Chemtura’s Patent restored

The Bombay High Court’s division bench has set aside the order of the IPAB revoking Chemtura’s patent IN213608 and has directed the Controller of Patents to restore the patent on the e-register ( Order dated 19-06-2017 ).

IPAB had earlier revoked Chemtura’s Patent for non compliance of section 8 and lack of inventive step. Chemtura filed a writ against the decision in the Bombay High Court.

The facts of the case are as follows: –

  1. Uniroyal Chemical Company Inc. (the predecessor of Chemtura) filed a National Phase Patent Application being IN/PCT/2001/00752/MUM before Patent Office with respect to the invention titled ‘A Bearing Pad Assembly’
  2. IPO on 9th January, 2008 granted patent to Chemtura after examining the same
  3. Revocation Petition being ORA/14/2009/PT/MUM was filed before the Intellectual Property Appellant Tribunal (IPAB). Chemtura filed its counter Statement along with the Affidavit to the petition on 21st August, 2009
  4. On 27th August, 2009, the petitioner counsel sent a letter to IPAB seeking withdrawal of the revocation petition being ORA/14/2009/PT/MUM. On 12th October, 2009 the Registry on behalf of IPAB sent a letter calling upon petitioner to file a Miscellaneous Petition seeking withdrawal of the said revocation petition
  5. Thereafter on 7th October, 2010 a hearing on the said revocation petition came to be posted under the caption ‘FOR WITHDRWAL’. However, due to some administrative reasons the matter was adjourned to 1st June, 2011. On 1st June, 2011 the matter was again adjourned to 28th November, 2011.
  6. On 28th November, 2011 when the matter was posted for hearing the counsel for Petitioner submitted that he had oral instructions to argue the Revocation Petition being ORA/14/2009/PT/MUM and in light of the said submission IPAB directed the parties to argue the matter on merits
  7. On 26th May, 2012, Petitioner filed a Miscellaneous Petition seeking withdrawal of the said revocation petition and subsequently, on 11th June, 2012 amended and again filed another Miscellaneous Petition seeking unconditional withdrawal of ORA/14/2009/PT/MUM.

It was argued by Chemtura that the order revoking the patent was passed despite a Miscellaneous Petition being M.P No. 107 of 2012 filed by Party seeking revocation and is therefore not maintainable. It was also contended by Chemtura that once a revocation petition has been withdrawn the Vakalatnama executed in favor of the Advocate ceases and the application cannot be heard. The counsels of Chemtura also relied upon the decision of the Supreme Court in Shiv Prasad v. Durga Prasad [1975] 1 SCC 405] which observed that every applicant has the right to unconditionally withdraw his application and his unilateral act in that behalf is sufficient and that no order of the Court is necessary permitting him to withdraw the application. The Court may make a formal order disposing of the application as withdrawn but the withdrawal is not dependent on the order of the Court. The act of withdrawal is complete as soon as the applicant intimates to the Court that he withdraws the application.

The Bombay High Court applied the ratio in Shiv Prasad (Supra) that the application should have been treated as withdrawn as of that date i.e on 25th July, 2009 and if not, at least as on date of filing Miscellaneous Petition namely 11th June, 2012. Bombay High Court further held that the IPAB erred in proceeding with the hearing in the face of the said application for withdrawal. In the circumstances, the Bombay High Court quashed the impugned order of the IPAB dated 24th August, 2012. Patent No. 213608 has also been restored on the Register of patent.

Reasons beyond control necessary for condoning delay in submitting response to Examination report

The Indian Patent office while considering a petition filed by Cisco Technologies under rule 137 for condonation of delay in filing response to examination beyond the statutory period, refused to allow such delay as according to the controller all possible reasons as mentioned by the applicant’s agent such as lack of knowledge about the issuance of examination report or lapse on the part of the previous agent in providing true facts/ First Examination Report, are not the reasons sufficient enough to qualify the status of “beyond the control of applicant” as mentioned in section 21(1) of the Act.

The application was therefore considered to be deemed abandoned under section 21(1) as applicant has not refilled the documents within stipulated time period i.e. within 12 months from the date of issuance of first examination report.

The facts of the case are as follows:-

  • The application 2440/DELNP/2006 was filed on May 01, 2006 claiming priority of USA 10/702,167 dated November 05, 2003 through its agent Evalueserve.com Pvt Ltd.
  • Request for examination was made on October 18, 2006.
  • The First examination report were communicated dated July 29, 2010 to the applicant’s address for service on record.
  • After the issuance of FER, Form-13 was filed on June 22, 2011 to incorporate the change in address for service as applicant has transferred the responsibility to prosecute the matter to Mr. Dinesh Jotwani of M/s Aggarwal Associates.
  • The last date to put the application for grant was over on July 30, 2011 and official requirements were not complied.
  • Petition u/r 137 was filed by the applicant dated September 14, 2011 through patent Agent, for delay in filing the response of examination report read with section 81 of the Patent Act, 1970 within stipulated time i.e. 12 months from the date of issuance of first examination report.
  • Response to first objection report was filed on September 26, 2011.
  • Further Form -13 was filed on February 04, 2015 to incorporate the change in address for service as applicant has once again transferred the responsibility to prosecute the matter to M/s K & S Partners.  

To analyze the decision of the Controller it would be essential to read the following to section:-

  • Section 21(1) says ” An application for a patent shall be deemed to have been abandoned unless, within such period as may be prescribed, the applicant has complied with all the requirements imposed on him by or under this Act, whether in connection with the complete specification or otherwise in relation to the application from the date on which the first statement of objections to the application or complete specification or other documents related thereto is forwarded to the applicant by the Controller.” Explanation.-Where the application for a patent or any specification or, in the case of a convention application or an application filed under the Patent Cooperation Treaty designating India any document filed as part of the application has been returned to the applicant by the Controller in the course of the proceedings, the applicant shall not be deemed to have complied with such requirements unless and until he has re-filed it or the applicant proves to the satisfaction of the Controller that for the reasons beyond his control such document could not be re-filed.

The agents argued that the delay was unintentional as applicant was unaware of issuance of Examination report.

The argument that applicants were not informed about the issuance of first examination report was not considered sustainable as according to the controller:

  1. Status of every patent application is freely available on patent office website i.e. http://www.ipindia.nic.in.
  2. At the time of filing of Form-13 dated June 22, 2011, more than one month time was available to the applicants to meet the official requirements.
  3. Petition u/r 137 was filed on September 14, 2011 for condonation of delay in filing the response of examination report whereas response to first objection report was not filed along with the petition. The same was filed on September 26, 2011 delayed by further 12 days.

As per the controller the above clearly shows negligence in part of erstwhile patent agent. It is hard to believe that delay caused was unintentional. The term “unintentional “means where the agent of the applicant/ applicant itself was not aware about the issuance of first examination report and the deadline to comply with the requirements as raised in first examination report. The controller further held that it is negligence not only at the part of erstwhile patent agents but also at the part of applicant as well. If it is to be considered that it was the duty of previous agents to transfer all the previous proceedings to another authorised patent agent for processing instant patent application, then applicant is also duty bound to insure for smooth transfer of all related proceedings form one patent agent to other patent agent.

 

Annual Report – IPO

The annual Report 2015-16 of the Office of Controller General of Patents, Designs & Trade Marks has been published. Some noticeable points are as follows:-

  • 10% increase in patent filing compared to 2014-15. Total filing in 2015-16 being 40,946. 8% filings have increased by Indian applicants, and approximately 10% by foreign residents.
  • 52.80% increase in disposal of applications compared to 2014-15. 21987 applications disposed of, which includes 6326 grants, 13908 applications abandoned, 432 applications withdrawn , and 1321 applications refused. See Detail here.
  • Top 5 Indian Patentees Include:- CSIR, Samsung R&D Institute India, BHEL, DRDO.
  • Top foreign Patentees include:- GM Global Technology operations, Qualcomm incorporated, LG electronics Inc., Philips electronics N.V., Honda Motor Co. Ltd.
  • 290 pre grant oppositions were filed in 2015-16. This number is slightly higher compared to 247 which were filed in 2014-15. 88 were disposed off in 2015-16.
  • 6 post grant oppositions were filed in 2015-16. 10 were disposed of in 2015-16.

DHC reinstates the agreement between Monsanto Inc and Nuziveedu Seeds

Justice R. K. Gauba of the Delhi high court (DHC) by an order dated 28th March 2017 ruled that Monsanto Technology LLC’s termination of its sub- licence agreement with Nuziveedu Seeds Ltd was illegal and arbitrary.

DHC has reinstated the agreement, however, the trait fee to be paid to the plaintiffs, for the use of the suit patent and trademarks have been directed by the Court, to be in accord with the prevalent local laws, as in force. The court also directed the agreement to be modified according to the format of the GM Technology Agreement Guidelines, 2016 issued by the government.

The facts of the case are as follows:-

  1. Suit for infringement and passing off was filed by Monsanto Technology LLC, Monsanto Holdings Private Limited and Mahyco Monsanto Biotech (India) Pvt. Ltd. impleading three defendants, namely Nuziveedu Seeds Limited, Prabhat Agri Biotech Limited and Pravardhan Seeds Private Ltd., on the groubds that the defendants were continuing to “market and sell” Genetically Modified Hybrid Cotton Planting Seeds inspite of termination of the sub-license agreements between the parties, alleging violation of their intellectual property rights covered by the registered patent (214436), and trademarks BOLLGARD and BOLLGARD II.

  1. The defendant submitted two counter claims. One counter claim prayed for a declaration that the sub-licensing agreements (of 2015) is “valid, binding and in force” and consequently, the defendants being entitled to “all the rights and benefits” thereunder. The other counter claim prayed for revocation of the plaintiffs‟ patent 214436.

  1. The Plaintiffs patent 214436 claims a method for producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence comprising a plant functional promoter sequence operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis ᴕ- endotoxin protein, wherein said plastid transit peptide functions to localize said ᴕ- endotoxin protein to a subcellular organelle or compartment” (claims 1 to 24) and a nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said 5-endotoxin protein, and wherein said fusion protein functions to localize said 5-endotoxin protein to a subcellular organelle or compartment” (claims 25 to 27).

  1. The marks “BOLLGARD” and “BOLLGARD-II” having been registered, in India, under the Trademarks Act, 1999.

  1. Mahyco Monsanto Biotech (India) Pvt. Ltd. entered into sub-license agreements with defendants (2004), and under such sub-license agreements, the defendants received 50 grams of Transgenic Bt. Cotton seeds in consideration of Rupees Fifty Lakhs. The said sublicense agreement also contained an obligation on the defendants to pay a “trait value”.

  1. During the currency of the sub-license agreements of 2004, some dispute arose with regard to the “trait value” and the 2004 sub-license agreements were replaced by new sublicense agreements executed separately in favor of each of the three defendants (sub-license agreements of 2015).

  1. In the meantime, the Central Government in terms of Cotton Seeds Price (Control) Order, 2015, issued a notification via which the maximum selling price of Bt. Cotton Seeds packets were fixed. The MSP for BG I being Rs. 635 per packet, with zero trait value being payable, while the MSP for BG II version being Rs. 800 per packet inclusive of Rs.751 towards seed value and Rs. 49 on account of trait value.(The  intervention of the Central Government by above noted Cotton Seeds Price (Control) Order, 2015, was challenged and such challenges by and large being still sub-judice.)

  1. Licensing and Formats for GM Technology Agreement Guidelines, 2016, were also notified and published by the Government of India. These Guidelines primarily made to ensure non-discriminative licensing to encourage competition and availability of GM cotton seeds to cotton farmers at fair and reasonable prices.

  1. The defendants by their communication informed Mahyco Monsanto Biotech (India) Pvt. Ltd. that the trait value payable under the 2015 Sub-License Agreements stood statutorily modified and that Mahyco Monsanto Biotech (India) Pvt. Ltd. should charge the trait value. This request was turned down and this took the matter to the High Court of Judicature at Bombay.

  1. For the kharif 2015-16 season, Mahyco by further communications called upon the defendants to pay the trait value in terms of 2015 Sub-License Agreements, but such demand was not being complied with. Instead, by their similar communications, the first and second defendant requested the plaintiff to refund the trait fee statedly paid “in excess”, referring to the Government of India price control orders. This demand did not find favour with Mahyco and Plaintiffs alleging breach terminated the agreement. Hence the present suit.

Arguments and finding

 

  • Validity of suit patent:-

Validity of the suit patent was challenged under various provisions of the law like Section 3(f), 3(h) and (j), Section 8, Section 10 (4) and Section 59 (1) etc.

The court held that, whether or not the suit patent is liable to be revoked is a question which would need to be addressed at an appropriate stage only after pleadings in that regard are complete and evidence is adduced on issues thereby raised. No comments were made on such aspect of the dispute.

The court however made a prima-facie finding regarding patentability under section 3(j). The Court agreed with the submissions of the plaintiffs that Section 3(j) of the Patents Act, cannot deprive the patentee of due reward of human skill and ingenuity resulting in human intervention and innovations over and above what occurs in nature. Suit patent involve laboratory processes and are not naturally occurring substances which only are to be excluded from the purview of what is an invention by virtue of the provision contained in Section 3(j). These claims being products or processes of biotechnology are rightly entertained by the Indian Patent office.

  • Protected by the Plant Varieties Act

 It was also submitted by the defendants that impugned acts on the part of defendants are protected by the provisions of the Protection of Plant Varieties and Farmers Rights Act, 2001, by virtue of Section 92, overriding the Patents Act, 1970. The use of any variety as an initial source for the purpose of growing other varieties as is the activity undertaken by the defendants, the limited right of the person claiming ownership of the intellectual property right of such variety is to claim “benefit sharing” under Section 26.

The Court however did not agree with the Defendant and held that the invention which is the subject matter of suit patent is not same as development of a variety within the meaning of Plant Varieties Act. The right to use the genetic material is the subject matter of a patent granted and protected by the Patents Act, in general, and Section 48 thereof, in particular. Section 30 of the Plant Varieties Act is a provision meant only for “researchers” and not for entities such as defendants out to make commercial exploitation and further that it gives, at the most, right to use a “variety” to develop other varieties but not so as to confer the right to use DNA or genetic material.

The contentions of the defendants based on the provisions of the Plant Varieties Act or the import of possible remedy of “benefit sharing” available to the plaintiffs thereunder, or the question as to whether the same would be more efficacious, or extinguishes or erodes the rights conferred by Section 48 of the Patents Act, 1970 has however been left to be addressed at the time of final adjudication

  • Infringement:-

It was also contended that the fact that the defendants’ product comprises of components or genetic material conferring other traits in addition to the DNA construct or nucleotide sequences of the suit patent therefore there is no infringement. However this was considered to be irrelevant, as the presence of other components is immaterial so long as the patented invention is contained within the defendants’ product, this itself being sufficient to constitute infringement.

It was also argued by the Defendants that the claims are directed to a method performed in lab, the biological process adopted by the defendants however is essentially based on the other claims which though submitted with the application under PCT (Patent Corporation Treaty), were withdrawn, the same not being not patentable under section 3(j) and 3(h). The claims were therefore argued to be not infringed.

The court disagreed with the Defendants and accepted the argument of the Plaintiff that infringement by “use” of the patented invention in claims 25 to 27 stands made out because the defendants have admitted that their cotton varieties and hybrid exhibit Bt. trait which would have been triggered only on account of DNA construct or nucleotide sequence on claim nos.25 to 27. The use of the claimed construct was therefore held to be infringement. Court in this respect also relied upon the view taken by the Supreme Court of Canada in Percy Schmeiser vs. Monsanto, (2004) 1 SCR 902, wherein it was argued that ultimately what matters is whether the defendants are taking advantage (in whole or in part – directly or indirectly) of the technical contribution or patented invention of the plaintiffs.

  • Agreement

 The court held that the plaintiffs were duty bound to consider the request of the defendants as made by the communications beginning July 2015, for modification of the terms as to the rate of trait fee payable under the 2015 sub-license agreements for which the mechanism had been agreed upon in the agreement. Since the plaintiffs did not adhere to their obligation under the contract, the demand of payment under the contract terms being not lawful, it apparently being higher than the trait fee permitted by the law in force, the defendants could not have been found to be in default or to have breached their obligations. The termination of the sub-license agreements was therefore held to be prima facie illegal and arbitrary. The parties remain bound by their obligations under the terms and conditions of the 2015 Sub-License Agreements for the period(s) stipulated therein, or till the same are lawfully terminated.

The court also directed that the plaintiffs would be entitled to all the rights under the 2015 Sub License Agreements except as to the rate of trait value payable thereunder and the same has to be in accord with the prevalent local laws prescribed by Cotton Seeds Price (Control) Order, 2015 as indeed of the Licensing and Formats for GM Technology Agreement Guidelines, 2016, both promulgated by the Government of India.

DHC reinstates the agreement between Monsanto Inc and Nuziveedu Seeds

Monsanto Inc, sued Nuziveedu Seeds and its subsidiaries for continuing to sell cotton seeds using its patented technology despite termination of its sub-licence agreement in December 2015.

Justice R. K. Gauba of the Delhi high court (DHC) by an order dated 28th March 2017 ruled that Monsanto Technology LLC’s termination of its sub- licence agreement with Nuziveedu Seeds Ltd was illegal and arbitrary.

DHC has reinstated the agreement, however, the trait fee to  be paid to the plaintiffs, for the use of the suit patent and trademarks, have been directed by the Court, to be in accord with the prevalent local laws, as in force.

The court also directed the  agreement to be modified according to the format of the GM Technology Agreement Guidelines, 2016 issued by the government.

 

Stay tuned for a detailed report of the 96 page order!

Writ for Enzalutamide admitted by the DHC

The Regents of University of California, has filed a writ against the order of the Controller refusing the grant of an application filed by them in India, covering the drug product Enzalutamide (Xtandi). On 2nd March 2017 the matter was listed before Hon’ble Mr Justice Sanjeev Sachdeva of the Delhi High Court (DHC) and Mr Chidambaram made the following arguments on behalf of the Petitioner:-

  1. That the present Writ Petition has been filed against the common order dated 8th November 2016 allowing the five pre-grant oppositions, rejecting the Petitioner’s Patent and the said order has been passed in gross violation of the principles of Natural Justice;
  2. That the Patent Application which is the subject matter of the Writ Petition has been granted Patent in around 50 countries;
  3. Further, the marketing approval has been granted in around 75 countries;
  4. That the patent applicant had filed evidence affidavits of three witnesses including the two inventors. However, the impugned order grossly erred in not considering or even referring to the evidence filed by the patent applicant.

In view of the above, the Hon’ble Judge has issued notice in the Writ Petition, returnable on 2nd May 2017.

Business Standard and http://www.india.com reported as to what transpired in Court on 2nd March 201, and the same can be accessed here:

http://wap.business-standard.com/article/pti-stories/hc-seeks-reason-for-denial-of-prostrate-cancer-drug-patent-117030500251_1.html

http://www.india.com/news/agencies/hc-seeks-reason-for-denial-of-prostrate-cancer-drug-patent-1894207/

Stay tuned for more updates!

 

 

Evidence is only a proof of pleadings

Interim applications filed by Defendants, Natco and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy) in respective suits of Infringement filed against them by Hoffman La Roche, averring that a portion of the deposition of the expert affidavit filed on behalf of Hofmann by way of examination-in-chief was beyond the pleadings of Hoffmann has been found to be valid by the Delhi High Court.

Hoffmann’s expert affidavit was found to be beyond pleadings by the Court and the objection of the Defendants, Natco and Dr. Reddys on the same were found to be valid.

Hoffmann filed a suit to restrain Natco from infringing the drug patent of Hoffmann. Hoffmann thereafter filed another suit to restrain Dr. Reddy’s Laboratories Ltd. (Dr. Reddy) and Natco, from infringing the same patent. The need for impleading Natco in the second suit arose because Natco was supplying Dr. Reddy the active pharmaceutical ingredient.

Natco, as well as Dr. Reddy filed counterclaim in the suits. Separate issues were framed in the two suits and the counterclaims therein. Subsequently, the suits were consolidated and Hoffmann commenced leading its evidence. The first witness of Hoffmann was examined and cross-examined by Dr. Reddy as well as Natco. Hoffmann thereafter filed affidavit by way of examination-in-chief of Dr. Alexander James Bridges. Hoffmann, along with the said affidavit, filed about 14 documents which had not been filed by Hoffmann at any earlier stage.

IA No.10698/2016 and IA No.10685/2016 were filed by Natco in the respective suits averring that a portion of the deposition of Dr. Bridges in the affidavit by way of examination-in-chief was beyond the pleadings of Hoffmann and seeking striking off of the said paragraphs of the affidavit.

The objection taken by Natco were found to be tenable by the Court and the portions of deposition of Dr. Bridges which are beyond the pleadings of Hoffmann, dealing with “polarity” and “toxicity” were held by the court to be liable to be struck down. The court held that the opinion of the expert is only a proof of the pleading and no different. Just like only those facts which are pleaded can be proved in evidence, similarly expert opinion can be given only of a scientific fact pleaded. Without the scientific fact having been pleaded and if controverted, having issue framed thereon, no evidence thereof in the form of expert opinion in proof thereof can be adduced. If the expert transgresses the pleadings, certainly the opposite party would be entitled to object that part of the deposition of the expert.

However, the Court also accepted the fact that the present controversy is a result of there being no clarity on procedure, partly owing to absence of Rules and owing to the erroneous framing of issues without crystallizing the real controversy and owing to Dr. Bridges deposing as a witness on the validity of the patent on behalf of Hoffmann even before Natco, on whom the onus of the issue qua validity rests, leading its evidence. For this reason, the court held that it would not be appropriate to deprive Hoffmann of an opportunity to defend the patent in its favor on the grounds urged for the first time in the deposition of Dr. Bridges. Court has therefore also directed counsel for Natco to inform the counsel for Hoffmann whether Natco requires to cross-examine Dr. Bridges further and if it is so, Hoffmann shall at its own cost produce Dr. Bridges for further cross-examination by Natco.