Tag: drug patents

Countries Are Adapting Intellectual Property Laws to Prioritise Health During COVID-19

A number of flexibilities available under the TRIPS Agreement can be applied by governments to ensure that IP rights do not constrain innovation and availability of health technologies required for responding to COVID-19.

COVID-19 response is critically dependent on rapid and mass-scale innovation, and the supply of products necessary for the prevention, diagnosis and treatment of the disease. In particular, strengthening local production of medicines and vaccines is urgently required in developing countries. With the rising incidence of COVID-19 infections, developing countries will require these products in substantially large volumes, overcoming challenges of limited local manufacturing capacity and heavy import dependence.

Intellectual property (IP) rights can potentially impede mass production of existing health products, as well as innovation and research and development of new products. IP rights can be exercised by their owners to grant or withhold from licensing the technology required for manufacturing or further developing a product. If a license is denied, the technology will not be available for other firms to manufacture or supply.

Usually, a bundle of several IP rights can exist around a particular technology. It is very common patenting strategy in the pharmaceutical industry to take separate patents on the main compound of a drug and a large number of secondary patents on different formulations and combinations, dosage, as well as other possible therapeutic use of a drug. This can make it difficult for follow on innovators to invent around the thicket of IP rights.

There have been instances where transfer of technical designs or knowhow have been denied to third parties to manufacture products required to respond to COVID-19. Italian volunteers desiring to manufacture ventilator valves through 3D printing technology were denied access to the designs of some components, forcing them to engage in reverse-engineering. In the United States (US), the governor of the state of Kentucky admitted to difficulties in procurement and manufacturing N-95 masks owing to several patents.

Patents on critical enzymes may also restrict the development of testing kits. Trade secrets may restrict access to health technologies required to respond to COVID-19. For example, the multinational pharmaceutical company Roche initially refused to share with Dutch companies the secret formula for producing a buffer solution that is required for use in RC-PCR tests for COVID-19.

Through a resolution of the World Health Assembly on COVID-19, member states of the WHO have recognised the possible need for countries to adopt measures to ensure that IP rights do not constrain global equitable access to health technologies for COVID-19 through the full use of the flexibilities of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as well as voluntary pooling of patented technologies, data and know-how.

TRIPS agreement and its flexibilities

National laws of all countries that are members of the WTO must comply with standards of IP protection and enforcement established by the WTO TRIPS Agreement. The TRIPS Agreement requires WTO members to grant patent protection for pharmaceutical products for a minimum term of 20 years. This has impacted the ability of countries to develop a robust local pharmaceutical industry.

India had to amend its patent law to effectively enable foreign pharmaceutical companies to obtain patent protection for medicines. Thus, Indian generic companies have to obtain a license from the patent holder to produce and supply remdesivir for use in COVID-19 treatment. Only five Indian companies have been granted a license by the patent holding company – Gilead – to produce remdesivir. In the absence of patent protection, a larger number of Indian companies could produce the drug to ensure sufficient availability of the same at affordable price.

A number of flexibilities available under the TRIPS Agreement can be applied by governments to ensure that IP rights do not constrain innovation and availability of health technologies required for responding to COVID-19. Till date, the national measures that have been adopted by different countries largely focus on measures enabling ministries of health to grant compulsory licenses or government use authorisations with some countries also offering indemnity against IP infringement proceedings and use of competition law. Below are some examples of national measures taken by some countries.

National measures taken by countries

Enabling laws to facilitate grant of compulsory licenses 

Canada

Canada enacted the COVID-19 Emergency Response Act, which allows the government to issue a compulsory license without first negotiating with the rights holder, or establishing its own ability to supply a product, and the patent holder is only entitled to receive an amount as remuneration instead of a compensation. While the Commissioner of Patents has the discretion generally under the Canadian patent law to grant a government use authorisation on the application of the government, the Emergency Response Act has removed this discretion and mandates the Commissioner of Patents to grant such authorisation upon the application of the Ministry of Health.

Chile

The parliament of Chile adopted Resolution No. 896 declaring that the global coronavirus outbreak justifies the use of compulsory licensing to facilitate access to vaccines, drugs, diagnostics, devices, supplies, and other technologies useful for the surveillance, prevention, detection, diagnosis and treatment of the coronavirus in Chile.

 Germany

Germany adopted the Prevention and Control of Infectious Diseases in Humans Act, which authorised the Ministry of Health to issue government use authorisation under the patent law, upon the declaration of a national epidemic by the lower chamber of the German federal legislature (Bundestag). Such authorisation by the ministry was made applicable to medical products including active ingredients, starting materials and excipients for medicines, medical devices, laboratory diagnostics, aids, items of personal protective equipment and products for disinfection.

Also read: How the COVID-19 Pandemic Is Rekindling the Debate Around ‘Access to Content’

Israel

Israel issued a government use authorisation under the Israeli patent law for the importation of generic lopinavir/ritonavir combination for the treatment of COVID-19 patients from an Indian generic company by a local company acting on behalf of the health ministry.

It is noteworthy from these instances that only two developed countries (Canada and Germany) very rapidly adopted legal measures to enable the government to issue compulsory licenses for government use for COVID-19, by making use of the provisions relating to the grant of compulsory licenses under their existing patent laws. Developing countries like India can review the provisions relating to the grant of compulsory licenses in their patent laws and assess whether similar enabling legislation would be required to explicitly guarantee the freedom of the government to grant compulsory licenses for COVID-19 related technologies.

Indemnity against infringement claims

Another approach that countries can take is to suspend the enforcement of IP rights for COVID-19 related technologies and grant indemnity against enforcement actions and infringement lawsuits. It has been argued by some that the recent notice of declaration published by the US Department of Health and Human Services under the Public Readiness & Emergency Preparedness (PREP) Act, conferring immunity from tort litigation for those engaging in acts related to COVID-19 countermeasures, also grants indemnity against patent infringement liability for third parties that use health technologies in relation to COVID-19. Though this interpretation has not been tested out in a court of law, this suggests that countries can adopt specific legislation suspending the enforcement of IP rights. 

Use of competition law

It is also possible for countries to use measures for anti-competitive use of IP protected technologies in relation to COVID-19. For instance, recently the European Commission (EC) launched a preliminary investigation on the abuse of the dominant position in the Dutch market by the pharmaceutical company Roche, on account of its refusal to share the secret formula for producing a buffer solution that is necessary for use in COVID-19 testing kits.

The EC has also stated that during the pandemic it will continue to closely and actively monitor relevant market developments to detect instances of undertakings taking advantage of the current situation to breach European Union (EU) competition law, either by engaging in anti-competitive agreements or abusing their dominant position. It is possible for developing countries to also use competition law to prevent anti-competitive behaviour by IP right holders over products that are critical for COVID-19, both for the development of the local industry for such products as well as to protect the interests of patients and healthcare workers. 

Exercise of absolute sovereign powers

France has enacted a new law No. 2020-290 which introduced a new article – L.3131-15 – to the French public health code, allowing the prime minister to order the seizure of all goods and services necessary to fight against sanitary disaster, to temporarily control the prices of products, and to take any measures necessary to make relevant medicines available to patients. IP-related measures, including revocation of patents and grant of compulsory licenses could also fall within the scope of measures that can be adopted by the government under this law.

Also read: Can a US-India Trade Deal Permanently Alter the Way Indians Access Medicines?

Other possible measures

In accordance with the TRIPS Agreement, a number of other IP-related measures can be taken by countries. Under Article 73(b) of the TRIPS Agreement, a country can take any action which it considers necessary for protection of its essential security interests, taken in the time of war or other emergency in international relations. Thus, in furtherance of its health security interests, a country can take measures such as suspending the grant of patent protection, and grant indemnity against enforcement actions. In accordance with article 6 of the TRIPS Agreement, a country can also undertake parallel importation of needed products, including from countries where they are produced under compulsory licenses.

What developing countries must do

With the rising incidence of COVID-19 infections in developing countries, it may be necessary for them to look at the IP rights applicable in their territories in relation to those products and technologies, and consider the legal measures that could be taken, where necessary, to ensure timely and affordable access for the population. To that end, a number of measures can be adopted by developing countries consistently with the TRIPS Agreement, by effectively implementing existing laws and regulations, amend them or adopt new enabling laws.

It is time for developing countries to review the extent to which such measures can be adopted, or what changes, if any, need to be introduced into their legal regimes so as to be able to act effectively and timely to address the devastating effects of the COVID-19 pandemic. Developing countries can avail technical assistance services to explore possible measures that could be taken in response to COVID-19 to ensure access to the required health products, in accordance with the legal obligations and flexibilities under the TRIPS Agreement.

Nirmalya Syam is Senior Programme Officer at the South Centre. The South Centre is  an intergovernmental organization of developing countries based in Geneva supporting their efforts to promote their common interests in the international arena,, including on adapting  their intellectual property  to support production and procurement of affordable and quality medicines so as to increase their in-country availability in the public and private sector. This article is based on a Policy Brief published by the South Centre.

TB Survivors Disrupt Global Conference, Demand That Drugs Be Made Cheaper

Companies owned by people in the Global North control the science and business of TB, making medication unaffordable for poor people in developing countries.

Hyderabad: “F*@#ing killing me! Don’t kill me! This is my life. I don’t want to die…We want medicines. We are dying here. God save us…F*@#ing patents.F*@#ing monopolies. This is my life…”

That was Ganesh Acharya, shouting in front of a global audience of scientists, doctors and others in the public health sector, demanding that tuberculosis drugs be made cheaper and accessible to people like him in the developing world.

Acharya knows about this the hard way: he has survived TB twice and has committed his life to working for TB and HIV patients in India.

Acharya was shouting himself hoarse along with a number of TB survivors and health activists who had come to the renowned World Conference on Lung Health organised by The Union in Hyderabad last week.

TB survivors used the opportunity to repeatedly confront the global audience about the unaffordability of TB drugs, especially by people in the developing world where the disease hits the hardest. India tops the world with 2.69 million TB patients, 27% of the world’s TB burden.

After the protest by Acharya and other TB survivors, Sambuddha Ghosh, an Otsuka Pharmaceutical scientist, took the mic to respond to them: “We do acknowledge that the price is high but we are working on it.”

Also read: New TB Vaccine Gets More Efficient; Another $30 Million Allotted for Research

Otsuka makes the life-saving TB drug Delamanid, which the company is selling for a minimum price of $1,700 (Rs 1,19,887) for one course. Delamanid is often taken along with other drugs like Bedaquiline, which is being sold for $400 (Rs 28,208) per course.

TB survivors and activists were not impressed by Ghosh’s muted response and continued their protest: “Otsuka! Drop the price! Delamanid ke patents se azaadi (Freedom from the patents on Delamanid)!” they shouted, as they held up posters, distributed flyers to the audience and then left the hall.

TB’s disproportionate burden on the developing world 

TB survivors also disrupted a session where a top executive from Cepheid was present. Cepheid makes the important diagnostic tool called GeneXpert and there was due to be a discussion on how important their product is while diagnosing TB.

TB survivors stormed this session and shouted slogans saying that GeneXpert’s technology was developed primarily with public tax money from the US and UK. Apart from the fact that the machine itself is expensive, the cartridges that need to be refilled in it are also adding to the cost of using this technology.

Survivors shouted, “What time is it? It’s time for five!”

According to calculations made by TB survivors and activists from Médecins Sans Frontières and Treatment Action Group, cartridges should be priced at $5 in order to make it viable for the company but also affordable for TB patients. Nearly 12 million cartridges have apparently been sold in 2018, just in the public sector.

Also read: Health Care Is an Essential Human Right – and so Is a Proper Diagnosis

Phillipe Jacon, a senior Cepheid official, addressed them and said, “We appreciate everything the activist community has said here.” He said his company has received a number of questions from the activists and that Cepheid would respond in a week.

The tension between pharmaceutical company executives and the TB survivors pointed out to the unequal burdens of TB: TB is a disease of poverty and a disease of the developing world. All the high burden countries in the world for TB, led by India, are all in the developing world. But companies owned by people in the Global North control the science and business of TB, making it unaffordable for poor people in developing countries.

The Global North has already dealt with TB and no longer faces a crisis. In some Western countries, their entire TB burden is in double digits, whereas India has 2.69 million TB patients. 

One clear example of the burden of TB is in travel visas: Indians who wish to travel to the UK for a long period have to get screened for TB before being given a visa. This ensures that TB is contained in developing countries.

TB drugs unaffordable for developing world

TB survivors disrupted at least four sessions at the conference in which pharmaceutical company officials were speaking. They demanded that companies and organisations like Johnson and Johnson, Otsuka, TB Alliance and Cepheid bring down the prices of life-saving drugs and diagnostics.

Survivors were particularly interested in and protested against the high prices of Bedaquiline (made by Johnson and Johnson), Delamanid (made by Otsuka), Pretomanid (which was developed by the TB Alliance) and the GeneXpert diagnostic (made by Cepheid).

TB survivors also staged an intervention at the opening ceremony of the global conference. Soon after Vice-President of India Venkaiah Naidu left the hall, TB survivor Nandita Venkatesan did a Bharatanatyam dance performance.

She delivered a rousing speech after that, demanding that the global community stops making decisions for TB patients without thinking of patients’ best interests. “Nothing about us, without us,” she said.

As she wound up her speech, about 50 TB survivors and activists took the stage. “This disease is not just about the science. It’s about those who lost their lives to the disease and the rights of those affected with the disease,” they said.

Also read: Dying in Dust: For Rajasthan’s Miners, Silicosis Deepens Struggle With TB

Another session where they protested at was the announcement of a new drug which is poised to be an important breakthrough in TB treatment. Pretomanid is the new drug making a buzz, as it has recently been approved by the US drug regulator.

Pretomanid, Bedaquiline and Delamanid are the only three drugs that have entered the scene in the last nearly four decades with any hope of treating TB. However, the TB Alliance says it will sell the drug at a minimum price of $364 (Rs 25,670). This drug too will need to be taken along with Bedaquiline and Linezolid and the cost of the entire regimen and course will be $1,040 (Rs 73,342).

Pretomanid has been developed by the TB Alliance with taxes and philanthropic money. TB Alliance is registered as a non-profit and not as a pharmaceutical company. So activists and survivors say they are surprised that TB Alliance has decided to file for patents in several countries, has licensed the drug out to only two pharmaceutical companies for manufacture and will sell the drug in only select markets, and has not published any of their data from their very small trial of the drug.

TB survivor’s shouted at a panel discussion with top officials of the TB Alliance: “Whose drug? Our drug!”

Mel Spigelman, president of the Alliance, then took the mic but refused to address any of the concerns raised by the survivors and activists. He told the audience, “This is not the forum to discuss this issue.”

Anoo Bhuyan was in Hyderabad reporting as one of ‘The Union’s Media Scholars’ at the ‘50th Union World Conference on Lung Health’.

Draft Patents Rules Undermine Safeguards Against Frivolous Patents

The government’s new proposals on patents may increase frivolous patents.

The Ministry of Commerce has floated proposed changes to the rules of the Indian patent Act.

Two of the proposed changes are very concerning. It proposes a new mechanism which will expedite decisions on patent applications. This proposed fast-track process seems to come with various other compromises on the functioning of India’s patent architecture and for protecting access to medicines, for example.

The monopoly of patents is often justified as an incentive to promote R&D. But in practice, patents are used to control competition and give fewer options to consumers. Towards this purpose, big corporations are known for obtaining multiple patents claiming minor changes on the same technology or molecule. This practice of creating patent-fences adversely impacts the industrial and technological development of countries like India, by preventing their firms from catching up with the latest technology.

As a technology-dependent country, India’s patents Act discourages patenting frivolous inventions and excludes patenting software, plants, animals or their parts and known chemical molecules.

But the proposed amendments to the Patent Rules seriously undermine this cautious approach of the Indian Patents Act on the scope of patentability.

Expediting patent approvals

Patentability standards contained in the Indian Patents Act are considered to be much more stringent than in the US or Japan.

The Patent Office examines patent applications filed by foreign applicants as per the provisions of the Act and decides whether a patent can be granted. Therefore, a grant of a patent in a developed country like the US or Japan does not guarantee a patent in India.

But despite these high standards on paper, in practice, it is a mixed bag. Researchers found that the Indian office granted patents in violation of the patentability standard contained in the Act. For instance, a study shows that there is a 72% error rate in granting patents in the area of pharmaceuticals.

Also read: India’s R&D Spending Up But It’s Not All That Matters

Now the proposed changes for fast-track examination say that if a patent is granted in a foreign patent office, then the applicant can apply for fast-tracking of the same application in India, provided that there is a bilateral agreement between the Indian Patent Office and the concerned foreign patent office.

The proposed amendment reads: “the applicant is eligible under an arrangement for processing an international application pursuant to an agreement between the Indian Patent Office with another participating patent office”.

India recently entered into such an agreement with the Japanese Patent Office (JPO). At the India-Japan Summit Meeting on October 29, 2018, both countries agreed to start a Patent Prosecution Highway (PPH) pilot programme. Under the PPH programme, a patent applicant can ask for fast-tracking a patent application citing the granting of a patent in Japan. The PPH only allows for expediting patent examination, without guaranteeing the grant of a patent in India.

However, the danger is in the actual working of the mechanism.

The PPH may make the Indian patent examiners rely on the examination report of the JPO and grant patents ignoring the strict patentability criteria provided in the Indian Patents Act.

This may lead to the “harmonisation” of Indian patentability criteria with Japanese standards – so far the standards have been distinct from each other. But if this harmonisation occurs, the patent approvals in countries like Japan can end up having a persuasive effect on their applications in India, going against India’s own high standards.

It can also lead to the granting of patents prohibited under the Indian Patents Act, such as a patent on software or a known molecule. In other words, the stringent standards for granting patents set by parliament in the Act would be ignored in practice.

Also read: Affordable Drugs Need a Compensatory Patent Commons

Developed countries want to achieve the global harmonisation of patent law by removing the existing difference in the application of patentability criteria. Since the legal route to achieve harmonisation involves public attention and resistance, the covert way to achieve the goal is through initiatives like PPH, which would ensure harmonisation at the functional level.

Japan’s Ministry of Economy Trade and Industry (METI) website states: “the Japan Patent Office (JPO) continues supporting Japanese companies to promptly acquire patents overseas, by expanding the PPH network, as well as standardizing and simplifying the procedures at IP offices worldwide.”

Recognising the threat of functional harmonisation, India opposed initiative like WIPO at the international forum. For instance, during the 19th Session of WIPO’s Standing Committee on Patents (SCP)(2014) India stated: India “work sharing would create a dividing line, i.e., the offices of some countries would forever remain on the receiving side of the dividing line thus depending upon the product delivered by the other countries […], enhancement of the competence of the offices would thus be a more preferred option”.

A government official aware of this matter explained to this author that the pilot PPH for now, would confine itself to IT-related patent applications and therefore was not a great matter of concern. But India does not allow the patents on software. Even so, a number of patents have been granted on software applications.

Once a mechanism for harmonisation is set up, even if confined to software for now, it becomes easy to add on other things, such as pharmaceuticals. This can spell danger to Indian and global patients who depend on Indian generic drugs, for example.

With all this in mind, the government would be well advised to uphold the legislative intent of the parliament and the Indian Patents Act, and reconsider the decision to participate in PPH and amend the Patents Rules.

K.M. Gopakumar is a researcher associated with the Third World Network (TWN). TWN is an independent, not-for-profit organisation that carries out policy research and advocacy on issues around trade and development, with a focus on third world countries. 

New Government Report Affirms India’s Patient-First Commitment on Pharma Patents

A government review says it is well within its rights to put Indian patients and the Indian generic pharmaceuticals industry first.

A government review says it is well within its rights to put Indian patients and the Indian generic pharmaceuticals industry first.

India supplies cheap generic medicines to large parts of the world. Credit: PTI

As various countries await the US’s ‘Special 301 report’, where the US government discusses intellectual property negotiations with other countries, , the Indian government has published a report of its on the same topic, affirming its sovereign commitments  to India’s generic drugs industry and healthcare.

The report was prepared by the Department of Industrial Policy and Promotion (DIPP) in the Ministry of Commerce. It reviews India’s positions on the subject and reiterates the government’s stance – domestically and multilaterally – apropos patents, trademarks and copyrights.

Significantly, the report makes multiple comments about the protection of public rights on pharmaceutical patents via the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation (WTO). India signed up to TRIPS in 1995, and following a 10-year transition period, assumed its terms as binding.

The DIPP report itself reads that the TRIPS agreement “should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”

It also comments on patent issues like data exclusivity, patent linkage and compulsory licensing, all of which impact how a country can approach patents – either with a view to protecting the private rights of industry or balancing the rights of the public as well.

Supporting the use of TRIPS-flexibilities

The document reaffirms India’s commitment to the TRIPS and makes it clear that it is within India’s rights to use the TRIPS provisions to protect public health. Excerpt:

“A review of the Doha Declaration on the TRIPS Agreement and Public Health adopted on November 14, 2001, clarifies any further doubts in this regard. Paragraph 4 of Doha Declaration has expressly noted that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, the Agreement should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”

The Doha Declaration was the outcome of the Doha round of talks on the TRIPS in 2001 and summed up the agreements made by the WTO on issues like intellectual property.

It also responds to pressure by developed countries applied on those like India to adopt ‘TRIPS-plus’ provisions like data exclusivity, which are designed to benefit international pharmaceutical companies.

The Wire had earlier reported on how developed countries were forcing India to give in on patents, such as at the Regional Cooperation on Economic Partnership (RCEP) discussions. India had hosted one round of RCEP talks in July 2017. There, negotiators from countries such as Japan and South Korean had asked others to consider ‘TRIPS-plus’ provisions. Before a later round of talks, many India officials told The Wire that India would not in fact cross any “red lines” on generics.

Article 39.3 of the TRIPS says governments can seek data from the industry but that such data will have to be protected from “unfair commercial use”. At the same time, TRIPS allows countries to make an exception “where necessary to protect the public.”

Countries have different periods of time during which the industry is allowed to keep its their data secret or “exclusive”. The US, Japan, South Korea and others have been pushing India to extend this period of exclusivity. In other words: to go beyond TRIPS into ‘TRIPS-plus’.

The impact of this is that it would delay the entry of generic drugs into the market.

On this, the the DIPP report says, “A large proportion of the Indian pharmaceutical industry is producing generic drugs. Extending data exclusivity at this stage would have a considerable impact on the Indian industry, especially in the short run. More importantly, data exclusivity provisions will impact access to medicines, which is a major social/human cost for a country which still has a large population living below the poverty line.”

It also says that other TRIPS-plus measures like patent linkage are “undesirable for the impact it will have by delaying introduction of generics.” Patent linkage is a measure by which the approval of any generic drug would be linked to the patent status of its branded equivalent, potentially inhibiting the approval of the generic variant. “There is no express provision under the TRIPS Agreement providing an obligation on the member countries to provide for protection akin to Patent Linkage,” the report says.

It also reiterates that the Drug Controller General of India (DCGI), whose office receives applications for approving drugs, is not required, empowered or qualified to examine the existence of patents before approving drugs. The report says that any attempt by the DCGI to follow the idea of patent linkage would be beyond their delegated powers.

The report also deals with the issue of compulsory licenses – when a government can allow a third party to produce a patented product, often for pressing public needs. India has issued only one compulsory license thus far, for the drug Nexavar (sorafenib), used to treat advanced renal cell carcinoma.

“The provisions relating to Compulsory Licenses under the Patents Act are fully compliant with Articles 30 and 31 of the TRIPS agreement and Article 15 of the Paris Convention.”

The report also references the work of the UN, Nobel laureate and economist Joseph Stiglitz and Bernie Sanders under a section titled, “Statements/Comments/Views favouring India’s stance on access to Health Care.” Specifically, that Stiglitz had said in 2015, “Greater IP protection for medicines would, we fear, limit access to life-saving drugs and seriously undermine the very capable indigenous generics industry that has been critical for people’s well-being in not only India but other developing countries as well.”

The document also quotes Sanders as having said, “Access to health care is a human right, and that includes access to safe and affordable prescription drugs. It is time to enact prescription drug policies that work for everyone, not just the CEOs of the pharmaceutical industry.”

How the University of California Is Fighting Proxy Patent Battle for Expensive Cancer Drug in India

The university appears to be representing pharmaceutical companies Pfizer, Medivation and Astellas in its patent battle. They aren’t telling the Delhi high court this, but they do talk about it in other documents.

UCLA appears to be representing the pharmaceutical companies Pfizer, Medivation and Astellas in its battle. They aren’t telling the Delhi high court this, but they do talk about it in other documents. 

Xtandi is a life-prolonging cancer drug. Credit: Twitter

Xtandi is a life-prolonging cancer drug. Credit: Twitter

New Delhi: Xtandi is a life-prolonging cancer drug and sells at about Rs 2.7 lakh for a month’s course in India – that’s for four tablets daily. It works for patients with stage-four prostate cancer who have exhausted their drug options and also cannot be treated with castration. The prostate is among the top ten sites of cancer in the Indian population and prostate cancer is the second most common cancer among men worldwide.

Xtandi does not have a patent in India. Its patent application was rejected in 2016 on the grounds of “obviousness and lack of patentable invention”. This means patients are able to avail of generic versions that cost about Rs 70,000 a month, nearly three times less than the trademarked drug Xtandi.

But the University of California, Los Angeles (UCLA), which developed the drug with US taxpayer money and holds the patent, has bypassed the patent office and is fighting a battle in the Delhi high court. They are represented by former Union minister P. Chidambaram, who has made two appearances in the case this year. Of the hundreds of pages they have filed in their writ petition, which The Wire has reviewed, they have not mentioned even once that there are big pharmaceutical companies with whom UCLA has commercial relationships on this drug. And curiously, a Pfizer lawyer has been given the power of attorney.

A proxy battle for Pfizer, Medivation and Astellas

But what does Pfizer have to do with UCLA’s patent battle? Absolutely nothing, if one goes by what UCLA has filed in their petition.

However, other documents as well as communication with The Wire reveal that Pfizer has a lot to do with UCLA pursuing this battle. In fact, the legal battle is “filed and is being controlled and managed by and at the request of Medivation and its commercial partner Astellas,” according to a letter from John C. Mazziotta, the CEO of the UCLA Health System, on September 7, 2017. Pfizer acquired Medivation in 2016.

Although UCLA developed the drug with public money and holds the patent, it has given up any role in setting the price of the drug. As a result, in the US, the drug is sold at the highest price compared to any developed country, according to the Union for Affordable Cancer Treatment (UACT).

Xtandi is now increasingly inaccessible to the very public that funded it in the US, where it sells for about Rs 6.9 lakh per month ($10,772). With a price of Rs 2.7 lakh ($4,172) per month and a patent battle threatening generic production in India, the drug becomes inaccessible to the rest of the world as well.

Globally, Xtandi is one of the top-selling cancer drugs, slated to be in the top five by 2022. This is good news for Pfizer and Astellas. Not having a patent in India on a drug like Xtandi is bad news for them.

Also read: Antibiotic Resistant Bacteria Are in Deep Shit – and So Are We

UCLA seems to be putting forth two different points based on where it is speaking. Inside court, it has presented itself as an aggrieved educational institution, promoting its academic interests. Outside court, documents reveal that the university is only proxy-battling this at the bidding of its commercial partners, fronting for one of the most expensive cancer drugs in the world.

UCLA denies acting on behalf of big pharma in court

Xtandi is a trademark of Astellas. Its active ingredient is Enzalutamide. Xtandi prolongs the lives of those who have metastatic, castration-resistant, prostate cancer for a few months. It is administered towards the end of a patient’s life when they are already in stage four of prostate cancer, as a third- or fourth-line drug. This is after doctors have already tried things like Bicalutamide, Abiraterone and Docetaxel. After Xtandi, doctors may still try Cabazitaxel.

“As such, by the time patients have reached the stage of Xtandi, they have already spent large amounts of money trying to prolong their lives by a few months with all these other drugs. Generic versions are far more affordable to patients at this stage,” says Dr Alok Gupta, a uro-medical oncologist at Max Hospital in Delhi. “In India, due to ignorance and low levels of screening especially among poor patients, they often come to us only when the disease is already presenting its symptoms. At these late stages, poor patients only have options like Xtandi to help them. We would of course like to prescribe drugs that can help them. But these prices are prohibitive,” says Dr Gagan Prakash, associate professor and urologic oncologist at Tata Memorial Hospital, Mumbai.

The UCLA medical school. Courtesy: Medical school insider

The UCLA medical school. Courtesy: Medical school insider

Over the last year, health watchers from several countries, including India, have written to UCLA, asking them to drop their pursuit of this patent in India. Letters have also been written to Hollywood biggie Sherry Lansing, former CEO of the Paramount Pictures Motion Group. She has an entire foundation in her name dedicated to cancer research. At UCLA, she is the chair of the University’s Health Services Committee. UCLA’s school of medicine was named after another Hollywood heavyweight – David Geffen of DreamWorks SKG – who donated $200 million to the university in 2002, making it the single largest gift to a US medical school.

The Wire sent UCLA nine questions. The Wire also sent five questions for Lansing. UCLA’s Phil Hampton, sent a 163-word reply, answering no question in specific. He also did not confirm if he had forwarded the questions to Lansing. Lansing’s other offices have not replied to The Wire nor to those who have petitioned her for action.

UCLA’s reply says “UCLA’s licensee is pursuing a patent in India under an agreement not subject to re-negotiation.” The licensees here are Pfizer through Medivation and Astellas.

With this, the university says that the licensee is pursuing the patent and not the university itself.

But UCLA’s statement to The Wire is contrary to the writ petition they have filed in court – the university itself, and not the licensees, have filed a writ petition in India against the rejection of its patent. In fact, UCLA’s petition has not mentioned the licensees even once, it has denied any attempt to conceal them from the court in its subsequent filings, and has definitely not made these commercial bodies a party to their case, although they are apparently the ones “pursuing a patent”.

This isn’t all. On September 7, 2017, Mazziotta replied to letters from the UACT and Knowledge Ecology International (KEI), both of whom have been writing to UCLA on the pricing and patent strategies behind Xtandi. Mazziotta says in technical detail that the patent appeal in India has been “filed and is being controlled and managed by and at the request of Medivation and its commercial partner Astellas”. He says Medivation is the commercial licensee for Xtandi and “The licensee usually has a significant role in the prosecution of patent applications,” including paying for its cost and choosing which countries to pursue patents, he said.

With this, UCLA says that the reason for pursuing this case is because the commercial licensees have asked for it. But this does not answer why UCLA is saying in court that the university has filed the case of its own accord.

There is no official trace of Pfizer, Medivation or Astellas in this litigation, except for the power of attorney granted to Samir Kazi, care of Pfizer Limited, Jogeshwari, Mumbai. He has sworn to court that all the affidavits of UCLA have been “drafted on the basis of instructions given by me” and “nothing material or relevant has been concealed therefrom”. Pfizer has not replied to The Wire’s email with queries on this.

A man walks past Pfizer's world headquarters in New York April 28, 2014. Credit: Reuters/Andrew Kelly/File Photo

A man walks past Pfizer’s world headquarters in New York April 28, 2014. Credit: Reuters/Andrew Kelly/File Photo

Likewise, UCLA ignored the three specific questions on this asked by The Wire. However, an answer comes from one of the subsequent documents they filed in the Delhi high court, where they said, “It is completely irrelevant that the product XTANDI is apparently manufactured for or on behalf of Medivation Inc, a subsidiary/ sister company of Pfizer Inc, and is sold by Astellas Pharma”. They continued, “It is denied that the failure by the Petitioner to specifically identify the purported commercial interested entities referred to above is deliberate”. They also denied that they have concealed material in their writ petition “in an attempt to secure relief that it is not entitled to, including information relating to the true party or parties who have or may have an interest”.

Seen in light of UCLA’s contradictory statements inside and outside court, Pfizer deputing an attorney on this case seems unsurprising; after all the company has an undeniable commercial interest here. But what is not clear is why the university is fighting the public and proxy-battle for these companies.

Also read: Abbott Fails to Comply With India’s Directive on Safety but Withdraws Its Stents Anyway

It is these contradictory statements which have made health advocates suspicious of this case. “University of California, at the time of licensing this product, did not look at serious access issues in the developing world. The drug is virtually in the hands of Pfizer. This case is basically Pfizer, using the name of University of California, asking the court to review this patent,” says Leena Menghaney, head of the access campaign for South Asia at Medecins Sans Frontieres. “We expect Pfizer or Astellas to pursue the patent in India, but the University of California should have done things differently,” says James Love, director of KEI.

UCLA contradicts own ‘Licensing Guidelines’ 

Replying sharply to Mazziotta’s letter, Manon Anne Ress, the acting director for UACT, said that this case is “a sobering reminder of the excessive and shamefully unaffordable prices associated with your invention in India”. She told him to “stop patronising” them. In court, the case is being opposed by two pharmaceutical companies, two individuals and the Indian Pharmaceutical Alliance. Globally, the patent is being opposed by health advocates in India, the US and even Chile.

Ress draws attention to UCLA’s own Licensing Guidelines in a reply to questions from The Wire. The guidelines spell out how UCLA could pursue its intellectual properties.

UCLA’s Licensing Guidelines advise the university and its licensees to pursue patents only in those developed countries which can afford it and to not seek patent protection in developing countries. This is part of the university’s “public benefit mission” to promote access to essential medical innovations in the developing world through “humanitarian patenting and licensing strategies”. The guidelines call for “alternate licensing” in the developing world, to allow generic manufacture to provide the same drugs without license agreements with UCLA and to even forego royalties in these countries.

Healthcare watchers see none of this reflected in the UCLA’s conduct in the US or in India. “The university claims its license carries an obligation to assist in the litigation, but it should not have a contract that runs counter to its own licensing policy guidelines,” says Love.

Menghaney, Ress and Love all point to India’s status as the generic drug supplier for much of the world. “The grant of a patent on Xtandi in India would prevent generic competitors from supplying the drug at an affordable price, in India and in other countries where there is no patent,” says Ress. 

With these differing approaches inside and outside court, UCLA’s case is slated to come up in the Delhi high court in December 2017.