January 2017 Petition Filed by Regents of the University of California before the Delhi High Court regarding Xtandi (full Writ petition and annexes)

The following records were provided by KEI from UCLA on September 28, 2018, following a freedom of Records Request.

This page describes the contents of on very large PDF file, the “Combined IN Writ Petition DHC,”  which is 1,309 pages long,

The files are part of a  January 2017 petition filed by Regents of the University of California before the Delhi High Court regarding the UCLA patent claimed on enzalutamide, a prostate cancer sold by Astellas under the brand name Xtandi .

UCLA licensed the patents to a company named Medivation in 2005.   In 2009, Medivation entered into a license with Astellas.   In 2016, Pfizer acquired Medivation.   In January 2017, UCLA appeared a decision by the India patent office, rejected the Indian patent application.

The PDF file is available here:

https://drive.google.com/file/d/1GRGD97tqdXV9UzlUZKNNfLsXHSFixuVm/view?usp=sharing

The following are notes on the documents in the PDF file.

Page 6. 

Index 

Volume I

The Regents of the University of California v. Union of India & Ors.

January 31, 2017

 

Page 8.

Urgent Application

Extra Ordinary Civil Writ Jurisdiction 

Regents of the University of California v. Union of India & Ors.

January 2017

Submitted by Anand and Anand

 

Page 10.  

List of Dates and Events

January 31, 2017

 

Page 15.

Writ Petition – “A Civil Writ Petition Under Articles 226 & 227 of the Constitution of India Seeking Setting Aside/Quashing of Order Dated November 8, 2016 Passed by the Assistant Controller of Patents Rejecting the Petitioner’s Patent Application No.9668/DELNP/2007” 

January 31, 2017

 

Page 43.

Affidavit of Mr. Samir Kazi, S/O Mr. Salauddin Kazi, Aged about 40 Years, c/o Pfizer Limited, Pfizer Centre, Patent Estate, S.V Road, Jogeshwari(W), Mumbai 400 102

Counsel for Petitioner, Regents of the University of California

 

Page 44.

Annex P1

Section 25(1) Patent Opposition

The Regents of California, applicant

and

1) Fresenius Kabi Oncology Limited

2) BDR Pharmaceutical International Pvt. Ltd.

3) Umesh Shah

4) Sheela Pawar

5) Indian Pharmaceuticals Alliance (IPA)

Opponents

 

Order rejecting patent application “as the claimed invention is lacking inventive step under section 2(1)(ja) and also not patentable under section 3(d) and 3(e).” 

 

Signed by Umesh Ch Pandey (Asst. Cont. Patents & Designs)

 

August 11, 2016

 

Page 87.

Annex P2

Power of Attorney 

Regents of the University of California appoint Samir Kazi and Swati Chauhan as the Company’s true and lawful attorney in respect of all suits, writ petitions and/or any other legal proceedings already instituted or proposed to be instituted [in this matter]. 

January 18, 2017

 

Page 89.

Annex P3

The Patents Act, 1970
Complete Specification of Patent Application No. 9668/DELNP/2007

Section 10

“Diarylhydantoin Compounds”

 

Page 250.

Letter No.:-CHEM/2013/586

To, Anand & Anand, 

Advocates,

B-41, Nizamuddin east, New Delhi-110013

May 24, 2013

 

Page 252.

Letter from Archana Shanker of Anand and Anand Advocates 

Agent for the Applicant

Re:  India Patent Application No. 9668/DELNP/2007

February 7, 2014

 

Page 260.

Form 1

The Patents Act 1970

(39 of 1970)

Application No. 9668/DELNP/2007

February 11, 2014

 

Page 272.

The Regents of the University of California v. Union of India & Ors. 

Index

Volume II

January 31, 2017

 

Page 273.

Annex P4

Letter to the Controller of Patents, The Patent Office, Delhi from Dr. Sanchita Ganguli, Agent of Opponent, Fresenius Kabi Oncology Limited

Re:  Opposition under Section 25(1) against

Patent Application No. No. 9668/DELNP/2007

Applicant:  The Regents of the University of California

Opponent:  Fresenius Kabi Oncology Limited

Enclosing Pre-Grant Opposition and Attachments
December 1, 2012

 

Page 337.

Letter from Anand and Anand to the Controller of Patents, The Patent Office, Delhi 

Re:  Pre-grant Opposition in respect of Indian Patent Application No. 9668/DELNP/2007
under Section 25(1) of the Indian Patents Act, 2005 

Title:  Diarylhydantion Compounds 

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

Enclosing Reply Statement and Attachments

August 26, 2013

 

Page 390.

Letter from Anand and Anand to the Controller of Patents, The Patent Office, New Delhi 

Re:  Pre-grant Opposition in respect of Indian Patent Application No. 9668/DELNP/2007
under Section 25(1) of the Indian Patents Act, 2005 

Title:  Diarylhydantion Compounds 

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

Enclosing “the original apostilled affidavit of our exert Prof. Michael E. Jung and Dr. Charles L. Sawyers in the aforementioned matter.” 

April 3, 2014

 

Page 393.

Declaration of Dr. Charles L. Sawyers

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

February 11, 2014

 

Page 406.

Declaration of Prof. Michael E. Jung

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

January 22, 2014

 

Page 427.

Letter from Anand and Anand to the Controller of Patents, The Patent Office, New Delhi 

Re:  Pre-grant Opposition in respect of Indian Patent Application No. 9668/DELNP/2007
under Section 25(1) of the Indian Patents Act, 2005 

Title:  Diarylhydantion Compounds 

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

Enclosing “the original apostilled affidavit of our ex[p]ert Mr. Josh Schafer in the aforementioned matter.”

August 29, 2014

 

Page 430.

Affidavit of Josh Schafer, Aged [43], Resident of [USA]

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

August 19, 2014

 

Page 437.

Letter from Anand and Anand to the Controller of Patents, The Patent Office, New Delhi 

Re:  Pre-grant Opposition in respect of Indian Patent Application No. 9668/DELNP/2007
under Section 25(1) of the Indian Patents Act, 2005 

Title:  Diarylhydantion Compounds 

Fresenius Kabi Oncology Ltd. v. The Regents of the University of California 

Enclosing “Written Submissions for the hearing held in respect of the above matter on 2nd and 3rd of July 2015 in respect of the Opponent Fresenius Kabi Oncology Limited.” 

September 11, 2015

 

Page 553.

Documents Relied on in the Representation and

Additional Documents Referred During the Hearing Held on July 03, 2015

July 27, 2015

 

Page 585.

Regents of the University of California v. Union of India & Ors. 

Index 

Volume III

January 3, 2017

 

Page 586.

Annex P5

Letter from Government of India Ministry of Commerce & Industry to Anand & Anand Advocates

Re: “Pre-grant Representation to the grant of a Patent Application No. 9668/DELNP/2007”

Enclosing “a copy of the said pre-grant representation filed by M/s. B.D.R. Pharmaceutical International Pvt. Ltd.[.]” 

October 23, 2013

 

Page 623.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi 

Re:  Pre-grant Opposition in respect of Indian Patent Application No. 9668/DELNP/2007 under Section 25(1) of the Indian Patents Act, 2005 

Title: Diarylhydantion Compounds 

BDR Pharmaceutical International Pvt. Ltd. v. The Regents of the University of California

Enclosing “our reply statement along with the evidence (in duplicate).” 

January 23, 2014

 

Page 662. 

Declaration of Prof. Michael E. Jung

BDR Pharmaceutical International Pvt. Ltd. v. The Regents of the University of California

January 22, 2014

 

Page 68269.

Declaration of Dr. Charles L. Sawyers

BDR Pharmaceutical International Pvt. Ltd. v. The Regents of the University of California

January 20, 2014

 

Page 694.

“Rejoinder in response to the reply statement submitted by the Applicant, the Regents of the University of California in relation to the Pre-grant Opposition filed u/s 25(f) of the Patents Act, 1970.” 

April 25, 2014

 

Page 743.

Affidavit of Dr. Guruprasad Ramchandra Wader, Technical Director at BDR Pharmaceuticals International Pvt. Ltd. 

April 22, 2014

 

Page 770.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Enclosing “The original apostilled affidavit of our expert Mr. Josh Schafer[.]”

September 5, 2014

 

Page 773. 

Affidavit of Josh Schafer, Aged 43, Resident of USA

Dated August 28, 2014

 

Page 780.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Enclosing “our Written Submissions for the hearing held in the above matter on 3rd of July 2015 in respect of the BDR Pharmaceutical International Pvt. Ltd.” 

September 14, 2015

 

Page 850.  

In the Matter of a Pre-grant Opposition under Section 25(!) read with Rule 55

In the Matter of:  Indian Application No. 9668/DELNP/2007 filed on 13/12/20017

Representation By: BDR Pharmaceutical International Pvt. Ltd. v. the Regents of the University of California

Written Arguments on Behalf of the Petitioner/Opponent

April 18, 2016

 

Page 866.

Regents of the University of California v. Union of India & Ors. 

Index
Volume IV

January 31, 2017

 

Page 868.

Annex P6

Sub:  Pre-Grant Opposition 

Reg: 9668/DELNP/2007 

Title:  Diaryhdantoin Compounds

Applicant:  The Regents of the University of California

Opponent: Mr. Umesh Shah

February 3, 2015

 

Page 896.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Re:  Pre-grant Opposition in respect of Indian Patent Application No. 9668/DELNP/2007

Umesh Shah v. the Regents of the University of California

Enclosing:

  1. Reply statement 
  2. Notarized evidence of experts Dr. (Prof.) Michael Jung
  3. Notarized evidence of experts Dr. Charles L. Sawyers

May 19, 2015

 

Page 938.

Declaration of Prof. Michael E. Jung

Umesh Shah v. the Regents of the University of California

May 15, 2015

 

Page 952.

Declaration of Dr. Charles L. Sawyers

Umesh Shah v. the Regents of the University of California

May 25, 2015

 

Page 963.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Re: Indian Patent application No. 9668/DELNP/2007

Opponent:  Umesh Shah

Enclosing “Written Submissions for the hearing held in respect of the above matter on 2nd and 3rd of July 2015 in respect of the Opponent Umesh Shah.” 

September 11, 2015

 

Page 1022.

Annex P7

Form 7-A

Representation for Opposition to Grant of Patent 

Sheela Pawar (Opponent)

July 27, 2015

 

Page 1038.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

RE:  Reply Statement to the Pre Grant representation Indian Patent Application No. 9668/DELNP/2007 Opponent:  Sheela Pawar 

Enclosing Reply Statement to Pre Grant representation filed by Opponent Sheela Pawar

July 8, 2016

 

Page 1050.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Re: Indian Patent Application No. 9668/DELNP/2007 Opponent:  Sheela Pawar 

Enclosing “hearing submissions in respect of the hearing attended in the matter on 25th July 2016.” 

August 1, 2016

 

Page 1058.

Letter from Kavita Rao Parmar, Gopakumar Nair Associates  Controller of Patents, the Patent Office, New Delhi

Re: “Written submissions on behalf of Opponents pursuant to the oral hearing held on July 25, 2016”

August 1, 2016

 

Page 1080.

Regents of the University of California v. Union of India & Ors. 

Index 

Volume V

January 31, 2017

 

Page 1082.

Annex P8

In the Matter of the Patents Act, 1970

(as amended by the Patents (Amendment) Act, 2005)

and 

In the Matter of the Patent Rules, 2003

(as amended by the Patent (Amendment) Rules, 2006)

and

In the Matter of Indian Patent Application No. 9668/DELNP/2007 filed by the Regents of the University of California 

and 

In the Matter of a Representation by Way of Opposition under Section 25(1) and Rule 55 thereto by Indian Pharmaceutical Alliance

Representation by Way of Opposition U/S 25(1) 

June 7th, 2016

Signed by Nayan J. Rawal

 

Page 1116.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Re:  “Reply Statement to the Pre Grant representation Indian Patent Application No. 9668/DELNP/2007 Opponent:  Indian Pharmaceutical Alliance”

July 6, 2016

 

Page 1153.

Letter from Anand and Anand to Controller of Patents, the Patent Office, New Delhi

Enclosing Written Submissions in Relation to India Patent Application No 9667/Delnp/2007

Regents of the University of California v Indian Pharmaceutical Alliance.

Hearing date July 25, 2016.  

On Behalf of Archana Shanker, Devinder Singh Rawat, Gitika Suri.

Dated August 1, 2016, signed by Archer Shanker, agents for the applicant.

 

Page 1203.  

Annex P9, US Patent No. 5,411,981.

 

Page 1231.  

Annex P10. US Patent No. 6,518.257 B1

 

Page 1271

Annex P11.   A Ligand-Based Approach to Identify Quantitative Structure–Activity Relationships for the Androgen Receptor.

 

Page 1283. 

Annex P12, US Patent 4,636,505

 

Page 1294.

Annex P13. US Patent 4,097,578

 

Page 1297.

Extra Ordinary Writ Jurisdiction

Regents of the University of California v Union of India & Ors.

Application under Section 151 of the Code of Civil Procedures for Interim Relief

January 31, 2017.   Anand and Anand, Advocates for the Petitioner

 

Page 1305.

Affidavit of Mr. Samir Kazi, S/O Mr. Salauddin Kazi, Aged about 40 years, c/o Pfizer Limited, Pfizer Centre, Patent Estate, S.V. Road, Jogeshwari(W), Mumbai 400 102.

Regents of the University of California v Union of India & Ors

January 31, 2017

 

Page 1309.

Power of Attorney, Regents of the University of California v Union of India & Ors

 

 

ANNEX 1, Timeline for selected events

 

UCLA/Medivation License:

 

    • 2005.  August 12.  Exclusive license agreement between Regents and Medivation
    • 2005. November 4. Amendment to exclusive license agreement between Regents and Medivation

 

  • 2006. May 8.  Second Amendment to exclusive license agreement between Regents and Medivation

 

 

 

Medivation/Astellas

 

October 27, 2009—initial press release on collaboration

https://www.sec.gov/Archives/edgar/data/1011835/000119312510057020/dex1015.htm

 

FDA approval.

 

  • 2012. May 22. Astellas FDA NDA application
  • 2012.  August 31. FDA Approval of Xtandi

 

 

Medivation/Pfizer

August 22, 2016. Press release on acquisition

https://www.sec.gov/Archives/edgar/data/1011835/000119312516686961/d245915dex991.htm

 

US Orange Book Patents

 

US Patent 7709517

 

Inventors: Sawyers; Charles L. (New York, NY), Jung; Michael E. (Los Angeles, CA), Chen; Charlie D. (Los Angeles, CA), Ouk; Samedy (Costa Mesa, CA), Welsbie; Derek (Northridge, CA), Tran; Chris (New York, NY), Wongvipat; John (Nanuet, NY), Yoo; Dongwon (Los Angeles, CA)

 

Title: Diarylhydantoin compounds

Filed: May 15, 2006.

Granted: May 4, 2010.

GOVT: This invention was made with United States Government support under National Institutes of Health SPORE grant number 5 P50 CA092131 and Department of Defense (Army) grant number W81XWH-04-1-0129. The Government has certain rights in the invention.

CoC: Three.  Nov 16, 2010.  Delete Welsbie and Yoo as inventors.  Dec 21, 2010.  

April 19, 2011. Patent extension, 455 days.

 

 

US Patent 8183274

Title: Treatment of hyperproliferative disorders with diarylhydantoin compounds

Inventors: Sawyers; Charles L. (New York, NY), Jung; Michael E. (Los Angeles, CA), Chen; Charlie D. (Shanghai, CN), Ouk; Samedy (Costa Mesa, CA), Tran; Chris (New York, NY), Wongvipat; John (Nanuet, NY)

Assignee: The Regents of the University of California (Oakland, CA)

Appl. No.: 12/708,523

Filed: February 18, 2010

Granted: May 22, 2012

GOVT: This invention was made with United States Government support under National Institutes of Health SPORE grant number 5 P50 CA092131and Department of Defense (Army) grant number W81XWH-04-1-0129. The Government has certain rights in the invention.

CoC: none

 

 

US Patent 9126941

Title:  Treatment of hyperproliferative disorders with diarylhydantoin compounds

Inventors: Sawyers; Charles L. (New York, NY), Jung; Michael E. (Los Angeles, CA), Chen; Charlie D. (Los Angeles, CA), Ouk; Samedy (Los Angeles, CA), Tran; Chris (New York, NY), Wongvipat; John (Nanuet, NY)

Assignee: The Regents of the University of California (Oakland, CA)

Appl. No.: 13/448,964

Filed: April 17, 2012

Granted: September 8, 2015

GOVT: This invention was made with Government support under Grant No. W81XWH-04-1-0129 awarded by the United States Army, Medical Research and Materiel Command; Grant No. CA092131 awarded by the National Institutes of Health. The Government has certain rights in this invention.

CoC