The battle continues…

For those of us who thought that Roche vs CIPLA dispute concerning Erlotinib Hydrochloride was over following from the findings by the Division Bench, here is an update –  CIPLA has now filed a SLP before the Supreme Court of India.

Stay tuned for more updates on this segment.

SWEET VICTORY FOR ROCHE -VALIDITY OF PATENT UPHELD; INFRINGEMENT OF PATENT ESTABLISHED

In another landmark judgement by the Delhi High Court towards expounding and interpreting the Patent law in India in F-Hoffman La Roche vs CIPLA_2015, the Court not only upheld the validity of the suit patent but also ascertained that the patent is being infringed.

The suit patent (IN196774) was granted in February 2007 by the Controller of Patents, covering patent rights over Erlotinib Hydrochloride molecule which demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor which spiked survival benefit in cancer including non-small cell lung cancer (NSCLC) patients.

This decision is in respect of the appeal/cross-appeal filed against the order of the Single Judge, Justice Manmohan Singh of the Delhi High Court. The Division Bench in the appeal reversed the finding of the Single judge and held that as CIPLA’s Erlocip, admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B) clearly infringes the IN ‘774 patent. Further, the Bench maintained the finding of the Single judge in terms of validity of the patent. The patent is considered to be non-obvious and complaint with section 8 of the Patents Act.

However, keeping in view of the fact that the life of the patent is soon to expire in March, 2016, the Bench did not grant an injunction as prayed for by Roche against CIPLA, keeping in view that there is no interim injunction enforced against CIPLA. Roche has also been awarded cost of Rs. 5 lakhs.

A detailed analysis of the order will follow shortly.

Registration of license/assignment deed under the Patent Acts –Not mandatory for Validity

In an interesting twist, a division bench of the Delhi High court in a cross-appeal between Sergi Transformer and CTR Manufacturing Industries Ltd., held that it is not mandated for a license/assignment to be registered for it to be valid. The license/assignment would be valid the moment it is executed and the non-registration thereof does not invalidate the same. At the prima facie stage, the court can always refer to the assignment deed without formal proof thereof.

The Hon’ble court further held that the learned Single Judge on 16 April, 2014 in the case ‘Sergi Transformer Explosion vs. Kumar Pratap Anil & Ors.’ has erred in holding that the exclusive license agreement is not to be considered in evidence by the Court and the benefit of the document for the purpose of seeking relief in a case of infringement would accrue as and when the said document is registered in the office of the Controller.

In order to understand the aforementioned, the scope of Section 68 was analysed by the court. The Hon’ble Court drew a comparison between Section 68 as it stood prior to the year 2005 amendment and as it stands post the 2005 amendment. The comparison showed that an assignment had to be registered for it to be valid prior to 2005 . The amended Section 68 however does not mandate that that an assignment  has to be registered for it to be valid. The amended provision requires that the assignment should be in writing and the agreement between the parties is reduced to a form of a document embodying all the terms and conditions governing their rights and obligations and duly executed.

The Hon’ble court also noted that the Parliament has specifically excluded from the amended provision the words ‘and the application for registration of such document is filed in the prescribed manner with the Controller within six months from the commencement of this Act or the execution of the document, whichever is later or within such further period not exceeding six months in the aggregate as the controller on application made in the prescribed manner allows’.

The fact that the above words have been omitted from Section 68 clearly shows that registration is not mandatory for an assignment to be valid,  and the limitation for applying for registration has also been done away with. This clearly shows that under the amended provision there is no period prescribed for making an application for registration of the agreement. The omission of the proviso to section 68 prior to its amendment i.e. ‘PROVIDED that the document shall, when registered, have effect from the date of its execution’ shows that he registration was a must prior to the amendment for the document to be valid and once registered, the assignment would be valid from the date of its execution. Post deletion, registration is not a pre-condition for the document to be valid and the assignment is valid from the date of its execution. In light of this, in the present case, the licence agreement was stated to have been executed on 01.08.2006 and  the application seeking registration has been filed with the Controller of Patents on 15.03.2010. The suit has been filed on 06.08.2010.

The Hon’ble court further held that for consideration of an application under order VII rule 11 of Civil procedure Code (CPC) what is relevant is that prima facie it is seen whether there is an assignment deed in terms of section 68 of the Act. Further, merely because the document is not registered on the date of the filing of the suit does not ipsofacto imply that the suit would not be maintainable. The fact that a document has been set up by the plaintiff stating the document to be a licence agreement, the plaint cannot be rejected at this stage under Order VII Rule 11 of the CPC.

In addition to that, reading of Section 69(5) shows that the said provision does not completely prohibit the admission of a document by Controller or by any Court as evidence of title under each and every circumstance. The court or the Controller before whom an unregistered licence agreement is produced as an evidence of title is empowered, for reasons to be recorded in writing, to accept the same as an evidence of title. Admissibility of such an agreement is not completely prohibited. The Court or Controller are empowered to admit such an agreement in evidence even though the same may not have been registered with the Controller of Patents. Prima facie it cannot be said that the document i.e. a deed of assignment would not be admissible under each and every circumstance in the absence of registration. At the prima facie stage of consideration of an application under Order 39 Rules 1 and 2 of the CPC for grant of injunction or otherwise, the court would be empowered to take into consideration the same as a document of title.

DASATINIB: Injunction to continue against BDR

On 29th June, 2015, Justice Manmohan Singh of the Delhi High Court upheld BMS’ patent for anti-cancer drug Dasatinib (marketed as Sprycel).  The order was passed in Bristol-Myers Squibb vs. BDR Pharma case of interim injunction, which is a quia timet action filed by the Plaintiffs.

BMS had filed a suit for a qua timet injunction against BDR back in 2009 when it suspected that BDR was planning on marketing Dasatinib following BDR’s application at the DCGI for approvals. BDR in turn alleged (among several other defenses) that the patent in Dasatinib is invalid.

Justice Manmohan Singh held that the interim injunction would continue during trial proceedings for the various reasons, but primarily because the defendants have failed to establish a prima facie credible defence pertaining to any harm being caused to the them with injunction in force, particulary because BDR has not yet commenced with launch of its products in the market.

The Court was of the opinion that the plaintiffs have got a valid patent and the defences raised by the defendants do not cast doubts on the validity of the patent. They require further substantiation prior to arriving to conclusionary view .

While deciding over the validity of the patent the Court held the patent to be prima facie non-obvious opining that “It is common in the field of the medicines that the chemical compounds are pre-existing and there are further improvements upon treatment and workings on the compounds so as to increase their efficacy by reacting with chemical compounds and the group of the reactants. Therefore, the commonality of the base compound like thaizole derivatives and its characteristics may be one of the attending circumstance which can act as a starting point to consider the plea of the obviousness but it cannot be said that the said commonality is the sole basis which yields to inference of the obviousness to the person skilled in the art. Thus, commonality of few integers would not alter the position unless the cause and effect relation between all the integers are present and indicating towards arriving at the subject invention in the suit patent which is missing in the present case.

 The Judgment also upheld the patent on other grounds of section 3(d), section 8 amongst others.

Thee court did not accept any plea in relation to public interest or the drug being not available to public because the plea of public interest may be invoked once the Court would find that prima-facie the case of credible defence is made out.

This tussle between Bristol-Myers Squibb and BDR Pharma dates back to the first in 2013 when BDR filed for a compulsory license for Dasatinib, citing the price of the drug to be unreasonably high. The application was rejected as the authorities found that BDR had not acted in good faith during the negotiations for a voluntary license preceding the application.