Tuesday, November 6, 2012

Indian ‘Intellectual Property Appellate Board’ revoked the patent for Roche’s ‘Hepatitis C’ drug ‘Pegasys’ – Propaganda Vs Facts

Pegasys - www.pegasys.com
In the latest patent encounter, Roche (F.Hoffmann-La Roche AG) lost the case for its ‘Hepatitis C drug called Pegasys in India. Thus, Pegasys also joined in the league of Bayer’s ‘Nexavar’ and Novartis’s Glivec.

Board’s observations

In the decree board observed that,

1. Public interest is a persistent presence in intellectual property law.
2. It was known that, pegylation of interferon reduces in vitro antiviral activity but increases anti-proliferative activity in human tumour cells. These are all admittedly common general knowledge on the date of invention and therefore improved activity could not have been a surprise; it was expected.
3. Interferons are known and known to be bi-functional; Preparation of PEG conjugates is known; Effects of conjugation are known; Variation of tissue uptake and distribution with variance in molecular weight is known; Effects on urinary clearance and liver clearance due to variance in molecular weights of the conjugates are known.


There were two important questions before the board;

1. Whether Sankalp Rehabilitation Trust is a ‘person concerned’ or not.
2. Validity of patent for Hepatitis C medicine called Pegasys.

Intellectual Property appellate Board’s verdict

Whether Sankalp Rehabilitation Trust is a person concerned or not?

 “...appellant claims that it is a society which works for the community of HCV and HIV sufferers. This is not challenged.  The invention is admittedly for the use in the case of hepatitis-C.  The continuance or removal of the patent will definitely affect the interest of the community for whom the appellant claims to work... if the challenge succeeds, the monopoly will be broken.  This is something that the appellant is interested in, since it will bring the drug within the reach of the community for whom it works, not only because of reduction in cost, but also because of increase in supply...

...Further public interest is a persistent presence in intellectual property law and will not melt into thin air, nor dissolve. We therefore hold that the appellant who works for a community which needs the medicine is definitely a ‘person interested”

In short board reached the decision that ‘Sankalp Rehabilitation Trust’ is a person concerned.
Chemical Structure of Polyethylene glycol (PEG)
Validity of patent for Hepatitis C medicine – Pegasys

Board observed that,

“The interferon is a pharmaceutically active protein which has antiviral and anti-proliferative activity. It was also known that interferonα2a which we are concerned with was in particular a similarly active protein with the same activity. Interferon was known to be useful to treat hairy cell leukemia and Kaposi’s sarcoma.  It was active against hepatitis-C... improved activity could not have been a surprise it was expected.”
Citing the work of Somak board reached a conclusion that, Controller erred in identifying the difference while granting the patent to Roche.
Board also cited United States Court of Appeals for the Federal Circuit’s decision on Pfizer Vs Apotex.  In that case US court held that, 
“...obviousness cannot be avoided simply by showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.   The Court held that indeed, a rule of law equating unpredictability to patentability, applied in this case, would mean that any new salt – including those specifically listed in the ‘909 patent itself – would be separately patentable, simply because the formation and properties of each salt must be verified through testing...”
Board further told that,
“Monfardini which is admittedly a prior art has acknowledged that Somack et al had recommended high MWPEg for protein modification. Then the inventor cannot deny that the person skilled in the art would have known the utility of using high molecular weight while PEGylating, he would not have thought that this was restricted to enzymes alone or only to Superoxide dismutase. The utility of high molecular weight for protein modification is in the prior art.  The comparison of the properties of the linear conjugated protein and branched conjugated protein was before the persons involved in the art. ”
“The specifications show experiments only with the unconjugated IFN, though this invention is said to be superior to the other conjugates and linear conjugates. For this we have no contemporaneous intrinsic or extrinsic evidence...  inventor claims surprising activity when compared to other conjugated interferon which is not shown. Hence the evidence for the “surprising activity “ is not adequate.”
However the Board rejected the attack on drug’s novelty. “To defeat novelty, the appellant should show that an earlier document, disclosed all that the patentee is seeking to patent. And that each limitation of the claimed invention is found in a single prior art reference. The appellant has not done this. So the attack on novelty is rejected.”

And finally board stated that, “In the end, the invention is held to be obvious.  The appeal is allowed and the grant of Patent No.198952 is set aside...”

In short, patent for the drug was revoked based on board’s observation that, new drug is not a revolutionary invention as the activity of similar structures were already known.
1RH2 Recombinant Human Interferon Alpha 2b - Structure
Compulsory patent decrees from other countries

“President (Indonesia) Susilo Bambang Yudhoyono quietly issued a decree in September 2012 authorizing government use of patents for seven HIV/AIDS and hepatitis B medicines held by the likes of Merck and Co, Glaxo Smith Kline, Bristol-Myers Squibb, Abbott and Gilead” – Asian Tribune

“...amended patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public” – Asian Tribune

“...Thailand had issued 3 compulsory licenses way back in 2006/2007, for the heart disease drug clopidogrel (patent: Sanofi-Aventis’ - Plavix), HIV/AIDS drug, lopinavir/ritonavir (patent: Abbott - Kaletra), and HIV/AIDS medicine, efavirenz (patent: Merck Sharp and Dohme’s Stocrin)” – Asian Tribune

In India

“ Earlier this year (2012) in March... compulsory licencing approval... to manufacture and sell a generic version of Bayer's patented anti-cancer drug, Nexavar (to treat kidney and liver cancer) bringing down its price from INR 2.8 lakh to INR 8,880 for a 120-capsule pack for a month's therapy—a reduction of 97%. Natco will pay a 6% royalty on net sales every quarter to Bayer and is also committed to donating free supplies of the medicines to 600 patients each year. The licence will be valid till such time the drug's patent is valid, i.e. 2020.”

“Novartis appeared to suffer a setback in the Supreme Court of India in its attempt to obtain a patent for its anti-leukemia medicine imatinib mesylate, which the company markets under the brand name of Glivec" – Asian Tribune

My Remarks

1. It is easy to dump Intellectual Property Appellate Board’s decision; to set aside this particular patent is in line with strengthening India’s compulsory patent system. But I am of the view that, board reached its decision after going through evidence presented in front of it.
2. Many media outlets combined excessive cost of medicine with verdict; but it is to be noted here that, board took the social angle only in answering the question ‘whether Sankalp Rehabilitation Trust is a person concerned or not?’ Not for arriving the final verdict on drug.
3. Generic medicine is not a wholesale solution to the problem. If I am not wrong, for manufacturing generic medicine industry needs an established formula. In other words some company somewhere has to go through painstaking research, long clinical trials, maintaining qualified staff, research breakthroughs, overcoming costly failures, long drawn approval process etc. Remember that, they have to face more failures than success.


I am neither an expert on drug formulas nor commenting on technical validity of board's decision. Appeal court may or may not repeal board’s verdict. What I am trying to say here is, before adding this verdict to the list of India’s compulsory patent system, people should go through the judgement. Verdict’s focus is on patentee’s claims about the originality of their innovation, obviousness of drug formula, novelty of the claims etc.

For society, generic medicines may sounds good. Unfortunately, they can’t replace the original ones. Trying out hundreds of solutions for a disease, finding out a set of promising ones, trails on animals, failures, retrials, fixing on a formula, long clinical trials, administrator’s approval are long drawn process and required huge investments. But generic companies don’t have to go through all these process.

It’s not the manufacturing of tablets that costs but finding out the formula.

At the same time, we need to find a balance between society’s needs and original manufacture’s interests. We can’t allow people to die, simply because they are not able to buy life saving medicines because of its cost. According to ‘Sankalp’, Pegasys costs 4, 36,000 INR for 48 weeks (also available at a discounted price of 314,496 INR). However, you have to take this medicine along with ‘ribavirin’, which costs another 47,160.

So, government needs to find a balance between cost of medicines and generics. I believe that, compulsory patents for life saving medicines are necessary, at the same time there should be some way to compensate original manufacturing companies as well- if Intellectual property board observes that innovation is original and patent is valid.



1. Intellectual Property Applete Board - GOI
2. Patients Overturn First Ever Product Patent On Medicine In India - Asian Tribune
3. FirstPost - India revokes Roche patent in new blow for Big Pharma
4. Peginterferon Alfa-2a - National Library of medicine

Photo courtesy: pegasys.com. wikipedia


  1. According to GOI's statement before Supreme Court on October 11th, "likely to notify the new National Pharmaceutical Pricing Policy by November 25, provided it got a nod from the Cabinet". - Business Standard

    Let us wait and watch what 'National Pharmaceutical Pricing Policy' says.


  2. We're a group of volunteers and opening a new scheme in our community. Your website offered us with valuable information to work on. You have done a formidable job and our whole community will be thankful to you.
    my webpage: webdesigndubai7.Yolasite.Com