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 § 262(l)(2)(A) notice of USFDA review.             In Amgen v. Apotex, the Federal Circuit rejected Apotex’s contention that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” procedure of the Biologics Price Competition and Innovation Act ("BPCIA"), expanding... 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 Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention... 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. is an Indian bulk drug manufacturer based in Hyderabad. Among other drug products, it manufactures Linezolid, an antibacterial used to treat skin and blood infection including pneumonia. Symed owns two process patents (IN213062 and IN213063) for the manufacture of intermediates for linezolid. The product patent... 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 rejected the injunction application by MSD against Glenmark. This article aims to analyze the Delhi High Court judgment by the Division bench in detail. The detailed judgment can be found here. Facts of the case: Merck Sharp & Dohme (hereafter “MSD”) aggrieved by the dismissal... 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 exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol and is currently selling under the brand name Onbrez. The said drug is one of the... 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 of the Indian Patent Act, has the power to revoke patent in public interest, after giving patentee an opportunity to be heard. According to section 66, “Where the Central Government is of opinion that a patent or the mode in which it is exercised is... 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 revocation decisions at Intellectual Property Appellate Board (IPAB) ruled on section 3d giving precedent of Novartis. In addition, these decisions also seem to be setting higher standards of non-obviousness as compared to countries such as United States. Case I: Fresenius Kabi Oncology Limited v. Glaxo... 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 proof of enhanced therapeutic efficacy vis-a-vis lapatinib di-HCl salt (known compound). Still IPAB discusses the grounds of obviousness and non-compliance with S.8 in detail as it considers these grounds important. Section 3d IPAB very straight forwardly failed the test of section 3d for the ‘171... 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 Controller of Patents on lack of inventive step under 2(1)(ja) in view of three prior art references and under section 3d. The final set of amended claims contain four claims, the independent claim is as follows: 1.  A method of producing a transgenic plant comprising... 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. Myriad had enjoyed sole monopoly over testing services for BRCA1 and BRCA2 in the United States, since the grant of 2 genes in 1990s. On May 12, 2009, The American Civil Liberties Union and the Public Patent foundation sued the US Patent and Trademark Office,... Read More