Category: Pharma/Biotech Patent Litigations

Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § … Continue reading Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

Read more »

Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche’s patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs … Continue reading Revocation of Valganciclovir patent by Controller of Patents, Chennai

Read more »

Division Bench of Delhi High Court passed an interim order in Glenmark v. Symed (July 2015)

The High Court of Delhi has passed an interim order wherein the  Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the patented processes of the respondent (Symed). Background: Symed Laboratories Ltd. … Continue reading Division Bench of Delhi High Court passed an interim order in Glenmark v. Symed (July 2015)

Read more »

Supreme Court stayed the Delhi High Court order of injunction against Glenmark over the Generic drug “Sitagliptin”

Reportedly, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. The Delhi high court on dated 20th March 2015 set aside an order of single judge bench of Delhi High Court which … Continue reading Supreme Court stayed the Delhi High Court order of injunction against Glenmark over the Generic drug “Sitagliptin”

Read more »

CIPLA’s plea for revocation of Novartis Patents for Onbrez may face major set back by the Government

As reported in TOI, the Indian Government has found very little merit in Cipla’s plea for waiver and cancellation of Patent rights for chronic obstructive pulmonary disease (COPD) drug over which Novartis has exclusive rights. We have reported on Cipla’s plea here. Background: Cipla, previously approached the Department of Industrial Policy and Promotion (DIPP) to … Continue reading CIPLA’s plea for revocation of Novartis Patents for Onbrez may face major set back by the Government

Read more »

Cipla Files Representation with Govt. Seeking Revocation of Novartis’ Patents

It has been recently reported in Economic times that Cipla has filed representation with the government (Department of Industrial Policy & Promotion) seeking revocation of five patents of Novartis on indacaterol, a respiratory drug for the treatment of chronic obstructive pulmonary disease (COPD) and marketed as Onbrez by Novartis. The central government, under section 66 … Continue reading Cipla Files Representation with Govt. Seeking Revocation of Novartis’ Patents

Read more »

Why Protecting Patents in India is Giving Hard Time to Drug Patent Holders

Introduction A lot has been discussed on the Novartis ruling indicating much higher standards of patentability under Indian law under section 3d. The ruling decided that any new form of known compound (in medicine) would be patentable only if there is enhanced ‘therapeutic efficacy’ over the known compound. Post Novartis ruling, a couple of patent … Continue reading Why Protecting Patents in India is Giving Hard Time to Drug Patent Holders

Read more »

GSK’s patent on lapatinib ditosylate revoked by IPAB

GSK’s granted patent IN221171 (‘171) on lapatinib ditosylate (marketed as Tykerb), a tyrosine kinase inhibitor for treating breast cancer, was revoked by IPAB by its order of 27th July, 2013. A revocation application was filed by Fresenius Kabi Oncology Limited. The patent is revoked on ground of non-compliance with S.3d alone on basis of no … Continue reading GSK’s patent on lapatinib ditosylate revoked by IPAB

Read more »

Monsanto’s Patent on Method of Producing Transgenic Plants refused by IPAB

Monsanto’s Indian patent application 2407/DEL/NP/2006 on transgenic plants with heat/salt/draught tolerant plants is rejected by IPAB.  The subject patent application is directed to a method of producing a draught/stress/heat/salt/drug tolerant transgenic plants by inserting a recombinant DNA molecule that expresses a cold shock protein CspA or CspB. The subject patent application was rejected by the … Continue reading Monsanto’s Patent on Method of Producing Transgenic Plants refused by IPAB

Read more »

Understanding Gene Patenting

We are sure that all of you must have learnt about the latest US Supreme Court decision in Association for Molecular Pathology V. Myriad Genetics on June 13, 2013, which has ended the long brawl of 5 years. Yes! the sole provider of BRCA1 and BRCA 2 tests, Myriad Genetics Inc., has lost the battle. … Continue reading Understanding Gene Patenting

Read more »