Amoxicillin patent case

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Nishidh Patel [email protected] BEECHAM GROUP’S AMOXYCILLIN APPLICATION 1

Transcript of Amoxicillin patent case

Page 1: Amoxicillin patent case

Nishidh Pateln i s h i d h 4 1 @ g m a i l . c o m

BEECHAM GROUP’S

AMOXYCILLIN APPLICATION

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A patent that covered an extensive class of α -amino acid derived penicil l ins comprising various amino acyl substituted (the amino patent) was registered in 1959.

In 1962, a fur ther patent of addit ion was included in the UK (but not NZ) for the preparation of al l three regio isomeric phenol derivatives/variants of α -amino-α - phenyl penicil l ins from the corresponding o- , m- and p-hydroxyphenyl -α -amino acids; three pairs of epimers (diastereoisomers) ensued as a result of using the racemic aminoacids. This patent is known as the OMP patent as it claimed al l three epimeric pairs; amoxycil l in is the (R) -α -amino-p-hydroxyphenylisomer

In 1969, Beecham filed for a patent for amoxyicil l in in NZ. I t was referred to in the specification as a development of our [Beecham’s] Brit ish 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 penicil l in have also been attentively patented.

AMOXYICILLIN-PATENT HISTORY

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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.

AMOXYICILLIN-PATENT HISTORY

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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.

AMOXYICILLIN-PATENT HISTORY

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Selection invention allows patenting of compounds which fall

within disclosure of earl ier patent if :

1. compounds not specifically disclosed in earl ier patent, and

2. compounds have unexpected advantages over those compounds

specifically disclosed in earl ier patents.

The three part novelty test:

The claimed range must be narrow

It must be sufficiently distant from preferred known ranges

It must not be an arbitrary chosen part of prior ar t

All of the compounds which are the subject of a selection invention

must exhibit some unexpected properties, or overcome a

disadvantage, of the earl ier class of compounds. Therefore,

selection inventions tend to be directed to a narrow class of

compounds.

SELECTION INVENTION

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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, amoxyicil l in 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 amoxyicil l in, potentiates the antibiotic effect of amoxyicil l in. 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.

COLLOCATION OF KNOWN AGENTS

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New Zealand is a common law country.

The Patents Act 1953 is the relevant legislation.

Unicameral legislature so issues of federalism do not arise.

NEW ZEALAND-THREE LEVELS OF

COURTS OF RECORD

Supreme Court (Estd. in 2004)

Court of Appeal

High Court

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Court of Appeal

High Court

Assistant Commissioner

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A S S I S TA N T

C O M M I S S I O N E R ’S

DE C I S I ON

Beecham Group Ltd v Bristol-Myers Co.

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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.

BEECHAM GROUP LTD V. BRISTOL-MYERS CO.ASSISTANT COMMISSIONER’S DECISION

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HIGH COURT’S

DECISION

Beecham Group Ltd v Bristol-Myers Co. [1980] 1 NZLR 185 (HC)

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The benefit of the doubt has to be given to the patentee inopposition proceedings, particularly where there appears tobe conflict of fact or credible expert opinion. This wasdiscussed in Beecham Group Limited v. Bristol Myers Company(No2) [1979] NZLR 629 at 632-634, which includes, at 634, aquote from Lord Diplock in General Electric Company’sApplication [1964] RPC 413 at 453:

The right principle is that if on the face of the written evidence filedthere appears to be a bonafide Conflict of fact or credible expertopinion 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 thegrant unless, after cross-examination of the witness if he thinks fitfor to order it, the conflict is clearly resolved in favour of the partyopposing the grant.

BEECHAM GROUP LTD V BRISTOL-

MYERS CO. [1980] 1 NZLR 185 (HC)

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The prior art relied on by Bristol -Myers was a British patent in thename of Beecham that was directed to a broad group of semi-synthetic penicil l ins. The Court held that the prior art patent didnot provide clear and unmistakable directions to makeamoxyicill in because it did not give full and explicit directions forthe entire process of preparing the compound.

The Court stated that even though it was common ground that askilled chemist could resolve the necessary issues tomanufacture the compound by following routine methods, thiswas 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 wedo not consider that the invention claimed can fairly or accurately bedescribed as “published,” even if a skilled chemist would realise that tomake the compound by routine means would be practicable.

A making of the compound and a discovery of its properties is necessarybefore the “invention” has occurred and can be published.”

BEECHAM GROUP LTD V BRISTOL-

MYERS CO. [1980] 1 NZLR 185 (HC)

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The Court referred to the judgment of Buckley LJ in E.I. Du Pontde Nemours & Co. (Witsiepe’s) Application in support of thisview.

The E. I. Du Pont de Nemours & Co. judgment also considered aselection 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 possiblechemical compound.

The fact that the special qualities of the compound…were unknown untilthey were discovered by the applicants emphasizes that the compound,although it was chemically predictable, was not a known substance untilthe applicants made it.”

The High Court overturned the Assistant Commissioner’s decisionand directed that the patent be sealed. This decision was in turnappealed to the Court of Appeal.

BEECHAM GROUP LTD V BRISTOL-

MYERS CO. [1980] 1 NZLR 185 (HC)

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COURT OF

APPEAL

Beecham Group Ltd v Bristol-Myers Co.

[1981] 1 NZLR 600 (CA)

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The Court in Beecham also indicated that a “mere scintil la” of

invention is sufficient to provide patentable subject matter. These

tests are used by the Intel lectual Property 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 courts 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 Court of

Appeal in Hallen v. Brabantia [1991] RPC. 195, p 217, that a

mechanical selection invention is a possibil ity.

BEECHAM GROUP LTD V BRISTOL-

MYERS CO. [1981] 1 NZLR 600 (CA)

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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.

BEECHAM GROUP LTD V BRISTOL-

MYERS CO. [1981] 1 NZLR 600 (CA)

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The Court in Beecham held that prior publication requires that the compounds have to be made, even if a skil led chemist would understand that the compound could be made by routine means.

However, the requirements set out in IG Farbenindustrie AG’s Patent stil l must be met for a selection invention to be valid.

The selection must satisfy the test set out in IG FarbenindustrieAG’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.

BEECHAM GROUP LTD V BRISTOL-

MYERS CO. [1981] 1 NZLR 600 (CA)

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• The opposition succeeded on both grounds

• Appealed to the High Court

Assistant Commissioner

• Overturned the Assistant Commissioner’s decision

• This decision was in turn appealed to the Court of Appeal

High Court

• “mere scintilla” of invention is sufficient to provide patentable subject matter

• To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions

Court of Appeal

SUMMARY

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THANK YOU

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