Order refusing UOC’s Patent application for Enzalutamide set aside by the DHC and the matter remanded back for reconsideration

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:-

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

Natco Prohibited from Manufacturing Generic Ceritinib

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:

  1. 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.
  2. 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.
  3. 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.