Post grant Opposition filed on or before one year of publication under of grant is maintainable

In a recent decision, Asstt. Controller of Patents and design, Dr. Rachna Yadav has held that a post grant Opposition filed at the Indian Patent office on or before the expiry of one year of publication of grant under section 43(2) is maintainable.

Two Oppositions were filed on 30.03.2017 and 31.03.2017 by the Opponents, Shantha Biotechnics Private Limited and Biological E. Limited, respectively, under Section 25(2) of the Patents Act against Panacea’s Patent number IN272351. On 5th April, 2017, the Patentee was served with a copy of the notice of opposition and evidence by courier service, by e-mail on 27th April 2017 and by speed post on 1st May 2017 (agent of Patentee) and 2nd May 2017 (Patentee).

The Patentee filed an Interlocutory petition that the opposition is not maintainable as the Patentee has been served with the post grant opposition by email as well as speed-post by letters dated 28th April, 2017 which are beyond the prescribed time.

The Controller noted that section 25 (2) requires that a post grant opposition be filed at the Indian Patent Office on or before the expiry of one year of publication under section 43(2) i.e., before 1st April 2017. The same has been done in the present case.

Further, the Controller held that the Patentee has admitted to the fact that the copy of Opposition (including written statement, evidence and notice) was received on 5th April 2017 by courier, and later by e-mail and speed post. The Controller held that the Patentee has admitted that they have received the Opposition, by not one but several modes and the opposition has been timely filed at the Indian Patent Office as per the timeline of Section 25(2), the opposition is therefore maintainable.

 

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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.

IPAB ADMITS APPEALS ON ORDERS ISSUED UNDER NON-APPEALABLE PROVISIONS

In two landmark cases,the Intellectual Property Appellate Board treated orders issued under non-appealable provisions of section 11(B) (4) and 77(f) as appealable.

The first such order was issued under section 11(B) (4) treating an application for patent as ‘deemed withdrawn’ for failure to file the request for examination within the prescribed time period of 48 months from the date of priority of the application. The case of the petitioner was that the Indian Patent Office (IPO) made an incorrect entry in the cash receipt stating that the fee for examination was filed after the expiry of the prescribed period in spite of the timely filing of the same. The Petitioner brought the incorrect entry to the notice of the Patent Office. In what can be seen as a gross violation of the principles of natural justice, the Controller of Patents issued an order treating the application as withdrawn without issuing a hearing notice to the Applicant.

Statutorily, orders passed under section 11(B) (4) are not appealable but the attorneys of the Appellant argued that since the Applicant had timely filed the request for examination, said order should be taken as an order under section 15 of the Indian Patents Act which bestows upon the Applicant a right to appeal. The Appellate Board agreed with the submissions of the Appellant and allowed the appeal.

In the second case, an order issued in a pre-grant opposition, which was treated as a review petition under orders of the Delhi High Court to correct a procedural irregularity that had ensued due to a patent being granted without processing of a pre-grant opposition, was treated as patentable by the IPAB. The IPAB held that the order issued in the review petition under section 77(f), was in effect an order in a pre-grant opposition that was being treated as a review petition under directions of the High Court and since orders in pre-grant oppositions are appealable, the order in this case was also held appealable.

These orders have brought in their wake a stand to draw curative measures to address administrative errors.

Tofacitinib caught in section 3(d) turmoil

The Controller of Patents, Mumbai  issued an order rejecting a patent application of Pfizer for Tofacitinib for the second time. The primary ground for rejection of Tofacitinib was Section 3(d) and the Controller relied on the Supreme Court’s order on the Glivec case. The Controller said that the claimed form is an enantiomer of a compound (known compound) and the Applicant has failed to establish the enhanced therapeutic efficacy of the claimed compound over the base compound.  The Controller held that the base compound is a “known compound” for the purpose of section 3(d) even if the prior art which discloses it was not published before the priority date. The said prior art being Applicant’s own patent application was known to the them.

The Controller also held that the advantage of the claimed form over other possible enantiomer forms of the base compound does not prove enhanced efficacy over base compound.

The Controller also rejected the application on the grounds of Anticipation by prior claiming. The controller held that Example 14 of WO 01/42246 (D1) discloses the compound of present claim without reference to the stereo chemical configuration (base compound) which is also claimed in the prior art. Further the controller held that D1 teaches that the compounds have asymmetric centres and exist in different enantiomeric and diastereomeric forms. D1’s reference to enantiomeric and diastereomeric forms of the compounds was held to represent an unambiguous technical teaching making available to the public all four stereo chemical configurations of the compounds according to example 14. Therefore the form (3R, 4R) of the compound claimed by the applicant was considered disclosed in the prior art. The Controller also considered present form to be anticipated as he held that the Applicant has failed to compare the compound claimed with the compound of prior art D1 to overcome lack of novelty.

This is the second time that the same application has been rejected by the Indian Patent Office. The patent application was rejected for the first time by a different Controller and the Patent office in Mumbai was directed by Intellectual Property Appellate Board (IPAB) to re-consider Pfizer’s patent application on account of flagrant violation of principles of natural justice. The matter was heard afresh by Controller of patents  on January 2015. The application has been rejected again by the recent order on the 3rd of September, 2015