Showing posts with label patent. Show all posts
Showing posts with label patent. Show all posts

Friday, February 23, 2018

IPR and Innovation 41, Governments and the UN on patent prizes

I am reposting below a good article by a friend. Enjoy.
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How governments can screw up the development of new drugs
by Philip Stevens

THE PATENT-BASED system of drug development will come under further pressure from key countries aiming to increase access to medicines at the executive board meeting World Health Organization in March.

Critics of the system want reform, arguing it makes drugs too expensive and fails to provide cures for those in need who may be unable to pay, such as people in developing countries. They want to slash drug prices by replacing intellectual property rights with government-funded prizes as the primary innovation incentive for medicines.

Developers of new drugs would gain government cash prize rewards for the successful development of a new medicine.

In return, companies would be forced to hand over their intellectual property rights to the government, allowing generic manufacturers to enter the market immediately. Competition between generic drug manufacturers would boost access to those in need as new drugs would be sold at their marginal cost of manufacture, so the theory goes.

Meanwhile, governments would control and plan what disease areas are rewarded by prizes, ensuring that funding is allocated to health priorities in a fair and transparent fashion.

“Delinking” the cost of R&D from the final price paid for a medicine, and making governments the funders and planners of drug development, sounds like a simple public health care solution. But so far, no country has taken the plunge.

This is not surprising; “delinkage” is not the silver bullet claimed by its supporters.

One charge leveled against the patent-based system is that it creates losses for patients by inflating medicine prices well beyond their manufacturing costs. This downplays the economic benefits of new medical technologies from averted hospitalization and fewer sick days for workers. But more to the point, an innovation system based on prizes could create just as many, if not more, economic losses.

The prizes fund would have to come from taxpayers; their burden would be at least the $141 billion spent by the private sector on R&D each year. Income tax hikes would distort labor markets and interfere with job creation.

Then there would be the added costs of the enormous new bureaucracy to manage the prizes system.

In the absence of private sector investment, which country would be willing to fill this funding gap? Here the rhetoric of many countries, including India, at World Health Organization meetings in Geneva has not been matched by serious action. Even modest WHO R&D delinkage “demonstration projects” fall $73 million short of the $85 million required, with contributions from only 10 countries.

This new world of government-funded prizes to drive medicine innovation does not look promising.

Money apart, designing prizes that work is even more of a problem. Government committees would struggle to determine the true economic and social value of medicine before it is even created.

With estimates for developing a new medicine between $1.2 billion and $2.6 billion, this matters a whole lot.

For prizes lower than the true market value of the invention, drug developers — and the venture capitalists so instrumental for start-ups — would direct their capital away from medicine R&D towards politically safer but less socially useful areas. New medicines would dry up.

If a government prize committee overvalues the prize, it would trigger duplication of R&D as competitors swarm. Curious then that proponents of these prizes argue they will end the supposedly “wasteful” and duplicative R&D under the patent system.

Finally, there is the problem of politicization. A prize system would hand significant new discretionary powers to government officials as the judges of which medicines win prizes. Political factors would influence decisions on where to allocate funding, rather than clinical need. Diseases that could summon the most vocal lobby groups would get attention from prize bureaucrats, while less fashionable diseases may be ignored.

Political connections and lobbying could both play a role in securing a prize, while elected officials may attempt to influence R&D spending by government agencies.

Patents, on the other hand, represent a far less arbitrary form of innovation incentive. Government merely sets the framework of patent law, under which all companies compete. And competition is the key to innovation.

Take hepatitis C, until recently an incurable disease afflicting around 12 million Indians. Since 2013, no fewer than 10 new treatments have come onto the market, offering clinicians a huge range of options. Such breadth and speed of innovation under a winner-takes-all prize system is hard to picture.

Despite their superficial attraction, no country (other than the technologically backward former Soviet Union) has yet replaced intellectual property rights with prizes. The reasons are clear. Prizes risk economic distortions, undermining incentives for innovators, and adding a new layer of bureaucratization and politics. Be warned, therefore: delinkage and drug development do not go hand in hand.


Philip Stevens is director of Geneva Network, a UK-based research organization focusing on trade, innovation and health policy.
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Friday, December 29, 2017

My first article in BWorld, Oct 2007, on IPR

I just rediscovered this image from my old emails a decade ago -- my first article in BusinessWorld. Reposting.


Intellectual Property Rights
BWorld, October 24, 2007, page 5.

Downloading pirated songs from the internet is cool. Dying from counterfeit medicine is not. But the pirates and the slack law enforcement that give you one also give you the other--and there are people who will tell you this is a good thing.

Many governments and humanitarian groups want you to believe that patents and intellectual property rights on medical innovations deprive the poor of important medicines and should be discarded in the name of public health.

But if one's innovation and invention that produces welfare to society, like producing medicines to cure malaria or cancer, using extracts from the leaves and fruits of the most common fruit tree in a particular country, is not respected, why would some guys innovate in the first place? It is protection of patents that brought those useful drugs into existence, along with millions of other products, wonderful and mundane alike: yielding to the slogan "patients over patents" would hurt poor patients the most by depriving them of new inventions.

Say you are an unknown band, performing in bars. You wrote a few good original compositions and your audiences like them. Suddenly your songs have been recorded and patented by someone else, on albums and CDs, with no mention of you and no royalties. How would you feel?

You are a researcher or academic. You presented a paper to a conference. A few months later, you see a paper published in some magazine or journal that contains most of your paper--your methodology, scientific model, data, results and conclusions. How would you feel?

You are an ordinary inventor. You invented a device that can reduce fuel consumption in diesels by 35% and you're selling it for a few bucks because you don't have a wide marketing network, or you don't have the capacity for mass production. Then, a few months later, your device is patented by someone who is selling it a handsome price, with no mention of you.. How would you feel?

The civil contracts of intellectual property, like deeds to physical property, underpin innovation, creativity and growth, as well as personal and political freedoms. Left-leaning health activists claim that breaking patents would hit multinationals and "Big Pharma" hardest--but these guys are innovators, they can find their way out like investing their money and people into something else, like new cosmetics and perfumes. It's the poor who will suffer most, from bad products, lack of new effective medicines, and economic stagnation.

And how do the consumers feel when they get these rip-offs? If you buy a pirated book or CD and it turns out to be of bad quality, you only lose your money. But if you buy pirated and bad quality medicine, you can lose your health--even your life.

This year Kenya found 20,000 counterfeit doses of anti-malarial Duo-cotecxin, one of many counterfeits in an uncontrolled market where some 35,000 people die of malaria each year. The fake, probably from China, does not just fail to cure the disease, it can increase drug resistance and make patients worse.

Governments around the world like to play the hero by promising to reduce prices, usually by price controls or patent infringement but never by cutting taxes on goods or service. My older brother, our eldest in the family, died of prostate cancer more than a year ago. His earlier hormonal chemo-theraphy cost around P25,000 per session excluding the physician's fee. Of that amount, government VAT collection alone was P3,000 per session. After several sessions, he did not get well. He was later given chemo that cost P90,000 per treatment, of which government's VAT was nearly P11,000 per session. The import tax, corporate income tax, business permit and other related taxes not included yet.

If a government wants to bring down the price of medicines, rice, clothing, fertilizers, farm tractors, or any commodity essential to life and economic growth, the first thing would be to drastically cut, if not abolish, the import duties and direct taxes that hit the poor hardest.

So the next time your government blames foreign companies or international rules for high prices, find out what taxes and covert barriers it is hiding from you--and shout the truth out loud.

Sunday, May 08, 2016

IPR and Innovation 34, When 95% of WHO's EML are off-patent

I am reposting this good article by a good friend, Philip. Enjoy.



MAY 3 — Debates on how to improve healthcare in developing countries often start from the same premise: patents can potentially raise drug prices, so they should be abolished for better public health.

In the early 2000s this argument drove the campaign against patents on HIV drugs in South Africa. This week it is motivating campaigners against the Regional Comprehensive Economic Partnership in Asia — a proposed Free Trade Agreement between 16 Asian countries that may impose new intellectual requirements.

NGO disquiet about drug patents has even led to the creation of a UN High Level panel on access to medicines, due to report its recommendations in New York next month.

Such concerns may in fact be overblown. This is an implication of an interesting new study by researchers at the University of Ottawa and published in April by the World Intellectual Property Organization (WIPO) in Geneva.

To better understand how patents impact access to medicines, the researchers counted how many of the World Health Organisation’s (WHO) List of Essential Medicines are subject to patent protection in developing countries. This list contains 375 or so medicines considered most important by WHO experts.

It’s a hugely influential list, and one based purely on the clinical usefulness of a medicine, not cost or patent status. Developing country governments and large international donors use it to guide which medicines they will procure.

The researchers checked national patent registries in developing countries and double-checked with manufacturers. They found that patents for 95 per cent medicines on the list had expired.

Put simply, patents are not relevant to the vast majority of drugs typically used by physicians in developing countries.

Most of the remaining 5 per cent of medicines — around 20 products — on the WHO list with patent protection are for HIV/AIDS. But patent owners either don’t register or enforce their patents in the poorest countries. For middle-income countries, manufacturers often enter into voluntary licensing deals with generic manufacturers to broaden access, meaning there are cheap generic copies on the international market.

The one medicine with no generic equivalent is the cancer drug, bevacizumab (marketed as Avastin by Swiss patent-owner Roche). This modern so-called ‘biologic’ drug is used against many cancers, and works by starving tumours of their blood supply through blocking a key protein.

Patented or not, these biologic drugs are difficult for generic competitors to copy cheaply.

Unlike most drugs, which are chemically synthesised and made from just a few  molecules, biologic drugs are manufactured in living systems such as plant or animal cells, and have complex molecular structures. Their manufacture demands significant investment and technical know-how, meaning such drugs will never be as cheap as, say, generic aspirin.

One implication of the study is that if patents were abolished tomorrow it would make little difference to the cost or availability of most medicines used in developing countries.

Even so, these medicines are frequently unavailable in public health systems.

In 2014, researchers at the University of Utrecht in the Netherlands found that, on average, essential medicines are available in public sector facilities in developing countries only 40% of the time.

While generic medicines are cheap to make with no royalties to pay, they are still too costly for most people in developing countries.

One example from the WHO list is budesonide, commonly used by asthma sufferers. A single inhaler costs a staggering 50 days wages in Mozambique. In the US, one inhaler costs only US$5 to US$7 (RM20 to RM27) — around 30 minutes work on the median hourly wage.

The reasons behind the expense and scarcity of essential medicines in developing countries are complex, but failures of governance loom large.

Mark-ups along the distribution chain inflate the final price of medicines and include import tariffs, sales taxes, value-added taxes and retailers’ and wholesalers’ margins. In Kenya, mark-ups add 300 per cent to the manufacturer’s price; in Brazil it’s 200 per cent, says IMS, the global healthcare data provider.

Dysfunctional medicine supply chain management is another culprit. A 2015 survey by humanitarian NGO Medecins Sans Frontières reported one in three health facilities in South Africa have shortages of key HIV and tuberculosis drugs. The drugs are imported in sufficient quantities but fail to reach patients due to “local logistical and management problems, ranging from inaccurate forecasting to storage or transport issues”, said MSF.

Governments under-invest in health too. While most European Union countries commit 8 per cent to 11 per cent of GDP to health, few Asian and African countries spend more than 5 per cent: not nearly enough given their enormous health challenges.

These are the major influences on access to medicines. Public health would be best served if the political focus were on these issues, rather than patents.

* Philip Stevens is senior fellow at the Southeast Asia Network for Development (SEANET) and director of Geneva Network, a research organisation focusing on health, intellectual property and trade.
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Sunday, February 07, 2016

IPR and Innovation 30, Patents and pharma issues in Asia in 2007

The first time that I attended a formal discussion on IPR issues like patents of newly-invented medicines was nearly 9 years ago, during the 1st Pacific Rim Policy Exchange in Hawaii. There was one special topic on IPR-busting policies like issuance of compulsory licensing (CL), special CL, "international exhaustion" of a patent worldwide once a patent has expired in one country.

I just found my notes last night, no soft copy, so I took photos of one brief handout. The speaker was from an innovator company. He said that below were the important issues in the industry, ie circa 2007.



For the Philippines, the main issue that time was the "cheaper medicines bill" that later became the Cheaper Medicines Act of 2008 (RA 9502) via amendment of the Intellectual Property Code (IPC). Among the important IPR provisions of the bill were:

-- encourage parallel importation by implementing the principle of "international exhaustion" for patents and trademarks of innovator pharma products,
-- easier process to issue CL by eliminating some of the safeguards provided at the WTO TRIPS Agreement, and
-- deny new patents for new uses and indications of pharmaceutical compounds.

For Indonesia, the issue based on media reports, was that the Ministry of Health was considering issuing a CL for certain popular innovator medicines. In Malaysia, either a price control or CL, and data exclusivity via FTAs.

Singapore and Japan (and S. Korea?) seemed to be the only Asian countries where IPR protection of newly-invented medicines and vaccines was not a problem.

I thanked the International Policy Network (IPN) and the Property Rights Alliance (PRA), two of the 6 co-sponsors of the Hawaii conference, for giving me the opportunity to attend such a great forum.

Among the photos (I combined 2-in-1 here) in that event, from left: Martin Krause (ESEADE, Argentina), me, Julian Morris (IPN, UK), Alec van Gelder (also from IPN), and Barun Mitra (Liberty Institute, India)
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Saturday, September 19, 2015

IPR and Innovation 26, Countries with most patent applications, most innovative universities

I was surprised to see this data from the WEF this week, that China has so many patent applications compared to the US, Japan, S. Korea and Germany. Original data is from WIPO. Anyway, Asia's four biggest economies are in the top 10.


source: WEF, Which countries file the most patent applications? September 14, 2015.

Meanwhile, Reuters conducted its own study on the world's most innovative universities and the result for 2015 was released also this week. The study used 10 different metrics, criteria "focused on academic papers, which indicate basic research performed at a university, and patent filings, which point to an institution's interest in protecting and commercializing its discoveries." 


source: Reuters, The world's most innovative universities, September 15, 2015.

Nineteen (19) Asian universities landed in the top 100 mostly dominated by US universities. The Koreans are rising fast in the technology and innovation ladder, some brands are already top global players like Samsung.

I'm curious if many of these top Asian universities are state-owned and operated, like the NUS. The top US universities though are private.

Now there seems to be a "disconnect" between the two data above. China's universities are not so known in innovation (only one landed in the top 100, at least based on the Reuters study and ranking) yet China is #1 in the world in patent applications. More data and interpretation may provide the explanations.
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Sunday, August 02, 2015

IPR and Medicines 36, On patent protection, data exclusivity and TPP

There was a DOH Advisory Council on the Implementation of RA 9502 (Cheaper Medicines Act of 2008) last April 20, 2015 that I was not able to attend. The Secretariat failed to invite me, but at least they sent me the minutes of the meeting, Among the speakers that day was Atty. Allan Gepte of the Intellectual Property Office (IPO), DTI and he was asked to give updates about the US (and PH?) Free Trade Agreement (FTA) and the European FTA (EFTA). He said that he was not aware of any current (PH-) USFTA negotiations and there are talks among EFTA countries. 

He gave some updates about IP concerns in the country instead, like the DTI-IPO-DOH public consultation on IP issues, with some NGOs last March 31, 2015. The topics covered data protection patent term extensions. I was not there in that meeting. 

But I  have attended the same DTI-IPO-DOH meeting last June 04, 2015 at the DTI International building. It was chaired by DTI Assistant Sec Rodolfo, IPO Dep. Allan Gepte, and DOH-NCPAM Doc Meme Guerrero. I learned about the meeting because three days ahead, June 01, there was another anti-TPP, anti-IPR forum at PRRM, QC, sponsored by IDEALS, MAG, AGAP and CHAT, and the speaker was Dr. Burku Kilik of Public Citizens, an NGO in the US. Then there was a belated invite to attend the March 31 meeting at the DTI.

I think it was a limited consultation because only very few NGOs were there, led perhaps by the Focus on the Global South (FGS) leader, Joseph Purugganan, plus the Fair Trade Alliance, they are campaigning against strong IPR protection in the non-existent EU-PH FTA or non-existent PH membership in the TPP. 

At the DTI consultation (a few CHAT members were also there, also Dave Escalona of Unilab), I commented that the PH is not even among the invited members of the TPP (only 4 of 10 ASEAN countries were invited to the TPP) and yet there are a number of noise against those proposed FTAs the issue of IPR.

Assuming for the sake of arguments that (1) there is a TPP Agreement already today or tomorrow, (2) the PH is a member of TPPA, and (3) all those "dreaded data exclusivity", etc. provisions are implemented -- then they will affect only a few, newly-invented medicines and not the 90-99% of off-patent, useful generic medicines in the WHO and DOH essential medicines list (EML). I think anti-IPR campaigners are not aware of this, perhaps they think that any extended regulatory data protection (RDP) and patent protection on innovator drugs also apply to off-patent, generic drugs. Far out, man.

I posted the above comments at the AC email loop. Atty. Joey Ochave, SVP of Unilab and a friend since the 80s in UP Diliman, replied to my comments. He said that

"data exclusivity can apply to off-patent, or even non-patented, drugs. Patent protection is different from data exclusivity but both seek to prevent the entry of generic competition and preserve the monopoly status of the originator. The only difference is patent protection is protected by TRIPs while data exclusivity is TRIPS Plus. Data exclusivity is NOT required by WTO. This is why the US tries to insert it in bilateral or multilateral trade agreements."

I thanked Joey for his comments. These are legal matters, outside my usual cup of coffee so I yield to his explanation.

For now, the PH government through DTI Sec. Domingo has officially signified its intention to join the TPP in the next round of membership expansion. I support this move, I believe that it is not possible for the PH to have a bilateral FTA with the US or even Canada, and the US will remain to be the biggest, most innovative economy in  the planet for the next decade or two. The only way to have an FTA with them is through the TPP.

If what Joey mentioned that data exclusivity is to "prevent the entry of generic competition", then it will have a rough sailing in the PH as access to generics is both a health and emotional issue here and in many other countries.

Things like this, the AC can discuss as RA 9502 is first and foremost, about IPC amendment and price regulation is just an add-on or after-thought chapter in the law. I have attended 2 fora already about TPP and IPR involving 2 foreign speakers who are generally anti-IPR and  both facilitated by IDEALS and CHAT. The first was a lady speaker from France, the 2nd was another lady speaker from the US, from Global Citizen. The 2 fora did not have legal minds as discussants after the presentation.
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Friday, June 19, 2015

BWorld 6, Biotechnology, Innovation and the Philippines

* This is my article yesterday in BWorld Weekender.

BIOTECHNOLOGY involves food production and healthcare. It involves life: from new rice or vegetable varieties that are resistant to certain pests -- and are flood tolerant and still high-yielding -- to new medicines that raise or improve the survival chance of a cancer patient by 10 or 30 percent compared with old and existing medicines and treatment.
Innovation -- endless improvement -- in the quality of biotech products and processes is the key towards a better life, a healthier and more productive life for the world’s peoples. While some people might complain that new seed varieties, new medicines and vaccines, and new literature are costlier, they tend to neglect the fact that overall productivity among enterprises and people is rising because of these new products, such as disease-killer drugs and treatment, brought by innovation.

Scientific American’s Web site has a regular report called the Annual World View Scorecard (WVS). The popular science magazine’s annual report for 2015 is its 7th, and it’s an analysis of the biotechnology’s innovation potential in 54 countries, including the Philippines.

GLOBAL RANKING
Unlike many annual reports that measure economic competitiveness or economic freedom or transparency, the WVS measures biotech innovation, a very specialized field. It is a privilege for the Philippines to be included in this annual study because it will give ideas to both government policymakers and private players on how to improve the national business and scientific environment and, thus, the country’s global ranking.

The WVS has seven categories covering 27 components, from biotechnology inputs and outputs through government protection and beyond. These categories are (1) Productivity of public companies, (2) Intellectual Property (IP) Protection, (3) Intensity of public companies per million population and biotech patents, (4) Enterprise Support for business-friendly environment, (5) Education/Workforce, (6) Foundations like infrastructure and public spending for R&D, and (7) Policy and Stability, including rule of law.

Scoring is 0 to 10, with the lowest-ranked nation scored as 0 and the highest-ranked as 10. Then the average score is computed. The results for WVS 2015 report are here. Take note that many countries did not make any score in category (1). 


Of the 10 ASEAN countries, five were included in this study and their respective scores for 2015: Singapore 5th, Malaysia 29th, Thailand 48th, Philippines 50th and Indonesia 52nd.

Five other East Asian economies were included in the study: Hong Kong 11th, Japan 16th, S. Korea 23rd, Taiwan 25th, and China 42nd.

The Philippines made a relatively surprising high score in category (2) on IP protection, which is composed of (2a) patent strength and (2b) perceived IP protection. One possible explanation here is that the country has a law on IP protection, the Intellectual Property Code of the Philippines (Republic Act 8293) enacted in 1997. It was revised focusing on patents of pharmaceutical products through the Cheaper Medicines Act of 2008 (RA 9502).

Although IPR tweaking that is consistent with TRIPS Flexibilities is contained in RA 9502, like the state’s power to impose compulsory licensing (CL) and special CL for some important medicines in case of “national health emergencies,” no CL or SCL application has ever been filed with the IP Office (IPO) until today.

The Philippines made a modest score in category (4) on Enterprise Support, composed of business-frienndly environment, biotech venture capital (VC), and VC availability. But the country scored very low on (3) Intensity, and fairly low on (5) Education/Workfore, and (6) Foundations.

As earlier noted, SA has been doing the WVS for seven years now since 2009. In this revised table, the scores for 2009 and 2010 have been omitted, partly because several countries were not included on those two maiden years of reporting. 


For the Philippines, the bad news is that it has been consistently ranking low all these years: 45th/47 countries in 2011, 48th/50 in 2012, 51st/54 in 2013 and 2014. The good news is that it has improved its ranking by one notch, from 51st in 2014 to 50th in 2015.

This is not enough, of course. Which means that the country’s government and private players must improve particularly in categories (3), (5), (6) and (7).

Change comes in marginal steps. The important thing is that the country’s private enterprises and educational capacity for biotech innovation must keep improving and evolving. The goal is improving the Filipinos’ health and well-being -- having a healthier and longer life. Improvement in the country’s global ranking in this report may be considered as icing on a delicious cake, additional accolade to improvement in public policies that respect and encourage innovation and intellectual property.

Bienvenido “Nonoy” Oplas, Jr. is the president of Minimal Government Thinkers, a Manila-based free market think tank, and a fellow of South East Asia Network (SEANET), a Kuala Lumpur-based regional think tank advocating free trade and inclusive growth in the ASEAN.
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Here is the scanned hard copy.

 
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See also: 
BWorld 2, Benefits of Trade Liberalization for the Philippines, May 16, 2015 

Tuesday, August 19, 2014

IPR and Medicines 29: Parallel Importation and Patent Linkage

This news report last August 8, 2014, was posted with discussion by Atty. Joey Ochave at the Medicines Transparency Alliance (MeTA) Philippines email loop. Joey is the Vice-Chairman of MeTA Philippines, SVP of Unilab, and a friend way back in UP Diliman undergrad in the 80s.





Here is Joey's discussion. Posting this with his permission. It is a well-written, well-argued piece as always, which many people outside of MeTA would be interested to learn. My short comments and Joey's reply further below. A bit long, about four pages, enjoy.
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Parallel Importation and Patent Linkage

I came across the attached article entitled “Pharmaceutical firms seek full implementation of generics law” in Philippine Star last August 8th. It mentions a forum in Manila where three companies called “for the government to strengthen the [Cheaper Medicines Act’s] implementation to allow drug outlets to carry a variety of medicine brands, including those sourced through parallel importation, and give choices to consumers.” (emphasis supplied) The three companies were raided by the National Bureau of Investigation agents for alleged “violation of infringement on patent rights” (sic) and selling “illegal drugs”. They argue that since their drugs have been registered with the FDA, they are “not illegal”.

As an IP & Health Law practitioner and an advocate of the Cheaper Medicines Act, I feel compelled to comment on this news article. (Disclosure: I have no involvement in this case. My only interest is to make sure that the Cheaper Medicines Law is properly understood.)

1.     I asked around and learned that the drug molecule in this case is etoricoxib. This medicine is indicated for “acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis; treatment of ankylosing spondylitis; acute gouty arthritis and primary dysmenorrhea; relief of acute pain; moderate to severe acute pots-op pain associated with dental surgery and abdominal gynaecological surgery.” It comes in two strengths – 30 mg. and 60 mg. (MIMS, 135th Ed., 2013). It is marketed in the Philippines as Arcoxia® by Merck Sharp & Dohme (MSD), who I believe is also the patent owner or at least authorized by the latter.

2.     The etoricoxib molecule has a valid and subsisting patent in the Philippines. The patent is on the molecule itself. It is therefore not a frivolous patent, which the Cheaper Medicines Law (CML) prohibits.

3.     Sec. 72 of the CML amended the Intellectual Property Code of the Philippines to allow parallel importation. The patent owner does not have the right to prevent third parties from importing a drug or medicine that has been “introduced in the Philippines or anywhere else in the world by the patent owner.” (emphasis supplied) By inserting the phrase “anywhere else in the world”, the Philippines adopted the “international exhaustion” principle, which means that if the patent owner sells the patented product anywhere in the world (not just in the Philippines), his patent rights over the patented product is exhausted. He cannot subsequently prevent the buyer of the patented product from selling or importing it into the Philippines. To illustrate, if patent owner X sells his patented medicine to Company Y in Thailand and the latter sells the product to Company Z in the Philippines, Company X cannot prevent Company Z from importing and selling the patented medicine in the Philippines. Why? Because Company X has exhausted its patent rights over the patented product when it first sold it to Company Y in Thailand. Stated differently, a patent owner loses his patent rights over a specific patented product the first time he sells the latter. It is also called the “doctrine of first sale”. The policy rationale behind this rule is that the patent owner has already recovered whatever economic benefits he is entitled to as a patent owner when he first sells the product. In short, kumita na siya when he made the first sale.

4.     The article mentions “parallel importation”. I do not know whether this is because the three companies believe they are engaged in parallel importation. In parallel importation, however, what may be imported is only the product of the patent owner. This means one can only import Arcoxia® or any etoricoxib brand manufactured or authorized by MSD. It is not parallel importation  if one imports a generic etoricoxib because it did not come from MSD. Again, under Sec. 72 of the CML only the product placed in the market by the patent owner anywhere in the world can be parallel imported into the Philippines. If one imports the generic equivalent of Arcoxia®, this means it was not MSD who placed it in the market and MSD has not derived economic benefit from it. It therefore patent infringement if you import the generic etoricoxib into the Philippines. Hindi siya parallel importation kapag generic equivalent ang inangkat.

5.     The three companies also argue that since they were able to secure Certificates of Product Registration (CPR) from the FDA for their etoricoxib product, they are free to sell the same in the Philippines. No, that is not true. They should still have to make sure that they are not infringing upon the IP rights (trademarks and patents) of others. The FDA has nothing to do with patents.  Patents are with the IPO. The role of the FDA is simply to make sure that the medicines you will market in the Philippines are safe, effective and of good quality. (This task is no joke given the proliferation of substandard medicines in the world.) This is why the CPRs issued by the FDA state that the CPR holder holds the FDA free and harmless from any damage resulting from any trademark or patent infringement suit against the CPR holder. This means that there is no linkage between drug registration and patents. This is what public health advocates fought for several years ago, which the then BFAD accepted. (Malaysia and Indonesia Drug Regulatory Authorities followed suit.) Unfortunately, with their argument the three companies are unwittingly arguing for patent linkage. (Offhand, I don’t think they realize the implications of their argument.) In any case, for the nth time, patent linkage is NOT required by the TRIPS Agreement. It is in fact a TRIPS Plus provision, or one that it not required by the World Trade Organization. The WTO Doha Declaration on TRIPS and Public Health itself (aside from WHO)  encourages developing countries to exercise the public health flexibilities afforded by the TRIPS Agreement. Removing any linkage between patents and drug registration is one of those flexibilities. Kapag naman ibinalik pa natin ‘yan, tayo na ang may problema. Sinabi na nga ng WTO that developing countries like us should make use of TRIPS flexibilities to protect public health, eh.

Wednesday, May 15, 2013

On IPR Abolition 18: Patent, Copyright and Jeffrey Tucker

Reposting below the exchange I had this morning in facebook. With permission from Mike Perez, Stephen Cutler and Dong Abay. A bit long, more than 2,300 words, 5 pages, enjoy.
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"If patents for inventions were part of the free market, to make and sustain them would not require legislation, constitutions, bureaucracies, filings, armies of attorneys, and years of litigation." -- Jeffrey Tucker, https://www.fee.org/the_freeman/arena/intellectual-property-rights

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Nonoy Oplas This is simplistic thinking. One, physical assets like cars, houses, shoes, laptops, etc. are part of the free market, and they require legislation, constitution, bureaucracies.. And so IPRs are also part of the free market, they are property rights that need respect and enforcement.

Two, private property rights can be enforced by the private sector or civil society, with or without govt penalties. If thieves and shoplifters are caught inside a mall, they are apprehended by private security guards, they can be photographed and their faces plastered in the mall in a wall of shame, other schemes. That is private punishment against violation of private property rights.

The same way, thieves of IPRs like patent, trademark and copyright can be penalized by an industry association, a civil society org. If someone sells burgers wrapped with fake McDo or Burger King wrappers and trademark, and the consumers get good poisoning, who will they sue -- (a) the orig McDo/BK, (b) the IPR thieves like those sellers, or (c) IPR abolitionists like Jeff Tucker? Obviously (a) and (c) will not accept responsibility so (b) must be prosecuted for misleading the public and consumers. If people get food poisoning after consuming food from the orig McDo/BK store, then they can be held accountable. But these companies take care of their trademark so carefully, they can assure the public of 0.00% possibility of food poisoning as they know the consequences of damaged brand and trademark.

IPR abolitionists like Tucker are just simplistic minded.

Joshua Gallardo Roa Woww you had stipulated it clearly....thank you for this info Nonoy Oplas

Nonoy Oplas There was a case of a local burger shop named “Mang Donalds” with logo somehow similar to MacDonald. The latter did not like this, so it sued the former over trademark issue, the former later closed shop, resurfaced as another food shop with a more unique name and encountered no legal issues, prospered. IPR forces people to be more unique, more innovative and creative. IPR abolition favors the lazy, un-imaginative and plain copycatters, http://funwithgovernment.blogspot.com/2011/09/on-intellectual-property-abolition-part_20.html

Stephen P. Cutler Nice work, Nonoy. These kinds of discussions keep us, as a nation, stronger. So many of us are intellectually lazy and just accept the ideas of others without question. Or we make personal attacks against the proponent of the idea,and fail to point out the weakness of that idea. THAT should be the focus. Thanks, again.

Saturday, April 06, 2013

IPR and Medicines 28: Politicizing Innovation, Rewarding Rent-Seeking

Indian government's intellectual property rights (IPR) system for medicines seems hazy. For instance, it did not give full patent protection for medicines before, until India joined the WTO in 2005. Even then, many innovator drugs have no IPR protection, like the case of popular anti-leukemia drug molecule imatinib, brand "Glivec" or "Gleevec" made by Novartis.

According to wikipedia, anti-chronic myelogenous leukemia (CML) drug imatinib, "more than 90% of patients will be able to keep the disease in check for at least five years, so that CML becomes a chronic, manageable condition."

So Novartis in effect is sort of a "hero" to many leukemia patients for coming up with this revolutionary drug. But many sectors in India (and elsewhere around the world) did not look at it this way. Rather, Novartis is looked upon as a blood-sucking multinational who profits from the sick and dying leukemia patients. Thus, its effort to seek IPR protection through a patent was not recognized by an Intellectual Property agency or office in India. So it went to the Indian Supreme Court to obtain such patent and after about a decade of legal and health debates, the SC has ruled against the company's request.

From wikipedia article about leukemia, there are four kinds of this disease. Their respective medication are as follows (image also from wiki):

(1) Acute lymphoblasticinduction chemotherapy.... For adults,... prednisonevincristine, and an anthracycline ....L-asparaginase or cyclophosphamideFor children... (prednisone, L-asparaginase, and vincristine)Consolidation therapy or intensification therapy ...  antimetabolite drugs such as methotrexate and 6-mercaptopurine (6-MP) 
(2) Chronic lymphocyticcombination chemotherapy with chlorambucil or cyclophosphamide, plus a corticosteroidsuch as prednisone or prednisolone....  fludarabine, pentostatin, or cladribine.... Younger patients may consider allogeneic or autologous bone marrow transplantation.
(3) Acute myelogenousMany different anti-cancer drugs are effective for the treatment of AML
(4) Chronic myelogenousstandard of care is imatinib (Gleevec) therapy
For Hairy cell leukemia,  . cladribine, ...  pentostatin... , rituximab ... Interferon-alpha. And for T-cell prolymphocytic...  purine analogues (pentostatin, fludarabine, cladribine), chlorambucil, and various forms of combination chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone CHOP, cyclophosphamide, vincristine, prednisone [COP], vincristine, doxorubicin, prednisone, etoposide, cyclophosphamide, bleomycin VAPEC-B). Alemtuzumab...
So there are many existing drugs against leukemia, depending on the cell type and on whether it is acute or chronic. So they are all non-patented or off-patent already in India?

Novartis and other innovator companies are brave to introduce their new and more revolutionary medicines to Indian patients without IPR protection. Or if they have have one, they have to live with the fact that a patent-confiscation government tool called compulsory licensing (CL) can be imposed by the Indian government anytime.

One result of this situation is an uneven competition. An innovator company that spent huge amount of money and many years in R&D and multiple clinical trials, must sell at a high price to recoup its high spending. Then generic producers that spent nothing to discover the original drug molecule but can produce their own brands of the same molecule can sell at a much lower price.

How can the former adjust with this reality? Plain old economic sense would dictate market segmentation -- different (or tiered) pricing for different buyers or patients with different budget. And for really poor patients, zero cost to them via public-private partnerships or via civil society partnerships. I am told by a friend that Novartis in India has various drug donation programs, like partnership with the Max Foundation, a cancer patient advocacy organization, and gave the Glivec International Patient Assistance Program (GIPAP) providing more than US$ 1.7 billion worth of Glivec to poor patients in India. In effect, the company was giving not cheap but free medicines to the poor, funded by high pricing to richer patients who can afford it.

I also read this interesting article, and I like the first of six "side effects" of the Glivec ruling in India: Patenting is a political act. It is not a scientific or economic act. One must go through strictly political process to obtain a patent. Or if one has it, go through the same political process to retain and protect it, until the patent has  expired. The author, William Looney, wrote,
what constitutes true innovation in an age where scientific advances are transforming the very definition of a drug?  This is a question that extends far beyond patent law into basic value judgments like how society should spend limited resources on medical technologies, in a way that balances patient access with the economic incentives needed to seed their development in the first place.  
It is not good to politicize innovation. There is too much politics in our lives already. Wages, fares, prices of certain commodities, setting up a business, closing a business, hiring and firing workers and managers, they are covered by politics. To extend politics to products of scientific discovery, when none of the money spent for such activity came from taxes, is OA.  

The climate for IPR in India has become more uncertain. Last year, the Indian government issued their first compulsory license, which permits local companies to make generic copies of a patented medicine for a small fee. Since January 2013, three additional compulsory licenses were issued for three different cancer drugs.

As more politics raid products of innovation, more rent seeking behavior is rewarded. This is not the proper role of government, to pick winners and losers based on certain subjective if not arbitrary criteria. The proper role of the government in this case, is to leave players to do their own thing so long as public health is not endangered. So if there are 30 or 50 innovator companies who would race with each other in producing a new medicine against prostate cancer or breast cancer or other killer diseases, so be it. These are on top of existing drugs and treatment against those diseases that are off-patent already. Let those innovator companies price their own products. For sure, competition among them will force them to develop various types of pricing and drug donation programs.

Less politics, less government intervention in the drug innovation business and competition. This is one cool way to ensure that present and future patients suffering from killer diseases can find solace and hope to lengthen their lives.
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See also:
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 27: More on Glivec and India's SC Decision