In a recent decision, Intellectual Property Appellate Board (IPAB) invalidated Pegasys patent from Roche (judgment available here), which was also India’s first product patent after introduction of patents in pharmaceutical products. It’s a landmark decision because it is the first decision in post grant opposition. It is another blow to big pharma world after first compulsory license that was issued to Natco.
· Roche was granted patent no. 198952 by Indian Patent Office (IPO) on 21st February, 2006. It had the title “A physiological active dranched peg-IFN conjugate”. This patent was termed as Pegasys because the drug was marketed by this name. Roche showed the priority data of US where it had priority date of 31st May, 1996.
Sankalp Rehabilitation Trust, which provides care and support to street-based drug users and seeks to prevent the spread of HIV/AIDS in Mumbai, filed post grant opposition in May 2006. Trust was stating that the drug was costly and Swiss company got monopoly in the market for the drug.
· The trust filed opposition in IP0 on the basis that drug was neither new nor it had inventive step. They even said that the technology of combining interferon and other biologically active proteins with PEG has been known for many years. Thus, under the Patent Law of India, this patent should not have been granted.
· IPO rejected the opposition of the Trust that there was no novelty because they did not disclosed any prior art to prove that there was no novelty.
· After this, the Trust filed an appeal in IPAB against the decision of IPO challenging the rejection of post grant opposition by IPO in March, 2009.
· The appeal was accepted by IPAB on 2nd November, 2012. The Coram which comprised of Justice Prabha Sridevan (chairman of IPAB) and D S Parmar (Technical Member of Patents) ordered, “In the end, the invention is held to be obvious. The appeal is allowed and the grant of Patent No. 198952 is set aside.”
Why this is important?
This case is an important case for Indian nationals because Pegasys was the only drug available in the market for the treatment of Hepatitis-C. According to Sankalp Rehabilitation Trust, 10-12 million people in India which also includes Injecting Drug Users are suffering from Hepatitis-C. Trust also stated that interferon has been found to be effective against hepatitis-C virus which if not treated, leads to liver cirrhosis, liver failure and liver cancer.
Trust opposed the patent against Pegasys saying that this provided the manufacturer monopoly in the Indian market which in turn led to high prices of the drug which was placed at 4.36 lakhs for six month course and also this drug had to be taken in combination with ribavarin which alone costs around Rs 47000. A spokesperson from the Trust was quoted saying that, “It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine.”
COURT FINDINGS AND DECISIONS
A detailed analysis of evidences was carried out by IPAB and than a final decision was given. IPAB discussed three matters in this case which are novelty, obviousness and Section-3d. Let us discus court’s perspective with the judgment delivered:
· Novelty (51st point in judgment): IPAB on novelty stated that, “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.”
· Obviousness (44th point in judgment): For obviousness IPAB stated that “Once the Court has the facts, it has to put clock back to the date of the invention and see if this ordinary man would have found it obvious to put this invention together. In the present case, Interferon had already been used to treat hepatitis C. There were problems in the use of this protein as such. PEGylation was known to improve the activity of the proteins. There was intense activity in the field of PEG chemistry and the person skilled in the art will be acquainted with it, if not directly involved in it. Linear conjugates of Protein showed improvement over unconjugated protein.”
· Section 3d (50th point in judgment): On section 3d IPAB said, “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. The examples in the Complete Specification show improvement over unconjugated interferon, but the inventor claims surprising activity when compared to other conjugated interferon which is not shown.
This is another victory in Indian Patent history where another multinational company (MNC) lost the case just because of Section 3d and their very high price of the drug. MNCs first develop a drug than patent it and then commercialize it in the market but at a very high price. This is done mostly to incur maximum profit in the time period of patent. MNC says that they are putting the cost just to level the cost that they put in the research and development of drugs and in this process forget about the common man that how he will pay for it.