The Economist: Patently Absurd

The Economist recently published an interesting opinion article on the impact of innovation on the economy — specifically the negative impact of patent backlogs on business (particularly small entrepreneurial business).

Patently Absurd

INNOVATION and jobs have become a modern version of motherhood and apple pie in Washington, DC. Everyone in America’s capital wants lots more of both, or so they say. So how come Congress and the White House have decided not merely to underfund a crucial cog in American’s innovation machine but actually to take away revenue it earns? And that at a time when that cog, the Patent and Trademark Office, is already struggling to keep up with the growing demands upon it? The recent budget deal for fiscal 2011 (the year to September 30th) allows the Patent Office to spend only $2.1 billion. That is less than it expects to collect in fees from applicants—$100m or so will disappear instead into Treasury coffers—and far less than it needs to do its job properly.

WIPO marks 2 millionth international patent filing

The World Intellectual Property Organization recently marked the filing of the two-millionth international patent application under WIPO’s Patent Cooperation Treaty (PCT).

The PCT makes it easier for companies and inventors to seek patent rights in multiple countries as a single application under the PCT has legal effect in all 142 countries bound by the treaty.  The PCT system consolidates and streamlines patenting procedures, postponing the payment of sizeable costs and providing applicants with a sound basis for important decision-making.

The value of the PCT system also lies in its capacity as a global repository of technological information. Under the PCT approximately 160,000 international patent applications are filed every year.

India’s PM wants country to be world leader in IP

According to an article in the Economic Times, India’s Prime Minister Manmohan Singh recently made a forceful plea for fostering an environment that promoted scientific advancement in the country to help it become a “world leader” in creating intellectual property.

“Innovation and knowledge will be the key-factors in our progress in the 21st century,” said the Prime Minister.  ”We must, therefore, foster an environment that promotes and nurtures scientific achievement and makes us a world leader in creating intellectual property.”

Singh also said that scientific and technological prowess was key to the country’s development, noting that ”scientific development is an integral part of the journey towards inclusive, balanced and sustainable growth.”

Access to medicines in India: feedback from a gov’t consultation on compulsory licensing

India’s Department of Industrial Policy & Promotion (managed by the Ministry of Commerce and Industry) recently released a Discussion Paper on Compulsory Licensing and invited feedback from civil society groups, industry, academia and other stakeholders to guide their formulation of a compulsory licensing policy.

The Discussion Paper expressed concern regarding the availability of new products and technologies in India, including medicines and other pharmaceutical products, and seeks to explore whether compulsory licensing could be a viable solution.

Many of the submitted comments, including those of foreign business lobbies, warned that a proposal to allow government-owned or private companies to manufacture products and technologies patented by other companies, to ensure they are not in scarce supply, could discourage overseas investment in India.

Of particular interest was a submission by the Organization of Pharmaceutical Producers of India, which noted that:

Even a prima facie analysis of the situation in India would make it apparent that patents are not the primary cause for poor access to medicines in India.  Sales of patented products account for much less than 1% of the Indian Pharmaceutical market.

Thus, compulsory licensing of patented medicines can have no meaningful impact on improving access to medicines for the vast majority of the Indian population who lack the financial capability to pay for even generic, off-patent, medicines that comprise even more than 99% or so of the Indian Pharmaceutical market.

Over the past several years, the experience in most middle and low-income countries has been that private-public partnerships and affordable publicly supported health insurance do much more to improve access to medicines.

We do not believe that compulsory licensing of patented inventions is a sustainable or viable course of action to address India’s healthcare challenges.   Proposals to promote the use of compulsory licenses could inhibit technological development in the pharmaceutical sector in India and thereby undermine efforts to make medicines and other products widely available to patients.

Other key points raised in the OPPI’s commentary included:

• The use of compulsory licensing is rarely the best policy option and cannot be a suitable tool to deal with the long-term healthcare issues confronting India.
• It has been demonstrated that patents are not a principal barrier to access to essential medicines, particularly here in India.  The World Health Organization (WHO) determined that during 2000-2007 period, India had significantly greater lack of access to essential medicines than many African countries, even though it had excluded pharmaceuticals from patent protection for almost 30 years.

The US-India Business Council (USIBC), which represents nearly 350 global companies, also expressed concern that adopting the proposed policy would inhibit the growth of intellectual property-intensive industries. It will create uncertainty and have a chilling effect on innovation and investment.  Similar views have been expressed by BusinessEurope, a European trade body, and Japan Pharmaceutical Manufacturers Association (JPMA), a drug industry lobby representing at least 68 top pharmaceutical companies in Japan.  (Source:  Livemint.com)

New study highlights the importance of partnerships in improving public health.

The Cameron Institute – a Canadian not-for-profit public policy think-tank – released a report highlighting the importance of public-private partnerships and of intellectual property protections to improving global health.  The evidence in this report (Pharmaceutical Access in Least Developed Countries: on-the-ground barriers and industry successes) strongly supports North-South, public-private partnerships as the preferred means by which to improve access to care and public health outcomes in least-developed countries.

Sustainable development is the way of the future for both North and South.  In order for there to be sustainable healthcare enterprise and optimal health outcomes in the least-developed countries, there must also be the necessary infrastructure, health human resources, political stability, and professional administrative legal structures.

– Dr. D. Wayne Taylor Ph.D., F.CIM, Executive Director of The Cameron Institute

The 200-page report shows that the research-based pharmaceutical industry has sponsored or participated in over 150 public-private partnerships that have successfully improved access to drugs – as well as health outcomes – for the 50 least developed countries.

Click here to download the full report.

WSJ opinion – Africa’s Health Crisis

An interesting opinion from the Wall Street Journal about challenges and barriers to improving public health in Africa.

How to Worsen Africa’s Health Crisis: Killing off drug patents will kill off innovation and patients.

By ALEC VAN GELDER

Faced with Africa’s devastation by HIV/AIDS, people are looking for scapegoats. Global pressure groups and now the World Health Organization are targeting “Big Pharma.” The drug companies do make easy targets but that doesn’t make them villains. The life-saving treatments they create remain Africa’s best hope. The misguided battle against pharmaceutical companies’ patent rights will only make Africa’s health crisis worse.

Intellectual property rights for AIDS drugs are “the biggest public health challenge” as they make them too costly for most Africans, Hans Hogerzeil, head of the WHO’s Essential Medicines program, recently said. They are “a barrier to access,” he previously claimed, but the real barriers are the lack of infrastructure and the diversion of aid money. Fewer than 5% of WHO’s 423 Essential Medicines are currently protected by patents; mostly advanced “second-line” anti-AIDS medicines.

US releases IP enforcement strategy

Today, Vice President Joe Biden and Victoria Espinel, Intellectual Property Enforcement Coordinator, released the U.S. government’s official IP enforcement strategy.  The plan — developed following extensive public consultation — identifies 33 key action items to combat intellectual property infringement, both domestically and internationally.

Download the PDF to read the complete 2010 Joint Strategic Plan on Intellectual Property Enforcement.

The following are highlights from Vice President Joe Biden’s remarks, delivered today at the Eisenhower Executive Office Building:

Whether we’re talking about fake drugs that hurt instead of help the patient or knockoff car tires that fall apart at 65 miles an hour causing injury and death, counterfeits kill — counterfeits kill.  There’s a reason why they counterfeit, they don’t know how to do it in the first place.

But to state it very bluntly and obviously, piracy hurts.  It hurts our economy to the tune of billions — some argue tens of billions of dollars — in lost private sector profit and government revenue.  It hurts our health and safety, the health and safety — that’s why the FDA commissioner is here, in part.

Piracy is theft, clean and simple.  It’s nothing but theft.

Why innovation is sometimes just as important as invention for pharmaceutical patents

An interesting article on incremental innovation, invention, access to medicines and IP — from Global Health Progress.

The Asian Age recently discussed the dilemma around the language of the Indian Patents Act, which requires “significant” improvements or efficacy in existing medicines for them to become eligible for pharmaceutical patents.  Reporter Deepak Joshi discusses the role of “incremental innovation” in many breakthrough inventions, including medical improvements like the new generation of HIV/AIDS treatments.  Joshi adds that these improvements, while not groundbreaking, nevertheless play an important role in medical progress.  Below is an excerpt from this article.

“In India, however, the debate about incremental innovations has become an unsettling one, particularly in the pharmaceutical sector. Section 3(d) of the Indian Patents Act has a controversial clause calling for “significant” improvement or efficacy in an existing compound to become eligible for a patent. Who defines “significant” and how? The issue is left delightfully vague.

Why does India more or less bar incremental innovations? There is a popular misperception that incremental innovations are unnecessary and will only result in more expensive medicines. The first point is plain wrong and the second one only half true. Of the 325 drugs on the World Health Organisation’s essential medicines list, 95 per cent are off-patent. This means they will be freely available to any drug manufacturer even if incremental innovation results in a better version also being in the market.

It is another matter that some two billion people worldwide don’t have access to these 325 drugs. That is an issue of access and health infrastructure. Patents and the presence or absence of incremental innovations have nothing to do with it. Look at it another way, if a large number of people across the planet don’t have black and white televisions, should the government stop attempts to develop and produce high-end plasma televisions? It may sound ridiculous, but that analogy holds true for the pharmaceutical industry.”

Read the full The Asian Age article here.

63rd WHA – update on discussions

The sixty-third World Health Assembly is coming to a close later today.  Some of the key issues raised at this year’s meeting included progress towards the Millenium Development Goals, counterfeit medicines, prevention of non-communicable diseases and the Global Strategy on public health, innovation and intellectual property.  The following is a brief overview from these discussions.

Millenium Development Goals (MDGs)

Experts from WHO, member countries and the Global Fund provided a progress update on the health-related MDGs and highlighted key challenges remaining.

Noting the impact of the financial crisis on health, participants emphasized the importance of sustaining investments in health.

Speakers highlighted the need for better coordination of funding mechanisms, global financing aligning with local priorities and national health plans, and mutual accountability for both the donors and the receiving governments.

Participants called for renewed action to achieve the health-MDGs.

Prevention and control of non-communicable diseases (NCDs)

NCDs cause 60% of all deaths worldwide, with 80% occurring in low and middle-income countries.

Noncommunicable diseases – mainly cardiovascular diseases, cancers, chronic respiratory diseases and diabetes – kill nearly 35 million people per year. Almost 90% of fatalities before the age of 60 occur in developing countries and are largely preventable.

Highlighted the changing health profiles of countries and the need to focus attention on the emerging priority of NCDs and their burden on the population and health care spending.

Counterfeit Medicines

The proliferation of potentially lethal or harmful counterfeit medicines has been on the rise, particularly with the increased usage of the Internet worldwide.

WHO will not drop use of the term ‘counterfeit’ to describe fake medicines despite generic producing nations complaints about possible confusion over the term.

“With substandard medicines, drug regulatory authorities know who to go to when a quality problem is discovered,” said Hans Hogerzeil, the director of the WHO programme on Medicines Policy and Standards. “But with counterfeit, false or fake medicines the identity of the producer is not known, and they easily cross national borders, so normal regulatory approaches cannot be used.”

“Every honest industry is interested in stopping this,” said Hogerzeil, as is every government because counterfeiting harms both patients and the legitimacy of the health system.”

Public health, innovation and intellectual property

Delegates discussed a global strategy and plans of action for public health, innovation and intellectual property. The debate focused on financing issues, including the rational use of funds, and conducting research through regional networks.

The item will be taken up for discussion later in the week.

Global eradication of measles

Approximately 20 delegates took the floor and endorsed targets set for 2015 as milestones towards the eventual global eradication of measles.

Success in achieving the measles 2015 targets is essential if the MDG 4 – reduce child mortality – is to be reached.

Food Safety

Many countries noted that diseases can be caused by unsafe food, that national food production systems are susceptible food safety problems and that more food is traded across borders then ever before.

WHO was encouraged to continue working directly with Food and Agriculture Organization of the United Nations (FAO), the World Organization for Animal Health (OIE) to strengthen public health, support economic development, and continue joint risk assessments through WHO/FAO expert bodies, and establish standards through the FAO/WHO Codex Alimentarius Commission.

Innovation, IP & India – commentary from the Indian pharmaceutical industry

Ranjit Shahani, President of the Organization of Pharmaceutical Producers of India released the following statement on Intellectual Property Day concerning the effect drug patent protection is having on innovation in India:

Emotion tends to override facts when it comes to patents and patients’ concerns. Consider the fears stoked when India joined the World Trade Organization in 1995. Many feared drug prices could rise, access to medicines could be reduced and many Indian pharmaceutical companies could close down.

Fifteen years later, these fears have proved unfounded: Drugs in each category are available at multiple price points, accessibility is clearly independent of patents, and Indian companies have become multinationals and enter[ed] foreign markets worldwide.

When India reinstated patent protection via IPR (intellectual property rights) reforms, many feared this would lead to decreased access to medicine and delayed entry of generic medicines. Despite the lack of pharmaceutical patents in India for 35 years and some of the lowest prices for medicine in the world, access to medicine in India remained among the lowest in developing nations. In other words, patents have little to do with the ability to access medicines.

While many try to point fingers at drug patents and IPR protection, the lack of healthcare financing and particularly health insurance are the real culprit[s]. Limiting the types of innovations which receive patent protection, as India currently does, won’t improve the health of Indians.

Small innovations that build on existing knowledge are the true backbone and a specific strength of the pharma industry. Yet, Indian laws prohibit certain types of pharmaceutical innovations from patent protection, thereby discouraging research. Indeed, this policy hurts Indian patients the most.

There are many meaningful benefits of continued research on existing medicines. For instance, drug formulations and delivery systems can be optimised for greater effectiveness in India’s hot, humid climate. Paediatric formulations could be developed for babies suffering from diseases more often found in adults. It could also promote the development of treatment for diseases prevalent in India — tuberculosis, malaria, filariasis and other tropical diseases — where breakthroughs are unfortunately rare.

Innovation, research and patent protection are critical to introducing new drugs into the market. Innovations and effective drugs are inseparable, as diseases constantly mutate and many have inadequate treatments

Without patent protection, innovations decline, as R&D needs immense investments. Due to high, ever-increasing R&D costs, only two in 10 approved medicines earn more than the average cost of developing a new drug. Statistics are telling: a new drug discovery cost around $138 million in 1975, $318 million in 1987 and more than $1.3 billion in 2006.

The Prime Minister, Dr Manmohan Singh, has acknowledged the critical role of innovation at the 97th Indian Science Congress held in Thiruvananthapuram recently: “Our Government has declared 2010-20 as the ‘Decade of Innovations’. We need new solutions in many areas… in healthcare, in energy, in urban infrastructure, in water management, in transportation… The country must develop an Innovation Eco-system to stimulate innovations… And innovative solutions with potential must be nurtured and rapidly applied.”

As we take a look at drug patents on Intellectual Property Day, we must not forget the important role they play in keeping India and the world healthy. With viruses that mutate constantly — HIV/AIDS, H1N1, and TB — incremental innovations are imperative to stay one step ahead in the war against disease. If all innovations are protected to expand treatment options, millions of patients in India and worldwide will benefit. At stake are not just patents, but the lives of millions.