A victory for patients & generic drugmakers vs Novartis in landmark patent case

The Indian Supreme Court’s ruling that only genuinely new inventions should be granted patents means that medicines can still be affordable.

The front office of Novartis in Mumbai, India, Monday, after India's Supreme Court rejected drug maker's attempt to patent a new version of a cancer drug Glivec. 

PATIENTS around the world who look to India for low-cost medicines to treat their ailments heaved a sigh of relief last week when the Indian Supreme Court turned down a claim for a patent for a cancer drug.

This means that drug companies in India can continue to produce generic versions of the same drug, Glivec or Gleevec, at a much lower price, thus making it affordable to thousands more cancer patients.

Glivec, produced by the Swiss-based company Norvartis, can cost a patient up to US$70,000 (RM217,000) for a year of treatment, whereas the generic versions of the same medicine made by Indian companies cost around US$2,500 (RM7,750). The drug is used to treat some forms of leukaemia as well as a rare type of stomach cancer.

The Supreme Court decision also seems to open the road for patents not to be granted for more medicines, since it confirmed that only drugs that are genuinely a new invention can be granted patents.

When a patent is granted to a company for a drug, other companies are not permitted to produce generic versions of the medicine for a period of 20 years or so.

The monopoly given to the patent holder enables it to charge high prices since there is a lack of competition.

Many or even most patients are unable to buy the medicines, giving rise to frustration and despair especially when their lives are at stake.

Some companies whose patents are about to expire apply for a new patent for the same drug after changing the composition slightly or changing the form of the drug.

The “new” drug is often not a new invention, but only a minor modification that is made with the aim of having the patent renewed for another period. This practice is popularly termed “evergreening” of the patent.

An extension of the patent term means that the company continues to enjoy the monopoly and high prices, which continue to be out of reach to many patients.

Although governments are obliged to have laws allowing for patents to be given for inventions under the World Trade Organisation’s TRIPS agreement, each country is allowed to set its own definition and standards for what is an invention.

The Supreme Court decision confirms that the Indian patent authorities exercised their powers lawfully and properly when they rejected the patent application for Gleevec on the ground that the medicine was not a new invention.

Novartis had challenged the interpretation given by the Indian Patent Office to Section 3 (d) of the Indian Patents Act that seeks to prevent the grant of patents for non-inventive new forms of known medicines.

The Novartis application had claimed a patent for a new salt form (imatinib mesylate), a medicine for the treatment of chronic myeloid leukaemia, sold under the brand name Gleevec (or Glivec in other countries).

The Indian patent office had rejected the patent application on the ground that the claimed new form was anticipated in an earlier US patent of 1996 for the compound imatinib and that the new form did not enhance the therapeutic efficacy of the drug. The decision was upheld by the Indian Patents Appellate Board.

The legal challenge from Novartis had caused anxiety among patients groups, governments of developing countries and some international organisations in view of the possible negative implications for access to affordable medicines if the Norvatis petition succeeded.

Most developing countries rely on Indian generic drug companies for the supply of low-priced medicines for many diseases.
A weakening of the interpretation or use of Section 3 (d) would have enabled multinational drug companies to extend their patent monopolies based on “evergreening” or “trivial” incremental improvements which could delay the supply of generic medicines for the treatment of HIV/AIDS, cancer and other diseases.

The decision by the Indian Supreme Court is thus of major significance not only for India but for patients and health authorities in the developing countries.

In interpreting Section 3 (d), the Supreme Court observed that this section was introduced in the 2005 amendment to the Patents Act to ensure that while India allowed product patents on medicines in accordance with its WTO obligations, it did not compromise public health through “evergreening” of pharmaceutical patents.

The court hence took into account the concerns about the impact of the TRIPS agreement on public health and on the development of an indigenous pharmaceutical industry.

Moreover, it considered the implications of the Novartis case for the availability of essential medicines at affordable prices globally.

The court decision reproduced two letters from Dr Jim Yong Kim, the former director of the Department of HIV/AIDS at the World Health Organisation (current president of the World Bank) and from UNAIDS to the Indian health minister expressing their concerns relating to the continuous availability of affordable Indian generic drugs in other developing countries.

Thus, the Supreme Court decision has implications beyond India. It upholds the high standards by which drug patent applications can be processed. While genuinely new inventions are granted patents, drugs that are not really new need not.

The implication is that Indian generic companies can be expected to produce many more medicines in future, and continue their reputation as the “pharmacy of the developing countries”.

It is also heartening that the court decision reaffirms the priority for concerns for the patients’ right to receive treatment at more affordable prices.

The court decision is also likely to spark interest among other developing countries about the Indian patent law and the policies guiding it. Developing countries can learn from the Indian approach of balancing patents and public health.

Global Trends
By MARTIN KHOR
Related posts:
 The US Pacific free trade deal that's anything but free?
ASEAN plans world's largest trading bloc in Asia, the ... 

Who invented bank deposit insurance?

I LOVE the Internet. The best Christmas present I got last year was a preview of a forthcoming book by a banker/historian in Boston. He sent me electronically his PhD thesis, a piece of masterly detective work on how ideas travel over time and space, become adopted successfully in a different place, and then comes back to where they started.

Dr Frederic Grant Jr's forthcoming book uncovered how the US bank deposit insurance system has its root in ideas borrowed from Canton (Guangdong province in southern China) of the 19th century. The origins of the US deposit insurance scheme arose from the 1828 The Safety Fund statute of the State of New York, drafted by a legislator named Joshua Forman.

In those days, if the state-authorised banks failed, the state would have to pay for their failure. Forman borrowed the idea from Canton that those authorised for privileged trade (in banks the privilege of private currency issue) should be responsible for their own debts.

The success of the New York Safety Fund inspired the adoption of similar schemes by 13 other American states. In 1933, the Banking Act of 1933 created the Federal Deposit Insurance Corp (FDIC), following the failure of many banks across the US. This idea of a national deposit insurance scheme has been adopted by many countries around the world, and is currently being considered in China.

How did Forman get the idea about the Canton Guaranty Scheme? Apparently, New York was already the major port for US-China trade and the scheme was familiar to New York businessmen.

How the Canton system evolved

It all came about because the Qing dynasty official merchants, namely merchant houses (or hongs) authorised by Beijing to conduct foreign trade, often require trade credit to conduct business with foreigners in Canton. If these traders defaulted on their loans, the foreigners threatened to take action on the weak Qing dynasty. Hence, in order to prevent individual merchant failure, the Qing government used a collective responsibility method evolved by the Manchu court in Beijing that ensured that those authorised to benefit from the foreign trade also collectively guaranteed each other's trade debt, and a premium was paid yearly into a fund to pay off any individual failure.

The Qing government solved the problem of defaults by imposing collective responsibility everyone was responsible for the group's debt. The good news is that the group as a whole made sure that no member got into trouble, engaging in what is today called “peer surveillance”. The bad news is that with collective guarantee, the smaller traders have an incentive to take higher risks, creating moral hazard private gain at collective loss. Moreover, as history showed, if trade was really bad, more traders failed and since the Qing government also borrowed or taxed the accumulated fund regularly, there were not enough money in the fund to settle all debts. Eventually the Canton Guaranty Fund also failed.

Corruption and misappropriation of fund was to blame, but the main culprit remained what Grant called “the perennial dilemma of inadequate capital and lack of access to affordable credit” for smaller hongs.

These problems plagued all deposit insurance schemes, even today. Large banks loath to support deposit insurance because they pay a larger share of the premium than smaller banks. Small banks enjoy the group insurance, but are more prone to failure because they were more likely to take more risks, which meant that there should be supervision to make sure that these riskier players do not destroy the group as a whole.

Deposit insurance worked very well in the United States, as the FDIC not only participated in supervision of the insured banks, but also engaged actively as the mortuary of failed banks. In the recent crisis, from 2009 to currently, the FDIC smoothly managed the exit of over 400 banks in the United States, without disruption to the system as a whole. But this time round, it was the failure of the shadow banks and larger banks that created the problem. Yes, smaller banks failed, but they did not take down the whole system because deposit insurance prevented large-scale bank runs at the retail level.

The time has come for China to adopt a formal deposit insurance scheme. There are at least three good reasons why it should occur. The first is that deposit insurance will help stop retail bank panic, exactly the reason for the Canton Guaranty Fund. The second is that there must be an orderly exit mechanism for financial institution failure. Some argue that a deposit insurance would duplicate supervision. Today we realise why we have two kidneys instead of one we need redundancy in the system, in case one fails.

The third, based on my personal experience, is that regulators who are good at daily operations may not always be very good at conducting the messy operations of restructuring failed banks. This is a very complicated process that needs strong skills, good bankruptcy laws and more investment banking skills than regulation. Deposit insurance is specialised work and needs specialised skills.

As Grant rightly said, the historical record of the Canton Guaranty System offers a number of valuable lessons to the modern world. “These include (1) that the tax that supports a guaranty fund must be based on measured risk of loss; (2) that the fund and its insureds must be made subject to strong independent supervision; (3) that laws enacted to avoid risk contingencies must be enforced; and (4) that both corruption and the diversion of fund assets must be strictly prohibited.”

The trouble with history is that we never seem to learn from history.

THINK ASIAN
BY ANDREW SHENG

 > Tan Sri Andrew Sheng is president of the Fung Global Institute. 

Related: 
FDIC: Failed Bank List
Innovation not the same as invention, the difference here...
Related Videos:

Innovation not the same as invention, the difference here...

Innovation practitioners know that they should not listen to the experts who approach life with rigid blinkers that prevent them from visualising anything outside their conditioned minds.

TAKING a leaf out of what our Prime Minister wrote in this space two weeks ago, innovative thinking is undoubtedly a significant driver in propelling the nation’s economy to new heights. It is imperative that Malaysians embrace a culture of innovation.

But let’s take a step or two back, before we can begin to move forward. It is important to pin down exactly what innovation means. Several readers have asked me if innovation is the same as invention, especially after reading about Malaysian researchers winning awards for their inventions. In fact, although they may appear similar at first glance, upon closer inspection both are very different indeed.

If you make something unique or original, that’s an invention. Whether the invention has value or not is immaterial. This is why we see whacky inventions like toothbrushes for dogs or a clip-on fan on chopsticks to cool down noodles. Both these examples are unique and original but offer little value to most citizens.

Innovation demands creating additional value, even though a product or service may not be unique or original. The innovator must first unravel customer needs, and then figure out how to inject greater value at different parts of the solution. Let’s look at two examples.

Forty-five years ago, the radical economist and philosopher E.F. Schumacher formed an NGO called Practical Action to help people in developing countries help themselves. Practical Action states that more than 1.6 million people in developing countries die of diseases and accidents caused by cooking and heating fires in homes. This is not surprising, given that one third of humanity still uses rudimentary stoves fuelled by wood, charcoal or dung.

Liquefied petroleum gas (LPG) is a viable solution as it costs less than wood or charcoal, but most villagers cannot afford the stoves. Some African countries have implemented an innovative “revolving fund” credit system that allows villagers to buy stoves. It works exactly like the “kutu” scheme prevalent in Malaysia for decades, although illegally. Ten households get together and form a fund, with each household contributing a fixed amount to the fund each month, for 10 months.

Every month, one household collects the contributions that month to buy a stove. The following month, another household gets the total contributions to buy their stove. Households draw lots to see who will get the fund over the next 10 months. Within 10 months, all 10 households get their LPG stove. Now imagine adapting this idea to meet the needs of entire communities and you see the power of this innovative funding system. No handouts or subsidies from the government and no bank loans either – the villagers help themselves, through innovation. This is a common sense solution, not rocket science. To be precise, this is innovation.

Let’s look at the second example. Does the number of new books that hit the bookshelves every month overwhelm you? It was predicted that the Internet would spell the death of the printed word, but in fact the reverse has happened. There are now more books in print than at any other time in history. How does one keep up?

As it is commonly known, a number of innovative online companies have found a practical solution to this. For a small fee, these companies provide a short summary of a book containing all the essential ideas presented in the book. Most people can read these summaries in 15 minutes, making it possible to read at least one book each day. This “compressed knowledge” is another example of innovation.

Ultimately, innovation is not confined to technologies, products or services. You can have innovation at every stage of the business cycle – from manufacturing to distribution to sales to post-sales support.

Just look at Nike, the world’s largest supplier of athletic shoes and apparel. It does not own a single manufacturing factory, but focuses on innovation in design and marketing. Another well-known example is DHL, a world-leading courier and logistics company that relies on innovation to accurately ship a document or parcel from the point of origin to its destination.

For you to benefit and profit from innovation, you have to dissect your business or activity into its key pieces or “parts”. The “eco-system” must be correctly identified, as dealing with just one part of the problem or value-chain is unlikely to bring satisfactory results. Nothing exists in isolation and even seemingly unconnected things are actually connected, so a “village” or holistic approach to innovation is necessary.

For each piece or part, you have to ask a fundamental question: How can I do this better, so that the outcome is greater than it is now – at a lower cost? Your brain will rebel at first and tell you that it cannot be done. Don’t listen to your brain; it is a lazy device looking for the easiest way out. Innovation practitioners know that the last person you should listen to is your own self. Don’t listen to the experts either, for they approach life with rigid blinkers that prevent them from visualising anything outside their conditioned minds.

Adopt a child-like disposition and question the assumptions that you and others have taken for granted. Persist until you have questioned each and every aspect of all the pieces of the puzzle and found answers that are uncommon.

This sounds easy, but it is the most difficult step as it questions all the sacred cows lurking in your belief system. Done correctly, however, it can lead to breakthrough innovations.
If you have been through this process, share your stories with me at kamal@pmo.gov.my so that other readers can benefit from your lessons too.

The Star Ignite
By DATUK SERI DR KAMAL JIT SINGH

> Unit Inovasi Khas CEO Datuk Seri Dr Kamal Jit Singh is hoping to jolt Malaysians out of complacency.

 

The Difference Between 'Invention' and 'Innovation'

Two and a half years ago, I co-founded Stroome, a collaborative online video editing and publishing platform and 2010 Knight News Challenge winner.

From its inception, the site received a tremendous amount of attention. The New School, USC Annenberg, the Online News Association and, ultimately, the Knight Foundation all saw something interesting in what we were doing. We won awards; we were invited to present at conferences; we were written about in the trades and featured in over 150 blogs. Yet despite all the accolades, not once did the word "invention" creep in. "Innovation," it turns out, was the word on everyone's lips.

Like so many up-and-coming entrepreneurs, I was under the impression that invention and innovation were one and the same. They aren't. And, as I have discovered, the distinction is an important one.

Recently, I was asked by Jason Nazar, founder of Docstoc and a big supporter of the L.A. entrepreneurial community, if I would help define the difference between the two. A short, 3-minute video response can be found at the bottom of this post, but I thought I'd share some key takeaways with you here:

INVENTION VS. INNOVATION: THE DIFFERENCE

In its purest sense, "invention" can be defined as the creation of a product or introduction of a process for the first time. "Innovation," on the other hand, occurs if someone improves on or makes a significant contribution to an existing product, process or service.

Consider the microprocessor. Someone invented the microprocessor. But by itself, the microprocessor was nothing more than another piece on the circuit board. It's what was done with that piece -- the hundreds of thousands of products, processes and services that evolved from the invention of the microprocessor -- that required innovation.

STEVE JOBS: THE POSTER BOY OF INNOVATION

If ever there were a poster child for innovation it would be former Apple CEO Steve Jobs. And when people talk about innovation, Jobs' iPod is cited as an example of innovation at its best.

But let's take a step back for a minute. The iPod wasn't the first portable music device (Sony popularized the "music anywhere, anytime" concept 22 years earlier with the Walkman); the iPod wasn't the first device that put hundreds of songs in your pocket (dozens of manufacturers had MP3 devices on the market when the iPod was released in 2001); and Apple was actually late to the party when it came to providing an online music-sharing platform. (Napster, Grokster and Kazaa all preceded iTunes.)

So, given those sobering facts, is the iPod's distinction as a defining example of innovation warranted? Absolutely.

What made the iPod and the music ecosystem it engendered innovative wasn't that it was the first portable music device. It wasn't that it was the first MP3 player. And it wasn't that it was the first company to make thousands of songs immediately available to millions of users. What made Apple innovative was that it combined all of these elements -- design, ergonomics and ease of use -- in a single device, and then tied it directly into a platform that effortlessly kept that device updated with music.

Apple invented nothing. Its innovation was creating an easy-to-use ecosystem that unified music discovery, delivery and device. And, in the process, they revolutionized the music industry.

IBM: INNOVATION'S UGLY STEPCHILD

 Admittedly, when it comes to corporate culture, Apple and IBM are worlds apart. But Apple and IBM aren't really as different as innovation's poster boy would have had us believe.

Truth is if it hadn't been for one of IBM's greatest innovations -- the personal computer -- there would have been no Apple. Jobs owes a lot to the introduction of the PC. And IBM was the company behind it.

Ironically, the IBM PC didn't contain any new inventions per se (see iPod example above). Under pressure to complete the project in less than 18 months, the team actually was under explicit instructions not to invent anything new. The goal of the first PC, code-named "Project Chess," was to take off-the-shelf components and bring them together in a way that was user friendly, inexpensive, and powerful.

And while the world's first PC was an innovative product in the aggregate, the device they created -- a portable device that put powerful computing in the hands of the people -- was no less impactful than Henry Ford's Model T, which reinvented the automobile industry by putting affordable transportation in the hands of the masses.

INNOVATION ALONE IS NOT ENOUGH

Given the choice to invent or innovate, most entrepreneurs would take the latter. Let's face it, innovation is just sexier. Perhaps there are a few engineers at M.I.T. who can name the members of "Project Chess." Virtually everyone on the planet knows who Steve Jobs is.

But innovation alone isn't enough. Too often, companies focus on a technology instead of the customer's problem. But in order to truly turn a great idea into a world-changing innovation, other factors must be taken into account.

According to Venkatakrishnan Balasubramanian, a research analyst with Infosys Labs, the key to ensuring that innovation is successful is aligning your idea with the strategic objectives and business models of your organization.

In a recent article that appeared in Innovation Management, he offered five considerations:

1. Competitive advantage: Your innovation should provide a unique competitive position for the enterprise in the marketplace;
2. Business alignment: The differentiating factors of your innovation should be conceptualized around the key strategic focus of the enterprise and its goals;
3. Customers: Knowing the customers who will benefit from your innovation is paramount;
4. Execution: Identifying resources, processes, risks, partners and suppliers and the ecosystem in the market for succeeding in the innovation is equally important;
5. Business value: Assessing the value (monetary, market size, etc.) of the innovation and how the idea will bring that value into the organization is a critical underlying factor in selecting which idea to pursue.

Said another way, smart innovators frame their ideas to stress the ways in which a new concept is compatible with the existing market landscape, and their company's place in that marketplace.

This adherence to the "status quo" may sound completely antithetical to the concept of innovation. But an idea that requires too much change in an organization, or too much disruption to the marketplace, may never see the light of day.

A FINAL THOUGHT

While they tend to be lumped together, "invention" and "innovation" are not the same thing. There are distinctions between them, and those distinctions are important.

So how do you know if you are inventing or innovating? Consider this analogy:

If invention is a pebble tossed in the pond, innovation is the rippling effect that pebble causes. Someone has to toss the pebble. That's the inventor. Someone has to recognize the ripple will eventually become a wave. That's the entrepreneur.

Entrepreneurs don't stop at the water's edge. They watch the ripples and spot the next big wave before it happens. And it's the act of anticipating and riding that "next big wave" that drives the innovative nature in every entrepreneur.

By Tom Grasty This article is the seventh of 10 video segments in which digital entrepreneur Tom Grasty talks about his experience building an Internet startup, and is part of a larger initiative sponsored by docstoc.videos, which features advice from small business owners who offer their views on how to launch a new business or grow your existing one altogether.

Related posts:

Who invented bank deposit insurance?

Related Videos: