SOFOSBUVIR
China: Base Patent
Patent International Publication Number: WO2005003147
Case Type: Invalidation
Case Status: Filed on April 18, 2017. In August 2018, Gilead withdrew 12 of the 16 patent claims on the base compound with the Chinese National Intellectual Property Association (CNIPA, formerly State Intellectual Property Office, SIPO). This outcome effectively creates an opportunity for lower-cost generic sofosbuvir to be made available.
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, still awaiting final 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. Gilead’s patent application was abandoned.
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 compliance with Section 8 (examination 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: Lack of inventive step, new form of a known substance lacking improved efficacy data, incorrect priority claim and assignment
GLECAPRIVIR
India: Base Patent
Patent International Publication Number: WO2012040167
Case Type: Pre-grant Opposition
Case Status: Filed on June 12, 2019
Grounds: Lack of inventive step and new form of a known compound with no significant efficacy
Opposition Documents: 1