Why would anyone develop new drugs if international patent law can just be ignored?

There are two ways to look at a ruling issued yesterday by the Indian controller general of patents, designs and trademarks: it can either be seen as a major victory for patients who had no prior hope of treatment with a highly effective anticancer agent because of its cost … or it can be seen as an international setback to the entire concept of patent and intellectual property law.

Sorafenib (Nexavar®) is a prescription drug sold around the world by Bayer Corp. and used in the treatment of cancers of the kidney and the liver. Its patent will run through about 2020, and in India the retail cost of the drug to patients is about US$5,600 a month. This is pretty obviously a cost that the average Indian with renal cell or hepatocellular cancer is not going to be able to afford.

The flouting of international patent and copyright laws in India has been going on for years, and until comparatively recently the Indian government had generally ignored attempts to insist that it bring its practices in line with those of other developed and developing nations around the world. On Monday this week, according to a story in today’s New York Times, India’s government authorized a local Indian drug manufacturer to make and sell a generic copy of sorafenib on the grounds that Bayer was charging “a price that was unaffordable to most of the nation.”

The “New” Prostate Cancer InfoLink is torn between the two extremes inherent in this decision. On the one hand, it is sad and terrible that we live in a world in which men and women and children who need specific forms of medical treatment suffer and die because they cannot afford these treatments. On the other hand, how can we expect to be able to invest in the development of new and better medicines and technologies to treat serious clinical conditions if there is no way to recoup one’s investment? It’s not as though most drug development is going to happen on a not-for-profit basis — even if it is theoretically possible. Drug development is a very costly business with a very high failure rate.

We believe that this is the first time a so-called compulsory license for the manufacture of a patented cancer drug has been granted in India. Indeed, according to the story in the New York Times, only one other nation has ever issued such a compulsory license. Compulsory licenses for the manufacture of drugs for the treatment of AIDS and HIV have been more commonly issued in the past.

If other nations around the world see yesterday’s ruling as a license to follow suit, we could see a massive transformation of the innovative pharmaceutical and biotechnology industries as their ability to protect patents on their products — and thus gain a return on their investments over a period of years — is eaten away by international lack of will to enforce patent laws. The ruling issued by the Indian controller general of patents, designs and trademarks effectively instructs Bayer that the company “has to” license the right to make generic sorafenib to a specific Indian generic manufacturer. The ruling does limit sales of sorafenib manufactured under this license to India, and it does provide for a small royalty to Bayer and to the original developer of sorafenib (Onyx Pharmaceuticals).

There is little doubt that Bayer and other western pharmaceutical and biotechnology companies will band together to fight this ruling in India. The real issue, however, is whether we need a new commercial model for innovative drug development and marketing that can assure that badly needed drugs become much more widely available at costs people in developing nations can afford, but nations like India can appreciate the importance of abiding by rationally applicable laws on intellectual property rights. This is not going to be an easy problem to solve. Governments from Russia to Indonesia and the People’s Republic of China are likely looking at the Indian decision this morning, and wondering whether this is a strategic initiative they should adopt too.

7 Responses

  1. Perhaps the Indian government should subsidize the cost of this drug for their citizens who can’t afford it, rather than steal it. India is trying to establish a robust pharmaceutical industry and could open themselves to trade war-type actions, such as having the sale of their drugs banned in the US. No doubt the US based pharmas would lobby for this type of action if the issue can’t be resolved another way. Many thieves justify their actions based on the excuse “They charge too much.”

  2. I see even more troubling stuff right here on American soil. Here are two examples:

    (1) Viagra was slated to come off patent this year, but a judge has ruled that Pfizer re-patented the drug for use for ED. (Its original use was for luminary hypertension and that patent was going to expire in April.) The newer patent was deemed valid so we are to pay 25 bucks a pill for another decade (or thereabouts). I expect Pfizer to find another use for it at that time and re-patent it again.

    (2) Here in Las Vegas, 3 years ago, a doctor started re-using syringes on patients, causing a hepatitis outbreak. He was arrested and has been in custody awaiting trial. Was he sued by the patients? Nope … too poor to sue after being arrested. So. The makers of propofol were sued by a single patient for 500 million bucks and he won. Why? Because the bottles the drug came in were too big and would tempt a criminally minded doctor to reuse syringes and drugs. One patient 500 million bucks and 110 more patients to go that are also suing the pharmaceutical company and not the doctor. Propofol is a very common drug and I am certain that the folks that will pay this tab are we the American patients.

    Two examples as to why we should never expect any help from lawyers to lower drug prices … LOL!

  3. Thieves? Maybe you should actually read the law before passing your comment. The Indian controller general of patents, designs and trademarks is following the law even if it has invoked a rarely used provision. The provision exists for a reason, all that Bayer can do is argue that this may not meet the criteria for the law to be invoked; something that they will find very difficult to do.

  4. In response to Doug Miller …

    Rather than the Indian government subsidizing the drug, maybe Bayer should consider two-tier pricing for lesser-developed markets, or offer some other form of subsidy in order to protect its patent.

  5. Why not look at the other end of the cost-development equation! How about reducing the cost and time for development of new and more powerful drugs. Super-computer simulation? Streamlining and modernizing FDA approval. The inevitable trend of the accelerated change brought by technology is: (1) very expensive, doesn’t work very well; (2) works better and cost less; (3) works extremely well and is very inexpensive. Medicine and Pharma … it’s time!

  6. Dear Bob:

    The pharmaceutical and biotech industry — and the regulators too — have been working for years to try to lower the costs of drug development. The fundamental problem is human beings. They (a) want to get paid for what they do; (b) are all slightly different and therefore respond differently to drug therapy; and (c) need to know that drugs are safe and effective in clinical trials.

    Supercomputers cannot model the unknown. Even “Watson” can only take known data and then make outstanding “guesstimates” of correct answers. The problem with putting new drugs into human beings is that utterly unpredictable things happen. No supercomputer could have ever told us in advance that thalidomide would cause devastating birth deformities in pregnant women — just to give you one fairly striking example of what can go wrong. The major cost in drug development is the clinical trials that are essential to demonstration of safety and efficacy. Supercomputers are already being used to conduct “rational drug design.”

    Last but not least, if you really want the FDA to be able to streamline drug approval, please tell your Congresspersons to appropriately fund the FDA. The FDA’s annual appropriation to oversee the safety and effectiveness of foods, drugs, cosmetics, medical devices, etc., etc., making up some 25% of the entire US economy is about the same size as that of the Maryland school district within which the agency is situated! (For more detail, see the web site of the Alliance for a Stronger FDA.) There are limits to what any agency can do when its funding bears little to no relation to what is actually being asked of it.

  7. A drug that is too expensive to be bought is exactly as good as no drug at all. It is much better for the general population that a given drug takes 10 years more to be researched than having it at a preposterous price that nobody is able to afford sooner.

    Besides that, the drug companies do anything but fair play. The technology has improved a lot in the last years, and the production costs have dropped dramatically for most drugs. The prices of these drugs has climbed though, especially those protected by patents.

    In my opinion patents are a thing from the past and should be scrapped. If you are an efficient company, the ability to sell earlier than your competitors should be reason enough to do research; if not, let those who think it is to do research.

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