UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX, INC. and APOTEX CORP.
`
`Petitioners
`
`V.
`
`ELI LILLY & COMPANY
`
`Patent Owner
`
`Patent No. 7,772,209
`Filed: July 11, 2007
`Issued: August 10, 2010
`Inventor: Clet Niyikiza
`
`Title: ANTIFOLATE COMBINATION THERAPIES
`
`Inter Partes Review No.: IPR2016-01191
`
`DECLARATION OF MICHAEL KELLEY, M.D.
`IN SUPPORT OF APOTEX, INC. AND APOTEX CORP.'S
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,772,209
`
`APOTEX 1041 -0001
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX, INC. and APOTEX CORP.
`
`Petitioners
`
`V.
`
`ELI LILLY & COMPANY
`
`Patent Owner
`
`Patent No. 7,772,209
`Filed: July 11, 2007
`Issued: August 10, 2010
`Inventor: Clet Niyikiza
`
`Title: ANTIFOLATE COMBINATION THERAPIES
`
`Inter Partes Review No.: IPR2016-01191
`
`DECLARATION OF MICHAEL KELLEY, M.D.
`IN SUPPORT OF APOTEX, INC. AND APOTEX CORP.'S
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,772,209
`
`APOTEX 1041 -0001
`
`
`
`IPR2016-01191
`
`1. My name is Michel Kelley, M.D. I have been retained on behalf of
`
`Apotex, Inc. and Apotex Corp. ("Apotex"). I understand that Apotex intends to
`
`petition for inter partes review of U.S. Patent No. 7,772,209 ("the '209 patent")
`
`(Ex. 1001 ). I further understand that Apotex will seek to join a prior proceeding
`
`brought by Neptune Generics, LLC ("Neptune"). I also understand that Apotex,
`
`like Neptune, will request that the United States Patent and Trademark Office
`
`cancel claims 1-22 of the '209 patent as unpatentable. I submit this Declaration in
`
`support of Apotex' s petition for inter partes review.
`
`I.
`
`Qualifications and Background
`
`A.
`
`2.
`
`Education and Experience; Prior Testimony
`
`I am over the age of eighteen (18) and otherwise competent to make
`
`this declaration.
`
`3.
`
`I am a Professor of Medicine at Duke University Medical Center
`
`where I am also a Member of the Duke Cancer Institute; Chief of Hematology and
`
`Oncology at Durham VA Hospital; and National Program Director for Oncology at
`
`the Department of Veterans Affairs.
`
`4.
`
`I received an undergraduate degree in Cellular and Molecular Biology
`
`(B.S.) at the University of Michigan in 1981 where I was a member of Phi Beta
`
`Kappa. I received my medical degree (M.D.) from the University of Michigan in
`
`1985.
`
`1
`
`APOTEX 1041 -0002
`
`
`
`IPR2016-01191
`
`5.
`
`After medical school, I completed my residency in internal medicine
`
`at Duke University Medical Center from 1985 to 1988. I became Board Certified
`
`by the American Board of Internal Medicine in 1988, and Board Certified by the
`
`American Board of Internal Medicine, Medical Oncology in 1991.
`
`6.
`
`Following residency, I was a research associate from 1988 to 1990 at
`
`the Laboratory of Cellular and Molecular Biology at the National Cancer Institute;
`
`a clinical associate from 1990 to 1993 at the National Cancer Institute; and a senior
`
`clinical investigator from 1993 to 1995 at the Navy Medical Oncology
`
`Branch/Medicine Branch at the National Cancer Institute.
`
`7.
`
`I also served in the United States Public Health Service from 1990 to
`
`1998, where I achieved the rank of Commander.
`
`8.
`
`I joined the Duke University Medical Center Department of Medicine
`
`as an assistant professor in 1998, became an associate professor in 2001, and
`
`became a full professor in 2014.
`
`9.
`
`In 2002, I was appointed the Interim Chief of the
`
`Hematology/Oncology department at Durham VA Hospital. In 2005, I was
`
`appointed to my current position of Chief of the Hematology/Oncology
`
`department.
`
`10.
`
`In 2007 I was appointed the National Program Director for Oncology
`
`at the Department of Veterans Affairs, and I currently hold that position.
`
`2
`
`APOTEX 1 041 - 0003
`
`
`
`IPR2016-01191
`
`11. My teaching responsibilities primarily concern adult oncology.
`
`12. During my career I have published extensively on the biology of and
`
`improving outcomes for patients with cancer, particularly lung cancer (over eighty
`
`peer-reviewed articles).
`
`13. My early publications examined the relationship between specific
`
`genetic alterations in lung cancer and clinically relevant applications including
`
`differential drug sensitivity, differentiation of metastases from second primary
`
`cancers, and application of patient-specific mutations as epitopes for
`
`immunotherapy. My research concerning the correlation of alteration of p 16 with
`
`drug sensitivity led to identification of a class of CDK4 inhibitor. My research
`
`also demonstrated that tubulin mutations are uncommon in lung cancer and
`
`described the artifactual detection of pseudo genes as the origin of a prior report
`
`claiming association of tubulin mutation with taxane sensitivity, thus correcting the
`
`scientific record. I served as the primary investigator or co-investigator in all of
`
`these studies.
`
`14. My research interests in lung cancer also involve conducting
`
`therapeutic and prevention clinical trials. These trials have primarily been
`
`translation of hypotheses derived primarily from laboratory-based biological
`
`observations including the GRP autocrine growth factor in small cell lung cancer, a
`
`phase I study of a pulmonary toxin in non-small cell lung cancer, mutation-specific
`
`3
`
`APOTEX 1 041 - 0004
`
`
`
`IPR2016-01191
`
`immunotherapy, and a putative chemopreventive agent for smokers. More
`
`recently, I have been an active member of the Respiratory Committee of
`
`CALGB/ Alliance including serving as principal investigator on a trial testing the
`
`addition of irinotecan to treatment of patients with small cell lung cancer.
`
`15.
`
`Through my clinical practice, I conceptualized and led a project to
`
`identify the underlying molecular basis of the May-Hegglin anomaly (a frequently
`
`misdiagnosed disorder) through classical genetics. My research also described
`
`genetic linkage for a rare familial cancer syndrome characterized by very high
`
`penetrance of chordoma, and studied regulatory-approved drugs for anti-growth
`
`activity to determine whether any could be repurposed for clinical use in patients.
`
`16.
`
`I am a member of the American Society of Clinical Oncology, the
`
`International Association for the Study of Lung Cancer, and a Fellow of the
`
`American College of Physicians.
`
`17.
`
`I have peer reviewed articles for, or been a member of the editorial
`
`board of, several medical journals including Journal of Clinical Oncology and
`
`Journal of Thoracic Oncology.
`
`18.
`
`I have prescribed and administered a wide variety of intravenous,
`
`intramuscular, subcutaneous, and intrathecal medications, including anti-folates.
`
`19.
`
`I consider myself to be an expert in the field of oncology.
`
`4
`
`APOTEX 1 041 - 0005
`
`
`
`IPR2016-01191
`
`20. Additional information concerning my education and experience can
`
`be found in my curriculum vitae, a copy of which is attached (Exhibit 1040).
`
`21.
`
`I have been retained by Apotex as a technical expert in this matter to
`
`provide various opinions regarding the '209 patent. I am compensated at my
`
`normal rate of $600 per hour. No part of my compensation is dependent upon my
`
`opinions given or the outcome of this case.
`
`B.
`
`Bases for Opinions and Materials Considered
`
`22.
`
`In forming the opinions set forth in this Declaration, I have relied on
`
`my experience, education, and training, as well as my detailed review of the
`
`Declaration of W. Archie Bleyer, MD, FRCP [GLASG] ("the Bleyer Declaration")
`
`(IPR2016-00240, Ex. 1024), including all exhibits referenced therein. I have
`
`considered the viewpoint of a person of ordinary skill in the art prior to June 30,
`
`1999.
`
`II. Opinions Regarding the '209 Patent
`
`16.
`
`I have reviewed the Bleyer Declaration, submitted in connection with
`
`Neptune's petition for inter partes review of the '209 patent (IPR2016-00240, Ex.
`
`1024), including materials and exhibits cited therein. I fully agree with, and hereby
`
`adopt, the opinions set forth in the Bleyer Declaration.
`
`17. While not relevant to my ultimate agreement with Dr. Bleyer's
`
`opinions concerning the obviousness of the '209 patent, for the sake of clarity I
`
`5
`
`APOTEX 1 041 - 0006
`
`
`
`IPR2016-01191
`
`provide the following corrections to minor typographical errors in the Bleyer
`
`Declaration below.
`
`18.
`
`In Paragraph 68, I would clarify that lometrexol is a generic name, not
`
`a brand name, and that Tomudex is also known by the generic name raltitrexed.
`
`19.
`
`In Paragraph 115, I note that the following underlined words are
`
`missing from the quotation from Refsum: "[T]he fate of intracellular ... "
`
`III. CONCLUSION
`
`20.
`
`I declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`
`Dated: June 29, 2016
`
`By:
`
`f1llrb-
`Michael Kelley, M.D.
`
`6
`
`APOTEX 1 041 - 0007
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
