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:
- Reply statement
- Notarized evidence of experts Dr. (Prof.) Michael Jung
- 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
- 2006. June 12. Third Amendment to exclusive license agreement between Regents and Medivation. https://www.sec.gov/Archives/edgar/data/1011835/000156459016013460/mdvn-ex1014_540.htm
- 2007. July 17. Fourth Amendment to exclusive license agreement between Regents and Medivation. https://www.sec.gov/Archives/edgar/data/1011835/000156459016013460/mdvn-ex1015_541.htm
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: