The document discusses the patent for the drug Pegasys, which is used to treat hepatitis C. Roche was originally granted a patent for Pegasys in India in 2006. However, this patent was immediately challenged by Wockhardt and Sankalp Rehabilitation Trust on the grounds that combining interferons with PEG was not a novel invention. In 2009, the Indian Patent Office rejected the challenge and upheld Roche's patent. Sankalp appealed this decision and in 2012, the Intellectual Property Appellate Board revoked Roche's patent, allowing for cheaper generic versions of Pegasys to be introduced in India.

1. Abhishekh B.Sharma
F.Y. M.Pharm. (Pharmaceutical Chemistry)
17PHC201

2. PATENT NO: 198952
DRUG: Pegasys.
PATENTEE: F. Hoffmann-La Roche A.G. (Roche).
OPPONENT: Sankalp Rehabilitation Trust and Wockhardt.
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3.  Pegylated interferon alfa-2a, sold under the brand name PEGASYS
is a medication used to treat hepatitis C and hepatitis B.
Pegylated interferon alfa-2a was approved for medical use in the
United States in 2002. It is on the World Health Organization’s List
of Essential Medicines.
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4. Roche was granted patent no. 198952 by Indian Patent Office on
21st February, 2006.
This patent was immediately challenged by local generic drug
maker Wockhardt and Sankalp Rehabilitation Trust.
The technology of combining interferons and other biologically
active proteins with PEG has been known for many years.
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5. In 2009, the IPO rejected their challenge and upheld Roche’s patent.
Sankalp subsequently appealed to Intellectual Properties Appellate
Board (IPAB) which announced its decision in favour of the group’s
challenge on 2nd November, 2012.
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6. In 2006, Pegasys received patent protection from the Indian Patent
Office (IPO).
The patent granted to Roche 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.
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7. This patent was immediately challenged by local generic drug maker
Wockhardt and Sankalp Rehabilitation Trust, a civil society group based
in Mumbai.
Concerned about the impact of this patent on access to medicines,
Sankalp filed a post-grant opposition challenging the grant of the patent.
Wockhardt and Sankalp challenged Pegasys on the grounds that it was
not a novel innovation or that it did not demonstrate inventiveness.
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8. The Sankalp Rehabilitation Trust hopes that the absence of a patent
barrier would spur generic competition to bring down the price of
the much-needed medicine.
Despite Sankalp’s case that Roche’s claims did not satisfy the
patentability requirements under Indian law, in 2009, the Patent
Office rejected the post-grant opposition filed by Sankalp and an
Indian company and upheld the validity of Roche’s patent. 8

9. Sankalp then filed an appeal before the IPAB challenging this decision.
Treatment of chronic hepatitis C requires a six-month course of Pegasys,
which costs around 436,000 rupees whereas generic version costs only 47,160
rupees.
The appellate board ruled that the drug did not deserve a patent on the
grounds that it didn’t demonstrate inventiveness.
The Board had also correctly held that Roche had failed to satisfy the
requirement of showing enhanced efficacy.
IPAB announced its decision in favour of the group's challenge and revoked
Roche’s patent on November 2.
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10. The IPAB decision was in the favour of public health.
The ruling is likely to help introduce cheaper copies of the drug in the
market.
Sankalp quoted that- “It is unacceptable that people are dying due to
Hepatitis C because they cannot afford to buy the medicine”.
The ruling suggested that generic versions of Pegasys could become
available in India at fair price.
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11. REFERENCES:
1.https://en.wikipedia.org/wiki/Peginterferon_alfa-2a#cite_note-Pro2017-1
2. http://www.thehindu.com/sci-tech/health/policy-and-issues/roches-patent-for-hepatitis-
c-drug-revoked/article4062590.ece
3. http://www.livemint.com/Companies/roW8AYtNIBchkx4Js5LEKO/IPAB-invalidates-
patent-on-Roche-hepatitis-C-drug-Pegasys.html
4. http://www.pharmatimes.com/news/india_revokes_roches_patent_on_pegasys_976312
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