`
`Paper No. __
`
`
`
`
`
`For the Petitioner
`Lead counsel: Robert W. Hahl, Reg. No. 33,893
`Backup counsel: Robert Mihail, Reg. No. 66,021
`Backup counsel: John K. Pike, Reg. No. 41,253
`Neifeld IP Law, PC
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`Coalition For Affordable Drugs V LLC
`Petitioner
`v.
`
`Biogen MA Inc.
`Patent Owner
`____________
`
`Case IPR2015-01993
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
`
`
`
`
`DECLARATION OF ROBERT MIHAIL
`
`
`Page 1 of 5
`
`
`
`1. I am an attorney employed by Neifeld IP Law, PC.
`
`2. On 9/19/2015 I accessed the URL https://clinicaltrials.gov/show/NCT00168701
`
`and saw that the top-level domain is a “dot-gov” domain.
`
`3. On 4/29/2015 I read that 41 CFR §102-173.30 states “Who may register in the
`
`dot-gov domain? Registration in the dot-gov domain is available to official
`
`governmental organizations in the United States including Federal, State, and local
`
`governments, and Native Sovereign Nations.”
`
`4. Based on the above findings, I concluded that the domain name clinicaltrials.gov
`
`of the URL https://clinicaltrials.gov/show/NCT00168701 is registered by an
`
`official governmental organization in the United States.
`
`5. On 9/19/2015 I downloaded the document contained at URL
`
`https://clinicaltrials.gov/show/NCT00168701, now marked as Ex. 1040.
`
`6. On 9/19/2015 I clicked the hyperlinked text “History of Changes” located on the
`
`first page of Ex. 1040. Upon clicking said hyperlink I was taken to URL
`
`https://clinicaltrials.gov/ct2/archive/NCT00168701. A copy of the webpage located
`
`at said URL is now marked as Ex. 1041.
`
`7. On 9/19/2015 I clicked the hyperlinked text “ClinicalTrials.gov Archive Site”
`
`located on the first page of Ex. 1041. Upon clicking said hyperlink I was taken to
`
`Page 2 of 5
`
`
`
`URL https://clinicaltrials.gov/archive/NCT00168701. A copy of the webpage
`
`located at said URL is now marked as Ex. 1042.
`
`8. On 9/19/2015 I clicked the hyperlinked text “Study” located immediately to the
`
`right of “2005-09-14” under the Column titled “Updated”. Upon clicking said
`
`hyperlink I was taken to URL
`
`https://clinicaltrials.gov/archive/NCT00168701/2005_09_14. A copy of the
`
`webpage located at said URL is now marked as Ex. 1022.
`
`9. On 9/19/2015 I accessed the URL https://www.clinicaltrials.gov/ct2/about-
`
`site/background and downloaded the webpage, now marked as Ex. 1043.
`
`10. On 9/19/2015 I read from the first page of Ex. 1043 that “The results database
`
`was made available to the public in September 2008. FDAAA 801 also established
`
`penalties for failing to register or submit the results of trials. See the History,
`
`Policies, and Laws page for more information about the development of
`
`ClinicalTrials.gov. Because ClinicalTrials.gov is a government Web site, it does
`
`not host or receive funding from advertising or the display of commercial content.”
`
`11. On 9/19/2015 I also read from the second page of Ex. 1043 that “[t]he full
`
`history of changes made to a record can be accessed by viewing the archival
`
`version of the record on the ClinicalTrials.gov archive. Once a study is registered
`
`on the site, the information about it is not removed.”
`
`Page 3 of 5
`
`
`
`Based on my observations of the information and documents contained in
`
`paragraphs 1-11 above, I concluded that (1) the webpage now marked as Ex. 1022
`
`is an archival page of the study marked as “NCT00168701,” that (2) the
`
`information on webpage now marked as Ex. 1022 was publicly available on
`
`09/14/2005 and (3) that information contained on the webpage now marked as Ex.
`
`1022 was not removed since 09/14/2005.
`
`
`
`In signing this declaration, I understand that the declaration will be filed as
`
`evidence in a contested case before the Patent Trial and Appeal Board of the
`
`United States Patent and Trademark Office. I acknowledge that I may be subject to
`
`cross examination in the case and that cross examination will take place within the
`
`United States. If cross examination is required of me, I will appear for cross
`
`examination within the United States during the time allotted for cross
`
`examination.
`
`
`
`I also swear under penalty of perjury of the laws of the United States that the
`
`foregoing is true and correct.
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted
`
`By: /RobertMihail/
`
`Robert Mihail (Reg. No. 66,021)
`Back-up Counsel for the Petitioner
`Date: 9/27/2015
`Neifeld IP Law, PC
`4813-B Eisenhower Avenue
`
`Page 4 of 5
`
`
`
`Alexandria, VA 22304
`Tel: 1-703-415-0012
`Email: rmihail@neifeld.com
`
`
`Page 5 of 5
`
`
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
