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1. WO2016135755 - AMORPHOUS APREMILAST, PREMIXES THEREOF, AND NOVEL CRYSTALLINE FORMS OF APREMILAST


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INTERNATIONAL SEARCH REPORT (ISR)
Part 1:  1  2  3  4  5  6          Part 2:  A  B  C  D  E 
International application No. Applicant's or agent's file reference
PCT/IN2016/050070 WO79
International filing date (day/month/year) (Earliest) Priority Date (day/month/year)
26 February 2016 27 February 2015
Applicant
MYLAN LABORATORIES LIMITED
FOR FURTHER ACTION: See Form PCT/ISA/220 as well as, where applicable, item 5 below.
This international search report has been prepared by this International Searching Authority and is transmitted to the applicant according to Article 18. A copy is being transmitted to the International Bureau.
It is also accompanied by a copy of each prior art document cited in this report.
1. Basis of the report
a. With regard to the language, the international search was carried out on the basis of:
the international application in the language in which it was filed.
a translation of the international application into                                          which is the language of a translation furnished for the purposes of international search (Rules 12.3(a) and 23.1(b)).
b.
This international search report has been established taking into account the rectification of an obvious mistake authorized by or notified to this Authority under Rule 91 (Rule 43.6bis(a)).
c.
With regard to any nucleotide and/or amino acid sequence disclosed in the international application, the international search was carried out on the basis of a sequence listing:
2. Certain claims were found unsearchable
3. Unity of invention is lacking
This International Searching Authority found multiple inventions in this international application, as follows:
1. claims: 1-18, 31, 34, 35
Subject-matter related to amorphous apremilast
2. claims: 19-26, 32
Subject-matter related to apremilast anisole solvate
3. claims: 27-30, 33
Subject-matter related to apremilast methyl ethyl ketone solvate
1.
As all required additional search fees were timely paid by the applicant, this international search report covers all searchable claims.
2.
As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite payment of additional fees.
3.
As only some of the required additional search fees were timely paid by the applicant, this international search report covers only those claims for which fees were paid, specifically claims Nos.:
4.
No required additional search fees were timely paid by the applicant. Consequently, this international search report is restricted to the invention first mentioned in the claims; it is covered by claims Nos.: 1-18, 31, 34, 35
Remark on Protest
The additional search fees were accompanied by the applicant’s protest and, where applicable, the payment of a protest fee.
The additional search fees were accompanied by the applicant’s protest but the applicable protest fee was not paid within the time limit specified in the invitation.
No protest accompanied the payment of additional search fees.
4. Title of the invention
The text is approved as submitted by the applicant.
The text has been established by this Authority to read as follows:
5. Abstract
The text is approved as submitted by the applicant.
The text has been established, according to Rule 38.2, by this Authority as it appears in Box No. IV. The applicant may, within one month from the date of mailing of this international search report, submit comments to this Authority.
6. Drawings
a.
The figure of the drawings to be published with the abstract is Figure No.     1    
as suggested by the applicant.
as selected by this Authority, because the applicant failed to suggest a figure.
as selected by this Authority, because this figure better characterizes the invention.
b.
none of the figures is to be published with the abstract.

A. CLASSIFICATION OF SUBJECT MATTER

     C07D 209/48 (2006.01)i; A61K 31/573 (2006.01)i
According to International Patent Classification (IPC) or to both national classification and IPC

B. FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols):
     C07D; A61K
Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched:
Electronic data base consulted during the international search (name of data base and, where practicable, search terms used):
EPO-Internal, BIOSIS, CHEM ABS Data, EMBASE, WPI Data, BEILSTEIN Data

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No.
(1)
X
US 2008234359 A1 (MULLER GEORGE W [US] ET AL) 25 September 2008 (2008-09-25)
1-18,31,34,35
page 28 - page 31
paragraph [0131] - paragraph [0134]; claims 1,32,33
(2)
X
WO 2014072259 A1 (RATIOPHARM GMBH [DE]) 15 May 2014 (2014-05-15)
1-18,31,34,35
cited in the application
page 5, line 15 - line 23
page 6, line 33 - page 7, line 5
(3)
X
WO 2012083017 A2 (CELGENE CORP [US]; CHEN MING J [US]; HUI HO-WAH [US]; SHEN XIOLE [US]) 21 June 2012 (2012-06-21)
9-18
paragraph [0114]; claims 14-23
(4)
X
GUILLORY J K ED - BRITTAIN H G, "GENERATION OF POLYMORPHS, HYDRATES, SOLVATES, AND AMORPHOUS SOLIDS", 01 January 1999 (1999-01-01), POLYMORPHISM IN PHARMACEUTICAL SOLIDS; [DRUGS AND THE PHARMACEUTICAL SCIENCES ; 95], MARCEL DEKKER INC, NEW YORK * BASEL, PAGE(S) I - II,183,
XP002350313
ISBN: 9780824702373
1-18,31,34,35
page 208 - page 219
(5)
X
HANCOCK B C ET AL, "Characteristics and Significance of the Amorpous State in Pharmaceutical Systems", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, US,Vol. 86, No. 1, 01 January 1997 (1997-01-01), page 1-12,
XP002286839
1-18,31,34,35
page 8, left-hand column; figure 1
page 1, left-hand column
(6)
X
MORONI A, "A Novel Copovidone Binder for Dry Granulation and Direct-Compression Tableting", PHARMACEUTICAL TECHNOLOGY, ADVANSTAR COMMUNICATIONS,INC, US,Vol. 24, 01 September 2001 (2001-09-01), page 8-12,
XP008083486
9-18
figures; tables
(7)
X,P
WO 2015173792 A1 (MAPI PHARMA LTD [IL]) 19 November 2015 (2015-11-19)
1-18,31,34,35
page 20; figures; examples
*
Special categories of cited documents:
"A"
document defining the general state of the art which is not considered to be of particular relevance
"D"
document cited by the applicant in the international application
"E"
earlier application or patent but published on or after the international filing date
"L"
document which may throw doubts on priority claim(s) or which is cited to establish the publication date of another citation or other special reason (as specified)
"O"
document referring to an oral disclosure, use, exhibition or other means
"P"
document published prior to the international filing date but later than the priority date claimed
"T"
later document published after the international filing date or priority date and not in conflict with the application but cited to understand the principle or theory underlying the invention
"X"
document of particular relevance; the claimed invention cannot be considered novel or cannot be considered to involve an inventive step when the document is taken alone
"Y"
document of particular relevance; the claimed invention cannot be considered to involve an inventive step when the document is combined with one or more other such documents, such combination being obvious to a person skilled in the art
"&"
document member of the same patent family

D. INFORMATION ON PATENT FAMILY MEMBERS

Patent document cited in search report Publication date
(day/month/year)
Patent family member(s) Publication date
(day/month/year)
US 2008234359 A1
25 September 2008
US 2008234359 A1
US 2011112307 A1
US 2012101144 A1
US 2014100259 A1
US 2015196535 A1
25 September 2008
12 May 2011
26 April 2012
10 April 2014
16 July 2015
WO 2014072259 A1
15 May 2014
CA 2890837 A1
EA 201590887 A1
EP 2730278 A1
EP 2916822 A1
US 2015306226 A1
WO 2014072259 A1
15 May 2014
30 September 2015
14 May 2014
16 September 2015
29 October 2015
15 May 2014
WO 2012083017 A2
21 June 2012
CA 2821805 A1
CN 103442698 A
EP 2651400 A2
JP 2013545814 A
US 2014018404 A1
WO 2012083017 A2
21 June 2012
11 December 2013
23 October 2013
26 December 2013
16 January 2014
21 June 2012
WO 2015173792 A1
19 November 2015
NONE
Name and mailing address of the ISA/:
European Patent Office
P.B. 5818, Patentlaan 2, 2280 HV Rijswijk,
Netherlands
Telephone No. (+31-70)340-2040
Facsimile No. (+31-70)340-3016
Date of the actual completion of the international search:
23 May 2016
Date of mailing of the international search report:
09 August 2016
Authorized officer:
Härtinger, Stefan
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