Indian Patent Office Seeks Comments to Draft Guidelines
The Indian Patent Office is seeking comments on its recently released “Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals”. These guidelines will add to the current practices and procedures followed by Indian patent offices, and are expected to help Examiners and Controllers in achieving consistently uniform standards when examining and granting patents.
The draft guidelines were formulated based on the analysis from the various courts decisions in relation to product patenting. The guidelines can be downloaded from here.
Comments/Suggestions can be mailed to office of Controller General of Patents, Designs and Trademarks by 21st March 2014 to [email protected]
Argentinian Community of People Living with HIV file pre-grant opposition against Gilead and BMS’s "ATRIPLA" patent
Argentina, December 4 , 2013
For the first time, communities in Argentina have filed a pre-grant opposition against a patent for a combination of antiretrovirals with priority use in the country.
A pricing study conducted by RedLAM, the Latin American Network for Access to Medicines, showed that TDF/FTC/EFV, sold exclusively in Argentina under the name and trademark "ATRIPLA", costs the public programme provision about U.S.$ 2605 per person per year.
U.S. companies Gilead Sciences and Bristol-Myers Squibb Laboratories are pursuing a pharmaceutical patent for ATRIPLA, and their patent application is in the review phase at the National Institute of Industrial Property (INPI).
This prompted the concern of the activists and organizations of people living with HIV who filed today a “Health Safeguard”, to oppose the patent application for TDF/FTC/EFV.
"This drug is very important for us because it is easy to administer, [as it comes] in a single daily dose, meaning just one pill per day " said Pablo Garcia, Secretary General of Argentina Network of Positive People, an organisation that has been working in the country since 1998 to improve the quality of life of people living with HIV, and which filed the patent opposition.
These guidelines indicate that combinations of existing compounds - which is the case with ATRIPLA, which combines tenofovir, efavirenz and emtricitabine (TDF + FTC + EFV) - are not patentable, on the basis that they lack novelty and inventive step to justify the granting of a new patent on active ingredients that are already in public domain.
"It is common practice for pharmaceutical companies to try to patent the same molecules making just small changes, or combining existing drugs, and this strategy is called "evergreening " said Jose Maria Di Bello, who filed the opposition.
The new manual for the examination of pharmaceuticals patent applications in Argentina stems from a joint resolution adopted by the Ministry of Health (MS 546/2012), the Ministry of Industry (MI 118/2012), and the National Institute of Industrial Property (INPI 107/2012), and establishes internal guidelines to prevent this abusive practice, an illustration of the barriers that pharmaceutical patents can have on access to medicines.
"We welcome the establishment of new guidelines for the examination of pharmaceutical patents in our country which take into account the needs of public health of our population" said Lorena Di Giano, Executive Director of the GEP Foundation, which filed the opposition with the INPI.
Evergreening is used by the multinational pharmaceutical industry to extend monopolies on essential medicines to treat diseases like HIV/AIDS, cancer, hepatitis C, among others, allowing them to charge exorbitant prices for drugs despite quality generic versions existing internationally at affordable prices.
The Indian generic version of TDF/FTC/EFV sells for US$139 per person per year, according to Doctors without Borders (MSF) in its publication Untangling the web.
"We are concerned about the sustainability of the Drug Supply Programme - even more so when new treatment guidelines indicate more people will need to start antiretroviral treatment earlier - as we see prices are getting higher because of patent protection," said Pablo Garcia.
"Argentina´s national patent legislation has mechanisms that can be used in cases of abuse of the patent system, and we have therefore filed the opposition to the patent filed by Gilead Sciences and Bristol-Myers Squibb" said Lorena Di Giano, Executive Director of GEP Foundation and General Coordinator of RedLAM.
"Pharmaceutical patents delay the market entry of generic drugs, prevent price competition and make it harder for the population to access health," said Alex Freyre, President of the GEP Foundation.
To ensure "universal access" to antiretroviral medications, Argentina currently invests more than 90% of the budget allocated to the DNS and ETS (National AIDS and Sexually Transmitted Diseases Department), Ministry of Health of the Nation in antiretroviral procurement.
According to information provided by the DNS and ETS, the budget allocated to purchase ARVs increased significantly in recent years, from $33.7 million in 2006 to $45.2 million in 2009 and $75 million in 2011. This is due to several causes, including the incorporation of new drugs to the list of drugs procured by public programme in 2009, and the rising cost of antiretroviral procured by the DNS and ETS.
The price of new generation drugs impacts significantly the budget allocated to the DNS and ETS. Most of these drugs are patented or have patent applications pending before the National Institute of Industrial Property (INPI).
We hope that INPI examines the patent application for TDF/FTC/EFV promptly, as it does not comply with the legal requirements of Art. 4 of national patent law (24481).
Representatives of signatory organisations held a meeting with the President of the INPI, Roberto Aramburu, at the time of the filing of the opposition, for the purposes of defining a joint programme of work.
Organisations which support the opposition to the ATRIPLA patent:
• Red Argentina de Personas Positivas (Redar Positiva)
Patent opposition filed in India on sofosbuvir, new Hepatitis C drug
In a bid to make the new oral Hep-C drug sofosbuvir affordable to patients across the world, the Initiative for Medicines, Access & Knowledge (I-MAK) filed a pre-grant opposition against Gilead Sciences’ patent application at Kolkata patent office. The opposition can be accessed at I-MAK’s website. Gilead’s patent application, pre-grant opposition and a brief landscaping of the drug is available on the Patent Opposition Database.
Sofosbuvir is one of the several oral hepatitis C virus (HCV) drugs coming out of the pipeline with high success rates, fewer side effects and much shorter treatment duration. The European Medicines Agency approved the drug for market use last week, with US FDA approval expected on 8 December.
Médecins Sans Frontières has started to treat people co-infected with both HIV and HCV, using today’s costly and complex regimen supported IMAK’s initiative. The opposition that would pave the way for speedy generic manufacturing was also welcomed by the Open Society Foundation in its statement.
The drug is expected to be launched by Gilead in the US market at an exorbitant price of US$80,000, although sofosbuvir can be produced at a cost as low as $62-134, according to a study published recently by Dr. Andrew Hill, pharmacologist at Liverpool University.
South Africans tell the government to Fix the Patent Law
Last month, the South African department of Trade and Industry released its Draft National Policy on Intellectual Property 2013, as part of the process of reforming the country’s patent laws. Tomorrow (17 October 2013) is the last day to submit comments, so join us in encouraging the country to fight patent abuse and take steps to encourage access to affordable medicines.
The stakes are high: by granting excessive amounts of patents, the current law has failed to ensure access to affordable medicines for the growing burden of communicable and non communicable diseases in the country. The draft policy is an attempt by the government of South Africa to introduce pro-public health flexibilities allowed under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) to counter abusive patenting practices.
The Treatment Action Campaign (TAC) has debunked some of the myths raised by big pharmaceutical companies on the reforms proposed by the draft policy and their impact on public health and economic growth.
You can support the Fix the Patent Law campaign by signing an open letter, from civil society in South Africa including TAC, Medecins Sans Frontieres and Section 27, which calls on the DTI to support many of the proposed reforms and gives recommendations for further improvements in the draft policy.
You can also join the March being organised on 17th October starting from Burger Park, Pretoria at 10h30 to deliver the civil society recommendations on patent law reforms to the DTI. To sign on to the letter, and for more details about this campaign, visit the campaign’s site.
Swiss drug major Roche to drop anti-cancer drug Herceptin patent in India
Via Economic Times
16 Aug 2013, MUMBAI: Swiss drug major Roche has decided not to pursue its patent for anti-cancer drug Herceptin, the patent which had come up for extension till 2019, paving the way for generic drug makers to manufacture this drug.
Trastuzumab, sold under the brand name of Herceptin, is used in breast-cancer treatment and costs close to Rs 1 lakh for a month. "Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent for Trastuzumab) and the related divisional applications. This decision takes into account the strength of the particular rights and the Intellectual Property environment in India in general," a Roche spokesperson said in an email query to ET.
Roche let the patent for Herceptin lapse in May this year, however, the company had time till November to pay the fee and claim its patent.
Roche said it will continue to enforce all other patents in India and remains committed to working with the Indian government. "We believe ensuring access to innovative medicines such as Herceptin is a complex issue and that significant progress will only be made through ongoing close collaboration between the government, industry and care providers without compromising intellectual property rights or biosimilar approval requirements," it added.
Incidentally, Herceptin is the same drug which the health ministry had proposed for a compulsory licence under Section 92 of the Indian Patent Act, which allows government to revoke a patent during emergency situation. But the government had hesitated to revoke the patent because it didn't know if there were other Indian drug makers who were ready with the copy of this drug.
Herceptin contributes close to Rs 127 crore to Roche's annual turnover, according to industry estimates. Roche's decision of giving up its patent is a smart move, say IP experts as there is no Indian company manufacturing this drug due to the complex science involved. So, even after giving up the patent, Roche will be the only company that will be manufacturing this drug, and the company knows it.
"While the patent for Trastuzumab may no longer be in force, it is important to note that there are currently no approved biosimilars of Trastuzumab in India. We support the Indian government's leadership in establishing a pathway and guidelines for the introduction of biosimilars onto the market that is based on science and is designed to ensure product quality and patient safety," said the company.
Biocon-Mylan, Reliance Life Sciences and BDR Pharma are a few companies working on a copy of Herceptin.
Multinational drug makers including Roche have come under severe pressure from the Indian government to cut the prices of key anti-cancer drugs as it is beyond the reach of a large number of the patients. Last year, the patent office issued the first ever compulsory licence to Natco Pharma to manufacture the cheaper version of German drug maker's kidney anti-cancer drug Nexavar.
I-MAK launches searchable patent database of Hepatitis C drugs
I-MAK (Initiative for Medicines Access and Knowledge) has created a searchable patent database for pegylated interferon alfa 2A and 2B (drugs used in the treatment of Hepatitis-C). The database is available here.
This database helps determine where patent barriers may exist to the legal production, exportation or importation of biosimilar versions of the currently marketed PEG interferon products Pegasys (Hoffmann La Roche) and PegIntron (Schering-Plough).
Data from the Patent Landscape Report for Pegylated Interferon Alfa 2A & 2B can be read here: full report
New resources from Argentina now available on PODB
Thanks to recent contributions from Argentina, the Patent Opposition Database (PODB) now has more resources available in Spanish.
25 patent oppositions have been submitted by members of CILFA (the Industrial Chamber of Argentinean Pharmaceutical Laboratories), including for the HIV medicines efavirenz, ritonavir, lopinavir, raltegravir, elvitegravir and the fixed-dose combination TDF/FTC/EFV, as well as medicines to treat other conditions like heart disease, diabetes, and arthritis.
Attempts at evergreening successfully blocked
Some of these new resources were used to successfully block attempts at gaining or extending patents on existing medicines.
Two patent applications on polymorphic forms of efavirenz for example were opposed by members of CILFA – the trade group representing the main Argentinian pharmaceutical companies. The applications were subsequently rejected by the patent office, allowing for the drug to be kept in the public domain – a critical objective given that efavirenz was never patented in Argentina, and several companies had therefore started to produce the drug, bringing the prices down.
Patent applications were also rejected for ritonavir, after oppositions were filed.
Pre-grant oppositions, known in Argentina as “observations” or “calls for attention”, are allowed, and although the patent office is not obliged to consider them, experience suggests they are taken into account.
To learn more about the oppositions presented by CILFA, visit their site (in Spanish).
Patent examinations in Argentina: a good model under attack
In May 2012, the Argentinean Patent Office together with several Ministries issued new guidelines for patent examination of pharmaco-chemical inventions in the country. See the guidelines for patent examiners in ENGLISH and in SPANISH (PDF).
The new guidelines represent a strong stand against evergreening strategies, since they specifically prevent the patenting of several types of secondary patents, such as new use, new form, and new formulation patents. They also provide a stronger push for sufficient disclosure and clarity in patent claims. If strictly applied, the new guidelines can bring a strong public health perspective in the patent examination process in Argentina. Like India’s Section 3 (d) these guidelines can become a precedent for other countries to streamline examination process of pharmaceutical patents. The adoption of the new guidelines is also a reaffirmation of countries’ right to set their own patentability requirements.
Figures from 2012 show that after the adoption of the new guidelines in May 2012, only two pharmaceutical patents were granted in Argentina compared to 53 patents granted before the issuance of the new guidelines. Further information can be found here.
But these guidelines are coming under fire. Some weeks after the issuance of joint resolution 118/12 (Ministry of Industry) – 546/2012 (Ministry of Health) – 107/2012 (Patent Office), which approved the new guidelines, the Argentinean Association of intellectual property Agents (AAAPI) presented an administrative complaint asking for the joint resolution to be revoked.
The CAEME (Argentinean Chamber of Medical Specialties), which represents multinational laboratories in Argentina, also publicly complained about the new guidelines.
Lorena Di Giano, from the Argentinean Network of People Living with HIV, says that the new guidelines can serve as a model for other countries, and that they should be defended. In its 2013 submission to USTRA, the US pharmaceutical lobbying group, PhRMA, also criticized these guidelines considering them contrary to the TRIPS Agreement (PDF).
Huffington Post: Patent Reform, System Should Be Abolished, Fed Economists Say
By Zach Carter
5 February 2012: Two economists at the St. Louis Federal Reserve published a paper arguing to abolish the American patent system, saying there's "no evidence" patents improve productivity and that they have a "negative" effect on "innovation."
The research suggests that President Barack Obama's 2011 patent reform legislation -- one of only a handful of major bills to clear Congress with bipartisan support in recent years -- was wrong-headed.
Patents are designed to encourage innovation by granting inventors long-term monopolies on new products. In recent years, however, several innovators in high-tech sectors have complained that the large volume of vague patents has become a major barrier to innovation. When start-ups attempt to unveil a new product, they risk violating a broad, obscure patent.
"Our preferred policy solution is to abolish patents entirely," the paper's authors, economists Michele Boldrin and David K. Levine, wrote. They conclude that problems with patents in fact run much deeper than many critics of the recent system have emphasized.
"The historical and international evidence suggests that while weak patent systems may mildly increase innovation with limited side effects, strong patent systems retard innovation with many negative side effects," Boldrin and Levine wrote. "More generally, the initial eruption of innovations leading to the creation of a new industry—from chemicals to cars, from radio and television to personal computers and investment banking—is seldom, if ever, born out of patent protection and is instead the fruit of a competitive environment."
The paper also argues that the patent system is damaging public health by raising the cost of prescription drugs, while failing to generate a plethora of innovative new treatments for life-saving diseases.
"Rather than just ratcheting up patent protection, there are a number of moves we could make to reduce the risks and cost of developing new drugs," Boldrin and Levine wrote.
Those approaches were not taken by the 2011 patent reform bill. Rather than decrease the overall patent load, the legislation sought to expedite the process and provide more safeguards against awarding low-quality patents. In September, the Obama administration commemorated the first anniversary of its patent reform bill with a blog post boasting of a faster, streamlined patent approval system.
"The U.S. Patent and Trademark Office is implementing the legislation in a manner that makes it easier for American entrepreneurs and businesses to bring their inventions to the marketplace sooner, converting their ideas into new products and new jobs," the post reads. "It will help companies and inventors avoid costly delays and unnecessary litigation, and let them focus instead on innovation and job creation."
The White House did not immediately respond to a request for comment on the paper.
But the problem of patent lawsuits has not been mitigated by the law. Since its passage, large tech companies have embroiled themselves in high-profile cases claiming patent infringement for everything from rounded corners to double-tapping a smartphone screen.
Hoping to improve patent quality, Boldrin and Levine say, is a lost cause.
"Why use band-aids to staunch a major wound?" Boldrin and Levine wrote. "Economists fought for decades -- ultimately with considerable success -- to reduce restrictions on international trade. A similar approach, albeit less slow, should be adopted to phase out patents."
A research article by Amy Kapczynski, Chan Park, and Bhaven Sampat
Background
While there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.
Methodology/Principal Findings
We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).
We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.
Conclusions/Significance
Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry.
Summary of key messages from Health Affairs paper by Tahir Amin (I-MAK) and Aaron Kesselheim on secondary patenting as a threat to affordable, generic HIV medicines by I-MAK.
Compulsory License for anti-cancer drugs in India – Update from Campaign for Affordable Trastuzumab
14 JANUARY 2013, NEW DELHI -- The Campaign for Affordable Trastuzumab welcomes the news that the Government of India has started the process of issuing compulsory licenses for the manufacture of three anti-cancer drugs – trastuzumab, dasatinib and ixabepilone.
See the Indian Express news report here: Govt moves to make three key cancer drugs cheaper, 12 Jan 13, New Delhi, Indian Expres
This move will come as a huge relief to the thousands of women with HER2+ breast cancer whose lives can be saved by trastuzumab, but who are unable to access this drug because of predatory pricing by Roche, which currently controls the drug. A full course of tratsuzumab treatment costs Rs. 6 lakhs to Rs. 8 lakhs at current prices.
Compulsory licensing for the generic production would result in significant price reductions. For instance, the price of sorafenib reduced by 97% (from Rs. 2.8 lakhs to Rs. 8,800 per month) after a compulsory licence was issued to an Indian company in March 2012.
In November 2012, the Campaign for Affordable Trastuzumab wrote an open letter to the Prime Minister, signed by over 200 cancer survivors, women’s groups, human rights and health rights campaigns and treatment activists from around the world, urging the government to make the drug affordable and freely available to patients.
See here for a copy of the letter.
“Drug companies are holding our health hostage to their greed for profits” said Kalyani Menon-Sen, campaign coordinator. “Roche should not be allowed to get away with such a predatory pricing policy. Courts and other authorities like the Competition Commission must take suo moto action against Roche for abusing its dominant position in the market.”
Breast cancer remains one of the leading causes of cancer death in women worldwide and is now the most common form of cancer in urban areas in India. In a worrying trend, ICMR data show that younger women are showing an increasing incidence of the aggressive HER2+ type of breast cancer. Trastuzumab, often referred to as a wonder drug, substantially reduces mortality for women with early stage HER2 positive breast cancer and increases survival time among women whose breast cancer has spread. No other cancer drug can be substituted to attain this effect.
In a related development, an international team of health activists has moved the WHO for the inclusion of trastuzumab in the WHO’s Model List of Essential Medicines (EML) for early stage breast cancer and metastatic cancers. An official submission which lays down the rationale for qualifying trastuzumab as an essential medicine is now under review. If accepted, this would be a powerful lever for making trastuzumab affordable and widely available in developing countries.
The submission by Knowledge Ecology International, University of California- San Francisco and Universities Allied for Essential Medicines is being made available on the WHO website here
Given this clear indication by the Government of India of its willingness to resist pressure from Big Pharma, the Campaign for Affordable Trastuzumab calls on the Indian pharmaceutical industry to rise to the challenge and hasten the process of developing and testing biosimilars of trastuzumab.
For further information please contact Kalyani Menon-Sen: kmenonsen [at] gmail.com, +91 9910306382.
New briefing doc from TAC, RIS, & MSF explains why South Africa should examine pharmaceutical patents
Should a developing country be satisfied with simply registering patents if they have been granted in a developed country and if basic administrative requirements have been met? Or, instead, should that country insist on a thorough technical or scientific examination of the validity of the claims of every patent application filed? Should a developing country attempt to develop national capacity to examine patent applications, in order to apply patentability criteria that may be nationally appropriate?
These are the questions that must be answered as South Africa embarks on a national debate on its industrial and IP policy.
A new briefing document lays out how South Africa is failing to take advantage of the flexibilities allowed under international rules in their national patent regime and how this is having a significant adverse impact on the affordability and accessibility of medicines for South Africans. It lays out the problems with South Africa's current patent regime, which registers but does not examine patents, and also proposes a solution, the establishment of a patent examination system.
Precedent-setting post-grant opposition revokes patent on crucial Hep C drug
In an important decision, India’s Intellectual Property Appellate Board has revoked the patent on Hepatitis C treatment drug pegylated interferon after post-grant opposition proceedings were initiated by Indian NGO Sankalp Rehabilitation Trust in 2007. Sankalp Rehabilitation Trust filed a post grant opposition to the patent, as the technology of combining interferon and other biologically active proteins with PEG has been known for years.
Despite Roche's arguments that patient groups do not have the right to initiate post-grant oppositions, the Board's decision establishes that patient groups are 'a person interested' under Indian law; i.e. they have the right to file post grant oppositions.
On 3 March 2006, Roche proudly announced it was becoming the first pharmaceutical company in India to receive a product patent under the new patent regime on peg-interferon alfa-2a (IN198952). This patent has now been set aside, five years before it was slated to expire, which will open up competition for affordable bio-similar versions to be developed and registered.
Roche's price for the medicine was over US$200 per dose.
This victory is important as it encourages other patient groups to challenge patents that have been wrongly granted on medicines for HIV, cancer and other diseases, through a post-grant patent opposition.
Below is a media release from the Lawyers Collective, who represented Sankalp throughout the case:
Source: Lawyers Collective
Hope for Hep-C patients: Patients succeed in overturning first ever product patent on medicine in India
2 November 2012, New Delhi.
In a landmark victory for patients’ groups fighting against patents to ensure access to medicines, the Intellectual Property Appellate Board (IPAB) has revoked a patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a (Pegasys, a medicine used to treat Hepatitis C) as well as held that a patients’ group can challenge the validity of granted patents.
Mr. Eldred Tellis, Director of Sankalp Rehabilitation Trust, who had challenged the patent, said, “We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C. We also hope that the Government will now take concrete steps to start providing access to this medicine. It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine.”
As may be recalled, 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. The patent granted a monopoly to Roche to market pegylated interferon alfa2a. Patients with chronic Hepatitis C, who need a six-month course of treatment of Roche’s pegylated interferon alfa2a, have to purchase it at a cost of approximately INR 4,36,000 [USD 8,752.38] (available at a discounted price of INR 3,14,496 or USD 6,313.28). Again, it has to be taken in combination with ribavarin, which alone costs INR 47,160 [USD 946.70].
Concerned about the impact of this patent on access to medicines, Sankalp—an organisation that provides treatment and rehabilitation support for injecting drug users—filed a post-grant opposition challenging the grant of the patent with technical and legal aid from Lawyers Collective HIV/AIDS Unit.
Mr Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS Unit, who appeared for Sankalp in this matter, said, “This victory will facilitate early entry of generics which is likely to lower the prices. If this happens, millions suffering from Hepatitis C, both in India and globally, will benefit. It is also historic because this was the first ever product patent granted on a medicine in India since 1970.”
Hepatitis C represents a huge public health problem in India and globally. An estimated 10–12 million people in India, including 50% of IDUs nationally and 90% of IDUs in the northeast, are infected with the Hepatitis C virus (HCV). Left untreated, Hepatitis C can lead to liver cirrhosis, liver cancer or liver failure. Hepatitis C is especially of concern for those co-infected with HIV, as several studies have shown that HIV-HCV co-infection leads to increased rates of disease progression. Injecting drug users are especially vulnerable to HIV-HCV co-infection with HIV-HCV co-infection rates as high as 93% among IDUs in Manipur. However, unlike both first- and second-line HIV treatment, which is available to all people living with HIV who need it, Hepatitis C treatment is not available in government hospitals largely due to its high cost and treatment programmes do not even bother to screen patients for HCV due to the unavailability of treatment.
Despite Sankalp’s case that Roche’s clams did not satisfy the patentability requirements under Indian law, in 2009, the Patent Office rejected the post-grant oppositions filed by Sankalp and an Indian company and upheld the validity of Roche’s patent. Sankalp then filed an appeal before the IPAB challenging this decision.
Before the IPAB, Roche also challenged Sankalp’s standing to file the post-grant opposition as well as the appeal. Roche argued that because Sankalp was not a business competitor or a researcher in the sector, it could not have challenged its patent at all. Sankalp argued that its members were directly affected by Hepatitis C as well as that it represented a community of drug users who are particularly at risk to Hepatitis C. The IPAB observed that “public interest is a persistent presence in intellectual property law” and also held that it was against public interest to “allow unworthy patents to be on the Register”. Holding that “the appellant who works for the community which needs the medicine, is definitely ‘a person interested’”, the IPAB noted that a successful challenge would “break the monopoly” and “bring the drug within reach of the community for whom it works, not only by reduction in cost, but also because of increase in supply”.
Mr. Grover said, “We are happy that the IPAB has recognised the element of public interest in setting aside undeserving patents and held that patients’ groups, who are directly impacted by patents on medicines, can challenge granted patents. This will be of import as concerned patients’ groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases.”
Setting aside the patent, the IPAB held that Roche’s pegylated interferon was obvious to a person skilled in the art. It also found that Roche has not provided any evidence, in the specification or even otherwise, to prove that pegylated interferon has enhanced efficacy. The IPAB, however, held that Roche’s claims were novel.
Welcoming the findings on obviousness and section 3(d), Mr. Grover said, “The IPAB has rightly observed that the patentee used conventional methods to pegylate interferon and obtained predictable results, thereby rendering it obvious to a person skilled in the art. It also correctly held that the patentee has failed to satisfy the requirement of section 3(d) of showing enhanced efficacy. We hope that the Patent Offices too follow these standards while deciding pre- and post-grant oppositions.”
The text of the order can be accessed at the website of the IPAB. We will upload a copy of the official certified copy as soon as we receive it.
Lawyers Collective HIV/AIDS Unit and Sankalp Rehabilitation Trust
Court stops Cipla's generic despite revoked patent on Pfizer's Sutent via Scrip Intelligence
15 October 2012
Anju Ghangurde
An Indian court has dismissed an appeal by Cipla in a case concerning the potential launch of its generic version of Pfizer's anticancer, Sutent (sunitinib malate). Activists have red-flagged the development given that the patent on Sutent was recently revoked in India and cut-price generic versions were expected to be available shortly.
Cipla is said to have moved a division bench of the Delhi High Court, after a single judge bench had, in response to a plea by Sugen Inc, disallowed Cipla from taking any steps towards launching its generic version of Sutent till 15 October. The case before the single judge has now been adjourned till 6 December, implying that the stay on Cipla's generic holds till then.
Activists say that the court's stance is of concern given that India had recently revoked the patent on Sutent (scripintelligence.com 5 October 2012) and a stay on the cut-price generic in the absence of a patent is a 'big concern' in terms of legal precedence. "We are not sure of the details of the ruling but it undermines the legal flexibility of post grant oppositions in India," said an official with an international humanitarian body.
The official also said that courts perhaps need to be 'more cautious' in their approach for granting injunctions especially in the pharmaceutical industry, given that lives of patients are at stake. Cipla's proposed generic version is expected to about 75% cheaper than Sutent, which currently carries a maximum retail price tag of Rs255,149 ($4,931) for a pack of 28 capsules, though it is said to be available to patients at about Rs196,000.
While details of the division bench's reasoning were not immediately available, the indications are that Sugen/Pfizer had apparently claimed that natural justice had been denied to them in the case. The multinational is believed to have claimed that it did not receive a copy on the recommendations of a three-member 'opposition board' [which is constituted by the patent controller and examines the notice of opposition etc] in the case, though this could not be officially confirmed. Pfizer told Scrip that it does not wish to make 'any comment' on the Sutent patent in India as the matter is currently sub judice.
Dr Nilanjana Mukherjee, assistant controller of patents and designs at the Delhi patent office, had in a ruling dated 24 September, held that the invention claimed in the [Sutent] patent did not involve an inventive step and was obvious to the person skilled in the art. Cipla had in 2008 filed an opposition against Sugen Inc and Pfizer's 2007 patent for Sutent in India. Pfizer has said that it will appeal to India's Intellectual Property Appellate Board (IPAB) against the revocation order.
Significantly, industry experts also told Scrip that while Cipla may have sit out of the market for now, other Indian players can technically launch their products, though it's unclear how many firms would do so. Moreover, it's also unclear if Pfizer would perhaps consider similar legal action against potential entrants.
"In an interesting development, Cipla has abandoned its patent application 733/MUMNP/2004 relating to “A combination of Azelastine and steroids” which had 50 claims. The application was abandoned after a pre-grant opposition was filed against it. Here is the 8-page decision delivered on October 14, 2012 by the Mumbai Patent Office, of which 6 pages contain only the claims of the application."
Azelastine is indicated for use in the local treatment of the symptoms of seasonal allergic rhinitis and perennial allergic rhinitis
via the Demanding Mistress: Indian IP Law & Policy
New article highlights how secondary patents delay entry of lower-cost generic medicines
ARTICLE: Secondary Patenting Of Branded Pharmaceuticals: A Case Study Of How Patents On Two HIV Drugs Could Be Extended For Decades
Authors: Tahir Amin and Aaron Kesselheim
Date: October 2012
Abstract
Pharmaceutical manufacturers rely on patents to protect their intellectual property and often seek to extend market exclusivity for their products to maximize their return on investment. One method is by obtaining patents on features other than the original active drug ingredient, including secondary patents on alternate formulations of the drug or on methods of administration. This article examines how secondary patents can extend market exclusivity and thus delay generic competition, using as an example two key antiretroviral drugs for the management of HIV: ritonavir (Norvir) and lopinavir/ritonavir (Kaletra). We identified 108 patents, which together could delay generic competition until at least 2028-twelve years after the expiration of the patents on the drugs' base compounds and thirty-nine years after the first patents on ritonavir were filed. Some of the secondary patents that were reviewed were found to be of questionable inventiveness. We argue that increased transparency for existing patents, stricter patentability standards, and increased opportunities to challenge patent applications and patents could reduce inappropriate market exclusivity extensions on brand-name drugs and open the door to lower-cost generics.
