Non-compliant defendants face permanent injunction

DSM Sinochem Pharmaceuticals has been granted permanent injunction against Sinopharma Weiqida pharmaceuticals as the defendants failed to timely submit the defense (written statement) and pay the costs imposed by the Court.

The Plaintiffs DSM Sinochem Pharmaceuticals sued Sinopharma Weiqida pharmaceuticals for permanent injunction to restrain them from using , manufacturing , distributing, selling, offering for sale or dealing directly or indirectly in API Amoxixillin Trihydrate produced by a process that amounts to infringement of Indian Patent number 247301, or a formulation thereof.

The defendants did not file the written statement inspite of three opportunities and did not pay the costs imposed by the court. During a hearing on 16th May 2017, the counsel of the Defendants said that the written statement is ready, an advanced copy of which would be handed over to the counsel of the Plaintiffs and the cost imposed would be remitted in the course of the day.  The matter was listed for the next day, provided an additional cost of 50,000 is paid.

During the hearing on the next day, the Court observed that no written statement has been filed nor the cost imposed on the Defendants has been paid. Considering the same, the Court closed the rights of the Defendants to file a written statement. The Plaintiff’s in the absence of any challenge to its patent was considered to be entitled to a decree of permanent injunction in its favour.

Ericsson on a spree of favourable orders

Delhi High Court passed an interim injunction order in the ongoing case of Telefonktiebolaget LM Ericsson v. Lava International Ltd that prevents Lava from importing, exporting, manufacturing, and selling any mobile phones that use Ericsson’s 8 SEP patents and technology.The defendant is also barred from exporting the impugned goods. The Custom Authorities have also been directed to not release the impugned mobile phones if received from overseas countries under technology of suit patents of the plaintiff. 

The interim order, which is passed on merit, directed defendant to  deposit a sum of Rs.50 crores with the Registrar General of the Court by way of FDR as security amount on or before 20th June, 2016, the operation of interim order shall remain stayed till the final disposal of the main suit. In addition to that, the defendant was also asked to file the statement of accounts for the period of 2011 to 31st May, 2016 before Court by 10th July, 2016 and continue to file the same every quarterly till the final judgment is delivered in the main suit.

Section 3(k)

With regard to Section 3(k), the Court held that, the ultimate object of the invention is an efficient encoder rendering the synthesized speech quality in relation to radio resource needed for transmission is as high as possible. The Court noted that the speech quality is an effect perceptible by the humans and is not just as abstract entity. The judge pronounced that:

 “Prima facie, it appears that these inventions which have resulted in an improvement (technical advancement) in telecommunication technologies and have had a huge effect upon the manner in which these technologies function thereby resulting in practical implementation and actual physical representation Mere mention of an algorithm or a mathematical formula in a patent document should not be inferred to mean that the invention is nothing but an algorithm. The similar issue has already been dealt by this court in a suit filed against INTEX in great details wherein the arguments of doubtfulness were rejected. Thus, no different view is possible in the present case.”

The Court also held that product patents cannot be labelled as algorithm because they are not a set of instructions and are not theoretical in nature. The Court further held the defendant has failed to raise any credible challenge to the suit patents.

As regards the licence agreement, the Court held that the defendant has been consistently delayed execution of the agreement with the plaintiff and in such a case, unlike in trademark and copyright matters, the infringement ought to go in favour of the plaintiff. The Court also held that the plaintiff has been trying to correspond and negotiate with the defendant for the past 4 years and that itself is a huge factor that militates any grant of further time to the defendant , especially in cases of standard essential patents, where a patentee always endeavors to negotiate before filing for an injunction. Moreover, it was held that the fact that the defendant was aware of the plaintiff’s patents but did not challenge the validity goes in favour of injunction.

Concealment of material fact by Ericsson and vacation of injunction on Xiaomi

The Delhi High Court on April 22, 2016 revoked the interim injunction on Xiaomi in the ongoing patent tussle with Ericsson in India. The Court in its judgement has pronounced that there was a greater onus on Ericsson to disclose the material fact- in this case the Multi Product License Agreement which it had with Qualcomm, especially when it was seeking an injunction ex-parte.

On December 9, 2014, the Delhi High Court (DHC) had passed an interim order ordering an interim injunction against Xiaomi.  The Division Bench of the DHC had then allowed Xiaomi allowed to sell its devices subject to certain conditions – to only sell Qualcomm based devices and not Mediatek-chipset based devices.

However, this development emerged as a result of Xiaomi telling the court that it had already got a license for patents (Ericsson’s 3G patent -; IN229632 and IN240471) through Qualcomm, which had in turn secured license from Ericsson. Xiaomi averred that Ericsson had deliberately suppressed the existence and contents of Multi Product License Agreement which it had with Qualcomm wherein Ericsson had granted license in respect of some of its patents to Qualcomm to make, use, sell and import and therefore, the claim of Ericsson that it is not getting royalties is moot. Moreover and additionally, Xiaomi also averred that Ericsson was fully aware that Xiaomi was using Qualcomm’s chips especially in view of the documents and the fact that testing was conducted on a device using Qualcomm’s chipsets.

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.

GENERAL PRINCIPLES OF PATENT INFRINGEMENT RE-ESTABLISHED BY BOMBAY HIGH COURT

In a recent order of Bombay high Court in CTR Manufacturing Industries Limited vs Sergi Transformer Explosion Prevention Technologies Pvt. Ltd, Hon’ble Justice G. S. Patel re-established the general principles of a patent infringement as follows:

Claim Construction

 In a combination patent, the invention cannot be a mere arrangement or rearrangement of previously known integers all functioning independently in a known way. These integers, though all themselves previously known, may be combined in a previously unknown way, acting inter-dependently, each of them essential, to produce a new and improved result. Each of the integers must be essential. If indeed any one of the integers can be taken out without affecting the final result, it is not essential.

Additionally, if a patent claim is overbroad by including every single non-essential and essential addition, then the patent may be prima facie invalid for want of novelty. No person can claim such a monopoly as would result in a bar to future improvements. If the patent is, on the other hand, so narrow that it excludes the addition of another essential integer, then there is no infringement.

Further, where a patent has been granted on the patentee disclaiming a particular integer, i.e., by saying it is not essential to his product, then the addition of that nonessential integer does not, per se, defeat the claim for infringement. It must be shown that the additional integer is essential, required and returns a result that is as or more efficient than that produced by the patent. Adding something superfluous to the essential integers does not defeat an infringement claim. It must be shown that what is added is also essential and that it satisfies the previous tests of interdependency, producing as good a result or a new and improved result. The patent must be read in a purposive manner to determine what constitutes its ‘pith and marrow’.

Validity

 At an interim stage, a Court is not required to examine the validity of a patent so much as its vulnerability; and this is to be tested not on a mere say-so, but with the aid of cogent and persuasive technical and scientific material, including reliable expert opinions and other data.

Further, the fact that a patent has been granted is not wholly immaterial at an interim stage. While the grant is not a complete answer to a charge of prima facie invalidity or vulnerability, it is still a factor to be considered and given appropriate weight.

The speed of grant of a patent is wholly irrelevant, particularly if it is made without a substantiated (and substantial) case on illegality and malafide intentions.

First Permanent Injunction Granted in a Patent Infringement Suit in India

Hon’ble Justice Mr. A.K. Pathak on October 07, 2015 granted the first ever permanent injunction in a patent infringement suit under the Patents Act 1970. The detailed judgment of 133 pages is in relation to the patent infringement action by Merck against Glenmark with respect to patent number 209816 which covers the type-II diabetes drug sitagliptin.

The judgement restrains the Defendant by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or deadline in sitagliptin phosphate monohydrate or any other salt of sitagliptin in any form, alone or in combination with one or more other drugs. The Plaintiff has also been entitled to actual costs of the proceedings under the order.

While Merck had claimed infringement of its 209816 patent, Glenmark argued that the product sitagliptin phosphate monohydrate being manufactured by them was actually not covered by the suit patent due to which their activities were not infringing. In addition, Glenmark claimed that Merck’s patent was invalid.

The Hon’ble Court held that since the patent relates to an invention of a chemical molecule/ compound in the medicinal field and is of a highly technical nature, the Court has to go by the opinion of the experts in the field and is not to impose their views over the views of the technical experts, more so when the Judges are not experts in the chemical/medicinal field.

The Hon’ble Court also discredited the independent technical expert of the Defendant as in the opinion of the Court said expert had taken contradictory stands which were in conflict with what was stated in his own publications (e.g. patent documents in which he has been named as an inventor) and in the publications of the Defendant. The Court also observed that the Defendant’s expert witness had a personal interest in sitagliptin since he was named as an inventor in a patent application related to sitagliptin pterostilbene phosphate. Furthermore, the Court observed that the Defendant’s expert witness gave evasive replies to questions which would inconvenience the Defendant. The Court found the Plaintiff’s independent technical expert’s testimony more favourable and reliable and found no reason not to accept the explanation provided by him.

On the question of whether sitagliptin phosphate monohydrate is covered by the suit patent since the suit patent exemplified only the hydrochloride salt of sitagliptin, the Hon’ble Court conceded with the Plaintiff’s independent expert’s testimony that the conversion of a salt to a free base and the free base to another salt was a very basic chemical transformation taught in all sophomore organic chemistry classes. Moreover, the suit patent claims sitagliptin and all its pharmaceutically acceptable salts and the phosphate salt is mentioned as a preferred salt in the specification.

The Court further observed that the Defendant’s technical expert and also the Defendant themselves in their own patent applications relating to sitagliptin have admitted that the salts of sitagliptin are generically encompassed within the scope of the suit patent which also discloses a process for the preparation of the sitagliptin and related compounds. Therefore, sitagliptin phosphate monohydrate is generically disclosed in the suit patent.

On the question of infringement, the Hon’ble Court held that a comparison of the Plaintiffs’ and Defendant’s package insert shows that all the products contain the same compound, i.e, sitagliptin phosphate monohydrate, a DPP-IV inhibitor used for the treatment of type II diabetes. Distinguishing the facts of the present case from those in F Hoffman La Roche v Cipla Ltd. (2012(52) PTC 1(DEL), the Court held that the Plaintiffs in the present case have not sought to establish infringement based on packaging and product inserts alone but also based on ocular and other documentary evidence on record.

The Court also held that the Defendant cannot conveniently disown what has been written on the packagings and the product inserts, which is a disclosure to the public at large including the doctors and consumers of the drug, about the contents used and the utility of the drug.

The Court stated that the use of sitagliptin free base alone in sitagliptin phosphate monohydrate tablet by the Defendant amounts to infringement of the suit patent. All the literature on record indicates that sitagliptin is the DPP-IV inhibitor. It is the sitagliptin free base which is the DPP-IV inhibitor and phosphate salt is used for the delivery of sitagliptin the body. Therapeutic efficacy is not enhanced by sitagliptin phosphate monohydrate since it is sitagliptin itself which is the active moiety and is effective for inhibiting DPP-IV enzyme and is useful for the treatment of type II diabetes. Sitagliptin phosphate monohydrate has enhanced properties in the sense that it has improved physical and chemical properties, but the active moiety is sitagliptin.

On the contention of the Defendant that they were using a process for the manufacture of sitagliptin that was different from the process used by Merck, the Court that no such different process was disclosed in the written statement and counter claim filed by the Defendant and no employee of the Defendant appeared as a witness to prove such a process. The process which was introduced in the evidence of the Defendant’s independent technical expert was not duly proved because he did not have occasion to verify said process having not monitored the manufacturing at any stage or having not involved himself in such a manufacturing process. Further, the independent technical expert did not personally analyse the products of the Defendant so as to verify the process.

The Defendant’s contention that Plaintiffs ought to have proved that Defendant was deploying the same process was considered inadmissible as it was the Defendant who took the plea of using a different process and therefore, should have proved the same, more so when the products of the Plaintiffs and Defendant contain the same chemical compound.

On the issue of obviousness of the suit patent the Hon’ble Court held that the onus to establish obviousness is on the Defendant which they failed to discharge by leading positive evidence. The technical expert of the Defendant has admitted to hindsight which is not permissible in an obviousness analysis. Further, the Plaintiff’s expert pointed to the non-obviousness of the suit patent in his affidavit which opinion remained unshattered in his cross-examination. Mere comparison of chemical structure is not sufficient and picking up parts of a chemical structures of different patents and clubbing them is also not sufficient as this appears to have been done based on hindsight.

On industrial application, the Hon’ble Court held that compounds that are derived from the suit patent will be a product as required under the provisions of the Patents Act and it cannot be denied that sitagliptin free base has therapeutic utility and sitagliptin phosphate monohydrate has better physico-chemical characteristics. Further, sitagliptin phosphate monohydrate is generically covered in the suit patent. There is no requirement under the law that the product has to be under a manufacturing process at the time a patent is granted.

On the issue of insufficient disclosure and broad claiming by way of Markush claims, the Hon’ble Court held that the Markush claims of the suit patent are not different from other patent documents (including those of the Defendant and their expert) which also contain Markush claims.

The suit patent is addressed to a person skilled in the art and not to a lay person. The Defendant themselves acknowledge in their patents that sitagliptin and its pharmaceutically acceptable salts are disclosed in the suit patent. The Defendant cannot be permitted to blow hot and cold in the same breath.

On the ground of non-compliance with section 8 of the Patents Act, the Hon’ble Court was in agreement with the decision of the Divisional Bench in Sukesh Bhel & Anr. Versus Koninklijke Phillips Electronics, that the power of the Court to revoke the patent on the ground of Section 8 violation is discretionary. The Court further ruled that no evidence was led by the Defendant to show that the non-disclosure of information was deliberate or for malafide reasons.

On public interest, the Hon’ble Court held that sale of the drug by the Defendant at a price lower than that of the Plaintiff cannot be a ground to decline injunction against the Defendant. The Court also held that public interest could not be a ground for denying infringement in the instant case as sitagliptin is not the only type II diabetes drugs in the market. There are several other DPP-IV inhibitors available, including, teneligliptin which is also manufactured and marketed by the Defendant.

In view of the foregoing, the validity of the patent was upheld and a permanent injunction was granted.