29 November 2012
US pharmaceutical company Johnson & Johnson has today announced - ahead of World AIDS Day on Saturday - that it won’t enforce patents on HIV treatment drug darunavir in sub-Saharan Africa and least-developed countries.
Médecins Sans Frontières (MSF) responds to Johnson & Johnson’s announcement on access to darunavir:
“Darunavir is especially important for people who have been on HIV treatment for a while and need to be switched to different medicines because their treatment is no longer working. MSF is using darunavir in several of its projects, but the drug is incredibly expensive.
This announcement by J&J is not as significant as it appears. In most countries included in J&J’s announcement, the real barrier to accessing darunavir is not patents, but the fact that the medicine is not registered. Also, J&J’s announcement does not cover the countries where the company does have patents, where HIV programmes have been running the longest and where the need for newer treatment options is therefore the most pressing. Brazil, for example, is paying $6,037 per person per year for darunavir alone.
J&J is in fact actively fighting the decision by India, where most of the world’s affordable generic HIV medicines are produced, to not grant patents on darunavir and it is also actively seeking patents on combinations of darunavir with other medicines.
A more helpful move by J&J would be to pursue wider registration of this drug in developing countries, or to put their patents on darunavir into the Medicines Patent Pool, which aims to facilitate access to affordable HIV medicines in developing countries.”
- Judit Rius-Sanjuan, US Manager, MSF Access Campaign
27 November 2012
On 8 November 2012, the US FDA tentatively approved Hetero’s TDF/3TC/EFV 300/300/600mg fixed-dose combination tablet. This is a significant move, as until now, only one quality-assured source (approved by WHO prequalification or by a stringent regulatory authority) existed for this product, produced by Matrix. As additional generic manufacturers are expected to receive prequalification soon, the price of this regimen should fall further.
The new price for Hetero’s FDC is US$0.362 per pill, or $132 per patient per year. This is an increase over the price Hetero provided for the 15th Edition of Untangling the Web (issued July 2012) of $0.350 per pill, or $128 per patient per year.
TDF/3TC/EFV 300/300/600mg is indicated as first-line treatment by the WHO 2010 treatment guidelines for adults and adolescents.
27 November 2012
Cipla’s lopinavir/ritonavir 80/20mg/ml oral solution was approved by US FDA on 29 June 2012. Previously, Abbott’s was the only quality-assured source for this product. Cipla’s therefore becomes the first generic source to be quality-assured (approved by WHO prequalification or by a stringent regulatory authority) and as such represents an additional procurement option for countries.
The price provided by the company is US$26 for the 160ml bottle ($0.163/ml). As such, the Cipla product is more expensive than Abbott’s Category 1 price ($0.101/ml), which is reserved for Africa and least-developed countries, but is more affordable than Abbott’s Category 2 price ($0.203 /ml) which Abbott reserves for a specific list of countries (see Annex 2 of Untangling the Web).
15 November 2012
On 12 November 2012, Ecuador issued a compulsory license on abacavir/lamivudine. (attached here) This follows the issuance of Ecuador’s first compulsory license in 2009 on ritonavir/lopinavir. In a press release issued by Ecuador’s Institute of Intellectual Property, Ecuador noted that compulsory licenses are an integral component of international trade rules that increase access to medicines by helping countries to meet the United Nations Millenium Development Goals:Las licencias obligatorias son un componente integral de las normas de propiedad intelectual, son la clave actualmente para impulsar el acceso general a los medicamentos. Además las licencias obligatorias son importantes para ayudar a los países que cumplan los objetivos de Desarrollo del Milenio para las Naciones Unidas.
Ecuador noted that a box of 30 pills of abacavir/lamivudine would retail in Ecuador at $753 per month; thus a year’s course of treatment of abacavir/lamivudine would be $9,036. Ecuador’s compulsory licensing order noted that in the United States, a box of 30 pills of abacavir/lamivudine cost $745 or $24.83 per pill. Ecuador granted a compulsory license on abacavir/lamivudine to Acroxmax, an Ecuadorean manufacturer. Through the issuance of this compulsory license, Ecuador endeavors to reduce the cost of abacavir/lamivudine by 75%. In determining the royalty rate, Ecuador use the 2005 WHO/UNDP Tiered royalty method (TRM) to set the royalty, which was calculated as 11.7 cents per capsule.
KEI Comment: Ecuador continues to lead on the implementation of TRIPS flexibilities by granting compulsory licenses on life saving drugs. This is the second time Ecuador has used the tier royalty method to set royalties. This approach takes the average US pharmaceutical drug royalty, based upon the US price and assuming a 5 percent average royalty, and then reduces the amount of the royalty per capsule, to reflect the difference in relative per capita nominal incomes.
15 November 2012
By: Meredith Wadman
Should a sick person in the United States have to pay US$9.18 for an anti-AIDS pill when a Canadian is paying $1.16 for the same tablet, and a New Zealander $1.15?
Four consumer and medical groups led by Washington, DC-based Knowledge Ecology International are asking the US National Institutes of Health (NIH) to say no to that question. On 25 October, they petitioned the agency to exercise a never-used legal privilege known as a ‘march in right’ to grant open licences to would-be makers of the protease inhibitor Norvir (ritonavir), now marketed exclusively by Abbott Laboratories.
March in rights are part of the Bayh-Dole Act, a landmark 1980 US law that aimed to spur the commercialization of government-funded inventions and helped to launch the biotechnology industry. The law says, in part, that the NIH can ‘march in’ and force open licensing of an invention it funded when the exclusive license-holder, in this case, Abbott, is not taking adequate steps to “achieve practical application” of the invention. (See section 203 of the Bayh-Dole Act here.) The NIH funded Norvir’s discovery by a scientist then at Abbott.
That language covers the situation where a licensee simply sits on an invention and doesn’t develop it, but the law also defines “practical application” to mean that the invention’s benefits are “to the extent permitted by law or Government regulations available to the public on reasonable terms” (see section 201 of the Bayh-Dole Act).
“The question is: is ritonavir being made available to the public on reasonable terms? If you think it’s reasonable for Americans to pay more than the rest of the planet for something we paid for as taxpayers, then you would deny our petition,” says James Love, the director of Knowledge Ecology International.
Greg Miley, the head of public affairs in Abbott’s US pharmaceutical products division, sent this statement by e-mail:
“Abbott has not received formal notification from the National Institutes of Health regarding a ritonavir march in petition. The price of Norvir has remained unchanged for nearly a decade and Abbott has significant patient assistance programs that provide access to Norvir for U.S. patients who need this medicine. NIH rejected a similar march in petition request in 2004 related to Norvir on several grounds.”
Abbott increased the price of Norvir by 400% in 2003, prompting a huge outcry. It has nonetheless kept to that pricing, except in the case of US state and federal government health programmes such as Medicare, for which it kept the price as it was before the increase.
The full petition was submitted to NIH by Knowledge Ecology International, the American Medical Students Association, the US Public Interest Research Group (PIRG) and the Universities Allied for Essential Medicines (UAEM).
The NIH said that it had no comment on an ongoing legal matter. But it added in a statement: “We expect to respond to the letter we received by the end of the year about whether there is sufficient information that would warrant the exercise of march-in rights.”
It’s clear that the petitioners will have some convincing to do: in the 32 years that Bayh-Dole Act has been law, the NIH has been asked to exercise march-in rights four times. It has declined all four requests.
For an excellent summary of those four petitions — including an explanation of how the arguments in the 2004 petition on Norvir differ from the current ones — see this Patent Docs blog post by biotechnology patent lawyer Kevin Noonan.
11 October 2012
"It’s a myth that every patent application that is filed is valid. When you look closely, a patent application may fail one or more of the legal tests it needs to pass. The idea behind this database is to help civil society and patient groups stop unwarranted patents from blocking people’s access to more affordable medicines."
13 September 2012
On 3 September, the Government of Indonesia issued a ‘government use’ decree - a type of compulsory licence that lifts a patent restriction on generic production - on seven drugs used to treat HIV and Hepatitis B. The drugs which are subject to the orders include efavirenz, abacavir, tenofovir, lopinavir/ritonavir, didanosine, and fixed-dose combinations tenofovir/emtricitabine and tenofovir/emtricitabine/efavirenz.The Presidential decree, if implemented fully, will allow for local generic production of the medicines - which will open up competition, and could significantly reduce prices - while each of the innovator companies will be paid a royalty of half a percent. There are 310,000 people living with HIV in Indonesia.“Indonesia has set an important precedent, not just for the people living with HIV within its country, who have been campaigning for this, but also for other developing countries”, said Michelle Childs, Director of Policy Advocacy for Médecins Sans Frontières (MSF) Access Campaign. ” This is one of the widest licences issued by a government and rightly reflects the reality that a range of treatment options are needed.”“As medicines for HIV and Hepatitis B are increasingly under patent in developing counties, Indonesia has shown that countries can and should take action to enable the production of low-cost versions of essential life-saving medicines for their citizens. The next step is full implementation of the decree. Other countries faced with blocks on access to generic medicines should consider following Indonesia’s lead”, Ms Childs added.
- 23 July 2012 56 notes
19 July 2012
MSF will launch the 15th edition of Untangling the Web of Antiretroviral Price Reductions on July 25, 2012 at the International AIDS Conference in Washington, D.C.
Be sure to visit utw.msfaccess.org to gain access to an updated online version of the site as well as to download the full report.
If you’re interested in MSF’s presence at this year’s IAC, please visit aids2012.msf.org
More news and features coming soon.
24 November 2011
On 18 Novermber 2011, the US Food and Drug Administration granted tentative approval for Matrix’s atazanavir sulfate and ritonavir fixed-dose combination (FDC) tablets, 300/100 mg.
MSF has long advocated for generic manufacturers to develop a heat-stable FDC of atazanavir/ritonavir (ATV/r). This is the first such FDC to receive approval from a stringent regulatory authority or the WHO prequalification programme.
Atazanavir – which needs to be boosted with ritonavir - is one of the two protease inhibitors drugs recommended by WHO in its 2010 ARV treatment guidelines for adults and adolescents as backbone for second-line regimens, in combination with two Nucleoside Reverse Transcriptase Inhibitors.
The introduction of this heat-stable formulation represents a step forward for access to second-line ARVs, as it provides the first FDC alternative to heat-stable lopinavir/ritonavir (LPV/r). It also has the added benefit of reducing the pill burden for patients – down from four pills a day for heat-stable LPV/r, to one pill a day for ATV/r.
However, unlike first-line HIV regimens which now come as one or two pills per day, as of now no three-in-one FDC exists that covers the full second-line regimen as per WHO recommendations.
Matrix has communicated to MSF the price of this new tablet. At US$ 25 per pack of 30 tablets (FCA Mumbai. Freight & Insurance charges are additional), this means a price of $307 per patient per year (0.84 per unit).
Regularly updated news feed of updates to the online version of Untangling the Web as well as related news articles.