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CIPLA’S PATENT APPLICATION FOR HIV DRUG REJECTED
The Indian Patent Office rejected CIPLA’s
patent application for its HIV drug pharmaceutical dosage form that comprises both
composition comprising a combination ritonavir and darunavir. D6 additionally discloses
that the compositions may be provided in a
of the drugs “ritonavir” and “darunavir”. The dosage form consisting of several layers and such
application, in particular, was directed to a ‘multilayer forms’ have the advantage of processing
pharmaceutical composition comprising a solid unit two active ingredients which are incompatible
dosage form comprising: (i) ritonavir; (ii) darunavir; with one another or The Controller also rejected
(iii) a water insoluble polymer and/or water controlling the release the application under section
soluble polymer, wherein the ratio of the weight of characteristics of the 3(d) of the Patents Act as he
ritonavir or darunavir to the weight of the polymer active ingredient(s). considered the new layered
can range from between 1:1 to 1:6. Further, the It was held by the form of a known combination,
claimed composition was a tablet composition Controller that the as being statutorily barred from
comprising ritonavir and polymer in the first layer claims are obvious. In
and darunavir in the second layer. The first layer is addition to this, the patentability u/s 3 (d).
obtainable by hot melt extrusion while the second Controller held that
layer is obtainable by direct compression or by wet the claimed subject matter does not clearly show
granulation. an advantage or surprising effect over the prior art
composition to establish an inventive step.
The application was rejected on the grounds of lack
of inventive step in view of the prior art documents. The Controller also rejected the application under
The Controller cited six prior art documents section 3(d) of the Patents Act as he considered the
and heavily relied on one particular prior art, new layered form of a known combination, as being
namely, US 2005/0048112 (D6) in his inventive statutorily barred from patentability u/s 3 (d).
step analysis. D6 describes solid pharmaceutical
dosage forms comprising ritonavir and a second The decision can be accessed at:-
species of HIV protease inhibitor, including TMC- http://ipindiaservices.gov.in/decision/1399-
114 (darunavir). According to the Controller, D6 MUMNP-2010-17091/Cipl1399.pdf
provides strong motivation to formulate a solid
INTERIM RELIEF TO DOLBY IN SUIT AGAINST
OPPO AND VIVOmerican Dutch Audio Visual Company, Oppo and Vivo have been allowed to continue their
operations in the country as long as they agree to
Dolby International AB dragged Chinese enter into a licensing agreement in accordance with
Acompanies Oppo and Vivo to Court on
26th October 2016 for patent infringement by using Fair, Reasonable and Non-Discriminatory (FRAND)
audio noise reduction, encoding and compression terms. Oppo and Vivo also have to furnish to Dolby
techniques. The company that made surround monthly details of manufacture, import and sale of
sound a trend in India is suing for Royalties since devices. Vivo and Oppo however, are attempting to
neither of the Chinese companies has obtained negotiate the interim royalty to INR 32 per piece.
any valid permission to exploit Dolby’s patented The litigation implies that the two smartphone
technology. companies may have been selling smartphones with
Dolby’s technology without paying royalties to the
As an interim relief, the Delhi High Court has audio company.
directed Oppo and Vivo to deposit in an escrow The decision can be accessed at:-
account a royalty by the amount of INR 34 per http://delhihighcourt.nic.in/dhcqrydisp_o.
smartphone imported or sold. In the meantime, asp?pn=208102&yr=2016
66 | Patents & Design

