Wednesday, August 22, 2012

The Myriad Decision: When commonsense took leave of American Jurisprudence

If you thought America's problems were the first-to-invent vs. first-to-file, or the Apple-Samsung trial or the medical device tax as various golf-playing company executives and clueless Republican Congressmen from Indiana would have you are wrong. The American legal system's problem is...what appears to be a disastrous lack of baseline commonsense! Why would I go ahead and say that?

If like me, you have been reading the real news instead of Taylor Swift and the Kennedy she is dating or why Shia Labeouf and his girlfriend threw a lachrymal part on the streets, you have already heard about the Myriad decision.

Irresponsibility - A systemic problem

From Antonin Scalia to Tom Head, an otherwise inconsequential Judge in Texas who predicts a civil war if Obama is re-elected, the American Judiciary system is full of some very irresponsible individuals. The fact that the country and her future rests in the hands of such people can best be described as appalling. And now the Myriad decision comes as sound proof of what a mix of lack of scientific education, ethical responsibility combined with partisan judges can do for the future of science, technology and ultimately business in this country.

Nature is not an excuse

In the Myriad case, allowing the company to patent BRCA1 and BRCA2 the judge writing the majority opinion wrote - “Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”

If you read that as if he was interpreting that breast cancer is man-made. The statement also seems to open the doors for people to patent minor variations on naturally occurring substances. However, the problem is a bit deeper. Somehow a collective majority of judges at an appeals court don't even seem to have the level of scientific background that a 6th grader would be expected to have. 

Dangerous Precedent

This ruling sets a very dangerous precedent! If uninformed judges are allowed to get carried away and make such poor decisions, then the life sciences industry will truly be in shambles. And this is not some conspiratorial warning for the future - it is already here. Unless a full appeals board or the Supreme Court strikes it down, you will have a whole bunch of patented genes. What will this lead to? The answer is blindingly obvious:

1. Research will be stifled. If something as basic as BRCA1 or BRCA2 is patented, then who would want to continue research and drug development that influences either gene? 
2. If someone did want to conduct research, what would they have to do? License the very act of handling, using or talking about the genes from Myriad? How stupid is that?
3. It is not a stretch to conceive that people will start patenting SNPs (Single Nucleotide Polymorphisms) and make even simple diagnoses fall out of the reach of the masses. 

There are several other small and large disturbing possibilities. 

Protecting ourselves from the judges...

Now that we know a bunch of geniuses are stalking the halls of American Justice, we need to find ways to make sure that research and industry make progress despite them and not because of them: 

1. Get Congress to pass specific laws barring naturally occurring genes from being patented.

2. Carefully examine how judges get elected to the various echelons of the judiciary.

3. Establish procedures and guidelines that will quicken the process of censuring runaway judges and if possible, impeach them, or nudge them to retirement.

4. Be vigilant about for-profit companies that would constantly want to find loopholes and exploit them. This one seems so obvious, and yet, it cannot be emphasized too much. 



Thursday, August 09, 2012

India's Pharma FDI Mess...

A note: "Apothecurry" - a blog with a very creative and meaningful name is my favorite blog to get some nifty scoops  on the status of the Indian pharma industry, and I suppose what the Indian Government is doing to it...

You can find the blog linked at the end of  the post.

The question everyone wants to ask: Why is the Indian Government f*ing up the pharma industry?

Among other things they have done:

1. They forced Bayer to license a Cancer drug in a very ambiguous manner. Bayer is no saint, the proposed drug cost and their stance is a direct evidence of either greed or self-loathing inanity - hard to say.

2. They have made a pledge to provide free drugs to India's teeming millions without a proper plan or even the semblance of one...

3. Now, they have threatened Foreign Direct Investments, and, according to Apothecurry, in quite a disparate manner.

Bringing the License Raj back:

Well, not the TBBT Raj, but the much maligned "License Raj", the practice of requiring companies to obtain licenses and burying them in reams of paperwork, promoting corruption, stifling even a whiff of innovation and essentially choking an industry.

Apparently, various arms of the Indian Government have their own plans to stuff their hand in the cookie jar. First apparently the Commerce Ministry wants every foreign investor to go through an intermediary agency called the Foreign Investment Promotion Board (FIPB).

A group of folks from various ministries, on the other hand have suggested that this hell befall only those foreign investors that dare seek more than 49% of a local pharma company. Either way, this is not good news for the Indian pharma industry.

Pharmaceutical Xenophobia

As with everything else, independent India simply misunderstood and maligned Gandhi's "Swadesi" exhortation. Untimely as his death would have ever been, were he to live today, he would pooh-pooh the anti-foreigner sentiment being used to gain popularity and votes while burying real issues.

You would think in a failing economy, the Indian Government, led by none other than Manmohan Singh, famous for bailing India out of the License Raj would not even think of suggesting protectionism.

However, like any other Government, they would like to blame their failings on someone else and thus would have you believe that India's impoverished healthcare system is a consequence of unscrupulous FDI. They may be unscrupulous, yes, but the bulk of the problem, all the way from apathy to lack of vision and corruption rests solely with India.

Whither India?

Someone should tell Sonia Gandhi, Manmohan Singh and their bandwagon of daylight dreamers that the Indian economy is not on a bed of roses. Rather than ease restrictions and make it easy for investor money to flow, the Indian Government is looking to take the country back and plunge it into the same darkness as the energy grids.

If they worry foreign investors would get carried away, they should put forth legal barriers, not imbue some Russian-Venezuelan axis of Xenophobic Hell on Earth.

If this continues, we will see that India's healthcare reach suffers worse than ever, drugs get pulled off the market, or never get into the market and the industry will whither away with stiff external competition.