By Germán Velásquez
GENEVA, Nov 10 2015 (IPS)

The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well-understood. Too often these are viewed as unrelated functions or responsibilities of the state. And the reason is clear: patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators.

Germán Velásquez

Given the impact of pharmaceutical patents on access to medicines, patent offices should continue to align their work in support of national health and medicine policies, using the freedom permitted by the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) to define patentability requirements.

The TRIPS Agreement requires all World Trade Organization (WTO) member states to incorporate into their legislation universal minimum standards for almost all rights in this domain: copyright, patents and trademarks.

A patent is a title granted by the public authorities conferring a temporary monopoly for the exploitation of an invention upon the person who reveals it, furnishes a sufficiently clear and full description of it, and claims this monopoly.

As with any monopoly, it may lead to high prices that in turn may restrict access. The problem is compounded in the case of medicines, when patents confer a monopoly for a public good and essential products needed to prevent illness or death and improve health.

According to the TRIPS Agreement, the patentability requirements used by national intellectual property offices require a product or manufacturing process to meet the conditions necessary to grant patent protection, namely: novelty, inventive step and industrial applicability (utility).

These three elements, however, are not defined in the TRIPS agreement and WTO Member States are free to define these three criteria in a manner consistent with the public health objectives defined by each country.

It is widely held that patents are granted to protect new medicines to reward the innovation effort. However, the number of patents obtained annually to protect truly new pharmaceutical products is very low and falling. Moreover, of the thousands of patents that are granted for pharmaceutical products each year, a few are for new medicines – e..g. new molecular entities (NMEs).

All of the above led the World Health Organization (WHO), in collaboration with the United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP) and the International Centre for Trade and Sustainable Development (ICTSD), to develop, in 2007, guidelines for the examination of pharmaceutical patents from a public health perspective.

The guidelines were intended to contribute to improving the transparency and efficacy of the patent system for pharmaceutical products, so that countries could pay more attention to patent examination and granting procedures in order to avoid the negative effects of non-inventive developments on access to medicines. The major problems can be identified in the current use of the patent system to protect pharmaceutical innovation: reduction in innovation, high prices of medicines, lack of transparency in research and development costs, and proliferation of patents.

A study carried out by the journal Prescrire analysed the medicines that were introduced to the French market between 2006 and 2011, arriving at the conclusion that the number of molecules that produced significant therapeutic progress reduced drastically: 22 in 2006; 15, 10, 7, 4 in the following years up to 2011, which was a year in which Prescrire declared that only one medicine of significant therapeutic interest was brought to the market. Given that France is one of the largest pharmaceutical markets in the world, the reduction in innovation confirmed France is a good indicator of the global situation.

Oncologists from fifteen countries recently denounced the excessive prices of cancer treatments, which are necessary to save the lives of the patients, and urged that moral implications should prevail; according to them, of the 12 cancer treatments approved in 2012 by the United States Food and Drug Administration, 11 cost more than 100,000 dollars per patient per year.

Since the 1950s, there have been some references to the costs of Research and Development (R&D) for pharmaceutical products. According to some sources the average cost of research for a new pharmaceutical product these figures have increased from 1 million dollars in 1950 to 2.5 billion dollars for the development of a single product.

During the summer of 2014, a number of European countries, including France and Spain, spent many months negotiating with the company Gilead on the price of a new medicine for hepatitis C known as Solvaldi. The price fixed by Gilead was 56,000 Euros per patient for a twelve-week treatment, or 666 Euros per tablet. According the newspaper Le Monde the price of each tablet was 280 times more than the production cost. In France, it is calculated that 250,000 patients should receive this medicine, the cost of which would represent 7 per cent of the annual state medicine budget.

The application of patentability requirements for medicines, given their public health dimension, should be considered with even more care than in the case of regular merchandise or luxury items. The first and most important step is to use the freedom permitted by the TRIPs Agreement to define the patentability requirements: novelty, inventive step and industrial applicability (utility) in a way that keeps sight of public interest in the wide dissemination of knowledge.

(End)

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By Carlos M. Correa
GENEVA, Sep 29 2014 (IPS)

The steady increase in patent applications and grants that is taking place in developed and some developing countries (notably in China) is sometimes hailed as evidence of the strength of global innovation and of the role of the patent system in encouraging it. 

Carlos M. Correa

However, such an increase does not correspond to a genuine rise in innovation. It points instead to a major deviation of the patent system away from its intended objective: to reward those who contribute to technological progress by creating new and inventive products and processes.

The increase in the number of patents reflects, to a large extent, the low requirements of patentability applied by patent offices and courts. Patents granted despite the absence of a genuine invention detract knowledge from the public domain and can unduly restrain legitimate competition.

Low standards of patentability encourage a large number of applications that would not otherwise be made, leading to a world backlog estimated at over 10 million unexaminedpatents.

This problem affects various sectors. For instance, Nokia is reported to hold around 30,000 patents relating to mobile phones, a large part of which are likely to be invalid, while Samsung holds more than 31,000 patent families. A study covering various fields of clean energy technologies, including solar photovoltaic, geothermal, wind and carbon capture, found nearly 400,000 patent documents.“The steady increase in patent applications and grants … does not correspond to a genuine rise in innovation. It points instead to a major deviation of the patent system away from its intended objective: to reward those who contribute to technological progress by creating new and inventive products and processes”

The proliferation of patents is particularly high and problematic in the pharmaceutical sector, where large companies actively seek to acquire broad portfolios of patents in order to extend patent protection beyond the expiry of the original patents on new compounds. These ever-greening strategies allow them to keep generic producers out of the market and charge prices higher than those that would otherwise exist in a competitive scenario.

For example, the basic patent for paroxetine, an antidepressant, expired in the late 1990s, whereas ‘secondary’ patents will extend up to 2018.

Ever-greening strategies by one company often force others to follow the same pattern as a defensive approach.  The proliferation of ‘secondary’ or ‘spurious’ patents can impose significant costs on patients and public health systems.

Several measures can be applied at the national level to avoid the proliferation of patents on trivial developments in full consistency with the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), because they fall within the policy space that World Trade Organisation (WTO) members have retained to design and apply their patent laws.

The most important policy that governments may implement is the rigorous application of the requirements of patentability, based on a thorough examination of patent applications. The TRIPS agreement neither defines the concept of ‘invention’ nor how such requirements need to be interpreted.

Thus, national laws may differentiate inventions and discoveries, and require that the former result from an inventive activity, thereby excluding pre-existing subject matter that is merely found, such as natural substances.

While some patent offices grant patents on the basis of legal fictions on novelty, there is no reason to follow such practices in other jurisdictions.

An example of this practice by some patent offices is to admit what are known as ‘selection patents’, whereby one of more items that were previously disclosed are independently claimed. This type of patents provide an effective means of ever-greening, because protection can be extended for the full length of a new patent, i.e. normally twenty additional years, despite the fact that novelty was actually lost when such items were first disclosed.

While some large patent offices, such as the U.S. Patent and Trademark Office, the European Patent Office and the Chinese Patent Office, seem to apply a lax inventive step standard thereby allowing for the granting of a large number of ‘low quality’ patents, there are strong public interest arguments to follow a different approach, particularly in developing countries.

A strict application of the industrial applicability/usefulness requirement, when provided for by the national law, may also contribute to prevent the grant of unwarranted patent rights.

This is the case, in particular, for claims on new medical uses, which are equivalent to claims over methods of treatment that have no industrial application or technical effect. The lack of industrial applicability may be a sufficient ground to reject such claims.

Given the policy space left by the TRIPS agreement to adopt their own definitions of the patentability standards, and to do so consistently with their legal systems and practices, governments can follow different methods to ensure that patents are granted only when there are sufficient merits under the applicable law.

Governments may introduce specific standards in the patent laws themselves. A notable case is the Indian Patent Act, as amended in 2005, which incorporated in section 3(d) specific standards to assess patent applications in the field of chemicals and pharmaceuticals.

In a case brought by Novartis (a Swiss pharmaceutical company) against the rejection of its patent application relating to a beta crystalline form of imatinib mesylate, the Indian Supreme Court held that the claimed invention failed in both the tests of invention and patentability.

The definition of the standards of patentability can also be made through regulations, including patent offices’ guidelines. A good example is provided by the guidelines on the patentability of pharmaceutical products and processes adopted by the Argentine government in 2012 to limit the ever-greening of pharmaceutical patents.

Finally, it is worth noting that in applying patentability standards, patent offices can differentiate, in line with the TRIPS agreement, among fields of technology in order to take into account particular features of specific sectors and public policies objectives, for instance in relation to the promotion of generic drugs.

Measures to accommodate these differences constitute a necessary response to the diversity of technologies and, consequently, a condition sine qua non for an intrinsically balanced system of protection that remains neutral in its effects on competition. (END/IPS COLUMNIST SERVICE)

(Edited by Phil Harris)

This column is taken from the author’s research paper on ‘Tackling the Proliferation of Patents: How to Avoid Undue Limitations to Competition and the Public Domain’, published by the South Centre (http://www.southcentre.int/research-paper-52-august-2014/).

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Rose growers in Bangalore, India, rely on sustainable rainwater harvesting techniques. Credit: Keya Acharya/IPS

By Keya Acharya
Jul 18 2014 (IPS)

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Thérèse Izayi, a Congolese engineer, invented two very unusual traffic robots. This one is situated at an intersection on Triumphal boulevard, near parliament in Kinshasa, the Democratic Republic of Congo’s capital. Credit: Taylor Toeka Kakala/IPS

By Taylor Toeka Kakala
GOMA, DR Congo, Apr 30 2014 (IPS)

“There are several robots in the world, but that one which regulates traffic is made in Congo,” Thérèse Izayi, a female engineer and the Congolese inventor of two very unusual traffic signals, tells IPS.

Situated at an intersection on Triumphal Boulevard, near the Democratic Republic of Congo’s parliament in the capital, Kinshasa, the 2.5-metre traffic signal looks like an actual robot — with arms, legs, a chest and a head.

The breastplate pivots as the lights on it change from green to red. Then, it raises its arm to stop the traffic on one road, allowing vehicles from another to pass. The talking robot — it speaks both French and the local Lingala language — instructs: “Drivers, you can leave the road to pedestrians.”

It is made from aluminium to withstand high temperatures and humidity, and the heavy rains of this equatorial climate. There are cameras by its eyes and on its shoulders, which continuously film the traffic. It is also solar-powered to ensure its independence from electricity.

This robot is now a part of everyday life here and there is a second one on Lumumba Boulevard — en route to the international airport. Both are locally patented by Women Technology, an NGO that Izayi founded to give women engineers a platform.

“The robot captures images, which it sends using the antenna on his head to the [Women Technology] centre that stores the data. It is also equipped with an automatic detection system that tells it that pedestrians want to cross,” Izayi explains.

Izayi says that the recorded film could be sent to the traffic police, to allow authorities to prosecute drivers who have committed traffic offences.

Thérèse Izayi’s robot is situated at an intersection on Triumphal boulevard, near parliament in Kinshasa, the Democratic Republic of Congo’s capital. Credit: Taylor Toeka Kakala/IPS

Kinshasa is a city where traffic lights are almost non-existent and the Highway Code is constantly violated. The capital city, with a population of  10 million, is known for its chaotic traffic.

“The robot just solved the problem of corrupt policemen,” a taxi driver tells IPS.

Traffic police, who earn small salaries, are often accused of extorting money from divers. They allegedly do this by stopping cars in the middle of the road to demand bribes, which results in constant traffic jams.

“Traffic jams are often linked to police harassment more than traffic density,” Val Manga, president of the National Road Safety Commission, known by its French acronym, CNPR, tells IPS. The robots on Lumumba and Triumphal ensure quick stops and no policemen.

According to CNPR, there are around 400,000 vehicles on Kinshasa’s roads. But of the total number of vehicles in the country, only five percent are new.

Each month, around 40 people are killed in accidents in Kinshasa, and 90 percent of these accidents are attributed to drivers’ faults.

Izayi dreams of being able to sell more robots and create manufacturing jobs throughout the country. She hopes that she will be able to market her robot internationally but points out that she is restricted by the country’s lax enforcement of laws, corruption and a very slow administrative system.

Izayi has tried numerous times to convince the government to support her project and still has not had much luck.

Obtaining a patent is a difficult process here. The costs vary and it takes six to 12 months to get approval.

Zacharie Kambale is a local inventor who has not been able to register a patent for his idea because he does not have the money for bribes.

“I have to pay money informally to officials to get things done,” Kambale tells IPS.

In 2012, Kambale developed Kongo Connect, a social network that is based in Goma. It has been nicknamed the “African Facebook”, and Kambale says it has more than 100,000 users.  The site is currently down as Kambale adds more functions to it.

Congolese economist Batamba Balembu tells IPS that he estimates four out of five companies in DRC have had to “give gifts” to get a business licence. He says that 55 percent of government revenue is lost to corruption.

There is also no enforcement of legislation relating to copyright protection here, says Chrysostome Kwede, a patent lawyer in Kisangani in northeastern DRC.

According to the World Intellectual Property Organisation (WIPO), legislation concerning industrial property was enacted here in 1982. Four year later, laws were put in place with regard to literary and artistic works.

However, WIPO says while there is legislation “from 1982 to date [1982 for industrial property and 1986 for literary and artistic works], legislative action in the DRC concerning both areas has stopped.”

“The legal vacuum is the basis of corruption in the Ministry of Industry,” Kwede tells IPS.

But government spokesperson Lambert Mende has told the media “the government’s view is very positive. But the administrative procedures [to purchase the robots] are very heavy.”

However, Izayi says interest has been expressed by the governments of Angola and neighbouring Congo-Brazzaville.

“But I am not ready to provide them with prototypes like those in Kinshasa because it is expensive,” Izayi adds.

The robots are expensive — around 15,000 dollars  — and they cost about 2,000 dollars a month to maintain.

By Martin Khor
GENEVA, Mar 9 2014 (IPS)

If you or some family members or friends suffer from cancer, hepatitis, AIDS, asthma or other serious ailments, it’s worth your while to follow the negotiations on the Trans Pacific Partnership Agreement and other similar bilateral trade agreements.

It’s really a matter of life and death. For the TPPA can cut off the potential supply of cheaper generic medicines that can save lives, especially when the original branded products are priced so sky-high that very few can afford them.

Recently, a cancer specialist in New Zealand (one of the TPPA counties) warned that the TPPA would prolong the high cost of treating breast cancer because of new rules to protect biotechnology-based cancer drugs from competition from generics. And this will affect the lives of cancer patients.

Some cancer medicines can cost a patient over 100,000 dollars for a year’s treatment. But generic versions could be produced for a fraction, making it possible for patients to hope for a cure and a reprieve from death.

In India, local companies are leading the fight to make medicines more affordable to thousands of patients suffering from breast, kidney, liver and

gastrointestinal cancer and chronic leukemia.

For example, an Indian company produced a generic drug for kidney and liver cancer 30 times cheaper than the branded product (140 dollars versus 4,580 dollars for a month’s treatment) after it was given a compulsory license.

India has a law that disallows patents for a newer form of drugs or known substances unless it improves the medicine’s efficacy or effectiveness. Under the World Trade Organisation (WTO) rules, countries are free to set their own standards for novelty, or whether a product is novel enough to be eligible for a patent.

Also, in many countries, the patent law allows for companies to obtain compulsory licenses to import or make generic versions of original medicines. Governments grant such licenses if the branded products are too expensive and the original companies do not offer attractive terms for a voluntary license to other firms.

Multinational companies have strongly opposed compulsory licenses or the Indian-type laws that allow for patents only for genuine innovations.

This is where the TPPA comes in. Mainly at the insistence of the United States, countries are being asked to accept standards of intellectual property, that go beyond the rules of the WTO’s.

Especially noteworthy is the U.S. insistence that the TPPA countries agree to give a type of intellectual property known as “data exclusivity” for five years to companies producing original medicines.

This is extended to eight or 12 years for “biologics”, or medicines made with biotechnology. Many of the new medicines for treating cancers are biologics.

This will cause immense problems for patients waiting for cheaper medicines because “data exclusivity” prevents generic companies from relying on the safety and clinical trial data of the original company to get safety clearance for their generic products.

Thus, even if a generic company can prove that its medicine is bio-equivalent to the original medicine that has already passed the safety standard required by the health regulatory authorities, it will not be allowed to sell its medicine unless it comes up with its own safety and clinical trial data.

This goes against the current practice of generic medicines and safety standards. But the U.S. is insisting on this in the TPPA.

Few generic companies have the funds or technical ability to do their own clinical trials, and thus generic medicines could well be prevented from being used in TPPA countries for five to 12 years – even if the medicines are not patented.

That is the most significant aspect of the TPPA, and this is why so many groups of patients, health organisations and independent medical experts have been outraged and outspoken in their opposition to the agreement.

According to Jamie Love of Knowledge Ecology International, an expert on drugs and patents, the average cost of eight biologic cancer drugs registered with the U.S. drug authorities in 2011-2013 is 128,000 dollars (for a year’s treatment), with the most expensive being over 390,000 dollars. At such prices, hardly anyone in developing countries can afford these medicines.

In mid-February, eight prominent organisations including Medicins Sans Frontieres, Oxfam, Public Citizen, Health Gap and Knowledge Ecology International, issued a strong statement on their deep concern about the public health implications that the TPPA’s measures will have for millions of patients in need of access to affordable medicines around the whole Asia-Pacific region.

Said the groups: “The negotiations must take into account the health needs of all patients living in TPPA countries, and the U.S. must halt its efforts to limit countries’ freedom and flexibilities, otherwise the TPPA will jeopardize many, if not millions, of lives.”

Developments in India, which is not a TPPA country, show the patient-friendly policies that can emerge when public health concerns are given priority.

For instance, an Indian company is producing a generic version of the drug Gleevac, which is used to treat a chronic form of leukemia as well as gastrointestinal cancer, bringing the cost of treatment down from 70,000 dollars a year (in the U.S.) to 2,500 dollars a year in India.

This was possible because the Indian government denied the original company a patent on Gleevac because it was not judged to be novel enough, and an objection to that decision was rejected by the Indian Supreme Court.

Countries that join the TPPA will find it very difficult or impossible to undertake policies and practices similar to India’s, should the U.S. proposals in the intellectual property chapter be accepted.

Moreover, countries that don’t produce the generic drugs have the option to import them from India and other generics-producing countries. But if the TPPA imposes data exclusivity rules of the type desired by the U.S., it would be difficult to import and sell them.

Some countries are opposed to some of the U.S. proposals. The views and positions that defend public health must prevail, for after all, it is a matter of life and death.

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Patented drugs limit patients’ access to public health care. Credit: Kristin Palitza/IPS

By Brendon Bosworth
CAPE TOWN, South Africa, Dec 12 2013 (IPS)

Paul Anley, chief executive officer of Pharma Dynamics, one of South Africa’s leading generic drug companies, wants to sell a cheaper version of popular birth control pill Yasmin. But he legally cannot because German multinational Bayer has patent protection on the drug in South Africa, even though its initial patent expired in 2010.

Generic versions of the contraceptive are available in the United States and Europe, where Bayer’s patent has been revoked.

Anley says South Africa’s patent system makes it easy for multinational pharmaceutical companies to make minor changes to their products and get multiple patents, each spanning 20 years, and keep generics off the market.

“Multinational pharmaceutical companies undertake a process of what we call patent ‘evergreening,’” Anley told IPS. “They will literally flood the patent office with hundreds of patents for every single molecule or product they sell, and they do it over a protracted period.”

Pharma Dynamics lost a court case against Bayer over the validity of Bayer’s patent, which relates to the rate at which the drug’s active ingredient dissolves, in March 2013. It is barred from selling its generic and has filed an appeal against the decision.

“Bayer will continue to vigorously defend its patents,” Bayer’s medical director, Dr. Gené van den Ende, told IPS in an emailed response. Van den Ende did not comment on allegations of evergreening.

Since 2002, Bayer has filed for 11 different patents in South Africa for one of the active ingredients in Yasmin.

Plenty of patents?

In September, South Africa’s Department of Trade and Industry released a draft national policy on intellectual property that proposes changing South Africa’s patent system.

Anley and patent reform advocates like HIV advocacy group the Treatment Action Campaign and Médecins Sans Frontières hope the proposals will curb the number of patents granted and increase access to cheaper medicines.

“We grant far more patents than other countries, both developing and developed,” Catherine Tomlinson, a researcher with Treatment Action Campaign, told IPS. “A lot of what we’re providing patents on is not actually meeting patent standards to provide something new and innovative.”

In 2008, South Africa granted 2,442 pharmaceutical patents, according to research by Carlos Correa at the University of Buenos Aires’ South Centre. Brazil granted just 278 patents between 2003 and 2008.

Supporters of patent reform point to the price difference between originator drugs in South Africa and generics available in countries like India – which has been strict in denying patents for formulations of new medicines – as a consequence of South Africa’s patent laws.

The Treatment Action Campaign found that generic versions of popular cancer drugs are available in India for between four percent and 44 percent of the cost of originator versions in South Africa, based on a comparison of 2012 prices.

India has made also use of compulsory licencing. In cases where government feels the price of a drug is too high, it can grant licenses that allow generics manufacturers to produce versions of drugs under patent protection without consent of the patent owner. The World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement allows for compulsory licencing.

As a signatory to the WTO agreement, South Africa can grant compulsory licences but has not done so in the past.

The draft national policy recommends introducing the use of compulsory licenses. But whether or not these are granted in the future depends on the interpretation of the courts, patent attorney Madelein Kleyn, who is the intellectual property manager for Oro Agri and a research fellow at Stellenbosch University’s Anton Mostert Chair of Intellectual Property Law, told IPS.

Long road to reform

Government’s draft intellectual property policy recommends introducing a search and examination process to the South African patent office that involves having experts assess the novelty or original merit of an invention.

Currently, those applying for patents in South Africa need to fill out the application documents correctly and pay the required fees. If a company or individual wishes to challenge the validity of a patent after it’s granted, the challenge must be done through the courts.

Intellectual property lawyers note that government does not have the staff required to perform search and examination procedures.

“The patent office, as it stands, currently lacks skilled force to implement such a system,” said Kleyn. “Patent examiners are highly qualified people who specialize in the different areas of technology and require an in-depth understanding of the patentability requirements to assess a new filed invention against the prior art of the specific technical area.”

Outsourcing this work to international or regional offices, as suggested in the draft policy, would make sense, she said.

Since patents can be revoked through the courts, and intellectual property professionals advise patent applicants to amend their claims based on foreign patent cases, the system in South Africa allows for strong and tested patents despite the lack of a search and examination process, Kleyn explained.

She recommended focusing on educating judges who deal with patent cases to make the legal system work more effectively instead. This shift would also be cheaper.

If introduced, the search and examination procedure would take a long time to alter the patent landscape.

“The system will not eliminate the weak patents that will be on the register by the time the system is introduced in say (being kind) five years,” wrote former deputy president of South Africa’s Supreme Court of Appeal Louis Harms in his comments on the draft policy. “This means that weak patents will still be around for 25 years.”

Anley, of Pharma Dynamics, agreed that the proposed changes would take time to take effect.

“We’re very encouraged that government recognises the problems facing generic pharmaceutical companies and has addressed most of them in the draft,” he said. “Our concern would be that the process of capacity building is a very long and difficult process.”

The Supreme Court found naturally occurring segments of DNA "not patent eligible" on Thursday. Credit: Phil Roeder/CC by 2.0

By Carey L. Biron
WASHINGTON, Jun 13 2013 (IPS)

The nine judges of the U.S. Supreme Court ruled unanimously Thursday that naturally occurring DNA, including component parts of that genetic material, cannot be patented.

The decision overturns three decades of practise to the contrary by the U.S. Patent and Trademark Office.

Health and civil liberties groups are celebrating the unusual unanimous ruling, as are consumer protection advocates.

Although the case dealt specifically with questions regarding the “isolating” of genes within the human genome, the judges did not limit their decision to human genetics, meaning the case will have an effect throughout the biotechnology industry.

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote in the court’s final opinion.

He noted that U.S. patent legislation “permits patents to be issued to ‘[w]hoever invents or discovers any new and useful…composition of matter,’ but ‘laws of nature, natural phenomena, and abstract ideas’ ‘are basic tools of scientific and technological work’ that lie beyond the domain of patent protection”.

The court did, however, leave open the possibility of patenting synthetic or “complementary” DNA, artificial copies of DNA that are either separated or constructed in a lab and allowed to evolve on their own.

The biotech industry has long argued that stringent patent protection is needed for companies to feel comfortable spending the significant capital required to fund related research and development.

Others have suggested that allowing such patenting actually quashes innovation by limiting competition, while also pointing to the significant federal money that is often available for such research."A product of nature cannot be patented."
-- Sandra Park

Still, the ruling will likely affect and potentially void thousands of patents on “isolated” genetic material taken out over the past decade or more, though experts say the legal process will now be required to move through each patent on a case-by-case basis. Isolated DNA is genetic material excised from chromosomes but not otherwise altered.

According to current estimates, about 40 percent of the human genome is currently covered in some way by patents.

Product of nature

“The court’s decision today represents a straightforward application of the ‘product of nature’ doctrine, which holds that a product of nature cannot be patented,” Sandra Park, a senior staff attorney with the American Civil Liberties Union (ACLU), a watchdog group, told reporters after the ruling.

“Maybe a product required great ingenuity to discover, but a product of nature needs to remain as part of the storehouse of knowledge.…This is a simple question but with profound consequences, and from our perspective this ruling is a victory.”

The ACLU has been involved in this case since 2009, when it helped bring a lawsuit on behalf of plaintiffs suffering from breast cancer who found themselves at the mercy of a U.S. company that had patented two genes linked to breast and ovarian cancer. Researchers working for that company, Myriad Genetics, isolated those genes and then developed tests for mutations based on the research.

“These patents here tied up all uses of those particular genes, so if you found a better way to do this testing, you couldn’t do it,” Jaydee Hanson, a policy analyst at the Centre for Food Safety, a Washington advocacy group, told IPS.

“In that way, this is a revolutionary change, and makes clear that the U.S. Patent Office has not understood what the Constitution says as relating to the patenting of naturally occurring things. This is very important, and we will be working hard to disallow Congress from trying to pass any new law suggesting that you can indeed patent DNA.”

In the initial lawsuits, plaintiffs argued that Myriad was able to charge exorbitant prices for the tests and that its patents disallowed competing labs from working with those genes in any way.

“Genes are not being held hostage by private corporations any longer,” Lisbeth Ceriani, a breast cancer survivor and original plaintiff in the case, told reporters Thursday.

“If you’ve been adopted or don’t know your medical history – say, if your parents are from other countries – up until today Myriad had been able to design the criteria for who should take their test, as opposed to doctor or patients. So I’m incredibly relieved, as something that’s been going wrong for more than a decade has finally been corrected.”

Moral obviousness

Medical experts are suggesting that the court’s decision will now have an immediate impact on public health, given that Myriad’s methods – and similar research based on isolated DNA – will be able to be put into broad clinical practice and subjected to further study.

Yet the implications of the ruling will almost certainly be felt beyond the confines of human health.

“Part of the significance of this ruling is that the judges did not specify that the decision applies only to human DNA, so this will now cover the whole range of DNA,” the Centre for Food Safety’s Hanson says.

“Many of the patents out there today are of other mammals, animals, plants and microorganisms. In fact, we’ve recently seen some decline in the number of human patents being issued, but large numbers of other patents are still being issued.”

He also notes that the decision has brought the United States somewhat more in line with legal precedent on this issue elsewhere, particularly in Europe.

“European patent law has set morality as a standard, so some countries have made restrictions on what is patentable gene sequence because it might be immoral to exclude people from being able to engage in certain testing or research,” he says. “In effect, the court has come down on the side of both the U.S. Constitution and moral obviousness.”

Still, those on the losing side of Thursday’s decision are suggesting that they are relieved the ruling did not go farther.

“I’m not fully happy with opinion, but it could have been much worse,” Greg Dolin, a co-director at the University of Baltimore School of Law’s Center for Medicine and Law who formally supported Myriad Genetics in the case, said in a press conference hosted by the Federalist Society, an association of right-wing attorneys.

“Luckily, the court did not undercut the biotechnology industry,” Dolin said. “It took a cautious step, but ultimately didn’t do too much damage – though that remains to be seen, in how the decision is applied to future cases.”

By Gustavo Capdevila
GENEVA, Apr 5 2013 (IPS)

India’s refusal to grant patent protection for the anti-cancer drug Glivec, developed by Swiss drugmaker Novartis, is a victory for the developing world, which depends on low-cost exports of generic medicines from the Asian giant, said public health specialist Germán Velásquez.

The triumph celebrated by the Colombian expert, who is a special adviser for health and development at the South Centre, was a landmark ruling against Novartis handed down Monday Apr. 1 by India’s Supreme Court.

The Geneva-based South Centre is an intergovernmental organisation of more than 50 developing countries that functions as an independent policy think tank.

Velásquez, who worked for over 20 years in the World Health Organization, explains in this interview with IPS his point of view on the legal battle in the courts in New Delhi and its consequences for developing countries.

Q: How do you interpret the ruling by the Supreme Court of India?

A: There are problems with the information that is being reported. Nearly everyone says that India rejected the patent for Glivec. That’s true, but it’s not all the verdict says.

Q: Could you explain?

A: At the heart of the verdict is the ratification of the criteria set by the Indian law for the approval of drug patents. That is, whether or not it meets the requisite of containing a genuine innovation.

Q: Could you describe the legal battle?

A: It all starts with the adoption of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), one of the treaties established at the same time the WHO was born, in 1995.

India was the only developing country to use the (entire 10-year) transition period to enforce TRIPS, in 2005, when it passed the patent act.

Q: What happened to the patent applications presented during that decade-long transition?

A: They accumulated, until there were around 10,000 applications, and it was not until 2005 that the patent office began to examine them. They included the application for the Glivec patent.

But the new standards turned out to be stricter, such as the one that indicates that the innovation can’t be just a small change to a molecule, but has to be something substantial. In short, the patent for local sales of Glivec was denied in 2006.

Q: How does the story continue from there?

A: Novartis challenged that decision and brought a lawsuit in a court in the city of Madras (the capital of the southern state of Tamil Nadu; the city was renamed Chennai in 1996.) But the High Court of that city, three years later, also rejected the application. That year, 2009, the company appealed the decision – and lost again.

Q: What options are left to the company?

A: This is the aspect that hasn’t been sufficiently reported. In a cynical, perverse and very serious move, Novartis says (prior to the ruling): “If they didn’t give me the patent, I’ll go to the Supreme Court, but to ask this time for the elimination of the strict criterion established in article 3 of the patent act.”

“If more flexible, lower standards are set, then my medicine will be in,” was its reasoning.

Q: So the dispute took on this other face?

A: Yes, because with the intention of introducing its drug by force, the transnational corporation was trying to modify the law of a country – and of a country like India. I think that its executives were being short-sighted when they made that decision. This has been very costly for them in terms of their image.

Q: How do you reach that conclusion?

A: It is clear that it was a misstep to denounce India’s patent law, with the risk of losing. The transnational industry in general had suffered a blunder in South Africa, when it was forced in 2001 to back down from legal action against a law that authorised the patenting of lower-price imported medicines in order to address the AIDS epidemic.

You could suppose that “Big Pharma”, as the major pharmaceutical companies are called, had learned the lesson. Especially knowing that Glivec was patented in 40 countries, including the United States, China and Russia.

Q: Are you insinuating that there may be a domino effect?

A: If Novartis loses in India, as it did on Monday, any of the governments of the 40 countries could ask themselves: “Why don’t I review that patent and revoke it?” That authority is granted by the legislation of all of those countries.

Q: What standing do those 40 countries that recognise the Glivec patent have?

A: Most of them are industrialised states, large markets. But they also include some that are currently experiencing severe economic difficulties, like Greece or Spain, whose authorities could ask themselves why they should pay 2,500 dollars a month per person for a treatment against cancer. They could say: “Why don’t I just have it produced as a generic drug, and invalidate this patent.”

I think the Novartis executives did not take that into account when they launched this legal battle. Obviously, after the first impetus, they continued on to the end, and today they’re going to see repercussions.

Q: What could those consequences be?

A: It should be a lesson for the rest of the countries of the developing South. They should try to follow India’s example and introduce in their legislation clauses like the ones contained in article 3d, which restricts and sets criteria with respect to what amounts to innovation, which is necessary in order to grant a patent. That there can’t just be a small change, which is sometimes merely cosmetic, to a molecule in the medication.

Q: What prospect is there for the spread of that criterion?

A: In India, the Philippines and Argentina, that prohibition already exists, while others are introducing it through alternative routes.

Q: And other consequences?

A: India will be able to continue to make generic versions of all new medicines that are not truly original, and it will continue exporting them without any problem. It’s necessary to take into account the fact that 95 percent of the antiretrovirals consumed in Africa come from that Asian country.

So that means the Indian Court’s ruling is extremely important, with very concrete repercussions for that medicine and some 10,000 others that are on the waiting list in the patent office in New Delhi.

Q: What percentage of those could get patents?

A: In 2010, Argentina approved 2,000 pharmaceutical patents, and China 4,000. But actually, just 40 or 50 products a year are true innovations.

Q: Why that enormous difference between patents that are granted and truly innovative products?

A: The pharmaceutical industry is facing huge difficulties in coming up with innovations.

So it clings to a very short-sighted way of thinking, very short-term, but enormously profitable. This consists of launching incremental innovations, as they are called – in other words, a small product with just a gradual change, but accompanied by a major marketing campaign.

Excerpt:

India’s highest court has dismissed Swiss drug maker Novartis AG’s petition seeking patent protection for a cancer drug, a serious blow to Western pharmaceutical firms which are increasingly focusing on India to drive sales.

In a landmark judgement, the Supreme Court said on Monday that the drug Glivec failed to qualify for a patent according to Indian law.

Since 2006, Novartis has been challenging the Indian government to give protection against Indian companies copying its drugs.

But the court ruled that the drug for which Novartis was seeking a patent “did not satisfy the test of novelty or inventiveness” required by Indian law.

In 2009 the company took its challenge against a law that bans patents on newer but not radically different forms of known drugs to the Supreme Court.

Al Jazeera’s Sohail Rahman, reporting from New Delhi, said the ruling is a “huge disappointment” for Novartis, as it allows Indian companies to continue producing cheaper generic medicine for domestic and international consumers.

Rahman said the ruling could raise questions about India breaking rules set by the World Trade Organization.

The case is the most high-profile of several patent battles being waged in India and could have far-reaching implications in defining the extent of patent protection for multinational drug firms operating in the lucrative market.

‘Dangerous precedent’

The Swiss firm threatened to halt supplies of new medicines to India if the court did not rule in its favour, London’s Financial Times reported on Sunday.

“If the situation stays as now, all improvements on an original compound are not protectable and such drugs would probably not be rolled out in India,” said executive Paul Herrling, who is leading the company’s handling of the case.

But Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), said a legal victory for Novartis could “set a dangerous precedent, severely weakening India’s legal norms against evergreening” – the name given to the industry practice of seeking new patents after making small modifications to existing drugs.

It would “be dire for people in the developing world who depend on generic drugs made in this country. It could seriously curb access.”

Generic drug firms in India – long known as the “pharmacy to the developing world” – have been a major supplier of copycat medicines to treat diseases such as cancer, TB and AIDS for those who cannot afford expensive branded versions.

The cost difference between generic and branded drugs is crucial for poor people around the world, MSF says.

It points out that Glivec – often hailed as a “silver bullet” for its breakthrough in treating a deadly form of leukaemia – costs 4,000 dollars a month in its branded form while its generic version is available in India for around 73 dollars.

In the case of Glivec, Al Jazeera’s Rahman also said that most of the consumers in India could not even afford the drug given the average wage is only 120 dollars.

But Novartis and other global drug makers say India’s generics industry inhibits pharmaceutical innovation and reduces commercial incentives to produce cutting-edge medicines.

* Published under an agreement with Al Jazeera.

Having met 97 percent of domestic demand for generic drugs, Bangladesh is poised to become a major exporter. Credit: Naimul Haq/IPS

By Naimul Haq
DHAKA, Nov 18 2012 (IPS)

Bangladesh has begun to shed its image as one of the world’s poorest nations and make a reputation for itself as a major exporter of cheap generic drugs to over 85 countries.

Listed by the United Nations as one of the least developed countries (LDCs), Bangladesh has exported drugs worth roughly 50 million dollars since 2011.

While this is admittedly just a fraction of the 170-billion-dollar global generic drug market, recent trends indicate that this South Asian country, home to over 150 million people, is poised to capture a larger slice of the market if it plays its cards right.

Competition for production of quality generics began in 1982, when the Drug Control Ordinance encouraged expansion in domestic production.

Following the exit of major multinational producers, local companies rushed to establish internationally recognised good manufacturing practices (GMP) and local investors were encouraged to join the flourishing market.

Local manufacturing giants like Square, Incepta Pharmaceuticals, Beximco and a host of others emerged within a very short period of time.

Abdul Muktadir, secretary general of the Bangladesh Association of Pharmaceutical Industries (BAPI), and managing director of Incepta Pharmaceuticals, the second largest drug manufacturer in the country, told IPS, “The drug industry grew at a steady pace and now Bangladeshi drugs are exported to many Asian, African and South American nations. The reason for this global expansion is quality, which has also (enabled) us to enter the European market. Soon we may get approval to export into the United States.”

“Our (share) of exports is still far too small, but growth patterns suggest we will soon overtake other major export sectors” such as garments, jute and tea, according to BAPI Vice President  Momenul Haq.

Cheaper prices also make drugs produced here an attractive product, he told IPS.

Out of a total of about 200 active local drug manufacturers, the top twenty companies have been exporting the lion’s share of drugs – about 85 percent – since the middle of the 1990s.

The boom in exports did not, however, accelerate until 2005 when the country’s original 1982 drug policy was revised.

The new programme, recognising that the industry already answered 97 percent of local demand, gave top priority to exports, which resulted in a decade of sharp growth.

In 2001 only a handful of generic drugs, with sales amounting to 3.7 million dollars, were exported to just 17 neighbouring countries; today more than 300 generics are exported to 87 countries, with sales topping 50.4 million dollars in 2011.

According to the Exports Promotion Bureau, some of the major beneficiaries in 2011 were manufacturers like Novartis Bangladesh, which exported drugs worth 10.8 million dollars; Beximco, whose sales receipts amounted to 9.6 million dollars and Square, which sold 7.8 million dollars worth of medicines abroad.

Haq, who is also the owner of General Pharmaceuticals, said, “Slow registration processes in destination countries, especially in moderately regulated markets (such as South Korea, Italy, Germany, Belgium, Spain and Singapore) make exporting difficult. But amid all these strict regulations Bangladesh has emerged as a successful drug exporter and it is still expanding.”

Out of about 1,800 generics or molecules manufactured in the country some 300 varieties are now exported, mostly antibiotics, analgesics, contraceptives, stimulants, vitamins, dietary supplements and non-conventional herbal and Ayurvedic medicines. Destination countries for these drugs include Saudi Arabia, Yemen, Kenya, Malaysia, Bhutan, Azerbaijan, Honduras and Mexico, among many others.

Strict tax codes ensure that a significant portion of these profits circle back into the local economy, which could boost Bangladesh’s efforts to graduate from LDC to middle-income economy status.

Already foreign loan dependency has fallen from 85 percent in the early 1980s to about two percent in 2012.

Per capital income has increased from less than 400 dollars in 2001 to 650 dollars in 2010.

A thriving export market could boost growth even further, experts say.

The domestic drug consumption market was worth 958.8 million dollars in 2010 and is expected to rise by at least ten percent every year, due largely to the expansion of quality healthcare services and increasing purchasing capacity.

Patents loom as threat to production

But the road ahead is not without its share of obstacles.

Zafrullah Chowdhury, widely acknowledged as the leading expert on pharmaceutical policy in Bangladesh and a key player in formulating the 1982 Drug Ordinance, told IPS, “It is time we started making raw or active ingredients, because after World Trade Organisation (WTO) patent exemptions expire in 2016” Bangladesh may not be able to produce generic medicines as easily as it does now.

According to the WTO’s agreement on the trade-related aspects of intellectual property rights (TRIPS), Bangladesh, along with other LDCs, is excused from patent regulations until 2016. However, when they kick in four years from now, patent requirements could deal a fatal blow to the industry.

“In January 2016, Bangladesh’s pharmaceutical market will face difficulties, particularly with under-patent drugs (new drugs invented after 1996),” Sayedur Rahman, professor of pharmacology at the country’s renowned Sheikh Mujib Medical University (BSMMU) in Dhaka, told IPS.

“At this moment, we have about 150 drugs of this category, the prices of which might increase as a consequence of royalties (demanded by) patent holders.”

“Initially, those patent holders may not claim royalty, but after some time they will definitely enter our market to sell their products, employ distributors or claim royalty from the local manufacturers.

“Failure to negotiate with patent holders may lead to removal of the drug from the market as well as delayed entry of new drugs,” he added.

“(TRIPS regulations) will not affect ‘out of patent’ or older drugs (drugs innovated 20 years ago), which can be sold at the same price even after 2016. Ninety percent of our patients can be treated optimally with these old drugs, though this will require some rationalisation of the present prescribing trend,” Rahman added.

However, the expiration of patent exemptions in 2016 could also be a moment for Bangladesh enter a gap in the international market that was hitherto filled by cheap drugs produced in India.

According to BAPI’s Muktadhir, “The global generic market is finding new growth pathways as more and more products face patent expiry. (A vast majority of countries) are now dependent on the supply of Indian generic drugs and they are seriously looking for an alternative source with a similar industry standard.

“BAPI is trying to develop the (local) industry to meet this gap in the international market,” he said.

Nasser Shahrear Zahedee, owner of Radiant Pharmaceuticals, described Bangladesh’s current export scenario as a “warm-up phase”.

“Unless we can embrace competition (that produces) quality drugs,” he said, “we will not be able to enter highly regulated markets, which should be our ultimate target.”

(END)

Protesters at the "We Can End AIDS Rally" Hold Up Pill Bottles. Credit: Amanda Wilson/IPS

By Amanda Wilson
WASHINGTON, Jul 26 2012 (IPS)

As the nineteenth International AIDS Conference continued in Washington Tuesday, thousands of protesters marched on the White House with a set of demands to end the epidemic.

At the forefront were calls for an end to free trade deals that protesters argue make vital AIDS medicines unaffordable.

The march comprised a coalition of AIDS advocacy and activist groups organised under the mantra “We Can End AIDS”, and ended with a dramatic display when activists gathered symbols of the fight against AIDS – pill bottles and money – tied them with red ribbons, and threw them in front of the White House.

A growing movement within the international advocacy community and those living with HIV/AIDS argue that free trade deals such as the Trans Pacific Partnership (TPP) – a deal the Barack Obama administration has been negotiating with 10 Pacific nations over the past three years –contain excessively stringent protections for pharmaceutical patents on AIDS drugs.

Lorena Di Giano of the Argentinian Network of Women living with HIV spoke at the rally, saying such free trade agreements “would make access to affordable drugs even more difficult”.

Medicine works, but who owns it?

Anti-retroviral (ARV) medicines are known to reduce the transmission of HIV, yet only one out of every two HIV-positive people are on ARVs worldwide. The number is lower for children, and still lower for people in the developing world. But, protesters say, patent protections do not help get more drugs to more patients, a step they say could dramatically halt the epidemic.

They say patents on drugs imported to developing or middle-income countries could block generic manufacturing, resulting in monopolies and higher prices for vital medications.

This trend, advocates say, will exclude and marginalise HIV-positive patients who do not fit within a narrow market of elite or middle-class consumers in middle-income countries who are increasingly targeted for drug sales.

That could mean bad news for patients in fast-growing, middle-income countries such as India and Brazil, where pharmaceutical companies have launched lawsuits against governments in order to enforce patents and block other manufacturers from producing their drugs.

Protesters say the situation is clear: pharmaceutical companies are suing governments for rights to exercise exclusive IP rights on effective new AIDS drugs, making clinical trials data secret, even as they target expensive new drugs to elites and a growing middle class while leaving the marginalised to fend for themselves, or even die.

Currently, certain free trade deals have some flexibility for countries that prefer not to enforce patents on pharmaceuticals. Under the World Bank’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), those exceptions expire in 2016. Protesters are arguing for their extension.

Brook Baker, a policy analyst and advocate on IP and access to medications with the U.S.-based AIDS advocacy organisation Health GAP, spoke at a panel session of the International AIDS Conference on Tuesday. He said a dramatic fall in prices for some drugs had lulled people into a false sense of security.

“We face a future in which IP protection in the form of data monopolies and patent monopolies stand in our way,” Baker said. “All new drugs are being created under much stricter IP regimes, and they can be two to three or even 10 times more expensive (than generics).”

Baker urged governments to accept recommendations related to IP in a July report issued by the Global Commission on HIV and The Law, an independent high-level legal commission made up of former heads of state and leading legal, human rights and HIV experts.

In its annual report, the commission this year recommended a moratorium on TRIPS patent enforcement on pharmaceutical products. “The HIV epidemic has exposed the serious problems of applying TRIPS to medicines and other pharmaceutical products,” the report notes. “This has implications well beyond HIV, for example, for non-communicable diseases which affect millions in high-, middle- and low-income countries.”

Baker said the need to address the link between patent law, pricing, and access was especially urgent in middle-income countries such as China, India, Brazil, and South Africa, which have 25 percent, or eight million, of all HIV-positive people.

“They (pharmaceutical companies) are interested in selling to the elites and a growing middle class,” Baker said. “If you get a right to exclude competition and you price your medications for the elite,” people are going to be marginalised, he said.

Tahir Amin, an international IP scholar, emphasised that, through a process called “evergreening”, many new patents on drugs are simply patents on slight changes in compounds being passed off as brand new drugs. “It shocks me to think that this is innovation,” he said.

Sarah Zaidi of the International Treatment Preparedness Coalition (ITPC), based in Thailand, pointed out that the number of free trade agreements had increased from eight in 2001 to 72 in 2012. She said strong IP clauses show the strength of the pharmaceutical patent holders.

“It’s really criminal when you know the evidence around treatment and prevention and the one thing that is keeping you from accessing these drugs are patents,” Zaidi told IPS. “It’s a tragedy.”