ETHIKOS 2: Pharma Companies and Patients

During the launching of Ethikos Movement last week, among the colorful speeches were those from two patient groups, the Kythe Foundation and the Philippine Alliance of Patient Organizations (PAPO) headed by Fatima "Girlie" Lorenzo, and the Psoriasis Philippines headed by Mr. Josefino de Guzman, photo below. Both Girlie and Josefino detailed how difficult, even draining -- financially and emotionally -- it is to help patients with difficult cases. The issues can range from helping poor patients with costly treatment and medications to dealing with social ostracism.

The two other colorful speeches were from the pharma federations, the Philippine Chamber of Pharmaceutical Industry (PCPI) represented by Dave Escalona, and the Pharmaceutical and Healthcare Association of the Philippines (PHAP) headed by Ted Padilla.

Dave emphasized that strict intellectual property rights (IPR) of newly-invented drug molecules via longer data exclusivity and frivolous patents is in effect unethical and not serving the patients. He added that many local pharma companies are small and hence, have lesser-known brands compared to products by the big multinational pharma companies. Ted on the other hand emphasized the importance of innovator or newly-invented drugs in saving more lives.

As I have argued in many papers in this blog, I believe that IPR is a good tool to encourage the research and development of new medicines against old or new diseases. If a firm is to spend $1+ billion to develop just one drug and such invention is not protected so that other pharma companies can jump in later and demand that they can also manufacture that drug molecule and sell it even if they did not spend money for its discovery, conducting several clinical trials involving hundreds or even thousands of people, that practice is not fair nor ethical.

Besides, Dave is from Unilab, the biggest pharma company in this country cornering one fourth (25 percent) of the total national pharma market. Their products are well known, from outdoor billboards to tv and radio to physicians and pharmacists. 

What patients need are more choices, more options. More medicine brands for each molecule with different brands, different prices. If the rich want the more known but more expensive drugs, so be it. If the poor want the lesser known but cheaper drugs, so be it. So long as those medicines are guaranteed to be safe and effective. More options among medical professionals, among hospitals, among diagnostic centers, among health insurance providers.

Finally, FDA Director Kenneth H. Go also gave a colorful discussion how they as food and drugs regulators, would deal with frequent lobbying by senior government officials (legislators, Cabinet Secretaries, Malacanang officials, etc.) in behalf of certain companies, or pressuring them to give information about the status of products by competing companies.

During the open forum, I briefly spoke and emphasized that a movement to emphasize business and professional ethics is indeed a civil society movement. There are existing government laws that regulate business practices and avoid unethical ones but these are often not followed. It is another case of government failure that was meant to correct any perceived market failure. Thus, people are moving on their own to have certain codes to guide their business behavior, and they are instituting their own set of rewards and punishment for violation of such code of ethics, outside of penalties and fines that are contained in government laws that are not properly enforced anyway.

What are truly unethical are government high or multiple taxation of health products and services like medicines, laboratory and hospital services. And government price control and forced discount policies that affect the financial condition of many small entrepreneurs like small drugstores.

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See also: 
ETHIKOS 1: MeTA-PH, PCPI, PHAP and FDA on launching, March 30, 2014

Drug Price Control 39: Presentation at USC, Cebu, March 2014.,  March 25, 2014 

MeTA 17: CHAT General Assembly, March 2014, March 31, 2014

IPR and Medicines 27: More on Glivec and India's SC Decision

A friend in our local health coalition, CHAT, commented in my earlier article, Novartis' Glivec and India's IPR Ruling and argued that

(A) medicine to be patentable should be NEW. This in essence only disallows evergreening of patents which seems to be what Novartis tried in the India case. And which most super power countries like the US and EU where most MNCs are from, would like to change through the insertion of TRIPs plus provisions in bilateral FTAs.  

Precisely why the TRIPs flexibilites are in place is to promote the primacy of public health and ensure that developing and undeveloped countries like ours and India (I presume) can have greater access to medicines. 

A friend from the innovator pharma camp told me today that

What does not get written about is that Novartis provided 95% of all originator Glivec for free to those patients who had been prescribed the medication in India! The remaining 5% were reimbursed, insured or participated in a generous co-pay program. Facts like these just don't get the media mileage.

The New York Times continue with its gloating and implicit celebration of the India Supreme Court ruling, with news today like Health Care Advocates Cheer Supreme Court Decision, saying,

...The case represents a high-stakes showdown between defenders of intellectual property rights, who say generic versions stifle innovation by drug makers, and Indian drug companies and international aid groups, who warned that a ruling in favor of Novartis could have dried up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases.

Huh? IPR advocates (me included) say that "generic version stifle innovation"? Where did they get that? ALL patented drugs will become off patent after sometime, and generic versions come in, and this has little or zero effect on promoting or stifling drug innovation. What stifles innovation is the uncertainty of patent confiscation by the government. An IPR for an innovator company in the form of drug patent (or song or book copyright or company trademark and logo) can be confiscated through compulsory licensing (CL) and the use of a new, commercial molecule will be given to somebody else, say a government pharma corporation or a private crony corporation.

Anyway, there is an interesting article that I saw today, 

Novartis Loses The Glivec Patent Fight In India, 

http://seekingalpha.com/article/1313001-novartis-loses-the-glivec-patent-fight-in-india?source=email_rt_article_readmore

The author, Derek Lowe, wrote:

Novartis (NVS) has never had a patent for imatinib (Glivec/Gleevec) in India. I'm not completely sure why that is, but I would think it's because that back when the compound was being developed was the era when Indian drug patents did not exist. As the country has entered the WTO, it has had to comply with the world's intellectual property framework and it's safe to say that the dust has not yet settled from this process. 

So when Novartis filed for an imatinib patent in India, it was for a different polymorph of the drug, which it ihoped would be patentable chemical matter. The Indian patent office disagreed in 2006, saying that this was merely a reformulation of an existing compound (which had been approved in the U.S. in 2001), and rejected the application. Novartis has been appealing that decision through the Indian court system ever since, and this latest ruling is the last from the Indian Supreme Court. As the court's decision says: 

In the application it claimed that the invented product, the beta crystal form of Imatinib Mesylate, has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity than the alpha crystal form of Imatinib Mesylate. It further claimed that the aforesaid properties makes the invented product 'new' (and superior!) as it 'stores better and is easier to process'; has 'better processability of themethanesulfonic acid addition salt of a compound of formula I'; and has a 'further advantage for processing and storing.'

Here is Novartis' take:

Glivec has been awarded patents in nearly 40 other countries, including China, Russia and Taiwan, but the IPAB is denying one for India. The IPAB acknowledges that Glivec satisfies the international requirements for novelty and inventiveness, but it does not find Glivec to meet the requirement under Section 3(d) of the Indian Patents Act of 2005. This act introduced a new efficacy enhancement hurdle for patenting new forms of known compounds. We believe that Section 3(d), the Indian legal paragraph intended as a hurdle for evergreening, should not be applicable to the breakthrough medicine Glivec, which has changed the lives of patients with rare cancers.

I like the author's concluding statements:

...(I might note that all the preening in the Indian press about the country being the "pharmacy to the world" would be more justified if any of the drugs being made had actually been discovered in India, through the ingenuity of Indian drug companies, risking Indian capital and shareholders' money. But they weren't.) What it does mean is that Indian drug patent law has gone from being nonexistent a few years ago, to being one of the strictest around. I hope that it's applied uniformly. Novartis has lost what was not a very strong case, to be honest, but the courts in India will hear stronger at some point.

So to my friend's query if Glivec in beta-crystalline form was a novel drug or not, the nearly 40 countries where it got a patent said Yes, it is a novel drug, that is why a patent was granted in those countries.

What is clear to me at this point are the following:

1. Glivec/Gleevec was a real, revolutionary, cancer-killer medicine. Physicians and patients were looking for it. Kudos to Novartis -- and not to anyone else -- for inventing it, for spending a billion dollars (industry average) in medicine R&D.

2. Because of this usefulness and revolutionary-ness of Glivec, many generic manufacturers in India salivated at the profitability of copying it even if they did not spend a single dollar in various clinical trials involving hundreds or even thousands of cancer patients. Since they did not spend any to invent this revolutionary drug, they can copy and sell it even at 10 percent or four percent of the innovator's price and still make a good profit.

3. This case does not seem to fall under the TRIPS flexibilities of WTO because there was no patent to null in the first place. There was no need to issue a compulsory licensing (CL), a tool in the TRIPS flexibilities and also in our RA 9502 (Cheaper Medicines Law of 2008), because there was no patent to start with. 

One implication of this case is that innovator companies -- of which there is few (or zero?) in India -- will have second thoughts whether to bring to India new, more disease killer medicines, or not. Or delay launching it there when the patent elsewhere is about to expire. In which case, patients will have to use old and existing, off-patent drugs. If they wish to get those more powerful drugs, they may have to fly to the US or Europe or Japan or HK, etc. and seek treatment there. And this makes healthcare becomes even more expensive.

Lest I will be accused of being "unsympathetic" or "antagonistic" to generic pharma, I am not. Generic producers have a role to play in public healthcare. After the patent of a popular and revolutionary medicine has expired, generics come in and provide their own versions at a lower price to the public. In the WHO's Essentials Medicines List, I read that about 99 percent of those medicines are off-patent and are available at various brands at various low prices. Thanks to generic pharma.

It is only in that short "patented period", usually only 8-10 years of the total 20-years patent life of a drug molecule (the 10-12 years are eaten by various clinical trials and approval process by the FDA) that is being debated.

Because of the important and useful role of innovator pharma companies in discovering new more powerful, more disease-killer medicines, certain government policies should not be antagonistic to them. Instead of just 100 or so innovator companies worldwide, we should have 300 or 1,000 of them worldwide. Let there be more competition among innovator companies, the same way that we wish to see more competition among generic companies. Competition and not more government regulation, is almost always a more effective tool to bring down prices.

Abolition or at least drastic reduction, of government taxes on medicines, will be a good start. This move will drastically reduce medicine prices and hence, address public clamor for cheaper medicines.

For a full copy, 112-pages long, India Supreme Court decision, see here,
http://www.scribd.com/doc/133343411/Novartis-patent-Judgement
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See also:
IPR and Medicines 23: Profitability of Innovator Pharma Companies, March 16, 2012
IPR and Medicines 24: Balancing Costly Innovation and Cheaper Drugs, March 20, 2012
PR and Medicines 25: Patents, Diagnostics and Technology Transfer, October 02, 2012
IPR and Medicines 26: Novartis' Glivec and India's IPR Ruling, April 01, 2013

IPR and medicines, Part 5

There is a discussion in one of my facebook groups, on intellectual property rights (IPR) in the pharmaceuticals sector. One argument goes like this:

When a person invents a useful “1st-gadget” people will want to buy it and the inventor will Profit. Inevitably someone else will make a cheaper or an improved “gadget mark 2”. Now Everyone will want to buy the “mark 2” version and the person who invented the “1st-gadget will lose a portion of his expected profits unless he makes a more attractive gadget. Of course, there is nothing to stop “1st-gadget” inventor from improving on “gadget mark 2” and start selling “gadget mark 3”. In this way the world progresses and life gets better and easier for us all.

Progress depends on what happens after the“1st-gadget” is invented. The “1st-gadget” inventor is not obliged to share this invention to “improve the world”. No one can force him/her to share the idea. He could rightfully keep it to himself. However, if he reveals this knowledge to the world, then others may act upon that knowledge. Will people be willing to share knowledge if others are able to make a bigger profit from an Invention than they made? That depends on the motives of the inventor....

The “1st-gadget” inventor might wish to call on the government to use the law to prevent anyone else from copying or improving on his“1st-gadget”. He then has a patent on “1st-gadget” and nobody else may sell it or make improvements to it without paying him. One problem is that it is impossible to invent something without using ideas of others who Came before. Every inventor is building on ideas that came from an idea, sight, book, or invention that touched him. If this is so, how can the “1st gadget” inventor are permitted to restrict other people’s freedom to use his invention for further inventions? What about intellectual rights – the right to own the use of ideas? Do the rules for inventing “1st-gadget” apply to “1st-song”, “1st-fi lm” and “1st-computer program”? Haven’t these originated from other people’s ideas and inventions of music, musical instruments, photography, computers, and programs? Would there be more harmony and less Aggression, more co-operative spirit and fewer disputes, without patents?

A number of good ideas and points above. But there are a number of faulty logic as well. Let me enumerate them.

1. An IPR like patent is granted on each specific invention. There are 1,000 composers of 1,000 different rock songs, so there are 1,000 copyright holders here. No one can claim that another band's rock song is also their invention, and no one has a monopoly on the rock songs category; instead, there are 1,000 "mini-monopolies" here.

2. People want a cheap but comfortable sedan, so Toyota invented Vios, Hyundai invented Getz, Honda invented City, and many other car manufacturers (Ford, Isuzu, Daewoo, Mazda, GM, Cherry, Tata, etc.) have their own invention of a cheap but comfortable car. There is no monopoly of a "people's car." Rather, there are dozens of mini-monopolies on the cheap and comfortable car category. Then there are dozens of mini-monopolies too, on the 2.0 to 2.5 engine displacement car category, on the SUV category, and so on. There is no industry monopoly.

3. People want a drug against prostate cancer (or breast cancer and all other cancer types). Pharma A invented a drug using molecules from tropical herbs, Pharma B invented a drug using molecules from temperate herbs, Pharma C invented a drug using molecules from sea shells, Pharma D invented a drug using molecules from big fishes like barracuda, sharks and blue marlin, Pharma E invented a drug using molecules from wild animals, and so on. No one has a monopoly on anti-prostate cancer drug. Rather, there are dozens of mini-monopolies and patents on anti-prostate cancer drugs.

4. Private property is private property, it can never be national or collective property, unless the inventor will voluntarily share his invention (a drug molecule, a song, a poem, a business software, etc.) to others. Or if he thinks that the cost of enforcement is much larger than the benefit of going through it. If we say that al IPR shd be confiscated, that's coercion. Let inventors decide whether they want their invention to be shared to all or be protected by IPR laws (patent, trademark, copyright, etc.).

5. Not all lawyers and players in the pharma sector are pro-IPR. Those working in innovator pharma companies (the multinationals) are generally pro-IPR. Those who work in generic pharma are, to some extent, anti-IPR, citing TRIPS flexibilities. Then there are also other NGOs, media and academics who argue on "patients over patents", "people over profit", "health is a right" arguments. The Cheaper Medicines Law (RA 9502) is generally an anti-IPR law for institutionalizing IPR confiscation via compulsory licensing, parallel importation, government use, and so on, with riders like drug price control provisions.
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Here are Part 4, Part 3, Part 2, in this "IPR and medicines" series.

Further references, just type "IPR and health" and related keywords in this blog or the major search engines.