The Indian Patent Controller has today rejected one of Gilead’s key patent applications which covered the drug sofosbuvir, used to treat hepatitis C (HCV). The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.

Challenges to some of the most important patent applications on sofosbuvir (a ‘patent opposition’ - a form of citizen review allowed in many countries) were filed in India by the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014.

Gilead has signed voluntary licence agreements with multiple generic producers in India, but these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug. With the patent being denied, other companies that have not signed the licence are now free to produce. Entry by additional generic manufacturers should increase the open competition needed to bring prices down dramatically, especially in those countries that have been excluded from the voluntary licence agreement, and thereby increase access to the medicine. Countries where the drug is unaffordable, and which were excluded from the licences, should make every effort to import more affordable generic versions from other producers who did not sign a licence in India.

MSF is in the process of expanding treatment for people with hepatitis C in nine countries, and has been negotiating access to this medicine, which is expected to become the backbone of any HCV regimen in the coming years.

Below are responses to the news by Doctors Without Borders/ Médecins Sans Frontières (MSF), the Initiative for Medicines, Access &Knowledge (I-MAK.org), the Delhi Network of Positive People (DNP+), and Dr. Andrew Hill, Researcher at Liverpool University

“Sofosbuvir has proved to be a billion-dollar blockbuster drug and we hope today’s decision opens the floodgates for more open competition that could rapidly lower the price. This drug makes hepatitis C treatment more effective and easier for patients and doctors, so broad access to affordable versions will allow treatment to be scaled up dramatically.  Gilead’s drug access programme for developing countries is already showing its limitations, with the company planning to impose conditions for the supply and distribution of the drug to patients and treatment providers in developing countries, in order to protect the company’s ability to charge unaffordable prices in wealthy countries. Getting sofosbuvir out of the stronghold of Gilead’s monopoly will be crucial to expanding treatment for people with hepatitis C globally.

“India’s status as the ‘pharmacy of the developing world’ is once again in the spotlight and this is a good opportunity for generic producers in India to swiftly ramp up production to levels needed to treat the 185 million people infected with hepatitis C worldwide.” 

Dr. Manica Balasegaram, Executive Director, MSF Access Campaign

“The move to reject Gilead’s patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug.  The bottom line here is that India’s patent law doesn’t give monopolies for old science, for compounds that are already in the public domain. Gilead’s strategy of charging as much as US$84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is – seeking to squeeze as much profit out of the sick as possible.”

Tahir Amin, lawyer and Director of the Initiative for Medicines, Access &Knowledge (I-MAK.org)

“This is a happy day for the millions of people who urgently need hepatitis C treatment across the globe. People with hepatitis C everywhere should be able to have access to this treatment, but millions of our friends in middle-income countries have been left out in the cold by Gilead. This decision provides hope that people in countries that have been excluded from Gilead’s licensing deals will be able to access low-cost generic versions of sofosbuvir.”

Vikas Ahuja, Delhi Network of Positive People (DNP+)

“We know from various manufacturers in India that they could produce this drug in the future for as little as $101 for the full three month treatment course.  That’s roughly $1 per pill, which is a big improvement over the $1,000 per pill Gilead is charging in some countries. At the current prices, sofosbuvir is unaffordable for widespread use in most countries of the world.”

 Dr. Andrew Hill, Senior Research Fellow, Department of Pharmacology and Therapeutics,

Liverpool University

On Thursday, 21 November 2013 I-MAK filed an opposition at the Kolkata Patent Office against Gilead/Pharmasset's application for Sofosbuvir (Applicaiton No. 3658/KOLNP/2009), a nucleotide prodrug.

The notice of opposition and accompanying documents can be found here.

Our press statement issued with MSF is below:

New Delhi/New York, 22 November 2013—Médecins Sans Frontières (MSF) supports the ‘patent opposition’ just filed at India’s Patent Office by the Initiative for Medicines, Access & Knowledge (I-MAK), which aims to prevent US pharmaceutical company Gilead/Pharmasset from gaining a patent in India on sofosbuvir, a drug for hepatitis C that is coming to market soon with an anticipated exorbitant price.

Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US. Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach. The patent opposition—a form of citizen review allowed in many countries—offers technical grounds to show a drug does not merit patenting under India's Patents Act. This opposition was filed to ensure that affordable generic versions of sofosbuvir can be produced to help the millions of people infected with chronic hepatitis C in developing countries access the drug. 

“Old science, existing compound,” said Tahir Amin, lawyer and director of I-MAK.org. “India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it.”

Sofosbuvir is the first of several oral hepatitis C drugs expected to come to market in the coming year. It cures hepatitis C in a much shorter time period than today’s available treatment, and for some forms of hepatitis C, eliminates the need to use the injectable drug pegylated interferon, which can be difficult to administer and causes many serious side effects. Gilead is anticipated to receive marketing approval for sofosbuvir in the US on 8 December.

MSF has started providing hepatitis C treatment for a small number of people co-infected with HIV in its clinic in Mumbai, but cost (as high as $5,000 per patient) and complexity of today’s available treatment means that patient numbers remain extremely low despite considerable needs.

“In our projects, we need access to medicines like sofosbuvir that are easier for patients to take so we can expand treatment to more people. If the drug is unaffordable, the majority of the most vulnerable groups will remain untreated,” said Dr. Simon Janes, medical coordinator with MSF in India. “We know from our experience providing HIV treatment over more than a decade in dozens of developing countries that treatment needs to be simple and affordable—preferably less than $500 to start with. An unaffordable price for this drug will have a chilling effect on funders and governments who need to start financing and providing treatment.”

The World Health Organization estimates there are 184 million people infected with hepatitis C worldwide, with the disease causing half a million deaths each year. The vast majority of these people live in developing countries where—with the exception of Brazil and Egypt—there is no provision for universal access to hepatitis C treatment in public healthcare programmes.

“The world is waking up to a new crisis with hepatitis C,” said Olga Stefanishina of the Ukrainian Community Advisory Board. “More and more people are being diagnosed with chronic hepatitis C but are left to die because there’s no affordable treatment. With this patent opposition in India, we are starting the fight for better treatment that people can afford and governments can provide. We have no time to wait for charity or country-by-country negotiations—low cost generic drugs must be made available to all high-burden countries without discrimination.”

India has been called the ‘pharmacy of the developing world,’ because it produces many affordable generic versions of drugs patented elsewhere. More than 80% of the HIV medicines used in developing countries come from India, which is able to produce these medicines because its patent law sets the bar high for which medicines do and do not merit patenting, allowing generic manufacturers to compete for the market and drive prices down.

“The hepatitis C drugs coming out of the drug pipeline, including sofosbuvir, are compounds that are relatively simple and cheap to make,” said Dr. Andrew Hill, a pharmacologist at Liverpool University who has published a study showing that sofosbuvir could be produced for as little as US $62-$134 for a 12-week treatment course. “The profit projections for the oral hepatitis C drugs are staggering, and stand in no relation to what it costs to make these drugs.”

Subsequently, five companies -- Teva, Mylan Generics UK, Roche, Hetero and Janssen (J&J) -- have filed post-grant oppositions at the EPO against granted patent EP1663183 B1 .  The post grant oppositions filed by these companies raise several of the issues and evidence raised in our pre-grant observations, but which the EPO did not require Abbott to address before finally granting the patent. We hope the post-grant opposition process addresses the issues that were not dealt with during examination.

Copies of the post grant oppositions are available here. The cases are pending and it will take at least another year before a final determination is given by the EPO.

However, from the parent Application No. 04816820.7, Abbott has three further divisional applications pending:

EP divisional Application No. 10181250.1: covers essentially the same product as the granted parent patent.  I-MAK's observation against this application was aimed at Abbott's claim that the addition of a surfactant with a hydrophilic lipophilic balance (HLB) of 4-10 was inventive. We argued that the inclusion of the surfactant with an HLB of 4-10 would have been obvious to a person skilled in the art in light of Abbott's prior patents, as well as publications in the field documenting the advantages of using surfactants in solid dispersion formulations. We also highlighted for the Examiner that this is a case of double patenting: the parent patent also covers what is claimed in the divisional application.

A copy of our observation and supporting evidence is available here.

EP divisional application 10181268.3: claims a method of preparing a solid dosage form which comprises preparing a homogeneous melt of ritonavir and/or lopinavir, at least one surfactant and at least one water-soluble polymer having a glass transition temperature of at least 50 degrees Celsius, and allowing the melt to solidify to obtain a solid dispersion product.

I-MAK's observation and evidence, a copy of which is available here, focused on three key issues arising from the examination history of the application to date:

1) The fact that the divisional claims were actually product-by-process claims and should be examined as such. Under the European Patent Convention, product-by-process claims should be treated as product claims, and the burden is on the applicant to demonstrate that the claimed invention is new and inventive, and results in another product over that already covered in the prior art.

2) If the claims were to be treated as method claims, the application should be rejected for lack of inventive step, since the use of melt extrusion technologies and methods as applied to poorly soluble compounds such as ritonavir and lopinavir were well-documented in the field prior to the application being filed and would have made their use obvious.

3) That Abbott has failed to address the technical problem it claims to have solved, namely that the claimed invention provides for a solvent-free method of making the solid dosage form of this product, since solvents have a number of disadvantages. Despite the Examiner agreeing with Abbott having solved the technical problem, our observation shows the patent specification as filed contradicts these findings as it specifically includes the use of a solvent process. Indeed, nowhere in the claims as filed in the divisional application are solvents expressly excluded from use in the claimed invention. Moreover the evidence submitted with our observation shows that known melt extrusion technologies already solved the problem of not needing to use solvents.

This issue was also raised in our final observation to the parent application 04816820.7 after Abbott reformulated the problem during examination in order to overcome objections to the patent. Unfortunately, the EPO failed to ask Abbott to address these issues before granting the patent. We hope the EPO takes notice of these issues this time around.    

EP divisional application 10181264: cover substantially similar claims to the parent application. The case is still being prosecuted and the Examiner appears unconvinced thus far about the patentability of this application. I-MAK is monitoring the examination of the application.

It should be noted that Abbott’s strategy of filing multiple divisional patent applications does not fall squarely within the classic defintion of life cycle management, or “evergreening”. The divisional patents, if granted, would expire at the same time as the parent patent. Instead, Abbott’s strategy of using divisional applications appears to be aimed at ensuring the broadest scope of protection given the various amendments to the claims it had to make as a result of our observations during the examination of the parent application.  Abbott is also likely concerned that since the post grant oppositions have been filed against the granted parent patent, obtaining granted patents for the divisionals may further delay any potential generic entry in Europe as post-grant oppositions at the EPO can take up to 2-3 years. To that end, these divisonals form part of the patent strategies companies use to increase transaction costs for generic entrants who might be seeking to challenge patents.

These cases at the EPO could have serious implications for low- and middle-income countries (LMICs) since patent examiners in LMICs (e.g. Viet Nam) often rely on EPO examinations in their own examination process.

More updates to follow.

The report is only a preliminary assessment as the full text of the granted Egyptian patents were not available to us at this time. As such the analysis was based on corresponding U.S., European and/or international patent (PCT) documents and whether they related to patents listed for marketed products on the U.S FDA Orange Book. However, with this initial information to hand, it is hoped that it will enable users to focus efforts and resources on obtaining the complete patent documents for those patents that may be of interest.

The projected was carried out in collaboration with Dina Iskander of the Egyptian Initiative for personal Rights, as part of her research on the impact of TRIPS on pharmaceutical patenting in Egypt.

At the consultation  civil society members, including I-MAK, presented critiques of the process surrounding the MPPF, (from its foundation to the lack of transparency around its negotiations and approval of the license), the terms of the license, as well as an assessment of whether the MPPF, and in particular the MPPF-Gilead license, adds value to the current status quo on access to anti-retrovirals. The presentations made at the consultation are available for download here:

• Analysis of the Patent Pool-Gilead Licenses
• The Broader Impact on Access to Medicines and the Generic Industry 
• Measuring the Impact of the MPPF-Gilead Licenses
• Measuring the Financial Impact of the MPPF - I-MAK/ITPC Counter Analysis

Additional documents relating to the consultation and the MPPF-Gilead licenses can be found here.

Unfortunately, members from civil society felt the issues raised were not adequately addressed by the MPPF and UNITAID staff. At the end of the consultation, it was demanded that the MPPF and UNITAID should:

1. Substantially revise or terminate the MPPF-brokered license agreement with Gilead, including any potential or pending agreements with sub-licensees, given Gilead’s bad faith and the controversial terms of the MPPF-Gilead agreement;
   
   
2. Institute an immediate moratorium on negotiations of any new license agreements, including any new or pending agreements with Indian generic producers (potential sub-licensees to the MPPF-Gilead agreement) or with other multinational drug companies (potential new licensors) until such time as standard terms and conditions or a model agreement is agreed to; and
   
   
3. Re-evaluate the current structure of the MPPF, including its governance and administration, goals and mission, and implement comprehensive reforms designed to enhance its transparency, accountability and adherence to core principles of health equity.

Immediately after the consultation, a letter (available here) was prepared noting our concerns. In less than a few days the letter received over 90 signatures of support from community organizations and networks in over 20 countries, including those with access to products through the license.

A summary of the concerns raised in the letter are set out below:

Summary of key concerns with respect to substantive content

1) The reliance on the original Gilead voluntary license (from 2006) as the template for the MPPF-Gilead 2011 agreement. The license agreement instead should have been based on standard terms and conditions for licenses developed in advance by the MPPF with community input. Ideally, these terms and conditions should be non-negotiable when the MPPF is brokering any agreement with a pharmaceutical company.  There has to be a threshold of concessions that the MPPF simply will not cross in negotiations with multi-national pharmaceutical companies;

2) The restricted geographical scope of the license for tenofovir (TDF) that excludes over 500,000 patients in more than 43 countries, and a greater number excluded for the pipeline medicines (e.g., Botswana and Namibia). The acceptance of restrictive terms and the lack of criticism of Gilead by the MPPF and UNITAID for these exclusions are of great concern. Furthermore, the claims made by MPPF of the benefits of the scope of the new license are exaggerated and not based on any empirical assessment. The benefit of the addition of 16 new countries in the TDF licensed territory is overstated. Those countries represent less than a one percent increase in patient coverage, whereas the addition of middle-income countries excluded from the agreement would have represented a 12 percent increase in access, significantly expanding the market;

3) The undermining of the free and full use of TRIPS flexibilities by countries through restrictive provisions in the licences including:

(a) circumventing the 2016 TRIPS deadline for least developing countries (LDCs) by allowing royalties on medicines supplied to them, even though these countries do not have to impose patents on essential medicines until 2016;

(b) the imposition of restrictions on the use of compulsory licenses (CLs) by requiring the prior permission of Gilead, thus affecting both importing and exporting countries (and placing additional barriers on the use of the August 30 Decision);

(c) blocking the ability of excluded countries to parallel import generic medicines, by allowing Gilead to directly intervene and cancel generic companies’ distribution agreements;

(d) undermining patent opposition work by requiring royalties to be paid until all related patents, including undecided applications, go through the entire legal appeals process and are finally rejected, which often takes several years; and

(e) the MPPF’s licensing of poor quality patents legitimizes and endorses weak patentability standards for medicines, which many agree requires reform and contradicts the flexibilities enshrined in the TRIPS agreement;

4) The introduction of royalties on drugs even in countries and regions where patents do not exist, and the payment of royalties and continuing restrictions on generic companies even before patents are granted;

5) Restrictions imposed through the licenses on generic production in any country except India, and through the control over the production and supply of active pharmaceutical ingredients (APIs). These provisions limit local generic production worldwide, which is essential to enhancing competitiveness and self-sufficiency and is one of the few options for countries excluded from the licensing agreement;

6) The MPPF’s inexplicable championing of the “unbundling” provision of the licence, which allows generic companies to opt out of some drug licenses while keeping others. No explanation has been provided to date as to why the MPPF did not negotiate four separate licences;

7) The MPPF’s failure to explain to the public the consequences for generic companies of severing the TDF license. If a generic company severs on TDF, it also loses the ability to produce and supply emtricitabine;

8) The MPPF’s incomprehensible waiver of its legal standing and right to enforce the provisions of the license in any dispute between Gilead and a sub-licensee at a secret arbitration. This neuters the MPPF’s ability to affect much of what occurs after a sub-licensee agreement is signed, including ensuring that the licence is implemented in a manner that increases access to medicines. This refusal to accept legal responsibility is inexplicable and unwarranted, hampering not only the MPPF’s effectiveness but also the influence of civil society groups over the implementation of any and all licenses.

Summary of key concerns with respect to process and MPPF principles

1) An absolute lack of transparency on the terms of reference, roles and responsibilities, selection criteria and selection process of the ad-hoc Expert Advisory Group (ad-hoc EAG), which was consulted during the MPFF’s negotiations with Gilead, and the permanent EAG currently being assembled. Furthermore, we perceive a lack of transparency around the EAG’s process, provision of inputs, and the extent to which these inputs are integrated into decision-making. Also of concern is the lack of involvement of PLHIV, and the under-representation of key organizations working on access to medicines for HIV/AIDS in the global South on the EAG (members of which were noted by the MPPF at the meeting on 2 October 2011). 

2) The refusal by MPPF staff to disclose i) the contents of the review by the ad-hoc EAG on the Gilead license agreement prior to its approval, and ii) the contents of the limited (if any) due diligence the MPPF may have conducted;

3) The lack of clarity around the process of determining whether a license negotiated by the MPPF meets the primary purpose for which the MPPF was created: to improve the health of people in low- and middle-income countries;

4) The provision stating that the MPPF is to receive 5 percent of all royalties paid by sub-licensees to Gilead up to the amount of $1 million per annum. We believe this represents poor judgment and a serious conflict of interest. (We note, though, that at the meeting on 2 October 2011, MPPF staff specifically acknowledged that even the appearance of conflict of interest in these agreements is harmful—and will consider the removal of this language in the existing license agreement and any potential future ones);

5) The public relations strategy of the MPPF around this agreement has confused and misled the public. On 12 July 2011, the MPPF-Gilead agreement was announced in London. Simultaneously, Gilead made a public announcement in India extending its partnership with four Indian generic pharmaceutical firms—Ranbaxy, Hetero, Matrix and Strides Arcolab—to produce and market two pipeline HIV drugs (elvitegravir and cobicistat) and a combination product known as the “Quad”. These separate agreements had no relationship to the MPPF and ensured these companies would remain outside the Pool.  These separate agreements with the four Indian companies segmented the market for the drugs in the pipeline, and completely undermined the MPPF-Gilead agreement. It is troubling that the MPPF representatives were aware of these “preferred partner” agreements, and yet did not publicly criticize Gilead for acting in bad faith or draw sufficient attention to the implications of the side deals.

Additionally, these side licenses require the Indian generic companies to pay royalties of between 10 and 15 percent for cobicistat, elvitegravir and the Quad in countries not included in the MPPF license (Botswana, Ecuador, El Salvador, Indonesia, Kazakhstan, Namibia, Sri Lanka, Thailand and Turkmenistan). To date, though, the MPPF and UNITAID have refused to comment on Gilead’s actions. To us, this signals that the MPPF and UNITAID value their relationship with a for-profit company far more than the principles on which both organizations were established; and

6) The exaggerated claims of actual benefit and potential impact in public relations by the MPPF, and supportive statements of these claims by UNITAID and other stakeholders, about this license and the MPPF’s overall strategy. These actions are both misleading and damaging as they allow originators and decision-makers to be complacent and satisfied with the notion that the MPPF solves most issues regarding access to medicines. Given that the licensing agreement leaves behind half a million patients, both UNITAID and the MPPF should reflect seriously on celebrating these licenses in the press.

However, a review of the licenses raise a number of serious issues that could impact the access to medicines movement within the broader context of patent law reform and trade policies.

In collaboration with the International Treatment Prepardeness Coalition (ITPC), an international coalition of people living with HIV/AIDS devoted to advocacy on HIV/AIDS treatment access, I-MAK has prepared a briefing paper which analyses the licenses and sets out what the potential broader implications are to access and patients. The paper also raises a number of pertinent questions about the role of the MPP and the process under which the licenses were entered into. The Briefing Paper - The Implications of the Medicines Patent Pool and Gilead Licenses on Access to Treatment can be downloaded here.

Gilead has 60 days from 10 May 2011 to appeal the rejection. Details of the status of the application can be accessed through INPI's patent database here.

Gilead's parent application no. PI9811045, also claiming tenofovir disoproxil fumarate, is currently under appeal by Gilead with the courts.

This means that presently there is no product patent in Brazil blocking the importation or generic production of tenofovir disoproxil fumarate.

Thanks to Francisco Viegas Neves da Silva for alerting us to these developments.

On 13 April 2011, the IPO issued a decision under s15 of the Patents Act refusing Abbott's application number IN/PCT/2001/00018/MUM ('00018), which claimed a polymorph of ritonavir. I-MAK had prepared and filed a pre-grant opposition to 00018 on behalf of Indian patient groups. The application was also opposed by Ranbaxy, Matrix and Cipla.

It appears that in light of the IPO maintaining its objections through the first examination report and pending pre-grant oppositions, Abbott abandoned the application.

The abandoning of 00018 follows an earlier correspondence from Abbott's Indian attorneys requesting that no further action be taken in relation application numbers 676/MUMNP/2007, 677/MUMNP/2007 (both divisional applications of 00018) and 726/MUMNP/2009 (a divisional of 339/MUMNP/2006 ('339), the refused heat stable form of lopinavir/ritonavir). We are still awaiting official correspondence from the IPO confirming the abandoning of the applications. Abbott had abandoned another divisional application of '339 (Application No. 2474/DELNP/2009) last year (see here).

According to our initial checks on the IPO database, no new divisional applications for the abandoned ones have surfaced as yet. However, it can take some time before such applications are published, so we wait to see. It is also possible Abbott may change the claims of its application 1638/MUMNP/2007 (also a divisional of '00018) back to the original claims covering the polymorph of ritonavir. The current divisional claims only cover a process for preparing a substantially pure ritonavir crystalline form.

With respect to the refused application for '339 relating to the heat stable form, the deadline for Abbott to appeal to the Intellectual Property Appellate Board (IPAB) was 31 March 2011. To date we have not received any notice of an appeal, but this can take time to be processed by the IPAB.



This drug combination, Lopinavir/Ritonavir, is considered to be the front line of defense for HIV positive patients who have failed to stay healthy with the first round of medicines available today. India, the world’s leading supplier of affordable medicines, can now supply this drug to patients across the globe who are desperately waiting for treatment.

The impact of the case is tremendous. There are over 33 million people living with HIV today and of these nearly 15 million require access to HIV drugs. Cost-savings generated over a three-year period by introducing generic Lopinavir/Ritonavir to 43 low- and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment who currently lack access. That is 130,000 lives that could be saved from opening up the market for this drug alone.

Cheaper generic versions of this drug are ready to reach patients in India and across the world. Most recently, the Clinton Health Access Initiative has negotiated a price of $440 per patient, per year for generic versions of this drug from four suppliers. Enabling competition amongst Indian suppliers has been demonstrated to consistently drive down prices on HIV medicines, from $10,000 per patient per year in 2000, to as little as $79 today.

This affordable pricing by generic suppliers in India is in stark contrast to the unaffordable pricing by Abbott Laboratories on HIV drugs across the world over the last decade. “Abbott’s track record on pricing this drug unfairly for poorer countries motivated us to take on this case”, stated Tahir Amin, Director of the Initiative for Medicines, Access & Knowledge, the not-for-profit organization who brought the legal action. “They have gamed the patent system for nearly twenty years to extend the patent life on this drug. The time has come to say, ‘enough is enough’.”

Abbott Laboratories holds at least 75 patents on Lopinavir/Ritonavir alone. The rejection of this patent application in India was for a combination of existing drugs and techniques. The Indian Patent Office has put a halt to Abbott Laboratories patenting which, simply put, was not an invention.

Documents on the case, including the decision, are available at http://www.i-mak.org/lopinavirritonavir.