India: Patient Group Challenges The Ever-Greening Patent Of Gilead's Lifesaving Hepatitis C Drug

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.

Footnotes

1. https://www.patentoppositions.org/en/drugs/velpatasvir/patent_oppositions/5b418334d2708f0005fd8aec

2. https://www.msfindia.in/people-living-hepatitis-c-and-hiv-challenge-evergreening-patents-lifesaving-hepatitis-c-drugs-india

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