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.
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1 thought on “Order refusing UOC’s Patent application for Enzalutamide set aside by the DHC and the matter remanded back for reconsideration

  1. Pingback: SpicyIP Fortnightly Review (May 20-June 2) | SpicyIP

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