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.