STANDARD ESSENTIAL PATENTS
To restrain an infringing device, a SEP holder does not have to sue based on each of the thousands of patents that it claims to own in the product; it can do so by showing that one, or a handful of representative patents are infringed.
Invocation of the jurisdiction of CCI by the Defendant, which is premised on the presumption of essentiality, implementation and dominance of Ericsson's patents, shows that the Defendant was very well aware that it was infringing the suit patents.
In the matter of Ericsson v Intex concerning SEPs, cross appeals were filed challenging the judgment of the single bench of the DHC that held Ericsson's eight suit patents to be prima facie valid and essential, and ordered Intex to pay 50% royalty at the interim stage and balance 50% by way of a bank guarantee. Ericsson appealed the impugned decision praying that Intex be directed to pay the entire royalty amount. Intex's contention was that Ericsson's patents were not standard or essential and should be revoked, and thus the same were not infringed by Intex. It was also contended that the single judge failed to appreciate the tests to be satisfied before directing to make payment of royalty in a SEP suit which is: (i) the asserted suit patents are in fact SEP, (ii) the technology used by the implementer infringes the SEP, (iii) the royalty rates are FRAND compliant, and (iv) implementer is unwilling to take the licence at the said FRAND rate. The Division Bench observed that Intex's contention is untenable in law, and injunction can be secured, even if the infringement of one patent is established either prima facie, or at the final stage. The Division Bench further observed that consequently, to restrain an infringing device, a SEP holder does not have to sue based on each of the thousands of patents that it claims to own in the product; it can do so by showing that one, or a handful of representative patents are infringed. The Division bench also opined that invocation of the jurisdiction of CCI by Intex, which is premised on the presumption of essentiality, implementation and dominance of Ericsson's patents, shows that Intex was aware that it was. infringing the suit patents.
The Court further stated that if Intex was of the view that it was not infringing Ericsson's patents and the same were non-essential, Intex instead of approaching CCI alleging abuse of dominant position, should have sought a declaration of noninfringement or of groundless threat under the Indian Patent Act. The Court observed that Intex till the date of passing of the impugned order had not filed any counter claim or expert evidence to dispute Ericsson's claim charts and/or to deny essentiality or the allegations of infringement. The Divisional Bench refused Intex's appeal, and directed Intex to pay the entire royalty amount to Ericsson within four weeks.
APPEALS FROM IPO DECISIONS
PRE-GRANT OPPOSITION TO BE CONSIDERED BEFORE PATENT GRANT/ REFUSAL DECISION
In Sonya Kapoor vs Controller General of Patent, Designs and Trademark and Ors., IPO's decision to grant patent numbered IN363697 without deciding the pending pre-grant opposition was challenged by the Opponent. The Defendants contended since the pre-grant opposition was not considered as it was not filed in a proper format. The Court observed that the right to oppose an application for grant of a patent is a valuable right, and cannot be permitted to be defeated on technical considerations. Given that a pre-grant opposition was, in fact, filed by the petitioner, albeit in the wrong format, the interests of justice would require the said pre-grant opposition to be considered before the Patent Office. The impugned order was quashed and set aside, and patent application was remanded to the Patent Office for reconsideration.
DE-NOVO CONSIDERATION REQUIRED
In Sapna Nangia vs The Assistant Controller of Patents and Designs, an appeal was filed challenging the unreasoned order of the Asst. Controller refusing grant to application numbered IN201911010599. The Court observed that even though impugned decision may not be entirely unreasoned, but is too perfunctory to sustain judicial scrutiny. Some amount of application of mind to the contentions advanced by the applicant in the FER response as well as the written submissions advanced before the learned Controller was required to be manifested in the impugned order. The impugned order was quashed and set aside stating that de novo consideration would be restricted to the objections contained in the hearing notice.
UNREASONED ORDERS BY IPO UNACCEPTABLE
In Kabushiki Kaisha Toshiba vs Asst. Controller of Patents and Designs (C.A.(COMM.IPD-PAT) 210/2022), an appeal was filed challenging IPO's decision refusing grant to patent application numbered 5817/DELNP/2013. The impugned order stated that the requirement of Section 2(1)(j) of the Patent Act was not complied, without providing any specific reasons for refusal. The Court observed that such unreasoned decisions cannot sustain the scrutiny of law. Reasons, it is trite, are life and soul of every judicial or quasi-judicial decision. Absent reasons, the Court is unaware as to why the Controller deemed it necessary to reject the application. The appeal was allowed, and the case was remanded back to the Controller for decision within 2 months.
INCOMPREHENSIBLE ORDERS ARE WORSE THAN UNREASONED ONES
In Art Screw Co., Ltd. vs The Assistant Controller of Patents and Designs, an appeal was filed against the IPO decision refusing grant of patent to application no. 6541/DELNP/2011 on the ground that it lacked inventive step in light of prior arts. The Appellant argued that the impugned order was completely incomprehensible. The Court observed that an order which contains reasons that no one can understand is worse than an unreasoned order. The Court found that the basis for holding that the invention of the petitioner is lacking in an inventive step is impossible to comprehend. A finding that an invention for which a patent is sought, lacks in inventive step is a serious finding. The Court ordered that the matter be placed before another IPO officer to obviate the possibility of any apprehension of predetermination. The impugned order was set aside, and the IPO was directed to decide the matter within 3 months.
PATENT CANNOT BE REJECTED ON OBJECTIONS NOT RAISED DURING EXAMINATION
In N.V. Satheesh Madhav and Anr. vs Deputy Controller of Patents and Designs, an appeal was filed against the IPO's decision refusing grant of a patent to application no. 2924/DEL/2008 for lacking inventive step and for being non-patentable under section 3(d) and 3(j) of Patents Act. The Appellant submitted that the Controller never raised the objection under Section 3(j) during the examination and even in hearing. The Plaintiff also argued that the claims of the application are in respect of a new product, i.e., 'a bio-bed with non-absorbent cotton', and the bar of Section 3(j) was not applicable as the subject matter of the invention is neither plants nor animals or parts of them thereof or seeds. The Court observed that the Controller committed an error in invoking Section 3(j) of the Act, and that the impugned order was passed in a cryptic manner without going into the explanation offered on behalf of the appellant with regard to the prior-art. The impugned order was set aside, and the application was remanded back to the Patent Office for disposal within four months.
ORDERS PASSED IN HASTE TO BE RE-ASSESED
In Impact Selector International LLC. vs Controller of Patents, an appeal was filed challenging the IPO's decision refusing grant to application no. 2366/DELNP/2006. It was the Plaintiff's submission that the Controller insisted the Applicant to file the written submissions on the same date on which the Hearing took place, and then passed the refusal order on that same day. The Court observed that an applicant had the right to file the written submissions within 15 days from the date of hearing, and the Assistant Controller insisting the applicant to file the written submissions on the date of hearing is a clear violation of the Rule 28(7) of the Patent Rules, 2003. The Court also found that the impugned order simply jumps to a conclusion that the subject invention lacks inventive steps, however there is no discussion as to why the subject invention would be hit by the prior art. The impugned order was set aside by the Court, and the patent application was remanded back to the Patent Office for fresh consideration by a different officer for disposal within 4 months.
ENLARGING THE SCOPE OF SECTION 59 - CLAIM AMENDMENTS DURING PROSECUTION
In Allergan Inc. vs the Controller of Patents, an appeal was filed against the decision of the IPO refusing grant of a patent to application no. 7039/DELNP/2012 on the ground that the amended claims are impermissible under Section 59 of the Indian Patent Act. The original claims filed by the applicant claimed a "A method for treating an ocular condition comprising the steps of ...". During examination, the Applicant amended the claims to claim "An intracameral implant comprising ...". Subsequently, the hearing notice issued by the IPO stated that the claims for "intracameral implants" are not supported by the originally filed claims, and has not been claimed either in International application or while entering national phase, thus refusing allowance to the amended claims. The DHC observed that if IPO's interpretation of Section 59 were accepted, the result would be that the appellant would be foreclosed from seeking a patent in respect of the implants which, according to it, are a result of the appellant's own inventiveness and which are intended to cure a wide variety of ocular ailments. Upon perusal of the Specification, the Court noted that a large part of the complete specifications dealt with the implants their peculiar compositional constitution, and found that the amended claims were in respect of the very same implants for the method of use of which the original claims have been filed. The claims and complete specifications in a patent have to be read together and as a whole. The impugned order was set aside, and the application was remanded back to the IPO for reconsideration.
CLAIM AMENDMENTS ALLOWABLE IN APPEAL
In Nestle vs The Controller of Patents and Design & Anr., an appeal was filed against the order passed by the IPO refusing grant of patent to application no. IN201817040811 for being a method of treatment u/s 3(e), impermissible amendments and lacking inventive step. The Court observed that the claims amended by the Appellant during prosecution claimed a "composition comprising DGLA directed towards treatment" and was not directed towards any method/process of prophylactic treatment. However, while amending the claims, the original scope of the Claims stood expanded, as instead of being a purpose-related Claim, it became a general Claim over the composition. Therefore, in the peculiar facts of the case, the Appellant was afforded an opportunity to present claim amendments at the appellate stage for consideration of the Court. Upon IPO objecting to such amendments, the Court noted that there is no provision in the Act which specifically bars the amendment of a patent at the appellate stage. In fact, post-grant amendments are also allowed. If the High Court, in appeal is considering the issue of grant of patent, it should necessarily have the same powers as of a Controller under Section 15, including the power to require amendment. Amendments were thus allowed at the appellate stage in the interest of justice. The Court also observed that the appellant has provided extensive experimental data in the specification showing the synergistic effect to prove efficacy of claimed composition, and therefore, the objection under Section 3(e) of Patents Act is not sustainable. The Court observed that when the subject matter of the patent application shows technical advancement over the cited prior arts, and when the prior arts are considerably old (more than 20 years old in the present case), it is a clear indicator of non-obviousness. The Court ordered the subject patent application to proceed for grant.
INTERPRETATION OF 'KNOWN PROCESS' UNDER 3(D)
In Tapas Chatterjee vs Assistant Controller of Patents and Designs and Anr., an appeal was filed challenging the IPO's decision refusing the grant of patent to application no. IN201911036748 for being non-patentable under section 3(d) and 2(1)(ja) of the Indian Patent Act. The Appellant contended that the Controller had failed to identify a reference point process that can be considered as a "known" or "old process" to reject the application on Section 3(d). As per the Appellant, "thermal decomposition" with repeated fractionation is a new step that leads to a new result, and even if some ingredients of the process or a step of the entire process is known, a combination of steps is still patentable under Section 3(d). The Court observed that a patent can be granted in respect of a "known process" only when such a "known process" results in a new product or employs at least one new reactant. In the case of discovery of a new form of a known substance, the patent can be granted only if the said new form results in enhancement of the known efficacy of the substance. The Court found that the processes used in the subject invention are nothing more than a mere use of a combination of known processes of the prior arts. Since the Appellant is also not using any new reactant in the said processes, nor is the final process resulting in the creation of a new product, the only difference between the patent and the prior arts is that the process of the patent is a zero liquid discharge process, and thus does not need any further treatment. Whereas the prior art processes result in the discharge of effluents. Since the useful product being produced by the subject patent is still the same, the invention does not overcome Section 3(d) of Patents Act. The appeal was accordingly dismissed.
PATENT INFRINGEMENT SUITS
COURT CLARIFIES WHEN A SPECIES PATENT COULD BE VULNERABLE TO INVALIDITY VIS-À-VIS KNOWN MARKUSH PRIOR ART
Novartis AG and Ors. vs. Natco Pharma Limited is a suit for infringement of Novartis's patent IN276026 (IN'026) for 'ceritinib' by Natco. Vide an earlier order dated 02.05.2019, Hon'ble DHC awarded an ad interim relief to Novartis by restraining Natco from manufacturing any fresh stock of pharmaceutical preparations containing the API Ceritinib, while allowing Natco to sell the stock already manufactured and lying with it. The peculiar facts of the case are that while deciding Natco's post grant opposition, the IPO revoked the IN'026 patent for lacking novelty vide order dated 16.08.2019. Consequently, vide order dated 28.08.2019, the Hon'ble DHC suspended the continuance of the ad interim relief. Subsequently, while deciding Novartis's appeal against the revocation order of the IPO, IPAB stayed the IPO's decision. Consequently, vide a subsequent order dated 21.08.2020, the Court restored the ad interim injunction granted. The issues before the Court were whether the patent is vulnerable on the ground of anticipation by prior claiming or prior disclosure, and whether the patent was obvious in light of existing art. Another specific issue before the Court was whether the Markush Formula 2 constituting Claim 1 in the suit patent is obvious from the various patents cited by Natco as prior-art. Novartis submitted that none of prior arts would enable a person skilled in the art to the USP of Ceritinib, which is the heterocyclic piperidinyl ring and its linkage to the N2 phenyl group by a carbon-to-carbon bond, especially Formula 2. Natco argued that it is practising the US 7153964 of AstraZeneca which too claims and discloses Ceritinib. The Court observed that in asserting that the suit patent is anticipated or obvious from the genus, the defendant is resorting to hindsight analysis by cherry-picking substituents from various substitutions suggested in the genus patent, so as to arrive at the species patent. Such cherry-picking is completely impermissible in law.
The Court observed that Natco has effected select substitutions from the various substitutions suggested in Claim 1 in IN'653 for the various radicals R1 to R8 and A (R9 being hydrogen). Clearly, therefore, what Natco has merely cherry-picked select substituents out of the myriad substitutions provided in the Markush formula in Claim 1 in IN'653, in order to arrive at Ceritinib, having, with it, the foreknowledge of the exact molecular structure of Ceritinib. The Court found it to be a clear case of hindsight analysis. The Court emphasized that suit patent could be said to be vulnerable to invalidity, vis-à-vis known Markush prior art, only if it is established, cumulatively, that:
- from the known prior art, it is possible to arrive at the suit patent, by effecting suggested substitutions in the Markush formula claimed in the prior art, from the substitutions suggested therein, and
- the Markush prior art contains the requisite teaching, as would suggest the substitutions which are to be so made in order to arrive at the suit patent.
Where (ii) is absent, the exercise undertaken by the defendant, in questioning the validity of the suit patent, is merely hindsight analysis, by cherry-picking those substitutions, from the substitutions suggested in the prior art, as would enable it to arrive at the suit patent, the molecular structure of which is already known to it. The law completely discountenances such an exercise. The Court recorded agreement with the Plaintiff's submission that every molecule of the millions which, theoretically, would result, by effecting the substitutions suggested in the Markush prior art at the suggested sites in the Markush moiety, are covered thereby. Theoretically, the synthesis of any such molecule, and its dissemination, without a license from the patentee of prior art patents, would infringe prior art. No person skilled in the art can, without hindsight analysis and cherry-picking of suggested substitutions, reach the suit patent from the prior art. The Court decided injunction in favor of Natco.
THE MARKUSH STORY
Two point test for invalidating a species patent based on a Markush patent:
- check if it is possible to arrive at the species patent, by effecting suggested substitutions in the Markush formula claimed in the prior art, from the substitutions suggested therein, and
- the Markush prior art contains the requisite teaching, as would suggest the substitutions which are to be made to arrive at the species patent.
COURT SETS PRE-REQUISITES FOR MAINTAINING QUIA TIMET ACTION
Novartis vs Zydus is a patent infringement suit where plaint was filed as a quia timet action, seeking a decree of permanent injunction restraining Zydus and Cadila from dealing in any pharmaceutical composition comprising a combination of Sacubitril and Valsartan. The Defendants contended that the plaint was liable to be rejected under Order VII Rule 11(a) as there is no cause of action. The issue before the Court was whether the averments made in the plaint satisfy the pre-requisites to maintain a quia timet action. The Plaint alleged that Zydus and Cadila applied to the Registrar of Trademarks for registering trademarks on proposed to be used basis for medical purpose, for medical use and chemical preparations of Valsartan and Sacubitril for cardiovascular purposes. The Court observed that what has to be seen, therefore, in assessing whether a quia timet plaint can be rejected outright under Order VII Rule 11, is: (i) whether the plaint alleges (i.a) a deliberate expressed intention to engage in activity the result of which would raise a strong possibility of infringement, (i.b) that the activity to be engaged in is imminent, and (i.c) that, if the defendant were to engage in the activity, the plaintiff would suffer substantial, if not irreparable, prejudice; (ii) that the claim of the plaintiff is not merely speculative, in the hope that sufficient facts, to support the allegations, would be gleaned on discovery during the course of trial, and (iii) that the plaint contains cogent, precise and material recitals of facts. Nothing more is to be seen, when examining an Order VII Rule 11 challenge. The Court found that the Plaint satisfies the pre-requisites to maintain a quia timet action.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.