CNS: Patent

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Experts demand compulsory licensing for generic production of a drug against Covid-19

Should not a medicine that has shown lifesaving effect in certain cases of Covid-19 be made available to all those who need it without delay? Even if Big Pharma has a patent, there are provisions in the global trade treaties that allow governments to issue compulsory licenses to such a lifesaving drug, and keep people over profit. This is why medical experts are demanding governments to use compulsory licensing for generic production of such a drug to help save lives.

Patents or people: The conundrum of healthcare industry

Abhay Singh, Divyansh Prakash, Isha Garg,

Jeevan Joseph, Ram Karthikeyan, Stuti Khandelwal

The first traces of SARS-CoV-2 virus (severe acute respiratory syndrome coronavirus 2) were discovered in November, 2019 in Wuhan, China. Since then, the novel coronavirus disease (COVID-19) has transformed from a local disease into a global pandemic. While countries across the world, rich and poor, are fighting the pandemic with all force, a common problem which stands in their way is the uneven distribution of resources and services in their societies. It is evident that a country cannot develop sustainably with the sole emphasis on the business motive of expanding profits, or enlarging the pie. Equal attention has to be paid to the distribution of this pie amongst the people. The division of resources must be sensitive to inequalities which manifest in various forms such as income, social, and gender disparities.

This Podcast features Anand Grover who was the keynote speaker for Sustainable Development e-Talks (#SDGtalks) on "Patents, right to health and access to medicine." Anand Grover, is a noted senior Supreme Court lawyer and former United Nations Special Rapporteur (UNSR) on the Right to Health (2008-2014). He co-founded the Delhi-based Lawyers' Collective in 1981. He has actively advocated for and represented human rights defenders as a lawyer, and also has been a globally respected voice on access to medicines and human right to health.

Be welcome to listen on Apple Podcasts, Google Podcasts, Spotify, Stitcher, TuneIn, aCast, Podtail, BluBrry, and other podcast streaming platforms.

Access to medicines is key for addressing hepatitis care needs

This Podcast features coversation with Charles Gore, Executive Director of the Medicines Patent Pool (MPP) with Shobha Shukla, CNS Managing Editor. Key highlight is where Charles Gore shares key learning of his engagement around hepatitis (both hepatitis C and hepatitis B related) spanning so many years. He also shares insights on range of issues such as access to medicines, voluntary licensing, and on his role at Medicines Patent Pool now, and way forward.

Thanks

CNS eLearning Programme Team
Email: webinar@citizen-news.org
Website: www.citizen-news.org

CNS Live eConversation with Charles Gore of Medicines Patent Pool

Medicines Patent Pool brings hope for kids living With HIV

Citizen News Service - CNS
The Medicines Patent Pool (MPP), an organization founded by UNITAID, and backed by the United Nations, signed today (24th February 2015) a licensing agreement with the American pharmaceutical company MSD (Merck Sharp & Dohme), known as Merck in the United States and Canada, for paediatric formulations of raltegravir- a key medicine approved for children living with HIV, one month of age and older.

Anand Grover is a lawyer from India who is known for his legal activism in Indian law relating to HIV. He is a co-founder member of the Lawyers Collective and has been UN Special Rapporteur on the Right to Health since 2008. He spoke with the ICAAP11 Insight team as the 11th International Congress on AIDS in Asia and the Pacific (11th ICAAP) got underway, stressing two points that are likely to feature in discussions this week.

Socialist Party (India) strongly supported the Supreme Court decision to uphold access to essential medicines and deny patent protection to dummy innovations as claimed by Novartis. Justice (retd) Rajinder Sachchar also extended his support to Socialist Party's position. Novartis had sought a patent for Imatinib (brand name Gleevac or Glivac) which noted lawyer and UN Human Rights Commissioner Anand Grover said was the same molecule with little ‘tweaking’. The cost of this drug is INR 120,000 per month for blood cancer (leukemia) patients. After Supreme Court ruling the price of drug may fall steeply from INR 120,000 to perhaps INR 8000 – this is a huge step forward in terms of advancing access to essential medicines and also in protecting public health from interference from profit-driven corporations and markets.

The growing trend by Asian countries to allow local production of cheap generic drugs got another feather in its cap recently in India. In a landmark victory for patients’ groups fighting against patents to ensure access to medicines, the Intellectual Property Appellate Board (IPAB), while holding that a patients’ group can challenge the validity of granted patents, has revoked a patent granted in India to Roche for pegylated interferon alfa-2a (a medicine used to treat Hepatitis C). This patent, granted to Roche in 2006, was the first product patent on a medicine in India under the new TRIPS-mandated product patent regime for medicines, as part of the country’s obligations under World Trade Organization's (WTO) international trade rules.

Close to the heels of the Indian Patent Controller order granting a compulsory license to an Indian company to produce and market a generic version of a patented cancer drug, (thus bringing down its cost by 97%, from US$5600 to US$176 per month) we have another landmark judgement delivered by the Kenyan High Court, with a view to safeguard the interests of people living with HIV (PLHIV) in accessing low cost generic HIV drugs.

GROUNDBREAKING MOVE SETS PRECEDENT FOR OVERCOMING DRUG PRICE BARRIERS

In a landmark case, the Indian Patent Office has issued the first-ever compulsory license in India to a generic drug manufacturer. This effectively ends German pharmaceutical company Bayer’s monopoly in India on the drug sorafenib tosylate used to treat kidney and liver cancer. The Patent Office acted on the basis that not only had Bayer failed to price the drug at a level that made it accessible and affordable, it also was unable to ensure that the medicine was available in sufficient and sustainable quantities within India.

International medical humanitarian organisation Médecins Sans Frontières (MSF) welcomes the decision by the Indian Patent Office to set aside the product patent it had previously granted to pharmaceutical company Roche for the drug valganciclovir. Valganciclovir is primarily used as treatment and prevention of an infection caused by cytomegalovirus (CMV) in organ transplant patients, a highly lucrative market which Roche has sought to defend by patenting the medicine. But CMV also affects people living with HIV, and if left untreated, can cause blindness and death. Read more

Major setback for scaling up Hepatitis C (Hep C or HCV) treatment

Major setback for scaling up Hepatitis C (Hep C or HCV) treatment

The Indian Patent Office has rejected a post-grant opposition filed against the grant of patent to drugs that are used for Hepatitis C (Hep C or HCV) treatment.

A Mumbai-based non-governmental organization, Sankalp Rehabilitation Trust, had filed this post-grant opposition against the grant of patent to F-Hoffmann-La Roche AG (Roche) for Pegasys (pegylated interferon alfa 2a) - a key drug used to treat HCV.

Hepatitis C is a blood-borne, infectious, viral disease that is caused by the hepatitis C virus (HCV). The infection can cause liver inflammation that is often asymptomatic, but chronic hepatitis can lead to cirrhosis and liver cancer. HCV transmission occurs when traces of blood from an infected person enter the body of a HCV-negative person. Like HIV, HCV is spread through sharing injection equipment, through needle stick or other sharps injuries, or less frequently from infected mothers to their babies.

HCV transmission rates are higher than that of HIV, and the condition is often more severe in drug users. People who share injection equipment are vulnerable to HCV and HIV infection, and in many places co-infection is not common.

Greater awareness about hepatitis C, more investment of resources, cheaper diagnostic and treatment services, and improved hepatitis-related treatment literacy, are all urgently needed by people co-infected with the hepatitis C virus and HIV.

"Hepatitis C treatment is mostly left out since AIDS activists are so focused on ARVs [antiretroviral drugs] or other prevention and treatment services," had said Umesh Sharma, in 2006, who had then completed a course of hepatitis C treatment.

The treatment for HCV was already very expensive - costing on average approximately US$250 per week. Interferon injections are given weekly, in addition to ribavirin tablets.With rejection of post-grant oppostion to granting of patent to pegasys (HCV drug), the monopoly will further exacerbate access, availability and affordability to HCV treatment.

The Lawyers' Collective in a posting on International Treatment Preparedness Coalition (ITPC) had said that In 2006, the Indian Patent Office had granted a patent to Roche for Pegasys. The Patent grants a monopoly to Roche, to market pegylated interferon alfa2a. Patients with chronic Hepatitis C, who need a six-month course of treatment of pegylated interferon alfa2a, have to purchase it at a cost of approximately Rs. 4, 36,000 [USD 8,752.38 ] (available at a discounted price of Rs. 3, 14,496 or USD 6,313.28 ). Again, Pegasys has to be taken in combination with Ribavarin, which alone costs Rs. 47,160 [USD 946.70 ].

In May 2007, Sankalp Rehabilitation Trust, a Mumbai-based NGO that works with drug users, filed a post grant opposition to challenge the patent.

Roche’s patent for Pegasys involves combining interferon alfa2a – a naturally occurring protein with known antiviral effects – with a structure called polyethelyene glycol (PEG), a known inert substance that prevents interferon from being broken down by the body, thus allowing it to remain in the bloodstream longer. This technology of combining interferon and other biologically active proteins with PEG had also been known for years prior to Roche’s claim for the patent, says the Lawyers' Collective posting.

Sankalp argued in its opposition that the patent was wrongly granted because given the existing knowledge at the time Roche filed its patent application, the “invention” that Roche was claiming was neither new nor inventive. Sankalp also urged that the pegylated form of interferon claimed by Roche is only a “new form of a known substance” without increased efficacy as compared to other known interferon conjugates and therefore is not patentable under section 3(d) of the Patents Act

Wockhardt, an Indian company, had also filed a post-grant opposition against the patent granted to Pegasys.

However, in a decision delivered on 17 March 2009, the Indian Patent Office dismissed the oppositions and upheld the grant of patent to Roche.

The impact of this decision is likely to be grim - with worsening access, availability and affordability of HCV treatment for those who need it most. Hope it gets reversed before it is too late.

- Bobby Ramakant