Decision Nº O/508/15 from Intellectual Property Office - (Patent decisions), 29 October 2015
| Judge | Dr L Cullen |
| Court | Intellectual Property Office (United Kingdom) |
| Administrative Decision Number | O/508/15 |
| Date | 29 October 2015 |
| Patent Number | GB1302651.3, GB1302653.9, GB1302654.7, GB1302924.4, GB1302925.1, GB1302926.9, GB1302928.5, GB1302929.3, GB1303867.4, GB1303868.2, GB1303983.9 |
| Parties | Oleg Iliich Epshtein |
BL O/508/15
29 October 2015
APPLICANT
Oleg Iliich Epshtein
ISSUE
The Patents Act 1977:
whether patent applications GB1302651.3,
GB1302653.9, GB1302654.7, GB1302924.4,
GB1302925.1, GB1302926.9, GB1302928.5,
GB1302929.3 , GB1303867.4, GB1303868.2, and
GB1303983.9 comply with sections 1(1)(a), 1(1)(c),
and 14(3) of the Act
HEARING OFFICER
Dr L Cullen
DECISION
Introduction
1 This decision concerns eleven patent applications filed in the name of Oleg Iliich
Epshtein as detailed below, and whether or not the invention as claimed in each of
these applications complies with the requirements of the Patents Act 1977
(hereinafter “the Act”) as set out in sections 1(1)(a), 1(1)(c) and 14(3) concerning
novelty, industrial application and sufficiency.
2 These eleven applications were originally filed and published under the provisions of
the Patent Cooperation Treaty (PCT). On entering the national phase in UK, they
were each subsequently re-published as GB applications as listed in Table 1.
Originally, a twelfth patent application GB1303865.8 was also involved with this
series of patent applications but it was confirmed at the oral hearing on 18 June
2015 that the Applicant would no longer be pursuing this application and had
withdrawn it.
3 All eleven applications relate to treatments for various medical conditions using oral
and solid dosage forms prepared from mixtures of ultra-low dilutions of antibodies.
These ultra-low dilutions of antibodies are referred to in these applications as
‘activated-potentiated forms’ or ‘release-active forms’ of antibodies.
2
Table 1: UK Patent applications in name of Oleg Iliich Epshtein at issue in this case
and their corresponding UK and PCT publication numbers
#
UK Application No.
UK Publication No.
PCT Publication No.
1
GB1302651.3
GB 2495885
WO 2012/007849
2
GB1302653.9
GB 2496076
WO 2012/007847
3
GB1302654.7
GB 2496794
WO 2012/007839
4
GB1302924.4
GB 2496799
WO 2012/010966
5
GB1302925.1
GB 2496342
WO 2012/010974
6
GB1302926.9
GB 2496800
WO 2012/010973
7
GB1302928.5
GB 2496343
WO 2012/010970
8
GB1302929.3
GB 2496801
WO 2012/010978
9
GB1303867.4
GB 2503066
WO 2012/017328
10
GB1303868.2
GB 2497453
WO 2012/017323
11
GB1303983.9
GB 2498276
WO 2012/018284
4 Before looking at the individual applications, I consider below the general approach
to ultra-low dilutions outlined in these eleven applications.
Activated-Potentiated Forms of Antibodies
5 All these patent applications relate to the preparation of mixtures of activated-
potentiated forms of antibodies, and the use of those mixtures in the treatment of
various diseases. The term “activated-potentiated” is disclosed in the applications to
mean that a series of dilutions are performed, either with water or with a
water/alcohol mixture, which gives rise to a therapeutic activity. Typically in the
applications, mixtures of the centesimal dilutions C12 (dilution factor of 1 x 1024),
C30 (1 x 1060), C50 (1 x 10100), and C200 (1 x 10400) are used. The “activated-
potentiated” terminology and the methodology of centesimal dilutions are described
as being borrowed from the field of homeopathy. However, the applicant has been
keen to point out that the present applications do not pertain to homeopathy in as
much as they are concerned not with treating “like-with-like”, as in homeopathy, but
are concerned with the treatment of diseases with antibodies that have been
subjected to the serial centesimal dilutions. In this respect, the approach outlined in
the current applications has been described as chimeric – a combination of
homeopathic methodology and the principles of conventional medicine. The term
chimeric to describe this approach was, so far as I can determine, first used in an
EPO decision concerning an EP patent application by the Applicant (see EPO
Technical Board of Appeal decision, T-1273/09 Homeopathic mixture/EPSHTEIN).
6 It is noted that such ultra-high dilutions (or ultra-low doses) statistically speaking are
highly unlikely to contain even one molecule of starting antibody. The C12
centesimal dilution (dilution factor 1 x 1024) on its own would result in a dilution below
the Avogadro limit (6.022 x 1023). Indeed, starting with one mole of substance and
subjecting it to the C12 dilution would result in a solution in which there is
approximately a 60% chance of there being one molecule of substance present. The
dilutions described in the present applications are significantly more dilute than this.
3
Nevertheless, each application describes the preparation of at least one composition
comprising a mixture of ultra-high dilutions of antibodies, and in each application
evidence is presented in support of the therapeutic activity of the mixtures of ultra-
dilute antibodies.
The Applications
7 Application GB1302651.3 “Combination pharmaceutical composition and methods of
treating genitourinary system disorders” was filed on 15 July 2011, claiming an
earliest priority date of 15 July 2010. It was published as GB 2495885 A on 24 April
2013. The Section 20 compliance period (as extended) expires on 15 November
2015. A first examination report was issued on 13 March 2013 that adopted sections
I, V, VII, and VIII of the International Preliminary Report on Patentability that was
issued on this application in the international phase of the PCT procedure.
Amendments were filed on 16 September 2013, and a subsequent examination
report was issued on 12 August 2014 in which issues of novelty, sufficiency of
disclosure, and industrial application were raised. After a telephone conversation on
13 January 2015, a request for an oral hearing was submitted on 11 February 2015.
A pre-hearing report was issued on 03 March 2015 that set out the outstanding
issues to be considered at the requested hearing. A hearing was appointed for 18
June 2015.
8 Application GB1302653.9 “Pharmaceutical compositions and methods of treatment”
was filed on 15 July 2011, claiming an earliest priority date of 15 July 2010. It was
published as GB 2496076 A on 01 May 2013. The Section 20 compliance period (as
extended) expires on 15 November 2015. A first examination report was issued on
19 March 2013 that adopted sections I, V, VII, and VIII of the International
Preliminary Report on Patentability that was issued on this application in the
international phase of the PCT procedure. Amendments were filed on 19 September
2013, and a subsequent examination report was issued on 11 December 2014 in
which issues of added matter, sufficiency, industrial application, and
novelty/inventive step were raised. After a telephone conversation on 13 January
2015, a request for an oral hearing was submitted on 11 February 2015. A pre-
hearing report was issued on 03 March 2015 that set out the outstanding issues to
be considered at the requested hearing. A hearing was appointed for 18 June 2015
9 Application GB1302654.7 “Combination pharmaceutical composition and methods of
treating and methods of treating functional diseases or conditions of gastrointestinal
tract” was filed on 15 July 2011, claiming an earliest priority date of 15 July 2010. It
was published as GB 2496794 A on 22 May 2013. The Section 20 compliance
period (as extended) expires on 15 November 2015. A first examination report was
issued on 12 April 2013 that adopted sections V, VII, and VIII of the International
Preliminary Report on Patentability that was issued on this application in the
international phase of the PCT procedure. Amendments were filed on 09 October
2013, and a subsequent examination report was issued on 14 August 2014 in which
issues of novelty, sufficiency, and industrial application were raised. After a
telephone conversation on 13 January 2015, a request for an oral hearing was
submitted on 11 February 2015. A pre-hearing report was issued on 03 March 2015
that set out the outstanding issues to be considered at the requested hearing. A
hearing was appointed for 02 July 2015.
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