An order of the Assistant Controller of Patents and Designs (Controller) vide which The Regents Of The University Of California’s (UOC) application for grant of patent Application No. 9668/DELNP/2007 was rejected, has been set aside by the Delhi High Court (DHC) and the matter has been remanded back to the Patent office for reconsideration.
The UOC filed a Writ petition before the DHC impugning an order dated 08.11.2016 passed by the Assistant Controller of Patents and Designs (Controller) whereby UOC’s application for grant of patent (Application No. 9668/DELNP/2007) was rejected. The UOC’s principal claim in the application is in respect of the compound ‘Enzalutamide’. Five pre grant oppositions were filed by five different pre grant opponents challenging the grant of the application. Whilst the Controller, accepted that the said compound is novel and not anticipated in view of cited prior art documents, he rejected the patent application on the ground that the claimed invention lacked inventive steps.
The impugned order has been set aside by the Delhi High Court the matter has been remanded for reconsideration afresh. The Delhi High Court has held as follows:-
- The UOC raised a grievance regarding non-compliance of principles of natural justice and stated that Fresenius Kabi oncology Ltd., one of the opponents had produced a prior art document, “the Bohl document” first time during the course of hearing. The UOC also contended that the written submissions filed by Fresenius Kabi oncology Ltd., infact further expanded the submissions made by them during the course of the oral hearing and UOC had no opportunity to deal with the same. Fresenius Kabi oncology Ltd., stated that since the UOC had filed its written submissions, much after filing of submissions by them, UOC had full opportunity to controvert the arguments taken. The Court held that the Controller cannot ignore relevant material that is produced before him at a pre-grant stage as pre grant opposition is a part of the process of examination by the Controller.
- The Court, however, did not filed weight in the contention of Fresenius Kabi oncology Ltd. The Court held that post hearing written submissions cannot expand the scope of submissions made in the oral hearing. Such submissions are clearly meant to record only the oral submissions made at the hearing in order to assist the decision maker. There is no scope for entertaining additional arguments after the oral hearing is concluded. If the Controller intends to take into account any additional arguments raised after oral hearing is concluded, he is, obviously, required to put the applicant to notice regarding the same. In the aforesaid view, the Court held that the impugned order inasmuch as it accepts the arguments raised by Fresenius Kabi oncology Ltd., after conclusion of the hearing, cannot be sustained.
- It was also contented by UOC that since the Post- Grant Oppositions and the documents produced alongwith oppositions, subsequently, were not supported by an affidavit, and therefore, the representation could not be accepted. The Court however did not agree with the contention of UOC and held that there is no requirement that a pre-grant opposition be supported by an affidavit. Section 25(1) of the Patents Act merely requires the said opposition to be in writing. Form 7A (the Form in which the pregrant opposition is required to be filed in terms of Rule 55 of the Patents Rules) also does not require any verification or affirmation. The reliance placed by the UOC on Section 79 of the Patents Act was also considered to be misplaced. The Court held that Section 79 of the Patents Act mandates that evidence before a Controller can be submitted by way of an affidavit but the Controller also has the right to accept oral evidence. It is not the import of Section 79 of the Patents Act that documents, which are available in public domain, be ignored by the Controller unless supported by an affidavit.
- The next contention considered by the Court was whether the impugned order is vitiated as the Controller had failed to consider the affidavit affirmed by Prof. Michael E. Jung and Mr Schafer and Dr. Charles L. Sawyers filed supporting the case of UOC. Fresenius Kabi oncology Ltd., submitted that the UOC had not referred to the affidavits of the experts at the hearing or in the written submissions and, therefore, it was not open for UOC to assert that the affidavits had been ignored.
- The Court held that in technical matter, like the present case, even a minor change in a compound used as a drug can bring in about significant changes in its therapeutic value. In this view, the affidavits affirmed by Mr Schafer and Dr. Charles L. Sawyers could not be considered as irrelevant. The Court also noted that the submissions of the UOC clearly indicate that the affidavits are part and parcel of the submissions. The Court held that even if it is accepted that the affidavits were to be rejected as being irrelevant, the Controller was required to indicate the same in his decision. However, the impugned order is completely silent on the affidavits submitted by them.
The Delhi High Court through order dated 2nd May 2019 prohibited Natco Pharma Ltd. from manufacturing generic Ceritinib capsules in a suit for infringement of Indian patent number 276026 (IN276026) of Novartis AG.
IN276026 relates to the compound Ceritinib, a drug for the treatment of non-small cell lung cancer (NSCLC). The Plaintiff contested that this drug, which forms part of a broader group of 2,4-diamino pyrimidines, is novel and inventive. Earlier patents granted to AstraZeneca and Rigel Pharmaceuticals in relation to said broad group of compounds did not disclose formula 2 of the suit patent or the compound Ceritinib within the scope of said formula 2. However, the Plaintiff sought a license from AstraZeneca in the U.S.A to obtain freedom to operate. The Plaintiff also disclosed that they had two additional patents, namely, IN240560 and IN232653 which related to the broad class of 2,4-diaminopyrimidines. The Plaintiff also submitted that a post-grant opposition against IN276026 filed by the Defendant was pending before the Indian Patent Office. The opposition board’s recommendations were in favour of the Plaintiff and the hearing in the opposition had been concluded.
The Defendant chose to launch Ceritinib capsules under the brand name Noxalk® even while their opposition was pending at the Indian Patent Office.
The Defendant challenged the novelty and inventive step of the molecule Ceritinib and asserted that the broad Markush formula disclosed in AstraZeneca’s and Rigel’s patents as well as in Novartis’s earlier patents covered Ceritinib. The Defendant also asserted that the Plaintiff while obtaining patent term extension in the U.S.A claimed that Ceritinib was also covered by the U.S equivalent of IN240560 and that this was an evergreening attempt as while IN240560 expires in India in 2024 the suit patent is valid till 2027.
The Defendant, based on the decision of the Supreme Court in Aloys Wobben and Anr. vs. Yogesh Mehra and Ors. AIR 2014 SC 2210, also contended that once a post-grant opposition is filed, the rights in the patent are yet to be crystallised till the post-grant opposition is decided.
After hearing both the parties the Court concluded the following:
- The drug license to the Defendant’s product was granted in January 2019, that is, after the post-grant opposition was filed and after the opposition board had given its recommendations. The Defendant launched their generic Ceritinib on 20th March 2019 while the decision in the post-grant opposition was pending. Thus the Defendant chose to launch the product during the pendency of the post-grant opposition. While the Supreme Court in Aloys Wobben held that patent rights would crystallise once the post-grant opposition is decided, the scenario of the Opponent opposing the patent launching a product in infringement of the very same patent did not arise in that case. The Court further held that the rights granted to the Patentee under section 48 of the Patents Act are not affected during the pendency of the post-grant opposition even though they may crystallise once the opposition is decided. The Court was of the opinion that the Defendant should have waited till the decision in the post-grant opposition was issued before launching their product.
- The Court further observed that considering that the drug was for the treatment of non-small cell lung cancer, stopping the sale of the Defendant’s product which was already manufactured would not benefit the community in any manner. Based on the same the Court permitted the Defendant to continue marketing their products which had already been manufactured but estopped them from undertaking any fresh manufacture of pharmaceutical preparations of Ceritinib until the next date of hearing.
- The Court further directed the hearing officer in charge of the post-grant opposition at the Patent Office to issue a decision in the post-grant opposition prior to the next date of hearing in the Court.
On May 6, 2019, Delhi High Court granted interim injunction to Eisai Co. Ltd. and Arena Pharmaceuticals (collectively called Eisai) against Dr. Reddy’s Laboratory Ltd. (DRL) in respect of their anti-obesity blockbuster drug Lorcaserin.
The suit was in respect of Eisai’s Indian patent No. 215528 covering Lorcaserin and its pharmaceutically acceptable salts including Lorcaserin Hydrochloride and Lorcaserin Hydrochloride Hemihydrate. Lorcaserin is used for treatment of obesity and sold by Eisai under the brand Belviq.
The case is particularly interesting and one of its kind where both the Defendants and the Plaintiffs did not have a product in the Indian market and the cause of action was based on the Defendants taking steps to obtain regulatory approval and their intention to launch their product in the market.
The contentions of the defendants were as follows:
- Non-Working of patent for more than 10 years since grant and 15 years since date of patent, disentitles interim injunction.
- Plaintiffs have admitted in IPO and EPO prosecutions for subsequent patents that lorcaserin HCl hemihydrate is not disclosed, taught, or enabled in the suit patent. Therefore, as Defendants approval relates to Lorcaserin HCl hemihydrate, therefore Defendants’ activities fall outside the scope of the patent.
- Suit patent is invalid in light of section 3(d) of the Patents Act.
Hon’ble Mr. Justice J.R. Midha held that the plaintiffs have made out a strong prima facie case for grant of interim injunction against the defendants for the reasons given hereunder:-
- Admissions by Defendants:
- Mr. Girish Parhate, Director (Regulatory Affairs) of the defendants, in his statement dated January 14, 2019 admitted that their drug is covered by the plaintiffs’ suit patent.
- The admissions made by the defendants in US patent application 2014/0187538A1 and in the pre-grant opposition filed by the defendants against the plaintiffs’ pending Indian Patent Application No. 311/KOLNP/2009 for LHH that the PCT application corresponding to the suit patent i.e. WO2003/086306 discloses Lorcaserin and hydrochloride salt of Lorcaserin and method of preparing thereof.
- Section 3(d): The suit patent is in the nature of an originating/genus patent and the various subsequent patent applications are for improvement/selection inventions, which specifically disclose and claim a particular “species‟ of the genus patent, i.e. the hydrochloride hemihydrate form. Merely because the plaintiffs have applied for a patent separately for a specific species of the genus, it does not mean that the species patent cannot be granted or that the species patent would not fall within the coverage of the genus patent (i.e. the suit patent in the present case). Grant of a subsequent patent, which is an improvement invention, does not take the said forms out of the first/basic patent, which in the present case is the suit patent.
- Non-working of patent: The defendants had a remedy to seek a compulsory License under Sections 83 and 84 of the Patents Act, 1970. However, the defendants, instead of applying for either a voluntary license or a compulsory license, decided to go ahead on their own volition and seek a marketing approval. The non-working of a patent particularly for a pharmaceutical product cannot have a bearing on the rights of a patentee under Section 48 of the Patents Act, 1970.
- Balance of convenience: The Court held that the balance of convenience for the grant of interim injunction lies in favour of the plaintiffs as the defendants have evidently not “cleared the way” before going ahead with obtaining a marketing approval for launch of the infringing drug.
- Costs: the Court held that the plaintiffs are entitled to the costs from the defendants. However, the order as to quantum of costs is deferred till the final decision of this suit. Both the parties have been directed to submit the actual cost incurred by them. The parties have been also directed to submit their estimate of future cost before the commencement of trial so that the parties shall have notice of actual cost that the other side estimate would be incurring in the course of litigation and the parties have an opportunity to take appropriate decision as to manner in which to conduct the litigation.
The matter will is now listed before the regular bench on July 4, 2019.
Draft Manual of Patent Office Practice and Procedure, 2019 has been published by Office of the Controller General of Patents, Designs & Trade Marks for suggestions/inputs from the stakeholders. The suggestions sent by Anand and Anand can be accessed here.
The Plaintiff, PepsiCo India Holdings Private Limited instituted a suit against some farmers in Gujarat who were alleged to be illegally growing, producing and selling, without PepsiCo’s permission , the potato variety FL2027 (commercial name FC-5) registered by PepsiCo under the Protection of Plant Varieties and Farmers’ Rights Act, 2001 (hereinafter referred to as ‘the PPFVR Act’). An application for interim injunction was also filed.
The registered variety is used in the manufacture of potato chips under the brand name Lays and PepsiCo claimed that the defendant is illegally growing, producing and selling without permission such variety in violation of PepsiCo’s statutory rights granted under section 64 and 65 of the PPVFR Act.
The registered variety which is a hybrid of FL 1867 and Wischip varieties, was applied for registration as a new variety with the Plant Variety registry on 2nd February 2012. PepsiCo granted licences to some farmers in Punjab to bring potatoes of said variety on the buy-back system. PepsiCo learnt of the infringement by the Defendant in January 2019 following which they collected samples from the Defendant’s premises in the presence of the Defendant and sent said samples for verification to their in-house laboratory as well as government laboratories, namely, to the ICAR and Central Potato Research Institute, Shimla. Both the Plaintiff’s in-house laboratory as well as the Government laboratory pointed that the DNA of the sample collected by PepiCo from the Defendant’s premises matched with DNA of PepsiCo’s registered potato. Based on the same PepsiCo claimed infringement of the registered plant variety. It was further submitted that balance of convenience was also in favour of PepsiCo and that they would suffer irreparable loss if an interim injunction was not granted and further that any delay in granting an interim injunction would defeat the very purpose of filing the suit.
The Court found a prima facie case in PepsiCo’s favour and granted an ex-parte ad-interim injunction till the next date of hearing.
The National Biodiversity Authoity (NBA) has notified “Draft (revised) Guidelines on Access to Biological Resources and Associated Knowledge and Equitable Sharing of Benefits Regulations, 2019” on 24th of April 2019. The revisions clarify that the guidelines would apply also to the State Biodiversity Board approvals.
Public comments and suggestions can be communicated to email@example.com by 24-05-2019.
The Central Government on direction of Justice JR Midha has created a Fund for Scientific Advisers in terms of Section 115 (2) of the Act.
The direction was passed during a patent litigation (Sandeep Jaidka Vs. Rohit Kapur & Ors.) in which the Court held that it would be appropriate to appoint an independent Scientific Adviser to assist this Court and give opinion with respect to the issues in dispute.
Court stated that the remuneration of the Scientific Adviser would be settled out of the funds provided by the Parliament for that purpose.