Patent amendment before the Federal Court in Australia

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Patent Amendment Before the Federal
Court
Wayne Condon
08/08/2013

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Court
 If proceedings commenced, any amendment application must
be brought under s 105 of the Patents Act
 Court cannot direct an amendment not allowable under s 102
 Even if allowable under s 102, Court has a discretion to refuse
an amendment application

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Court
 s 105 applications are becoming increasingly common
 Type of patents being litigated
 Age of patents being litigated
 Development of the case law in context of s 40

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Court
Bayer v Generic Health [2012] FCA 1510
 Patent relating to oral contraceptive Yazmin
 Composition comprising drospirenone (a synthetic progestogen)
and ethinylestradiol
 Method of providing dissolution of drospirenone
 Methods of inhibiting ovulation by administering drospirenone
 Use of drospirenone and ethinylestradiol for inhibiting ovulation

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Court
 AU patent based on a PCT filing dated 31 August 2000
 Priority claimed to EU and US applications dated 31 August
1999
 AU patent sealed in June 2005
 Bayer sued Generic Health for infringement of the AU patent
 No interlocutory injunction application
 Bayer sought to amend the patent after commencing
infringement proceeding

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Court
 Why commence infringement proceeding and then seek to
amend?
 Amend first, then sue, should be the rule shouldn’t it?

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Court
 AU specification stated :
‘To ensure good bioavailability of the compound it is therefore
advantageously provided in a form that promotes rapid
dissolution thereof’
and
‘… has surprisingly been found *that when drospirenone is
provided in micronised form … rapid dissolution … occurs’

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Court
 AU specification defined ‘rapid dissolution’
‘… dissolution of at least 70% over about 30 minutes, in
particular at least 80% over 20 minutes, of drospirenone from a
tablet preparation containing 3 mg of drospirenone in 900 ml of
water at 37ºC …’

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Court
 AU specification also referred to a trial and stated that the
results of the trial confirmed
- 2 mg was in the threshold region of ovulation inhibition
- 3 mg had a demonstrable ovulation inhibiting effect

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Court
 AU specification had 45 claims
 Claim 3 is representative
“A pharmaceutical composition in oral dosage form comprising;
from 2 mg to 4 mg of drospirenone and 0.01 mg to 0.05 mg of
ethinylestradiol, together with one or more pharmaceutically
acceptable carriers or excipients,
wherein at least 70% of said drospirenone is dissolved from said
composition within 30 minutes, as determined by USP XXIII
Paddle Method II using water at 37ºC as the dissolution media
and 50 rpm as the stirring rate.”

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Court
Bayer sought amendment to:
 limit the dosage of drospirenone to 3 mg
 confine the composition or preparation to a tablet form
 specify that the stated dissolution test is performed in 900 ml of
water
(“the three features”)

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Court
The three features clearly confine the scope of the independent
claims
Section 102 was satisfied
Question was whether the Court should exercise its discretion to
refuse the amendment

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Court
Bayer sought the amendments to head off an anticipated fair basis
attack on the dissolution claims
Bayer did not concede that without the amendments the dissolution
claims would be invalid
Amendments were sought out of an abundance of caution

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Court
 Generic Health did not initially plead that the dissolution test
claims are not fairly based
 Only during the amendment application did Generic Health seek
leave to amend its Particulars of Invalidity to introduce a lack of
fair basis attack on the basis that the dissolution claims omitted
the “three features”

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Court
The Court considered the prosecution history of the corresponding
patents and applications
PCT application
US application
EU applications – patent and divisionals
EU oppositions
UK revocation proceedings
AU application

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Court
The Court heard evidence from
 Bayer’s senior patent counsel
 Bayer’s external US patent attorneys
 Bayer’s Australian lawyer
Generic Health relied on evidence from
 Christian Schieber of Watermark

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Court
The dissolution test claims in corresponding Bayer patents and
applications were amended in many, but not all, countries where
applications corresponding to the AU patent were filed to introduce
the “three features”

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Court
 The US application was ultimately amended to also introduce
the “three features” into the dissolution claims
 The external US patent attorneys did this in the exercise of their
own discretion to overcome an Examiner’s objection that the
description of the dissolution test was unclear

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Court
The Discretion in s105
Not to be exercised hostile to amendment
The discretion is a wide one
The power exists for the benefit of the patentee
It is the conduct of the patentee, not the merit of the invention
which is relevant
Has the patentee abused the monopoly conferred?

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Court
The Discretion in s105 - Delay
Delay in seeking amendment may be an abuse of the monopoly
BUT not mere delay
Delay generally needs to be coupled with improper conduct or
detriment to a person or the public
The resolution of issues in foreign jurisdictions by amendment did
not compel Bayer to consider amendment of the AU patent
There was no relevant delay

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Court
The Discretion in s105 – Covetous Claiming
Assertion of unamended claims with knowledge of a need to
amend is likely to be disentitling
This is referred to as ‘covetous claiming’
Knowingly maintaining a patent in unamended form after patentee
is warned of objections against the patent i.e. knowledge that an
amendment should be sought may be disentitling

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Court
Court observed focus not on Bayer’s strategic decision with
respect to foreign equivalents but its conduct in relation to the AU
patent
No finding of covetous claiming

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Court
The Discretion in s105 – Taking of Unfair Advantage
Alleged unfair advantage by relying on unamended claims
On 15 February 2012 Bayer commenced infringement
proceedings
On 17 February Bayer wrote to 4,500 pharmacies advising that
the proceedings had been commenced
Bayer did not seek interlocutory injunctive relief
Court found that as a result of the pharmacy letter a small number
of pharmacies cancelled orders given to Generic Health

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Court
Court – commencing an infringement proceeding in which
amendment of claims is also sought is not disentitling conduct
leading to refusal of the amendment
Did the 17 February letter to pharmacies make a difference?

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Court
Take Home Messages
For Patentees
1.If patent infringement litigation is on the horizon, do your internal
review on your patent sustainability early and if you need to amend,
get on with it.
2.It is better to amend before commencing proceedings if you can.
3.If you have to amend in the course of legal proceedings, be
prepared for full and frank disclosure and the waiver of privilege
over documents relevant, not just to the AU patent being asserted,
but also foreign equivalents.

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Court
Take Home Messages
For Alleged Infringers
1.Be aware that the discretion in S105 is slanted in favour of the
patentee.
2.The patentee’s disentitling conduct will have to be particularly
blatant to result in a refusal of the amendment.
3.The position with respect to what happened in relation to foreign
equivalent patents has less relevance than what has happened in
relation to the AU patent.

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www.griffithhack.com.au
Thank you for your time… any questions?

Patent amendment before the Federal Court in Australia

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