Fix The Patent Laws

Accessing oral contraceptives, hepatitis B drugs and medicines for depression

Posted on | October 16, 2014 | No Comments

The South African Constitution guarantees the right to have access to healthcare services, and places a positive obligation upon the state to take measures that progressively realise that right. However, often people don’t have access to the medicines they need in South Africa because lifesaving drugs are priced out of reach, while cheaper generics are prevented from entering the market due to patent barriers. This affects all types of drugs: treatments for drug-resistant tuberculosis, cancer, hepatitis, newer antiretroviral medications for HIV, and oral contraceptives.

Read more about the following medicine examples

Why we need to Fix the Patent Laws in South Africa:

Polar Opposite Prices for Antipsychotic Aripiprazole

Oral Contraceptives: Yasmin®,Yaz® and Ruby®

Entecavir and Hepatitis B

Sorafenib & Cancer Treatment

Court Case Blocks Cheaper Version of Birth Control Pill

Posted on | September 18, 2014 | No Comments

Context: Patents on medicines block generic competitors from entering the market, and allow patent holders to charge high prices as long as they maintain a sales monopoly. High prices can limit people and governments’ ability to afford the medicines they need.

Companies often try to engage in patent “evergreening”—this means that after applying for an initial patent on a new compound used to produce a drug, they also apply in subsequent years for additional patents that cover drug combinations or small changes to a medicine. Secondary patents can block generic competition for years or decades after the initial 20-year patent expires.

Many countries do not consider secondary patents on medicines to be innovative enough to deserve a patent. In South Africa, however, evergreening is common because patent applications are not examined to ensure they meet national criteria—multiple patents are granted on the same drug over time, allowing Big Pharma to maintain sales monopolies, and keep medicine costs artificially high.

The following case study provides a prime example of how patent evergreening, and other shortcomings of the current patent laws prevent more affordable generic medicines from coming onto the market in South Africa, and what the government can do to “Fix the Patent Laws” in order to protect public health over company profits.

Oral Contraceptives case study: drospirenone (DSP)/ethinyl estradiol (EE)

Originator Manufacturer: Bayer AG (markets as Yasmin® and Yaz®)

Generic Manufacturers:

v  South Africa: Pharma Dynamics (markets as Ruby®–litigation brought by Bayer over patent has blocked active marketing)

v  Globally: Teva, Actavis, Sandoz, Lupin, Barr

Recommended Dosage (all products): One pill taken every day, no more than 24 hours apart.

Registered indications:

Yasmin and Ruby are oral contraceptives for use by women to prevent pregnancy.

Yaz is an oral contraceptive for use by women to prevent pregnancy. Yaz is also registered as a treatment for premenstrual dysphoric disorder (PMDD) and for moderate acne in women who are using the pill for birth control.

Is there any difference between Yasmin, Yaz, and Ruby?

Yasmin and Yaz are both manufactured by the pharmaceutical company, Bayer. They contain the same active ingredients, which are used to prevent pregnancy. Yaz features a lower dose of synthetic estrogen, and is a modified version of Yasmin, that was released at a later date—not a new drug.

Ruby is manufactured by Pharma Dynamics. Ruby is a generic version of Yasmin, meaning it is identical to Yasmin both chemically (in terms of the amount of the active pharmaceutical ingredients), and in terms of clinical efficacy and benefit. Like most generic products, it is cheaper than the originator product.

The below chart further explains some of the specific differences in the three products.

^Source: http://www.onlinelawyersource.com/yasmin-birth-control/

How big is the market for these drugs, and ho;w much to women pay?

Yaz and Yasmin are the first and second top selling contraceptive drugs by revenue in South Africa, respectively. Approximately 141,000 women used Yaz or Yasmin products in South Africa in 2013. All sales of Yaz and Yasmin are through the private sector—either through independent purchase by individuals, or through medical savings accounts. Yaz/Yasmin is also Bayer’s fourth bestselling drug globally, with over €853 million (R12.1 billion) in annual sales.  Emerging markets, including South Africa, comprise 37.5% to Bayer’s total annual sales of these products.

Pharma Dynamics is not allowed to market Ruby in South Africa—this is related to patents, and discussed more below. When Pharma Dynamics registered a generic version of Yasmin in South Africa in 2011—marketed as Ruby—it was to be available through the private sector at a price of R80.93 per pack, a 30% cost reduction from Yasmin (see table below for prices).

If everyone on Yasmin had made the switch to Ruby, South African women would have saved over R11 million per year in total. The availability of a cheaper product might also have resulted in more South African women deciding they could afford DSP + EE as a potential birth control option.

South African sales of contraceptives containing DSP+EE

Manufacturer Brand Name Units Sold in SA

(Oct 2012-Sept. 2013)^

Annual revenue in ZAR (Oct. 2012-Sept. 2013)^ Price per pack of pills in private sector*
Bayer Yaz 793 559 89 404 172 R139.80
Bayer Yasmin 903 531 84 196 100 R115.62
Pharmadynamics Ruby 0 0 R80.93

^Source is IMS data

*Source is Medicines Price Registry as of July 14, 2014

 Why can’t the cheaper product be made available in South Africa?

A court case over patent infringement is blocking Pharma Dynamics’ launch of Ruby on the market. Bayer’s primary patent on the compounds that make up Yasmin and Yaz expired in South Africa in 2011. Anticipating this patent’s expiration, generic company Pharma Dynamics registered a generic version of DSP+EE. However, Bayer has secondary patents on Yasmin which only expire in 2024. When Pharma Dynamics launched its product, Bayer obtained a court order against Pharma Dynamics regarding a secondary patent, forcing the generic off the market in South Africa.

Pharma Dynamics was found to be infringing upon Bayer’s 2004 secondary patent, but the generic company subsequently filed a counterclaim in 2013, requesting that the Bayer patent be revoked. Because patent applications are not examined prior to being granted, Pharma Dynamics questioned whether the patent was actually valid when compared to the national patentability criteria. If the patent was not valid in the first place, then Pharma Dynamics’ could not be infringing upon it. This counterclaim was dismissed, but Pharma Dynamics appealed. On August 28th, 2014, this appeal will be heard in a Bloemfontein court, with a final judgment expected at the end of 2014.

The same secondary patent being upheld in South Africa has been revoked by courts in both Europe and the USA, where generic versions of DSP+EE have already available for several years. These rulings found the patent invalid due to its obvious nature—the change made by Bayer to DSP+EE did not vary from previous industry know-how. This means that while generics are available in the markets where most of the initial investment in drug research and development was made (namely, the U.S. and Europe), countries like South Africa continue to pay high prices while Bayer pursues patent litigation.

There are effective birth control pills that are much cheaper in South Africa than any of these products—so why is this case over patents important?

This court case is not only about birth control pills—it is about people in South Africa being able to access the lifesaving medicines they need, or having affordable options of medicines that they choose to take. If a legal battle over patents on birth control pills can prevent availability of lower-cost generic products, there is nothing to prevent the same scenario from happening with lifesaving medications for cancer, drug-resistant tuberculosis, hepatitis, or any number of medicines. South Africa knows this all too well, from the many years and legal battles that were required to stop Big Pharma from enforcing patents on affordable antiretroviral medicines. Many thousands of people living with HIV/AIDS could not access treatment due to the high cost. These battles can continue to be fought drug-by-drug, disease-by-disease, but changes to the system for granting patents could prevent some of these battles from having to be fought in the first place.

How could the patent laws change to promote generic competition?

The Department of Trade and Industry (DTI) is in the process of finalising a National Intellectual Property Policy, which will lay the foundation for changes to South Africa’s patent laws. The DTI released a draft policy for public comment in September of 2013. This outlined a number of important reforms that would be important for improving access to more affordable medicines. All of these reforms have been implemented in other developing and industrialised countries, and all of them are legal under international trade agreements. These reforms include:

  • Strengthening the national patentability criteria to limit evergreening.
  • Establishing a patent examination system, to enforce national patentability criteria and reduce patent evergreening.
  • Allowing for patent opposition before and after a patent is granted, by a broad range of third parties. This allows third parties to provide evidence to the Patents Office to show that an application does not meet patentability criteria, or that granting a patent would have a detrimental impact on public health.

I’ve heard of this Pharmagate scandal—why is Big Pharma so opposed to patent law reform?

In January 2014, a scandal broke in the South African media, and was subsequently dubbed “Pharmagate”.  Twenty-five multinational pharmaceutical companies—including Bayer—had developed a covert strategy to finance South African front organisations, and have these organisations publicly oppose intellectual property reform that would protect people’s right to health in South Africa.

Companies like Bayer are opposed to making it harder to get patents, because it hurts their profits. If countries have high standards for earning patents, it means companies would have to invest in developing new and innovative medicines, rather than just tweak old drugs. Big Pharma doesn’t want reform, because they care more about profits than people’s lives. The CEO of Bayer, Marijn Dekkers, has even made public statements to this effect when discussing a cancer medicine: “We did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product.”

What can I do to change things?

Your government and multinational companies should know that you are tired of paying too much for patented medicines in South Africa. The Pharmagate scandal shouldn’t be tolerated, and the Department of Trade and Industry needs to finalise a National Intellectual Property Policy that promotes the right to health, so that the patent laws can start to change!

If you want access to cheaper generic birth control, tell @Bayer to back off in South Africa, and stop enforcing their patent on Yasmin!

Tweet @the_dti @HealthZA and at your Parliamentary representative and demand they @FixPatentLaw

#Pharmagate

For more information on how to “Fix the Patent Laws” in South Africa: Please visit: www.fixthepatentlaws.org

Follow us on Twitter: @FixPatentLaw

This brief was compiled by Doctors Without Borders (MSF) South Africa



[1]Medscape. Drug Patents and Evergreening. 2012. Retrieved from  http://www.medscape.com/viewarticle/775186_2

[2]Yaz drug information. http://www.drugs.com/yaz.html

[3]Yasmin® [package insert]. Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ; April 2012. http://labeling.bayerhealthcare.com/html/products/pi/fhc/Yasmin_PI.pdf?WT.mc_id=www.berlex.com. Accessed July 23, 2014.

[4] Yasmin® [package insert]. Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ; April 2012. http://labeling.bayerhealthcare.com/html/products/pi/fhc/YAZ_PI.pdf?WT.mc_id=www.berlex.com. Accessed July 21, 2014.

[5]Bayer AG. (2014). Annual Report 2013, pg. 158. Retrieved from http://www.annualreport2013.bayer.com/en/bayer-annual-report-augmented-version-2013.pdfx

[6]Bayer AG. (2014). Annual Report 2013, pg. 168. Retrieved from http://www.annualreport2013.bayer.com/en/bayer-annual-report-augmented-version-2013.pdfx

[7]World Intellectual Property Review. Yasmin case sends good signal to patentees. January 08 2012. Retrieved from http://www.worldipreview.com/article/yasmin-case-sends-good-signal-to-patentees

[8]Bloomberg. Bayer Patent on Yaz Birth Control Pill Ruled Invalid. April 16 2013. Retrieved from http://www.bloomberg.com/news/2013-04-16/bayer-patent-on-yaz-birth-control-pill-ruled-invalid.html

[9]http://patentoppositions.org/how_to_build_an_opposition#opposition_how_to_506961e174ca040002000009

[10] http://keionline.org/node/1908

WORLD HEPATITUS DAY: TAC Joins Organisations Calling for Improved Access to HepB Vaccines & Medicines

Posted on | July 28, 2014 | No Comments

On World Hepatitis Day, organisations call on SA government: protect infants with HepB jab at birth & reduce patent barriers to HepB therapies

July 28, 2014, JOHANNESBURG—On World Hepatitis Day, 26 organisations and individuals from around the world have called on the South African Department of Health (DOH) and Department of Trade and Industry (DTI) to address the public health threat of hepatitis, by implementing hepatitis B immunisation at birth, and reforming national patent laws to promote access to more affordable hepatitis therapies.

Hepatitis B is highly endemic in South Africa and across sub-Saharan Africa, where around 8% of people are chronically infected, and the rates of hepatitis B-related liver cancer are some of the highest in the world. Globally, viral hepatitis causes approximately 1.3 million deaths every year—more than either malaria or tuberculosis—with around 240 million people chronically infected with hepatitis B virus (HBV), and 140 million people with hepatitis C virus (HCV). Either of these viruses can result in liver failure and liver cancer.

“Preventing infant infection is undoubtedly the most important way to reduce the prevalence of the hepatitis B virus,” said Dr. Monique Andersson, a virologist at Stellenbosch University. “A safe, effective, and affordable hepatitis B vaccine has been available for over two decades, and remains the backbone of prevention strategies. Yet infants continue to be infected across sub- Saharan Africa because they don’t receive the immunisation early enough.” Read more

South Africa’s Statement on Access to Essential Medicines at WHA

Posted on | May 26, 2014 | No Comments

This statement was originally published on the Knowledge Ecology International website by Thiru Balasubramaniam:

On Friday, 23 May 2014, the World Health Assembly is currently discussing access to essential medicines in the context of resolution EB134.R16, tabled China in January 2014. The following statement was delivered by South Africa on behalf of the 47 members of the African region. South Africa highlighted the point that “vaccines and anti-cancer drugs remain out of reach of millions of people in both developed and developing countries.”

With respect to the concept of “essentiality” and the high cost of medicines, the WHO African region noted,

The high price of medicines, particularly in the private sector, is a key barrier to affordable essential medicines in developing countries. While affordable prices are a key determinant in improving access to medicines, we should not forget that adequate, sustainable and equitable financing of medicines is also required. The WHO essential medicines committee may consider producing a list of medicines that are essential for public health however they are at an unaffordable price. This would direct other low cost manufacturers to focus on their product portfolio.

The full statement follows.

Statement by South Africa
Item 15.5 Access to Essential Medicines

Chairperson, Honourable Representatives of Member States, distinguished delegates, South Africa is pleased to a speak on behalf of the 47 members of the African region.

We thank the secretariat for preparing this report on Access to Essential Medicines and the WHO Medicines Strategy as reflected in the Twelfth general Programme of Work: 2014-2019.

Progress towards achieving the MDGs will not be realised if there are still barriers to access medicines. While countries have made considerable progress in achieving MDGs, particularly with respect to accessing medicines to fight HIV, malaria and TB. Access to other drugs such as vaccines and anti-cancer drugs remain out of reach of millions of people in both developed and developing countries.

Access to medicines implies continuously available and affordable medicines at health facilities which are close to where people live. Barriers to access can be due to several factors such as inadequate financing, high-priced products, procurement of originator brands, and inefficiencies in the supply and distribution chain.

The high price of medicines, particularly in the private sector, is a key barrier to affordable essential medicines in developing countries. While affordable prices are a key determinant in improving access to medicines, we should not forget that adequate, sustainable and equitable financing of medicines is also required. The WHO essential medicines committee may consider producing a list of medicines that are essential for public health however they are at an unaffordable price. This would direct other low cost manufacturers to focus on their product portfolio.

Chair, public sector availability of medicines is low in many developing countries. In a survey of 27 developing countries found the average public sector availability was only 35 per cent. When medicines are not available in the public sector, patients will have to purchase these medicines from the higher-priced private sector, or forgo treatment altogether. Low availability of medicines is therefore another barrier to access.

Generically equivalent products are usually priced at a substantially lower level than the originator brand. Increasing the use of quality-assured generic medicines through competition is therefore a key strategy for improving the affordability of medicine. A range of policy options is available to promote the use of generics.

Patents also have a dramatic impact on access to medicines when they are used to prevent competition. When life-saving treatments for diseases such as HIV/AIDS, cancer and Hepatitis become unaffordable to those that need them, the consequences can be – and are – devastating. Yesterday we were discussing limited access to Hepatitis treatment at the Assembly. In developing countries, where people pay for drugs out of their own pockets and very seldom have health insurance, the high price of medicines becomes a question of life and death.

Communities in Africa have insufficient access to essential medicines, a situation compounded by fragmented medicines regulatory systems. The medicines regulatory harmonisation was approved by the AU Conference of Ministers of Health in 2007 (under the pharmaceutical manufacturing plan for Africa and launched in 2009) and aims to enable African countries to fulfil their national obligations to provide all citizens with safe, quality and efficacious essential medicines.

Chair, in conclusion:

We would like to recognise that there are several factors that affect access to medicines. These include :
• The purchase price of the medicine from the manufacturer is a key factor that influences access. This can be best addressed through a price regulatory system.
• Utilisation of the TRIPS flexibilities to promote access to medicines that impact on public health.
• A system to track the availability of medicines through the medicine supply chain.
• A simplified, harmonised, efficient and transparent regulatory approval process particularly for generic medicines.
• A generic substitution policy that is effectively implemented.
All of these interventions must be implemented in a integrated system to improve access to essential medicines. The member states of Africa support the resolution on Access to Medicine as key to improving people’s lives and fundamental to realising the right to health.

MINISTER ROB DAVIES – OUR LIVES ARE IN YOUR HANDS!

Posted on | March 12, 2014 | No Comments

FINALISE THE IP POLICY BEFORE ELECTIONS & GIVE US BETTER ACCCESS TO MEDICINES

Activists demand rapid completion of intellectual property policy six years in the making; Without internationally recognised public health safeguards policy will be health disaster

2014/03/11, PRETORIA — Marching to the Department of Trade and Industry (DTI), the Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 led 1,000 health activists to demand the finalisation of a National Intellectual Property (IP) Policy before the general elections, to provide South Africans better access to the drugs they need through legislative reforms.

“It’s been six years since the Department of Trade and Industry started work on the IP policy and we cannot wait any longer. DTI has to keep to its promise to complete it by April – before the elections on 7 May – so the laws can start to change. We cannot afford to keep lining the pockets of international pharmaceutical companies at the expense of South Africans who need vital drugs,” says Andrew Mosane of the Treatment Action Campaign.

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MEDIA INVITE: Photo opportunity as health activists take to the streets

Posted on | March 7, 2014 | No Comments

MEDIA INVITE: PHOTO OPPORTUNITY

FIX THE PATENT LAWS CAMPAIGN 

TUESDAY MARCH 11 – Department of Trade and Industry (DTI) offices, PRETORIA

THURSDAY MARCH 13 – Parliament, CAPE TOWN

Health activists to demand completion of South Africa’s Intellectual Property Policy outside DTI offices, Pretoria and Parliament, Cape Town.

Over 2,500 health activists across the Western Cape and Gauteng will march on the DTI offices in Pretoria and Parliament in Cape Town to demand that South Africa fix its intellectual property laws to improve access to affordable medicines in the country.

Activists are asking the DTI to resist pharmaceutical industry pressure and complete the National Policy on Intellectual Propertybefore the general elections, in line with the government’s Constitutional obligation to take legislative measures to realise the right to health.  Read more

Responding to PhRMA lies in the South African media

Posted on | March 7, 2014 | No Comments

Lotti Rutter from the Treatment Action Campaign responds to PhRMA opinion piece in BDLive on 26th February 2014

This Wednesday’s opinion piece – “Strong IP regime could boost FDI” – might have promised a simple solution for increasing foreign direct investment, but unfortunately the reality is much more complicated. Rather than strong intellectual property (IP) protection being the ‘dynamo of growth’ as suggested by PhRMA Vice President Rod Hunter, the available evidence from our developing country peers suggests the exact opposite.

A recent study by Mila Kashcheeva, of 103 countries from 1970 to 2009 found that strong IP protection has a negative correlation with FDI in developing countries. Instead countries with ‘lax’ levels of IP protection achieved higher growth in foreign investment. The actual drivers of FDI in the pharmaceutical sector prove to be labour and production costs and economic incentives.

If granting poor quality patents lead to increased FDI, one would expect South Africa to be awash in investment since virtually every patent applied for here is granted. Instead we have attracted far less FDI than countries with weaker IP protection. Since complying with international trade law, 35 pharmaceutical manufacturing plants have shut down. Read more

TAC paper responds to inaccurate industry claims following the pharmagate scandal

Posted on | February 13, 2014 | No Comments

“The Economic & Social Case for Patent Law Reform in South Africa”

Lotti Rutter and Catherine Tomlinson

This updated research paper from the Treatment Action Campaign seeks to respond with reasoned analysis to a number of inaccurate claims that have been made by the pharmaceutical industry, particularly following the PharmaGate scandal. The evidence highlights how South Africa’s current intellectual property system allows exploitation by foreign companies whilst impeding access to medicines and the growth of our local industry. Additionally, the paper demonstrates that there is little evidence to back up industry claims that the adoption of public health safeguards in South Africa will undermine the development of future medicines.

The reforms proposed by the Department of Trade and Industry in South Africa are not radical. They are moderate, legal, rationale reforms acknowledged by global institutions including the WTO, WHO and WIPO. Nothing in the proposed reforms to South Africa’s Patent Act will do a way with patents. Truly innovative new treatments will still be patentable. Instead, what the Fix the Patent Laws campaign seeks is a more rational patent regime that takes into account South Africa’s health, developmental, social and economic needs. A regime that is based on relevant evidence rather than ideology.

You can access the research paper here: The Economic and Social Case for Patent Law Reform in South Africa.

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Pharmagate and the economics of patent law reform

Posted on | January 28, 2014 | No Comments

A shortened version of this article was originally published in the Financial Mail of January 24-29. By Marcus Low, Treatment Action Campaign.

We are deeply perturbed by revelations in last Friday’s Mail & Guardian exposing what appears to be a very well-funded, covert plot by foreign pharmaceutical companies and their local subsidiaries to delay a democratic law reform process in South Africa. The law reform concerns the new draft intellectual property policy developed by the Department of Trade and Industry (DTI). This policy has already been delayed for many years. The leaked documents expose a secretive US$ 500,000 plot to delay the policy even further.

We do not dispute the right of the companies involved to argue against patent law reform. They have had ample opportunity to make their case during last year’s period of public consultation and during meetings they had with the DTI before that. What does concern us is the intent to deceive the South African public. The leaked documents indicate that this will be done through rigging research into the impact of policy changes and by setting up a front organization called Forward South Africa. Forward SA would have a prominent South African person as its public face, but would secretly be run from the U.S. It is the stuff of conspiracy theories, but set down in documents circulated between members of the Innovative Pharmaceutical Association of South Africa (IPASA) and endorsed by Michael Azrak, head of IPASA’s intellectual property committee.

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Statement of South Africa on Access to Essential Medicines (in the wake of Pharmagate)

Posted on | January 24, 2014 | No Comments

This statement was originally published on the Knowledge Ecology International website by Thiru Balasubramaniam:

On Thursday, 23 January 2014, Malebona Precious Matsoso (Director General of the South African National Department of Health) delivered the the following intervention at the 134th session of the World Health Organization’s Executive Board under agenda item 9.7 on Access to essential medicines in response to the recent Pharmagate imbroglio.

SOUTH AFRICAN STATEMENT

ACCESS TO ESSENTIAL MEDICINES

Chair, the recent leak by the multinational pharmaceutical industry of the strategy written by Public Affairs Engagement to undermine South Africa’s efforts to reform its Intellectual Property policies is unfortunate. One of the objectives of this policy is to contribute towards the protection and promotion of public health, and access to medicines in particular.

This is not the first time that South Africa has been under such an attack, even in the face of the most devastating HIV/AIDS and TB co-morbidities. The first time was when Nelson Mandela was the first respondent to the legal challenge.

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  • About the Campaign

    fix the patent laws
    Fix the Patent Laws is a campaign of the Treatment Action Campaign (TAC). TAC is a non-profit organisation that seeks to ensure that every person living with HIV has access to quality, comprehensive prevention and treatment services to live a healthy life. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.

  • Read the TAC and MSF campaign pamphlet

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