The Assistant Commissioner's decision found that Bristol-Myers' opposition succeeded based on lack of novelty and obviousness given the prior UK patent. On appeal, the High Court overturned this decision, finding that the prior patent did not provide clear directions to make amoxycillin and its properties were unknown. The Court of Appeal upheld the High Court's decision and affirmed that a "mere scintilla" of invention is sufficient for patentability and prior publication must contain clear directions to anticipate the patentee's claim.

1. BEECHAM GROUP’S Nishidh Patel
nishidh41@gmail.com
AMOXYCILLIN APPLICATION
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2. AMOXYICILLIN-PATENT HISTORY
 A patent that covered an extensive class of α-amino acid derived
penicillins comprising various amino acyl substituted (the amino
patent) was registered in 1959.
 In 1962, a fur ther patent of addition was included in the UK (but not
NZ) for the preparation of all three regio isomeric phenol
derivatives/variants of α-amino-α- phenyl penicillins from the
corresponding o-, m- and p-hydroxyphenyl-α-amino acids; three pair s of
epimers (diastereoisomers ) ensued as a result of using the racemic
aminoacids. This patent is known as the OMP patent as it claimed all
three epimeric pair s; amoxycillin is the (R) -α-amino-p-hydroxyphenyl
isomer
 In 1969, Beecham filed for a patent for amoxyicillin in NZ. It was
referred to in the specification as a development of our [Beecham’s]
British patent No 978178 (the OMP patent ).
 Beecham’s subsequent discoveries on the use of naturally occurring β-
lactamase inhibitors in conjunction with the semi-synthetic derivatives
of penicillin have also been attentively patented.
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3. AMOXYICILLIN-PATENT HISTORY
 In 1984, a combination of amoxycillin with clavulanic acid
was introduced and Beecham gained multiple NZ patents
covering dif ferent processes for the preparation of clavulanic
acid, its salts, and its use with penicillins, such as
amoxycillin.
 Beecham subsequently patented 39 dif ferent compositions of
amoxycillin with clavulanic acid and has continued to patent
methods of producing salts of clavulanic acid; the IPONZ
database lists twenty dif ferent patents for Beecham and
clavulanic acid.
 Of all the Beecham penicillin-related patents, the most
controversial in NZ is that for amoxycillin.
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4. AMOXYICILLIN-PATENT HISTORY
 The Bristol-Myers Company was not pleased with the world-
wide amoxycillin applications that extended Beecham’s
property rights for the compound.
 The NZ amoxycillin patent was disputed on the grounds of
novelty and obviousness (lack of inventive step) because of
the OMP patent filed in the UK in 1962 and subsequently
published in NZ.
 The UK OMP patent ran from 1962–1976 and the amoxycillin
patent from 1968–1982, thus extending protection by six
years.
 OMP was not patented in NZ but amoxycillin was covered, to a
point, by the 1959 amino patent (1959–1973 protection). The
amoxycillin patent in suit would extend protection by ten years
to 1983.
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5. SELECTION INVENTION
 Selection invention allows patenting of compounds which fall
within disclosure of earlier patent if:
1. compounds not specifically disclosed in earlier patent, and
2. compounds have unexpected advantages over those compounds
specifically disclosed in earlier patents.
 The three par t novelty test:
 The claimed range must be narrow
 It must be suf ficiently distant from preferred known ranges
 It must not be an arbitrar y chosen par t of prior ar t
 All of the compounds which are the subject of a selection invention
must exhibit some unexpected proper ties, or overcome a
disadvantage, of the earlier class of compounds. Therefore,
selection inventions tend to be directed to a narrow class of
compounds.
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6. COLLOCATION OF KNOWN AGENTS
 A further example of a patentable invention is the combination
of two or more previously known agents which together exhibit a
working interrelationship to produce a benefit or to overcome a
disadvantage.
 An example of this could well be a process which normally occurs
at a very slow rate, but which is sped up by an otherwise inactive
catalyst, or a combination of drugs exhibiting synergistic activity.
 For example, amoxyicillin is an effective antibiotic to which
bacteria quickly became resistant. Clavulanic acid is a beta-
lactamase inhibitor with no bactericidal activity in itself, but
when co-administered with amoxyicillin, potentiates the
antibiotic effect of amoxyicillin. Subsequently, this combination
was patented because the effectiveness of the combination was
superior to what could be expected by simply adding the two
compounds together.
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7. NEW ZEALAND-THREE LEVELS OF
COURTS OF RECORD
Supreme New Zealand is a
Court common law
(Estd. in 2004)
country.
The Patents Act
Court of 1953 is the relevant
legislation.
Appeal
Unicameral
legislature so issues
High of federalism do not
Court arise.
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8. Court of
Appeal
AMOXYICILLIN-PATENT CASE
High Court
Assistant
Commissioner
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9. ? ? A S S I S TA N T
COMMISSIONER’S
DECISION
?
Beecham Group Ltd v Bristol-Myers Co.
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10. BEECHAM GROUP LTD V. BRISTOL-MYERS CO.
ASSISTANT COMMISSIONER’S DECISION
 In the Beecham case, Beecham Group Limited applied for a
patent relating to amoxyicillin (a semi-synthetic penicillin)
which had been found to have outstanding levels of
absorption into the human body in comparison with related
semi-synthetic penicillins.
 Bristol-Myers opposed the patent application on the grounds
of prior publication and obviousness, relying on the prior
publication in New Zealand of a British patent owned by
Beecham.
 The opposition succeeded on both grounds and was appealed
to the High Court.
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11. ? ? HIGH COURT’S
DECISION
?
Beecham Group Ltd v Bristol-Myers Co.
[1980] 1 NZLR 185 (HC)
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12. BEECHAM GROUP LTD V BRISTOL-
MYERS CO. [1980] 1 NZLR 185 (HC)
 The benefit of the doubt has to be given to the patentee in
opposition proceedings, particularly where there appears to
be conflict of fact or credible expert opinion. This was
discussed in Beecham Group Limited v. Bristol Myers Company
(No2) [1979] NZLR 629 at 632-634, which includes, at 634, a
quote from Lord Diplock in General Electric Company’s
Application [1964] RPC 413 at 453:
 The right principle is that if on the face of the written evidence filed
there appears to be a bonafide Conflict of fact or credible expert
opinion upon a question on the answer to which the existence or non-
existence of the ground of refusal specified….depends, the
[Commissioner] should not exercise his jurisdiction to refuse the
grant unless, after cross-examination of the witness if he thinks fit
for to order it, the conflict is clearly resolved in favour of the party
opposing the grant.
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13. BEECHAM GROUP LTD V BRISTOL-
MYERS CO. [1980] 1 NZLR 185 (HC)
 The prior art relied on by Bristol-Myers was a British patent in the
name of Beecham that was directed to a broad group of semi-
synthetic penicillins. The Court held that the prior art patent did
not provide clear and unmistakable directions to make
amoxyicillin because it did not give full and explicit directions for
the entire process of preparing the compound.
 The Court stated that even though it was common ground that a
skilled chemist could resolve the necessar y issues to
manufacture the compound by following routine methods, this
was not enough for the invention to be considered as “published”
in New Zealand:
 “If such a compound has not been made before, its properties often
cannot be predicted with any confidence; and where that is the case we
do not consider that the invention claimed can fairly or accurately be
described as “published,” even if a skilled chemist would realise that to
make the compound by routine means would be practicable.
 A making of the compound and a discovery of its properties is necessary
before the “invention” has occurred and can be published.”
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14. BEECHAM GROUP LTD V BRISTOL-
MYERS CO. [1980] 1 NZLR 185 (HC)
 The Court referred to the judgment of Buckley LJ in E.I. Du Pont
de Nemours & Co. (Witsiepe’s) Application in support of this
view.
 The E. I. Du Pont de Nemours & Co. judgment also considered a
selection invention, and Buckley LJ stated that:
 “Something which has never yet been made can clearly not have been
‘known or used; nor can it, in my view, be properly described as ‘known’
if it has been no more than predicted as a theoretically possible
chemical compound.
 The fact that the special qualities of the compound…were unknown until
they were discovered by the applicants emphasizes that the compound,
although it was chemically predictable, was not a known substance until
the applicants made it.”
 The High Court overturned the Assistant Commissioner’s decision
and directed that the patent be sealed. This decision was in turn
appealed to the Court of Appeal.
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15. ? ? COURT OF
APPEAL
?
Beecham Group Ltd v Bristol-Myers Co.
[1981] 1 NZLR 600 (CA)
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16. BEECHAM GROUP LTD V BRISTOL-
MYERS CO. [1981] 1 NZLR 600 (CA)
 The Cour t in Beecham also indicated that a “mere scintilla” of
invention is sufficient to provide patentable subject matter. These
tests are used by the Intellectual Proper ty Office of New Zealand to
assess selection inventions.
 In most instances selection inventions relate to chemical
inventions, but the issue of selection is not confined to chemical
inventions (see e.g. Clyde Nail Co. Ltd. v. Russell , (1916) 33 RPC
291 (mechanical) and Bosch’s Application , (1909) 26 RPC 710
(electrical)).
 Although both these applications were refused, the cour ts stated
that selection inventions are patentable in the mechanical and
electrical fields provided they show an advantage or avoid a
disadvantage.
 More recently a clear statement was issued by the UK Cour t of
Appeal in Hallen v. Brabantia [1991] RPC. 195, p 217, that a
mechanical selection invention is a possibility.
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17. BEECHAM GROUP LTD V BRISTOL-
MYERS CO. [1981] 1 NZLR 600 (CA)
 To anticipate the patentee’s claim the prior publication must
contain clear and unmistakable directions to do what the
patentee claims to have invented.
 “A signpost, however clear, upon the road to the patentee’s
invention will not suffice. The prior inventor must be clearly
shown to have planted his flag at the precise destination before
the patentee.”
 This test was discussed and approved by the New Zealand
Court of Appeal in Beecham Group Limited’s (New Zealand /
amoxyicillin Application) i.e. present case.
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18. BEECHAM GROUP LTD V BRISTOL-
MYERS CO. [1981] 1 NZLR 600 (CA)
 The Court in Beecham held that prior publication requires that
the compounds have to be made , even if a skilled chemist would
understand that the compound could be made by routine means.
 However, the requirements set out in IG Farbenindustrie AG’s
Patent still must be met for a selection invention to be valid.
 The selection must satisfy the test set out in IG Farbenindustrie
AG’s Patent [1930] 47 RPC 289:
1. The selection must be novel;
2. Substantially all the members of the sub-class must possess an
advantage or avoid a disadvantage; and
3. The selection must be for “a quality of special character” which is
peculiar to the selection and is not obvious to an expert.
 Therefore, the Intellectual Property Office of New Zealand will
consider the disclosure of the prior art specification and claims
as a whole when assessing novelty.
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19. SUMMARY
Assistant • The opposition succeeded on both grounds
Commissioner • Appealed to the High Court
• Overturned the Assistant Commissioner’s decision
High Court • This decision was in turn appealed to the Court of
Appeal
• “mere scintilla” of invention is sufficient to provide
patentable subject matter
Court of Appeal • To anticipate the patentee’s claim the prior
publication must contain clear and unmistakable
directions
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20. THANK YOU
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