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Ocular Sciences LTD V Aspect Vision Care LTD (1997) RPC 289, 359-60

The document details the manufacturing process of soft hydrogel contact lenses, which involves creating a dry lens in two stages: the dry stage where the lens is cast in polypropylene moulds, and the wet stage where the lens is hydrated to achieve its final shape and optical power. It describes the precision required in the moulding process, including the use of metal moulds to create disposable polypropylene moulds, and the injection moulding process for producing these moulds. Additionally, it covers the design aspects of the lenses, including variations in thickness and optical characteristics to achieve desired vision correction.

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0% found this document useful (0 votes)
318 views8 pages

Ocular Sciences LTD V Aspect Vision Care LTD (1997) RPC 289, 359-60

The document details the manufacturing process of soft hydrogel contact lenses, which involves creating a dry lens in two stages: the dry stage where the lens is cast in polypropylene moulds, and the wet stage where the lens is hydrated to achieve its final shape and optical power. It describes the precision required in the moulding process, including the use of metal moulds to create disposable polypropylene moulds, and the injection moulding process for producing these moulds. Additionally, it covers the design aspects of the lenses, including variations in thickness and optical characteristics to achieve desired vision correction.

Uploaded by

x kheed
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Page 49 of 117

OCULAR SCIENCES LTD & ANR v ASPECT VISION CARE LTD & ORS GEOFFREY HARRISON GALLEY V
OCULAR SCIENCES LTD [1997] RPC 289

The manufacture of soft hydrogel contact lenses can be split into two parts. The first consists of making the dry
lens. This is called the dry stage of the process. The second, or wet stage, of the process consists of treatment of
the dry lens in a way which makes it absorb the correct amount of water and thus acquires its final desired shape
and optical power. It is possible to work out backwards from the shape of the final lens what the shape of the dry
lens (ie the lens before hydration) is. From this it is possible to work out what the shape of the mould should be in
which the dry lens will be cast.

(1) The moulds for making the dry lenses:

The essential stages in the production of the dry contact lens are illustrated by reference to the following drawings.
Figure 2 is a highly schematic drawing of a dry lens. (LEXIS EDITORS NOTE: We are unable to replicate this
drawing on the LEXIS database, please refer to the original) It has two major surfaces. The concave surface at the
back of the lens is the one which, after hydration, contacts the eye. The forward convex surface of the lens is the
one which primarily defines the optical characteristics of the lens.

The dry contact lens is cast in a two-part mould which is made of polypropylene plastic. The two parts of the mould
fit together with a defined space between them. It is into this space that the monomers will be placed to be cured.
Therefore one part of the polypropylene mould will define the forward convex surface of the dry lens. This part is
called the female mould. The other part of the polypropylene mould will define the rear concave surface of the dry
lens. It is called the male mould. In use the male mould fits into the female

[*351]

mould. Figure 3 is a highly schematic illustration of these two parts and the dry lens which is made in the space
between them. For ease of understanding, the parts are shown separated. (LEXIS EDITORS NOTE: We are unable
to reproduce this illustration on the LEXIS database, please refer to the original) In use the male mould fits snugly in
the female and the dry lens takes up all of the space between them. The figure also shows that it is the inner,
concave surface of the female mould which defines the front surface of the dry lens. It is therefore this surface of
the female mould which is optically significant and has to be made with precision.

Similarly it is the front, convex surface of the male mould which defines the rear surface of the dry lens. It also has
to be made with precision.

Each time a dry lens is made, the polypropylene male and female moulds within which it was cured is thrown away.
Therefore a contact lens manufacturer has to be able to make large quantities of male and female polypropylene
moulds. These parts are themselves made in a mould. However the parts of this mould are made of metal which
can be reused over and over again so that numerous identical polypropylene moulds can be made. Figure 4 below
(LEXIS EDITORS NOTE: We are unable to reproduce this illustration on the LEXIS database, please refer to the
original): is a schematic exploded vertical section through a metal mould used for making a female polypropylene
mould. The upper and lower metal parts are identified generally at A and B. The polypropylene mould made in it is
indicated at C. The metal mould, like the female polypropylene mould made in it, is circular in cross-section. In fact
the metal mould parts fit inside another piece of equipment called a 'bolster', the function of which is discussed
below. The drawing illustrates that

[*352]

the convex upper surface of the lower part of the metal mould (B) defines the inner concave surface of the female
mould. It is this surface of the steel insert which has to be made with precision. This is made from a circular rod of
steel the top surface of which is cut on a lathe to the right shape. This lathing operation is highly skilled. Once cut
on the lathe, the steel is polished. Because this is the part of the mould which defines the precision surface in the

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polypropylene mould, ie what will be the optical front surface of the finished lens, this steel item is called the “female
optic insert”. To fit this in the hole in the bolster, the insert is itself carried in a metal sleeve called the “female optic
sleeve”. The non-optic surface of the female polypropylene mould is defused by the shape of the upper part of the
metal mould (A). Like the lower part it is made in two parts; a centre stainless steel part called the “female plug” and
a “female plug sleeve” which is used to carry the female plug and which fits snuggly in a hole in a bolster.

[*353]

The equipment used to make the male polypropylene mould is made in a similar manner. It is illustrated in Figure 5
below (LEXIS EDITORS NOTE: We are unable to replicate this illustration on the LEXIS database, please refer to
the original): However in this case it is the upper, convex, surface of the polypropylene part which has to be made
with precision. Therefore the upper part (A) of the metal mould includes a precision cut steel insert, called the “male
optic insert” which is carried within a part called the “male optic sleeve”. The sleeve and insert fit together and will fit
snugly into a hole in a bolster. The bottom part (B) of the metal mould consists of a central steel “male plug” carried
in a “male plug sleeve”. The plug and sleeve fit snuggly in a hole in another bolster.

Having described how the polypropylene moulds are made, it is possible to describe the way in which the whole
process is operated. For the purpose of this description I have drawn heavily on the contents of a publicity video
made by Geoffrey Galley for CV Laboratories before PLL was formed. CV Laboratories operated a cast moulding
process which, save in relation to the floating edge feature, was in substance the same as that operated
subsequently by PLL. The PLL process was, in most respects, a copy of the process used by CV Laboratories and
was designed for PLL and installed and operated in its premises by personnel, most of whom had previously either
carried out the same function

[*354]

in CV Laboratories or had become familiar with the equipment and plant used there. It has never been suggested
that PLL did anything wrong by copying the CV Laboratories' process or the general features and design of the
equipment used by it. It is not now suggested that there is anything confidential in those general features of process
or equipment design or, if there is, that it belongs to either of the plaintiffs.

(2) The process for making the dry lenses:

The first stage of the manufacturing process consists of making the polypropylene moulds. As already mentioned,
the lenses are made from a polymer which is created by chemical reaction in situ inside the polypropylene moulds.
The polypropylene moulds themselves are made in a different way. Pre-made polypropylene is melted and has to
be squeezed under pressure into the mould made from the metal parts illustrated in Figures 3 and 4 above. This is
called an injection moulding process. Molten polypropylene is a viscous fluid. Injecting it into a mould requires the
use of considerable pressures. There are a number of companies which specialise in the manufacture of general
purpose injection moulding equipment which is capable of being used for injecting molten propylene or similar
materials. One well known and common type of injection moulding machine is sold under the name “BOY”. These
machines have been used by CooperVision/CV Laboratories, PLL and AVCL. The BOY machine contain rams and
pumps for bringing the parts of the mould together and filling it with molten plastic. So as to enable it to be used for
injection moulding a variety of different shaped objects, the machine, in common with similar machines from other
manufacturers, carries two bolsters. A bolster may be likened to the chuck on an electric drill – its function is to
receive a variety of different working parts. Thus the ability to fit a number of different mould designs into the bolster
enables one injection moulding machine to make a number of different designed moulded parts. The bolsters used
with the BOY machine were “six impression”. This means that they carry six sets of inserts so that six moulded
parts can be injected simultaneously. Each bolster therefore contains 6 holes into each of which the insert + sleeve
for making a mould fits. Thus one BOY machine will have two jaws which can be brought together. Each jaw will
carry a bolster. Each bolster will be capable of carrying 6 sets of tools for making a mould. For example, if the male
moulds are to be made from the metal parts illustrated in Figure 5 above, one bolster will be fitted with six sets of

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Male Optic Inserts + Male Optic Sleeves (A) and the other one will be fitted with six sets of Male Plugs + Male Plug
Sleeves (B). In use the two bolsters will be pushed together so that six mould cavities will be formed between the
six sets of tools. Another BOY machine can be set up to produce six mould cavities for the female polypropylene
moulds.

Once the bolsters have been brought together, the molten plastic is forced up a duct in the centre of the bolster and
from there it passes by a radiating array of 6 conduits into each mould cavity. The plastic is then allowed to cool and
set. In so doing it shrinks a small amount. The hardened plastic in the central duct, radiating array of conduits and
the moulds themselves are ejected as one piece when the jaws of the injection mould opens. The resulting piece of
plastic is called a “flower” and is illustrated in Figure 6 below (LEXIS EDITORS NOTE: We are unable to replicate
this illustration on the LEXIS database, please refer to the original): The polypropylene moulds attached to the end
of the radiating arms are called “petals”.

[*355]

The flowers containing the male moulds and the flowers containing the female moulds are then put in a degating
and pre-assembly machine. In that machine the male flower is “degated”. This means that the petals are severed
from the spokes and hub of plastic in the centre of the flower. The male moulds are suspended over the flower
which is still carrying the female moulds or petals. They are then dropped into a corresponding female mould. The
female is not degated. So the female flower still exists but now each 'spoke' has, at its outer extremity a female
mould which carries within it a matching male mould. This pre-assembly is then passed to the filling machine. In
this, the male moulds are temporarily lifted out of the female moulds and moved out of the way and a
predetermined quantity of hydrogel monomers together with other additives is dropped into each female mould. The
male moulds are then brought back over the females and are pushed down onto the monomer mix under controlled
speed and pressure. The sets of 6 filled moulds, still connected to the spokes and hub, are stacked one on top of
another and are then taken to a stage where they are heated, for example in a water bath or an oven, to a high
enough temperature for long enough to ensure that the chemical curing reaction has been completed. During the
curing stage the contents of the moulds shrink slightly.

The sets of 6 moulds containing the cured hydrogel is then taken to another degating machine where the spokes
and hub are removed. Each filled mould is now separated from the others. Each mould is then opened and the dry
lens within it is removed.

[*356]
(3) Hydration of the lens.

The dry lens is immersed in a fluid bath for long enough to ensure that any unreacted monomer and other
chemicals can leach out and for the lens to fully absorb water. The lens is now ready for packing. It may be subject
to a tinting process. The lenses may be put into sterilised vials or, particularly in the case of disposables, into
sterilised blister packs.

(4) The hydrogel.

The hydrogels used by PLL and AVCL, and many other companies, are known as Polymacon (otherwise known as
polyHEMA or just HEMA) and Methafilcon A. The mixture put into the moulds consists of monomer units (which
during curing stick to each other to form the polymer mass), a cross-linking agent (which effectively forms bridges
between the polymer chains creating a stable three dimensional structure) and an initiator (which is used with heat
to start off the polymerisation or curing reaction).

(b) Lens design.

The way in which lens designs are arrived at is covered with clarity in the evidence of Professor Efron. It is

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necessary to say something about it at this stage and to explain some of the terminology used. For this purpose it is
helpful to have in mind one of the drawings Professor Efron exhibited to his report. (LEXIS EDITORS NOTE: We
are unable to replicate this drawing on the Lexis database, please refer to the original):

[*357]

Soft contact lenses are frequently in the region of 14 mm in diameter. They cover not only the pupil but also spread
further and lie under the eyelids. The only part of the lens which assists in correcting vision is that which lies over
the pupil. This area is called the optic zone. It is normally circular and it therefore has a diameter, called the optic
zone diameter. The part of the lens surrounding the optic zone is called the peripheral zone. The thickness profile of
the peripheral zone is called its lenticular form. When the peripheral zone is of uniform thickness it is said to have a
parallel lenticular form and the lens is said to have a parallel lenticular carrier. The thickness at the geometric centre
of the lens is called the centre thickness. The thickness at the point where the optic zone meets the peripheral zone
is called the junction thickness. The thickness of the lens edge is referred to as the edge thickness.

The designer of a contact lens has a number of features which he can vary in order to arrive at a lens of the desired
power. For example it is the front radius of the optical zone which mainly determines optical power. For a particular
hydrogel polymer, it is possible to have different centre thicknesses which produce a lens of the same optical
power. However if the lens is too thick in the middle it may be uncomfortable or, more importantly, it may not be
sufficiently permeable to oxygen. On the other hand reducing the centre thickness may not be satisfactory because
it will reduce the junction thickness of the lens to a point at which the lens is difficult to handle by the patient or too
fragile. Alternatively the bulk of the lens could be reduced by reducing the centre thickness and, at the same time,
reducing the optic zone diameter. The following illustration demonstrates how reducing the optic zone diameter (the
optic zone radius/diameter on the left is smaller than the optic zone radius/diameter on the right) results in a
reduction in centre thickness for the same power lens. (LEXIS EDITORS NOTE: We are unable to replicate this
illustration on the LEXIS database, please refer to the original): This in clinical terms would mean greater comfort
and gas transmissibility but perhaps slightly compromised visual performance at the edges due to the reduced optic
zone.

When a range of lenses is designed, the designer will start with the design of one power of lens, say the -3.00
dioptre lens, and then iterate the design in 0.25 or 0.5 dioptre steps up and down the range. For all members of the
range he is likely to keep the overall diameter and back curve of the lens the same. He can alter the power by
changing the optic zone radius, the centre thickness, the optic zone diameter or the junction thickness. He may start
by changing the front optic radius, keeping the optic zone radius constant and allowing the centre thickness to vary
from lens to lens. However after a number of iterations he may get to a

[*358]

design in which the centre of the lens is too thick or the junction thickness is too thin. Then he will have to make a
decision as to whether to alter, for example, the optic zone radius. Alternatively he may decide to iterate by
changing the front optic radius but keep the centre thickness constant with the junction thickness or the optic zone
radius being allowed to vary from lens to lens. Once again a point is likely to arise during the iteration process at
which some feature of the lens makes it clinically or commercially unacceptable. At that point it may be necessary
to change the centre thickness. However he approaches the iterative design exercise, he will end up, with a series
of lens designs each one of which exhibits small differences from its immediate neighbours in the range.

(c) Translating the lens designs into mould designs.

The manufacturer has to determine what shape of metal inserts will produce the polypropylene moulds which, in
turn, will produce the dry lenses which, on hydration, will produce the soft lenses he has designed. This is not a
one-to-one relationship. What is involved can be explained by reference to the total diameter of the desired soft
lens. In many lenses that dimension will be of the order of14mm. However it might be that a particular hydrogel

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swells to twice its size on hydration. If that is so then a swell factor has to be added to the calculation of the size of
the dry lens from which the hydrated lens will be made. The dry lens will have to have a diameter of 7mm: Now the
dry lens is cured in the polypropylene mould. It shrinks slightly on curing. Furthermore the polypropylene mould
itself shrinks slightly when it cools. Therefore, because of shrinkage, the metal mould from which the polypropylene
mould is made will have to be larger than the expected final dry lens, If, due to shrinkage, the metal mould has to be
10% larger than the dry lens derived indirectly from it, then in this example the relevant diameter of the metal mould
will need to be 10% greater than the 7 mm of the desired dry lens, ie 7.7 mm. By taking into account the swell factor
and allowing for shrinkage, it should be possible to back calculate from the shape of the desired hydrated lens to
the shape of the metal inserts used in the injection moulding machine. That, at least, is the theory. In fact swelling
and shrinkage are not exactly even in all directions and, more importantly, it is not possible to control all the steps in
the manufacture of the lenses as precisely as the example given above assumes. Therefore swell factors and
shrinkage factors are used in the calculation of metal insert designs which are workable compromises. With the
benefit of these figures, which are dependent to some extent on the nature of the polymers used and the curing
conditions employed, it is possible to design back to metal parts which should be in the right 'ball park' to produce
the hydrated lenses of choice. Once the calculations have been done, a number of metal inserts are produced, as
close as manufacturing tolerances will allow to the calculated figure, and from them a number of trial lenses are
made. These are then inspected and their optical powers are measured. If the metal inserts produce lenses of the
desired power, those inserts are retained and used for commercial production. If not, they are discarded. The
process of making trial lenses and testing them is referred to as “validation” of the inserts.

The process of iterative calculation of the design of ranges of lenses and the subsequent determination of the insert
dimensions was facilitated in PLL by the use of a computer program written by Anthony Galley.

[*359]

The plaintiffs claim that the defendants have breached obligations of confidence relating to the design of the PLL
equipment and lenses, the process and materials used and certain software which has been written to help in the
management of the PLL business. I will have to consider each of these allegations in turn, but before doing so there
are questions of procedure and law which need to be considered.

(d) Pleadings in a breach of confidence action.

The rules relating to the particularity of pleadings apply to breach of confidence actions as they apply to all other
proceedings. But it is well recognised that breach of confidence actions can be used to oppress and harass
competitors and ex-employees. The courts are therefore careful to ensure that the plaintiff gives full and proper
particulars of all the confidential information on which he intends to rely in the proceedings. If the plaintiff fails to do
this the court may infer that the purpose of the litigation is harassment rather than the protection of the plaintiff's
rights and may strike out the action as an abuse of process. Such a case was John Zink & Co Ltd v Wilkinson
[1973] RPC 717 in which the Court of Appeal ordered particulars before defence. The case returned to the High
Court on a successful application to strike out. This is reported under the name John Zink & Co Ltd v Lloyds Bank
Ltd [1975] RPC 385. As Edmund Davies LJ put it in the Court of Appeal: ([1973] RPC 717 at page 725.)

“But this appeal does not, in reality, turn upon when an order for particulars may properly be made in the present case, but,
instead, whether such an order should ever be made, and, if so, what allegations it should relate to and under what
safeguards it should be complied with. As to whether an order should be made at all, it is not unimportant to bear in mind
that in these civil proceedings the plaintiffs have made allegations of a grave character against both defendants, charging
the second with procuring a breach of confidence or contract by the first by improperly divulging trade secrets. Some would
say that an assertion of criminal conspiracy is thereby made against both. They could cite in support of that proposition R v
Willetts (1906) 70 JP 127, where, notwithstanding that it is not a criminal act for a person to infringe copyright nor larceny to
pirate music (see R v Kidd (1907) 72 JP 104), it was held that an agreement to make pirated music for sale and so obtain
profits out of that music to which the parties thereto had no right is indictable as a conspiracy to deprive the owner of the
copyright of his property. If that decision is right (it is not without its critics) and if, as I think, the present case is analogous

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to it, it is pertinent to bear in mind that in Palamisto General Enterprises SA v Ocean Marine Insurance Limited [1972] 2
WLR 1425-a 'scuttling' case-Buckley, LJ said (at page 1440 F):

“where a party asserts his opponent's complicity in … criminal misconduct, the case is pre-eminently one in which not only
the RSC (Order 18 rule 12(1) and Order 72 rule 7(2)) but also fair treatment require that, so far as practicable, the matter
shall be pleaded with particularity, so that the party accused may know what case he has to meet.”

[*360]

But even if the allegations in the present statement of claim fall short of asserting criminal misconduct, they undoubtedly
impute conduct of a gravely improper character which call for no less clear particularisation.”

The requirement of particularity may impose a heavy burden on the plaintiff. In a case where the plaintiff has a large
quantity of confidential information and much of it has been taken by the defendant, the obligation to identity all of it
might involve a great deal of work and time. Whether in such a case the court would be receptive to a plaintiff who
asks for leave to pursue the defendant on some items of confidential information only, the rest being left to another
time, is a difficult question which does not arise in this case. The normal approach of the court is that if a plaintiff
wishes to seek relief against a defendant for misuse of confidential information it is his duty to ensure that the
defendant knows what information is in issue. This is not only for the reasons set out by Edmund Davies LJ in John
Zink but for at least two other reasons. First, the plaintiff usually seeks an injunction to restrain the defendant from
using its confidential information. Unless the confidential information is properly identified, an injunction in such
terms is of uncertain scope and may be difficult to enforce: See for example PA Thomas & Co v Mould [1968] 2 QB
913 and Suhner & Co AG v Transradio Ltd [1967] RPC 329. Secondly, the defendant must know what he has to
meet. He may wish to show that the items of information relied on by the plaintiff are matters of public knowledge.
His ability to defend himself will be compromised if the plaintiff can rely on matters of which no proper warning was
given. It is for all these reasons that failure to give proper particulars may be a particularly damaging abuse of
process.

These principles do not apply only to the question of the content of the pleadings. Just as it may be an abuse of
process to fail properly to identify the information on which the plaintiff relies, it can be an abuse to give proper
particulars but of information which is not, in fact, confidential. A claim based even in part on wide and
unsupportable claims of confidentiality can be used as an instrument of oppression or harassment against a
defendant. It can be used to destroy an ex-employee's ability to obtain employment or a competitor's ability to
compete. The wider the claims, the longer and more expensive the litigation. The defendant is likely to feel that he
has no alternative but to challenge the confidentiality of everything, even though he believes that much or most of
the technology pleaded cannot reasonably be thought of as secret. Furthermore a defendant faced with a narrow
claim may decide that the commercial realities point towards a tactical withdrawal. He may be able to relinquish use
of the contested information yet stay in business. The possibility of doing this reduces as the width of the plaintiff's
claims increases. The defendant is left no alternative but to fight on in heavy litigation, spending money on lawyers
which he would much prefer to spend on building up what may be a new business. The attractions of this to a
plaintiff bent on harming a competitor's business are obvious. Furthermore, the more technology put before the
court, the easier it may be to obscure the issues. A competitor or ex-employee is entitled to copy non-confidential
material, but if the plaintiff mixes a large amount of technology together, some of which has been copied by the
defendant, there is a risk that the court will jump to the conclusion that some of what was copied must have been
confidential. These considerations bring to mind the judgment of Templeman LJ in GD Searle & Co Ltd v Celltech
Ltd [1982] FSR 92 at page 104:

[*361]

“The injunctions originally sought by the plaintiffs would have created a new form of industrial slavery and made it
impossible for the individual defendants to work for anyone except the plaintiffs. The injunction C now sought is still
objectionably broad and vague. The evidence of Dr Felner in support attempts to blind the court with science by burying a

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number of secrets which are not threatened to be disclosed in a mass of techniques and information over which the
plaintiffs are not entitled to any monopoly. The application for injunctions A and B confuses information which is confidential
to the plaintiffs with information which is useful to the defendants but not confidential to the plaintiffs.”

In the present case, the plaintiffs were reminded at the very outset of the obligation to give proper particulars of their
confidential information. At the time of the interlocutory hearing before Sir Peter Pain, there was still no statement of
claim. The prayer for relief on the writ was in the widest possible terms. The issue of particularity was raised by the
defendants during the interlocutory proceedings. Sir Peter said:

“The plaintiffs have been pressed to specify in what particular documents or records they say confidentiality lies. This they
have wholly failed to do. Schedule B in their minutes of order sets out classes of designs, specifications, systems, etc, but it
does not refer to any particular design or specific document. My decision is that this contention of [counsel for the plaintiffs]
fails because firstly, the plaintiffs have failed to identify a design the property of OSI to which confidentiality might apply,
and the injunction sought is on any footing far too wide and appears to refer to the whole of PLL's process. In my view the
authorities clearly establish that an injunction protecting confidentiality must be quite specific as to what is protected. I refer
to Suhner & Co AG v Transradio Ltd [1967] RPC 329 as a striking example of the application of this.”

When the Statement of Claim came in a few days later it included a definition of the plaintiffs' confidential
information which, encompassed more or less everything. Insofar as material, it was in the following terms:–

“C. THE TRADE SECRETS AND/OR CONFIDENTIAL AND/OR PROPRIETARY INFORMATION OF OSI/PLL

10. In the course of the business of OSI … OSI provided detailed lens designs and/or specifications (including dimensions
and formulations) to PLL (“the Lens Designs”) for the soft contact lenses particularised below. [A list of all of OSI/PLL's
lenses was then set out]

11… . the Lens Designs were provided and communicated to PLL in confidence and/or the Lens Designs were and
remained at all times the trade secrets and/or confidential and/or proprietary information of OSI. Thereafter OSI tested and
approved the Lens Designs at prototype stage. For the avoidance of doubt, all such tests, test results and approvals are
included within the definition of Lens Designs and the same were and remained the trade secrets and/or confidential
information and/or proprietary information of OSI.

[*362]

12. Further … for the purposes of processing the Lens Designs and in and for the process of dry manufacture and wet
processing of contact lenses (and both before and after 30th September 1992) at its own expense PLL:

12.1 developed detailed lens specifications for each prescription of each Lens Design referred to at paragraphs 10 and 11
above;

12.2 produced engineering drawings and dimensions for each steel insert used to manufacture the moulds for each
prescription of each such Lens Design;

12.3 developed procedures for and produced materials and information relating to the testing and validation of each insert
and mould referred to at paragraph 12.2 above;

12.4 developed and/or used computer systems, programs, algorithms and software including but not limited to:

12.4.1 PLL's Management Information Systems; and

12.4.2 design software and, in particular, the software used to generate the aforesaid finished lens, steel insert and mould
specifications referred to above;

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12.5 developed and updated Standard Operating and Test Procedures (“SOTPs”) relating to all stages of the design and
manufacture of the said lenses;

12.6 developed and updated product descriptions, formulae and quality assurance, regulatory and other information
(including SOTPs) and embodied all such information in the Device Master Records;

12.7 developed and updated other regulatory and quality assurance forms, manuals and guidelines in relation to contact
lens manufacture;

12.8 produced, revised and updated drawings for and/or developed, manufactured (whether by PLL or by third parties to
PLL's designs) tooling and items of machinery for use by PLL in its said business including but not limited to the following
machines or items and drawings: [The list then included; the Bolster, the Insert Sleeve, the De-gating Machine, the Filling
Machine, the De-Petalling Machine, the De-Moulding Machine and the Floating off and wet processing sections and the
Tooling for Packaging]

12.9 made divers improvements, inventions, research and development projects, drawings, models, formulae, compositions
of matter, machinery and material and mask works relating to the development, design, manufacture, marketing and sale of
contact lenses and other optical equipment.

The divers matters set out above in this paragraph are referred to collectively as “the PLL Confidential Information”.”

[*363]

The relief which the plaintiffs sought, and still seek, includes injunctions to prevent the defendants from making any
use of or divulging to any person or attempting to make use of or divulging “the PLL Confidential Information”.

The statement of claim went on to make the following allegations of breach;

“16. In breach of their respective obligations of confidence to OSI and PLL [the defendants] have:

16.1 established or sought to establish AVCL as a manufacturer of soft contact lenses:

16.1.1 to precisely the same designs and/or specifications as the Lens Designs or some of them, namely those marked 1 to
12 inclusive of the Particulars of Lenses under paragraph 10 above;

16.1.2 using the PLL Confidential Information or some of it and/or the said Storage Media or some of them to provide AVCL
with a manufacturing process the same or materially the same as that of PLL;

17. By reason of the matters set out and complained of at paragraph 16 above, … the PLL Confidential Information (or
some of it) … have been communicated to and/or made use of by AVCL, …

18. Unless restrained by this Honourable Court the defendants and each of them threaten and intend to make use or further
use of and/or divulge or further divulge the … PLL Confidential Information (or some of it) …”

The plaintiffs reserved the right to expand the particulars of breaches after discovery or interrogatories. The
statement of claim was the subject of a request for particulars which was responded to on 9 May, 1995. It does not
qualify the scope of the confidential information relied on by the plaintiffs. Particulars of breaches were given,
including reference to the fact that the AVCL and certain of the personal defendants had used PLL drawings. On 16
January, 1996 the plaintiffs served another pleading which was amended on 4 June 1996. According to its title and
contents, it was a Schedule of Use the purpose of which was to identify those items of alleged confidential

Maria Bhatti

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