — $4.7bn or $390mn per month — over $100mn every 13 days Source: James Love, Director of Knowledge, Ecology International. (Full blog post - http:// keionline.org/node/1697)


Moderator
Comment by John on April 4, 2013 at 1:54pm

The pharmaceutical industry is amazing in that what they do seems nearly anti-healthcare.

Here are a list of (my) top gripes:

1) Prime time TV adds. That costs money. lots of it. The person off the street thinks they need a specific drug as advertised, and requests it from the Doctor?? that is bad medicine.

2) Highly advertised drugs are always under patent protection, and very expensive. As a consumer - you pay for that advertising. Without medical insurance, one cannot afford $500 for 30 pills a month. Especially when there are older drugs, side effects are well-known and tested across a huge statistical pool of the population, and they are generic and cheap.

3) The Time-released patent. They make a successful drug. It then becomes Generic. At that point, they release a time-released product of the medication. In many cases, time-released is better and doctors prescribe it. However - is using divided doses any different? nope. Just a patent gimmick.

4) if the US government funded the critical research, the darn companies should reimburse the US for that funding of the basic research. It belongs to the people of the country.

5) They only make medicine that a person  must take for an entire life. This is blood-pressure meds, psychotropics, cholesterol meds etc. Anti-biotics are taken maybe two weeks, and that is all the person ever needs. Creation of new antibiotics is not pursued, on purpose (or a very much lower priority).

6) Gimmick formulations. A cholesterol drug like Advicor is a combination of mevacor and Niacine (time released). Both are in the one/same pill. Mevacor is one of the oldest cholesterol drugs. Niacin (B-3) is over the counter. Buying the generic mevacor, and Niacin (over the counter -OTC). is very inexpensive. However, the pill that includes both sells for hundreds of $$ for 30 pills. It is a patented reformulation.

when I lost my health insurance...

I went through my meds, and tossed out the non-generic, switch to an older drug (sometimes a better drug!!). etc.

It cost less to buy full-price generics, and OTC items, than the patented formulation when/if I was on medical insurance. (I even research the darn drugs and ask for generic. Also - if they advertise on primetime top tv-slots, I won't take it).

I don't want to get started on this... But - then there was the insurance company that called my doctor and had me switch to a more expensive drug from a nearly identical equivalent. The only reason to do that would be a kick back from the drug company to the insurance company. Any other reason to do that??

sigh...

John


Moderator
Comment by M K Ramadoss on April 4, 2013 at 9:41am

World-wide many have applauded the decision of the Court which makes sense. It was good that Novartis went to the Supreme Court of India. It is one more instance where the courts have to take decisive action on an issue which affects the welfare of the people everywhere in the long term. Of course pharma business would continue to claim how they need all the money they can get for innovation. We will have see the snow ball effect in other developing countries where the masses need help from high prices of drugs.

Comment by Hari Menon on April 3, 2013 at 11:50pm

In India this generic was being sold for approx 8,000 Rupees or 167 USD for a months dosage , whilst the Multinational was marketing it at close to 100,000 Rupees or approx slightly less than 1900 USD for a months supply. It is sold in America for 70,000 USD for an annual dosage which is over 5,000 USD for a months dosage. The disparity is quite high and unconscionable - even accepting that the Average american earns way much more than his counterparts in a majority of the countries in the world -It does not make sense to penalize a person who pays taxes honestly all his working life to fall ill after all his efforts to stick to the straight and narrow. 

I think the authorities in the US should reexamine their relationship with Pharmaceutical Multinationals as also the patent office - though it is much easier said than done . High costs of social security and health care and deficits ultimately still land on the shoulders of the man who is trying to live honestly in the long run. China and Russia have no proper system for enforcing the law , which many Indian businessmen have found to their chagrin . It is more like doing business in the Middle East where insolvency is not recognized and the common man is put in Jail. first by the authorities and then asked to pay up !! A really convoluted way of enforcing payments - an already insolvent is asked to garner funds sitting in Jail . Commissions or rebates can never be recovered in business dealings with China  and in Russia they just lack the basic mechanism for enforcing justice . 

Comment by Capt. Anand Kumar on April 3, 2013 at 10:56pm

Today's Indian Express carries another detailed analysis.

Comment by Capt. Anand Kumar on April 3, 2013 at 8:37am

Prestigious newspaper The Hindu termed it A Just Order.

The order came about due to the failure of Novartis to establish its eligibility of patenteability of beta-crystalline form of molecule Imatinib Mesylate as against free base form of the same molecule. The Supreme Court of India thwarted the efforts of Novartis, to what is popularly termed as 'ever greening of patent', i.e. get a new patent on the same molecule before the expiry of old patent (20 years) and deny the generic manufacturer the opportunity to bring cheaper version in the market. So the patent remains evergreen. Times Of India explains this in Myths About India's Patent Rules.

What is most interesting to note that the original research into the development of this molecule had a publicly funded component, which was never disclosed by either Novartis or the US government. This has come to light in the wake of the judgment by the Supreme Court of India which is hailed by the father of the Glivec.

Those interested can read the full 112 page judgment here.

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