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On July 09, 2018, the Delhi Network of Positive People (DNP+)
filed two pre-grant oppositions at the Indian Patent Office against
Gilead's patent application for hepatitis C drug under Section
25(1) of the Patent Act, 1970 (the 'Act'). The DNP+ has
challenged the patent application of Gilead's
sofosbuvir/velpatasvir Fixed-Dose Combination (FDC), and polymorph
form of velpatasvir, a direct acting antiviral drug for the
treatment of Hepatitis C Virus (HCV) infection1.
Gilead Pharmasett, LLC (hereinafter the 'Applicant'), on
November 21, 2016, filed a patent application (Application no.
201627039572) with title "Solid Forms of an Antiviral
Compound" with 80 claims, seeking to patent a compound
which is used to treat Hepatitis C. The opponent, DNP+, is a
community based non-profit organization representing the needs of
people leaving with HIV/AIDS and HCV. DNP+ is also a network
working extensively in the area of access to medicines. In present
case, the opponent's key concern is access of affordable HCV
medicine, where, if patent is granted to such a product, it will
influence the affordability of the drug for people not just in
India but across all developing countries, since India plays a
critical role in supplying affordable, quality lifesaving generic
medicines to developing countries, largely because the
country's patent law strikes a balance between promoting public
health and access to medicines, while also protecting
companies' intellectual property rights by granting patents for
true innovative developments.
The grounds for opposition
The opponent filed pre-grant opposition under section (25)(1) of
the Act on the following grounds:
The invention claimed in complete
specification is obvious and does not involve inventive steps, and
fails under Sections 2(1)(j) and 2(1)(ja) of the Act. Therefore,
the opponent is filing this pre-grant opposition for obviousness of
invention under Section 25 (1)(e) of the Act.
The invention claimed in complete
specification is not an invention nor does it exhibits enhanced
therapeutic efficacy required under section 3(d) of the Act.
Therefore, the Opponent brings the opposition under Section 25(1)
(f) - that the subject of any claim of the complete specification
is not an invention within the meaning of this Act.
The Opponent brings opposition under
Section 25(1) (h) of the Act - that the Patent Applicant has failed
to disclose the information required by Section 8.
Gilead already has patent for sofosbuvir (Sovaldi) in India and
the company has applied for multiple patents on sofosbuvir based
formulations. DNP+ aims to prevent such unmerited patent
applications from being granted and encourages open competition on
the combination of sofosbuvir and velpatasvir after the basic
compound patents have expired or are revoked in countries excluded
from Gilead's license agreements.
Velpatasvir, a direct-acting antiviral (DAA), is one of the key
medicines used in combination with sofosbuvir for the oral
treatment in people with all six major genotypes of hepatitis C
virus. Its effectiveness as a pan-genotypic medicine makes it a key
drug in the fight against hepatitis C. Access to affordable generic
sources of this medicine, and its combination with sofosbuvir, are
therefore, critical for all countries with a high burden of people
living with Hepatitis C. Sofosbuvir/velpatasvir was launched in the
United States by Gilead at over $74,000 for a 12- week regimen in
2016 but the said combination is available in India at
approximately $286 per 12 weeks.2
The opponent refers the provisions of Indian Patent Act that
prevent patent ever-greening, which restricts the patentability of
a host of secondary patents, i.e., new forms of known substances,
new property or new use of known substances, use of known processes
without showing any enhanced therapeutic efficacy, and admixtures
without synergistic effect.
Note: ever-greening patent tactic to block
affordable lifesaving drugs that other countries may import in the
future. With these patent challenges, DNP+ hopes to prevent Gilead
from gaining unmerited patent rights on sofosbuvir + velpatasvir
combination. DNP+ also filed an opposition with Initiative for
Medicines, Access & Knowledge (I-MAK) at IPO against the
granting of a patent to AbbVie on pibrentasvir, which is in
comination with Glecaprevir indicated to treat hepatitis C.
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