Ever wondered why Novartis and Roche do not compete ? #Pharma


 

Glivec (Gleevec) film tablet made by Novartis.

 

Expectations of structural change and divestments will be reignited by the Symonds announcement, note analysts at Deutsche BankOne particular conundrum for investors is the 33 percent shareholding that Novartis holds in its compatriot Roche. Jimenez has ascribed an intangible value to the shareholding, which allows the company to have some say in any acquisitions Roche would choose to make that required the issuance of new shares. Investors may feel that the money could be spent more effectively elsewhere, particularly as Novartis’ financial stake in Roche is something of a Vasella heirloom and reminder that the former CEO often talked up the possibility of a Swiss mega merger.

 High-profile personnel changes at Novartis drive analyst speculation as CEO delivers consistent message 

 

(Ref: ViewPoints Desk)

In quick succession to the announced departure of chairman and former CEO Daniel Vasella in January, Novartis announced on Wednesday that Jon Symonds would leave the company at the end of 2013 after four years as CFO.

Despite CEO Joseph Jimenez using the company’s Q1 analyst call to drive home the message that Novartis remains committed to its current growth strategy, the departure of Symonds was a key focus for analysts in notes that were subsequently circulated to investors, and has fuelled speculation that further changes could be afoot.

Insight, Analysis & Opinion

Speaking about his pending departure at the end of the year, Symonds suggested that it was a positive time for a new CFO to take over. That man is the current CFO of Novartis’ pharmaceuticals division Harry Kirsch, who will preside over an emerging post-2013 growth narrative, added Symonds.

There remains some scepticism, however, and Bernstein analyst Tim Anderson suggested that the reason for Symonds departure is not completely clear. Furthermore, added Anderson, close proximity to the departure of Vasella raises the question ‘what next?’

Operationally, analyst reaction to Kirsch’s appointment was mixed. Echoing comments made by both Jimenez and Symonds on the Q1 conference call, analysts at Credit Suisse pointed to a strong record in driving productivity gains within the pharmaceuticals division (during a period characterised by EU austerity measures and generic competition) as a strong precedent for his impending role.

But it is the surprise nature of Symonds departure that analysts have found more difficult to interpret – one conclusion being that Jimenez is keen to appoint his own team and move the company away from the dominant shadow of Vasella (seeViewPoints: Was he worth it? Vasella commits loyalties to his Novartis legacy) Symonds was viewed by many analysts as a driver of improved capital allocation, with some suggesting that his operating role would be enhanced by the departure of the chairman.

Expectations of structural change and divestments will be reignited by the Symonds announcement, note analysts at Deutsche Bank. One particular conundrum for investors is the 33 percent shareholding that Novartis holds in its compatriot Roche. Jimenez has ascribed an intangible value to the shareholding, which allows the company to have some say in any acquisitions Roche would choose to make that required the issuance of new shares. Investors may feel that the money could be spent more effectively elsewhere, particularly as Novartis’ financial stake in Roche is something of a Vasella heirloom and reminder that the former CEO often talked up the possibility of a Swiss mega merger.

See also:

 

 

PRESS RELEASE- Demand for compulsory licensing for Trastuzumab, a life-saving drug for women with HER2+ breast cancer #womensday


CAMPAIGN FOR AFFORDABLE TRASTUZUMAB

8 March 2013

 

The Campaign for Affordable Trastuzumab has called on the Commerce Minister to mark International Women’s Day 2013 with an announcement of compulsory licensing for Trastuzumab, a life-saving drug for women with HER2+ breast cancer. Trastuzumab, the patent for which is held by Swiss pharma giant Roche, is currently priced at Rs.6-8 lakhs for a full course of 12 injections, and is out of reach for all but the most privileged. An estimated 25,000 new cases of HER2+ breast cancer are recorded in India every year, with younger women in the majority among patients.

Trastuzumab has been recommended for compulsory licensing by an Expert Committee set up by the Health Ministry. The recommendation is currently under the consideration of the Department of Industrial Policy and Promotion in the Ministry of Commerce.

The Campaign has urged the Minister to issue a notification under Sections 92 and 100 of the Indian Patents Act, which will end Roche’s monopoly and open the door for local manufacturers to enter the market with affordable biosimilar versions that can compete with Roche’s product.

The letter cites evidence to show that Roche’s pricing policy is irrational and unethical, reflecting its strategy of pushing the pricing envelope to the maximum extent possible.

The Campaign has also cited compelling evidence to show that measures such as negotiated price reductions and voluntary licensing floated by the Ministry of Chemicals and Fertilisers are weak in comparison to the option of compulsory licensing, which can bring prices down four times more than price negotiations. Moreover, while negotiated prices will apply only in India, Indian generics/biosimilars have the potential of increasing access across the developing world.

The letter expresses concern at the Government of India’s apparent reluctance to use the compulsory licensing option to ensure access, even though this measure is available under the Indian Patents At which was amended in 2005 to make it TRIPS-compliant. The first compulsory licence awarded in India – for production of a generic competitor to the liver cancer drug Sorafenib – has been recently upheld by the Intellectual Property Appellate Board.

The Campaign is endorsed by more than 150 Indian and global groups of cancer survivors, health rights activists, women’s groups, treatment activists and public interest organisations.

The full text of the letter is given below.

 

To the Hon’ble Minister for Commerce, Government of India

 

Compulsory licensing for breast cancer drug Trastuzumab

Respected Minister,

Greetings from the Campaign for Affordable Trastuzumab on International Women’s Day.

We are writing to you to enquire about actions taken by your Ministry on the recommendation from the Expert Committee set up by the Ministry of Health to explore the possibility of issuing compulsory licences (CLs) for encouraging the entry of low-cost generic/biosimilar versions of cancer drugs in cases where patents and predatory pricing policies of multinational pharma companies continue to block access to these medicines for the vast majority of patients in India.

Breast cancer drug Trastuzumab on short list for compulsory licensing

Trastuzumab, a patented drug that can save the lives of women suffering from HER2+ breast cancer, has been recommended for compulsory licensing by the Expert Committee set up by the Health Ministry. The patent for the drug is held by Roche and is valid for another seven years. This patent, weak though it is, is discouraging local manufacturers from investing in the development of biosimilars of Trastuzumab that can provide affordable alternatives to Roche’s product.

The recommendation for compulsory licensing of Trastuzumab was welcomed by us 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.

We surely do not need to remind you that breast cancer is now the second most common form of cancer in the country, and that young women constitute the majority of those affected by the aggressive HER2+ variant of the disease. An estimated 25,000 new cases of HER2+ breast cancer are reported each year.

Trastuzumab, often called a miracle drug for its efficacy in preventing recurrence and extending life in cases HER2+ breast cancer, is currently priced at between Rs.55,000/- and Rs 75,000/- per 440 mg dose, and is therefore out of reach for all but the wealthiest. An oncologist at the Tata Memorial Cancer Centre has been quoted as saying that less than 10% of the patients he sees are able to afford Trastuzumab at all, and even fewer are able to complete the recommended course of 12 injections. This is borne out by the testimonies of other survivors and their families1.

The recommendations of the Expert Committee were under consideration by the Department of Industrial Policy & Promotion (DIPP) under your Ministry. Since then, we – and thousands of women who are battling HER2+ breast cancer – have been waiting for a notification from DIPP that will open the door for domestic manufacturers to invest in the development, testing and marketing of biosimilars of Trastuzumab.

We are mystified by the delay in the issuance of a notification under Section 92 of the Patents Act to initiate the process of compulsory licensing for Trastuzumab. The case for compulsory licensing presented by us in our letter to the Prime Minister in November 2012 (see attachment) have been endorsed by over 150 organisations and citizens including cancer survivors, women’s groups, human rights organisations, health NGOs and treatment activists from around the world and eminent jurists. Our argument has now been validated by the recommendations of the Expert Committee of the Ministry of Health.

Discount schemes are no match for generic competition

There is plenty of evidence to show that Roche’s pricing and marketing policy is completely arbitrary and unethical. The so-called “voluntary price reductions” announced by Roche – from Rs.1.2 lakhs to Rs.92,000/- and then to Rs.75,000/- – each time the issue of over-pricing is raised, are merely pre-emptive measures to ward off competition and retain their control of the market. Roche is also using market segmentation to protect its monopoly. Trastuzumab is being sold under two different brand names – Herceptin (Roche) at Rs.1.2 lakhs for 440 mg, and Herclon (Emcure) for Rs.75,000/-.

There is also evidence of a nexus between Roche and doctors in private hospitals – patients are being pressurised to buy the drug from the hospital pharmacy at the official price of Rs.75,000/- per dose, rather than from retailers and agents who offer the drug at prices as much as 25% lower than the MRP.

The Indian Railways has been procuring Trastuzumab for the last three year at Rs.86,957/- per dose2. This is also the amount reimbursed under the CGHS3.

These figures leave little doubt that Roche’s pricing policy is determined primarily by their assessment of how much they can push the price envelope rather than by the idea of an ethical profit margin.

Perhaps the Honourable Minister for Chemicals & Fertilisers was not aware of these details when he stated in the Lok Sabha that Roche would be bringing the price of Trastuzumab down to Rs.75,000/- per dose4 under an upcoming deal with Emcure for local manufacture. Considering that the present MRP of the drug is Rs.75,000/-, and it is already being offered by retailers for 55,000/- per dose, we fail to see anything to cheer about in the Roche-Emcure deal. In fact, there are reports that Roche has imposed anti-competitive terms such as a ceiling on volume of sales and a mandatory minimum price.

Negotiated prices do not expand access

Respected Minister, you are no doubt aware that the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has recently released a report by a committee set up to examine the issue of price negotiations for patented drugs. We are concerned about the fact that this report being released at a time when a compulsory licence for Trastuzumab is under active consideration by both the Health Ministry and your Ministry.

While Roche’s actions in blocking any attempts at competition are understandable even if not justifiable, we are shocked that a government entity should seriously propose to negotiate with pharma majors without any reference to other concerned Ministries, and in complete disregard of global experience, which confirms that measures such as negotiated price reductions do not result in any significant expansion of access, since prices continue to remain beyond the reach of most citizens. Generic competition on the other hand can bring prices down to four times lower than negotiated prices 5.

Apart from yielding only limited benefits, time-consuming price negotiations with pharma companies can delay action on more rational options such as compulsory licensing, thereby putting thousands of lives at risk. The Government of Thailand, which began issuing compulsory licences in 2007, noted that “Prior negotiation with the patent holders is not an effective measure and only delays the improvement in access to patented essential medicines and puts more lives in less healthy or even dangerous situations.”

What is more, negotiated price reductions will be applicable only in India – a biosimilar of Trastuzumab from Indian manufacturers on the other hand have the potential for a global impact and can expand access to this life-saving drug across the developing world. India’s scientific and technical capacity in this sector is well recognised. The announcement of a compulsory licence for Trastuzumab will encourage local pharma firms to step up their investments in ongoing research projects for biosimilar development, and will facilitate the speedy entry of biosimilars into the market.

We have been greatly encouraged by the recent decisions of the Intellectual Property Appellate Board (IPAB) in revoking the patent for the Hepatitis-C drug pegylated interferon Alpha 2A, and now in upholding the compulsory licence for a generic competitor to Sorafenib. These decisions have been applauded and welcomed by health rights groups and public interest groups around the world, for whom they are an assurance of India’s political will to resist arm-twisting by pharma companies.

When India amended its patent laws in 2005 to make them TRIPS-compliant, there was widespread concern about the possible adverse impacts of this move on access to treatment. The then Union Minister of Commerce & Industry, Shri Kamal Nath had said at the time that “the government has built in enough safeguards in the Patents (Third Amendment) Act 2005 passed by Parliament to protect the interests of consumers by ensuring availability of medicines at affordable prices6. We are disappointed that eight years later, despite sharp increases in the number and prices of patented drugs, the Government of India is so reluctant to use the provision of compulsory licensing under Sections 92 and 100 of the Patent Act to expand generic competition, bring down prices and expand access.

We urge you to mark Women’s Day 2013 with the announcement of a compulsory licence for Trastuzumab – a progressive and principled step that will bring relief to thousands of Indian women and their families who are struggling to deal with HER2+ breast cancer and its economic, social and personal costs.

Thousands of lives are at stake – we look forward to your immediate and decisive action.

 

KALYANI MENON-SEN (on behalf of the Campaign for Affordable Trastuzumab)

1See for instance an interview with the husband of a cancer survivor who describes his experiences in accessing Trastuzumab. <http://newsclick.in/india/recounting-personal-experiences-accessing-herceptin>

2http://www.scr.indianrailways.gov.in/cris//uploads/files/1327919951035-ami2011-2012polist.xlsx.pdf

3 http://cghs.nic.in/Life%20Saving%20Medicines.htm

4http://www.business-standard.com/article/companies/roche-to-produce-two-cancer-drugs-locally-with-emcure-113030100297_1.html

5See attached press note for details.

6 ‘ENOUGH SAFEGUARDS IN PATENTS ACT TO PREVENT PRICE RISE’, Press Release, Ministry of Commerce,  04 April 2005, http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=1610

 

India’s cancer burden: Why the govt’s CL ruling is so important #drugpricing #goodnews


Jan 15, 2013, First post

Early last year, when the Union government allowed the production of
Nexavar, a liver and kidney cancer drug, by an Indian company against
the wishes of multinational pharma major Bayer, the prices of several
indigenously made cancer drugs tumbled.

It was a complete game-changer in affordable healthcare in India,
which not only reduced the price of Nexavar from a prohibitive Rs. 2.8
lakh a month to Rs. 6,600, but also led to the reduction of prices of
a few other cancer drugs as well.

The step that led to this dramatic fall of prices was by an
intervention of the Union government called “compulsory licensing
(CL), by which a national government can allow somebody to produce a
patented drug without the consent of the patent owner.

After Nexavar, the government of India has begun steps to issue
compulsory license for three more cancer drugs – Trastuzumab,
Dasatinib and Ixabepilone.

Compared to Nexavar, the impact of this move is going to be
unprecedented because Trastuzumab is a wonder drug against a certain
type of breast-cancer that affects about 100,000 women in India.
Breast cancer tops the cancer burden in urban India, and an aggressive
HER+2 type of cancer is increasingly more prevalent among young women.

Indian companies don’t have a generic alternative to the breast
cancer drug yet. Reuters About 28-35 per cent of all cancers among
women in major cities is breast-cancer. Trastuzumab not only reduces
the mortality of patients with HER+2 cancer, but also is effective
against the spread of malignancy to other parts of the body.

So far, there is no other drug against HER+2 cancer with such
efficacy. It can be administered alone, along with chemotherapy and
after surgery. In many cases, it even helps avoid surgery, which many
find disfiguring.

However, majority of women with HER+2 breast cancer do not benefit
from the wonder-effect of the drug because of the prohibitive prices
by its manufacturer and patent-holder, Roche, the multinational drug
company. A full course of the drug costs anywhere between Rs six to
eight lakhs. A generic version – in this case a bio-similar product –
should not cost more than a tenth of this price.

Unlike Nexavar (chemical name Sorafenib), no Indian company has yet
started making generic versions of Trastuzumab. According to available
information , three Indian companies are currently involved in
creating this molecule, but it is a difficult process because they
have to take the biotechnological route to replicate it.

Commonly, generic versions of patented drugs are chemical copies made
by reverse engineering of the final molecule through chemical
processes. In simple terms, what it entails is taking the final
molecule (of the drug) and working backward to create the same
molecule through an alternative process.

Technical expertise, research facilities, appropriate investment and
availability of high quality human resources are important for such
processes. Endowed with all the four, India is a leader in generic
production of drugs. What it requires, however, is an enabling
environment, most of which is legal and patent-related.

In the case of Trastuzumbad, the generic version will be a biological
equivalent and not a chemical copy because this drug cannot be
replicated chemically. A biological process is trickier and more
expensive.

The government decision on Trastuzumbad and the other two cancer drugs
will be significant because Indian companies are reluctant to invest
on developing a bio-equivalent, if the drug is still under patent. The
patent on this wonder drug is due to expire in 2014, but Roche has
filed several patent applications to Indian patent offices to block
any such development even beyond 2014.

Under such uncertain patent regimes, no company would risk its
investment. If the government issues a CL, the Indian drug companies
can safely invest and fast track the process. Apparently, one of the
Indian companies developing the drug is in the third stage of the
process and hence if a compulsory license comes through, the Indian
version will be out in the market sooner than later.

The latest development is yet another example of informed civil
society pressure leading to concrete results as seen in countries such
as Brazil and Thailand. In November 2012, the Campaign for Affordable
Trastuzumab, a citizens’ collective, wrote an open letter to the Prime
Minister, signed by around 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.

Drug companies are holding our health hostage to their greed for
profits” said Kalyani Menon-Sen, coordinator of the Campaign. “Roche
should not be allowed to get away with such predatory prices. Courts
and other authorities like the Competition Commission must take suo
moto action against Roche for abusing its dominant position in the
market.”

She also called on Indian manufacturers to expedite the production of
bio-similars of Trastuzumab.

Compulsory licensing is one of the two flexibilities provided under
the TRIPS (Trade Related Intellectual Property Rights) to allow member
countries of WTO (World Trade Organisation) to prevent the abuse of
patents. Contrary to the general belief, compulsory licenses are
issued not only by developing countries, but also by countries such as
Canada, USA, UK, France and Australia, whenever it suits them.

India joined TRIPS and complied with its rules in 2005 by amending the
patent act of 1970, which also meant giving up a lot. However, it does
have flexibilities such as CL to ensure that its citizens have access
to affordable care and multinational companies don’t get away with
predatory pricing. All that it takes for such a move is immunity from
vested interests and political will.

“Such a move will not only make healthcare more affordable, but will
also lead to domestic competition among generic manufacturers, which
in turn will lead to further fall in prices” said KM Gopa Kumar, legal
advisor and senior IPR researcher at Third World Network, a global
think tank on development issues.

The other TRIPS flexibility that WTO allows its members to protect its
citizens’s health is parallel importing, under which countries without
technical capability to produce the generics can import from other
countries. India may not be a beneficiary of this provision, but it
can help other countries. Indian generic drugs are imported by several
countries in the world.

Generic manufacture of potent MNC drugs against HIV and multi-drug
resistant TB and their dramatic price falls are the inspiring success
stories of the last decade. Cancer seems to be the new frontier. There
are also illnesses such as hepatitis-C, the treatment of which can
become affordable if a generic version of the MNC drug is available.
The MNC drug at present costs about Rs. 6 lakhs and the country has a
huge hepatitis -C burden.

In the coming years, the generic intervention and similar price cuts
will have considerable impact on treatment of cancers and other
non-communicable illnesses as well as infections such as hepatitis-C.

Without being apologetic to anybody – the MNCs and their parent
countries – the government just has to take proactive steps that are
vital for its citizens.

http://www.firstpost.com/india/indias-cancer-burden-why-the-govts-cl-ruling-is-so-important-589051.html

 

Immediate Release- Patients succeed in overturning first ever product patent on medicine in India #goodnews


Hope for hep-C patients:

Context and Background 

Today, the Bench of Intellectual Property Appellate Board, comprising Justice Prabha Sridevan (Chairperson) and Mr DPS Parmar (Technical Member), set aside the first ever product patent on a medicine granted in India to Roche for Pegasys (a medicine used to treat Hepatitis C) on an appeal filed by a patients’ group. 

In 2005, to comply with its international trade obligations, India re-introduced a system of granting product patents on medicines. In 1970, it had changed its patent law to disallow such patents precisely because they had resulted in high prices of medicines in India. This was the first product patent granted under the amended 2005 patent law.

As you know, a product patent on a medicine allows the patentee to prevent others from making or selling the medicine. This means that the patentee is able to set monopolistic prices. In the case of Pegasys, Roche charges approximately INR 4,36,000 for a course of six-months’ treatment. There may also be a relapse in which case the treatment course will have to repeated.

The Indian patent law provides for several tiers of protection to ensure that only genuine inventions are protected by patents. For instance, it allows “any person” to file an opposition challenging its grant. This could prevent a patent from being wrongfully granted in the first place. If a patent is granted, it can still be challenged by a “person interested” in a post-grant opposition or in a revocation proceeding. 

The order delivered by Justice Prabha Sridevan is important for several reasons. 

Sankalp, a patients’ group, had filed a post-grant opposition, which was rejected by the Patent Office. In the appeal filed by Sankalp before the IPAB, Roche sought to place a narrow interpretation on who a “person interested” could be. It argued that Sankalp is not a “person interested” because it was not a business competitor or a researcher. This issue probably arose for the first time before the IPAB. Rejecting Roche’s contentions, the IPAB held that a patients’ group that is a “person interested” in whether a patent is revoked or not. Justice Sridevan noted that the revocation of a patent could bring down the costs of the medicine as well as increase supply. She also held that public interest is persistently present in intellectual property law. 

On the merits, the IPAB revoked the patent on the ground that Roche’s claim of combining interferon (a protein known to treat Hepatitis C) with an inert PEG structure using conventional methods to obtain predictable results was obvious to a person skilled in the art. The IPAB also held that Roche did not show that this pegylated interferon showed enhanced efficacy over other known pegylated interferons —  a requirement under section 3(d) of India’s patent law.

By setting aside the patent , this order now paves the way for Indian companies that may decide to launch biosimilars of this medicine in India.

 

PRESS RELEASE

2 November 2012, New Delhi.

 

In a landmark victory for patients’ groups fighting against patents to ensure access to medicines, the bench of the Intellectual Property Appellate Board (IPAB) comprising Justice Prabha Sridevan (Chairperson) and Mr. D. P. S. Parmar (Technical Member), 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 on our website as soon as we receive it.

 

Lawyers Collective HIV/AIDS Unit and Sankalp Rehabilitation Trust

 

For further information, contact
Anand Grover: +91.9820184788, Eldred Tellis: +91.9820194363
Prathibha Sivasubramanian / Julie George: +91.11.46805506; +91.9968050357

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