Global Cases on Hepatitis C Medicines

I-MAK has challenged eight patents on two hepatitis C medicines. In addition, we have supported our partners to file eight cases in seven countries and at the European Patent Office (covering 38 countries). Find information on the cases below.

SOFOSBUVIR

China: Base Patent

Patent International Publication Number: WO2005003147
Case Type: Invalidation
Case Status: Filed on April 18, 2017
Grounds: Lack of novelty, lack of inventive step/obviousness, lack of sufficiency

China: Prodrug Patent

Case Type: Observation
Case Status: Filed September 2014. Patent rejected in May 2015. Gilead appealed the rejection, in March 2017 SIPO upheld rejection of the prodrug patent; Gilead must appeal to courts if they want to overturn the patent office’s decision.
Grounds: Lack of inventive step, not an invention under meaning of law, did not sufficiently describe the invention.

India: Base Patent

Patent International Publication Number: WO2005003147
Case Type: Pre-grant opposition
Case Status: Filed March 17, 2014. Patent application was rejected in 2015. Gilead appealed to the High Court. Patent office re-examined the case, opposition process starts again. Patent office issued a decision on May 9, 2016 granting the patent to Gilead. I-MAK immediately filed a writ at the Delhi High Court on the grounds that the reasoning in the decision was legally flawed, did not take into account key evidence, and did not follow the correct procedure. The merit of the writ was accepted for a full hearing with all parties concerned. Due to postponements, a decision has not yet been made.
Grounds: Lack of novelty, lack of inventive step/obviousness, Section 3D (not an invention), lack of sufficiency, Section 8 (failure by applicant to disclose status of examination in other countries)

India: Prodrug Patent

Patent International Publication Number: WO2008121634
Case Type: Pre-grant opposition
Case Status: Filed November 2013
Grounds: Lack of novelty, lack of inventive step, Section 3D (not an invention), Section 8 (failure by applicant to disclose status of examination in other countries)

India: Crystalline Patent

Patent International Publication Number: WO2011123645
Case Type: Pre-grant Opposition
Case Status: Filed February 23, 2017
Grounds: Lack of inventive step, not an invention (Section 3D), did not provide information on corrosponding examination in other countries (Section 8)

DACLATASVIR

India: Crystalline Patent

Patent International Publication Number: WO2009020828
Case Type: Pre-grant Opposition
Case Status: Filed on February 13, 2017
Grounds: Anticipation by prior claiming (another novelty argument), lack of inventive step, not an invention (Section 3D), insufficient description, did not provide information on corrosponding examination in other countries (Section 8), invalid priority claim (not filed within 12 months of first application)

India: Intermediate Patent

Patent International Publication Number: WO2011059858
Case Type: Pre-grant Opposition
Case Status: Filed on February 13, 2017
Grounds: Lack of novelty, lack of inventive step, insufficient description, not in complicance with Section 8 (exmaination in other countries)

PIBRENTASVIR

India: Base Patent

Patent International Publication Number: WO2012051361
Case Type: Pre-grant Opposition
Case Status: Filed on July 21, 2018
Grounds: Wrongful obtaining of the invention due to lack of patent assignment, incorrect priority claim and lack of inventive step

Join us to stay updated
and help make lifesaving medicines accessible to all