Life Sciences Newsletter, April 2009 - Part One

Click here to read Part Two

Click here to read Part Three

INTELLECTUAL

PROPERTY

Industrial Aplication

Tracy Ko

Supplementary protection Certificates

Fran Boateng-Muhammad

Zyprexa Patents

Tracy Ko

Sufficiency of Damages for a Wrongly Injuncted

Generics

Ralph Cox

EMPLOYEE

INVENTIONS

First ever court award of compensation to employee

inventors (UK Patents Act 1977)

Jeremy Morton

Biotechnology Patenting before the U.S. Federal

Circuit

Serge Lapointe

Validity of Selection Patents in Canada

Philip Swain

Early Working Exemption

Ralph Cox

Proposed Fee Reductions for Electronically Filed

Sequence Listings

Kevin Holbeche

INTELLECTUAL

PROPERTY

Industrial Application

By Tracy Ko

The English Patents Court

case of Eli Lilly & Co v Human Genome

Sciences Inc [2008] EWHC 1903 (Pat) gives guidance on the

requirement that an invention must have industrial application in

order to be patentable.

The case concerned a Human Genome

Sciences Inc ("HGS") European patent for the nucleotide

and amino acid sequence of Neutrokine-a (the "Patent"),

which was a novel member of the Tumour Necrosis Factor cytokines

("TNF") superfamily (a grouping of proteins that act to

cause inflammation in the human body).

The sequence was found through

bioinformatics, whereby computers identify new DNA sequences for

proteins by making comparisons to similar known sequences, rather

than by traditional laboratory methods. HGS filed a patent

application soon after the sequence was determined, without

carrying out any further research to explore its function, activity

or potential use.

Eli Lilly & Co

("Lilly") applied to revoke the patent. Lilly's

arguments included that the Patent did not disclose an invention

capable of industrial application and on the grounds of

insufficiency.

The judge, Kitchin J, reviewed the

limited amount of UK, EU and US law on industrial application and

the European Directive on the legal protection of biotechnological

inventions (Directive 98/44/EC). He set down the following

principles:

'Industrial' must be construed broadly and does not

need to be conducted for profit.

The capability of industrial exploitation must be derivable by

the skilled person reading the patent description with the benefit

of common general knowledge.

The description must disclose a practical way of exploiting the

invention in at least one field of industrial activity or a sound

and concrete basis for recognising that the contribution could lead

to a practical application in industry.

The purpose of the invention and how it can be used to solve a

certain technical problem must be disclosed in definite technical

terms. If the purpose and use is not obvious from the nature

of the invention or the background art, then there must be a real

prospect of exploitation directly derivable from the

specification.

Industrial application will be shown by: (a) a description of a

research result that might yield an unidentified industrial

application; (b) a speculative indication of possible objectives

that might or might not be achievable by carrying out research; or

(c) a description that leaves it to the skilled person to find out

how to exploit the invention.

The purpose of granting a patent is not to allow the patentee

to reserve an unexplored field of research or to give the patentee

unjustified control over others investigating the same area.

The industrial application requirement will be satisfied if it

is a substance which has a function essential for human health and

it is identified as having such a function. However simply

identifying the substance, even where the disclosure is considered

a scientific achievement of great merit, would not meet the

requirement if its function is unknown or not fully understood, no

disease has been identified to be linked to its excess or

deficiency, or no other practical use is suggested for it.

The mere use of the claimed invention to find out more about

its activities does not of itself satisfy the requirement.

Whilst it is relevant to how a skilled person would understand

the disclosure, the fact that an invention has been found by

homology studies using bioinformatics techniques does not prevent

it from being capable of being patented.

Taking into account the above

principles, Kitchin J concluded that HGS patent was invalid for

lack of industrial application, based on the following

findings:

The only contribution made by HGS' patent was to identify

Neutrokine-a, but its application was not obvious or

identified.

The patent specifications contained nothing more than mere

speculation as to possible conditions, actions and broad categories

of disease for which Neurokine-a may be useful and general

statements on its potential activity and expression but no evidence

to substantiate those claims. In Kitchin J's view, a

skilled person reading the patent would not have been able to

derive any industrial application from the patent.

Simply making Neutrokine-a available as research tool is not

sufficient to establish that the patent had industrial

application.

Kitchin J also agreed with Lilly

that the patent specification was wholly insufficient to allow the

invention to be performed by a skilled person, such that the patent

was also invalid on the grounds of insufficiency, as the skilled

person would be "faced with a substantial research programme

with an uncertain outcome" before Neutrokine-a could be put to

any therapeutic or diagnostic use.

Comment: In addition to giving guidance as

to how the requirement of industrial application will be

interpreted by the courts, the case illustrates the difficulties

that companies face when attempting to balance the desirability of

seeking early protection of the results of their research and the

risk of having the patent being held invalid; or waiting until

further research has been undertaken to ensure the validity of the

patent, at the risk of being pre-empted by competitors.

Supplementary Protection Certificates

By Fran Boateng-Muhammad

The case of Daiichi

Pharmaceuticals v Generics (UK) Limited looks at some of the issues

that can arise in relation to supplementary protection certificates

(SPCs), specifically the validity of the underlying patents and the

appropriate commencement date for an SPC.

Daiichi owned European patent (UK)

No. 0206283 for levofloxacin (an enantiomer of a racemic compound

called ofloxacin which is a member of the quinolone class of

anti-microbial agents. The (-) enantiomer of ofloxacin was called

levofloxacin) and a process for its preparation (the

"Patent"). Daiichi also held an SPC granted in July 1998

on the marketed product based on the Patent. The Patent expired on

June 2006 but the SPC is not due to expire until June 2011.

Generics challenged the validity of

the SPC under article 15 of Council Regulation (EEC) 1768/92 (on

SPCs) because grounds existed which would have justified the

revocation of the Patent, or its limitation to the extent that

levofloxacin would no longer have been protected by the claims on

the grounds, inter alia, of lack of novelty and obviousness.

Generics also challenged the SPC on the basis that the SPC's

term should be based upon earlier marketing authorisations for

ofloxacin as the first marketing authorisation, rather than that of

levofloxacin. Both challenges were dismissed by the court.

As to the validity of the Patent, on

the evidence presented, none of the attacks were entitled to

succeed and in those circumstances, the challenge to the SPC

failed. Even though the skilled person would appreciate that

ofloxacin was a racemate, and that one enantiomer might have better

activity than the other or the racemate, the judge acknowledged the

potential in relation to quinolones and that there was uncertainty

as to whether the enantiomers of quinolones would produce a better

compound than the racemate. The Court decided that the skilled

person would consider it obvious to try to resolve ofloxacin into

enantiomers only if it were relatively easy to do so. Generics'

own evidence indicated the difficulties in resolving the ofloxacin

into its enantiomers.

The Court also rejected the second

challenge to the term of the SPC. The judge determined that

ofloxacin and levofloxacin were different products commenting

"that an authorisation to place ofloxacin on the market as

a medicinal product cannot be considered an authorisation to place

levofloxacin on the market as a medicinal product".

Comment: This

case represented a rare victory for research-based companies as to

the validity and term of an SPC. The court appeared to be

influenced by the greater expertise of Daiichi's' experts

in the field of quinolones and the claimant's failure to

demonstrate that the resolution of ofloxacin was relatively

easy...

Zyprexa Patents

By Tracy Ko

The October 2008 case in the

Patents Court (Dr Reddy's Laboratories (UK) Limited v Eli Lilly

and Company Limited [2008]...