07 December 2005
Between 1992 and 1993, Hall developed an idea for an article of headgear for protecting the wearer from sun, wind and rain. Broadly, the idea consisted of a visor to which material was attached to cover the top of the head and hang down at the sides and back of the head and neck. Hall coined the term "Araphat" for the article. Hall filed a patent application on 6 January 1995, claiming priority from 10 January 1994. Letters Patent No. 684592 was subsequently granted to Hall.Hall also obtained a registered design no. 143028. This case addresses the issue of design infringement as well, but that aspect is not discussed in this post.
It appears that there was some form of business relationship between Lewis and Hall centred on the hat. Shortly after the end of 1999, this relationship was terminated. Lewis began to manufacture and sell her own hat, "Le Hood".
Hall claimed that manufacture and sale of "Le Hood" by Lewis amounted to an infringement of the patent. The initial trial was held in the Supreme Court of Western Australia and on 21 October 2004, that court declared that the appellant had infringed the patent. The court ordered that Lewis be restrained from infringing the patent. Lewis appealed.
As far as the patent was concerned, the question to be determined in the appeal was the proper construction of the words "a plurality of fastening means" as used in claim 1 of the patent.
The parties agreed that claim 1 could be reduced to the following essential integers:
1. a substantially forwardly projecting peak or visor;
2. an adjustable head engaging band;
3. a length or sheet of material;
4. the head engaging band being attached or attachable to the peak or visor at or near the rear edge thereof;
5. the length or sheet of material being attached or attachable to the peak or visor and extending rearwardly thereof, whereby the peak or visor may be positioned on a wearer's head such that the material covers the wearer's head and hangs therefrom about the shoulders and neck of the wearer;
6. the head engaging band is positioned about a rear of the wearer's head such that the peak or visor is held in position thereon;
7. the material having provided thereon a plurality of fastening means whereby the material may be fastened to protect the wearer's neck and/or face; and
8. the fastening means being arranged on the material such that the material may be drawn to a number of positions in front of the wearer's neck and/or head and/or face and the material fastened together releasably in a number of arrangements as desired by the wearer.
Lewis accepted "Le Hood" embodied all the above terms except for items 7 and 8. Lewis contended that "Le Hood" did not have a plurality of fastening means whereby the material may be drawn to a number of positions and fastened to protect the wearer's neck and/or head and/or face. Lewis submitted that the two components of a "Velcro" fastener attached to the material provided only one fastening means. Hall of course contended that the two components of a "Velcro" fastening device did constitute such a "plurality of fastening means" for the purposes of claim 1.
Their honours emphasized some important judicial precedents as listed below:
1. Proper construction of the claims must keep in mind that the claims are addressed to a person skilled in the art at the relevant date (The General Tire & Rubber Company v The Firestone Tyre & Rubber Company Ltd  RPC 457 ).
2. Information provided in the body of the specification cannot overtake the plain meaning of the words used in the claims and be the source of further meaning that alters the monopoly claimed. However, that information can be used to resolve unambiguity or uncertainty in the meaning of the claims (Marconi's Wireless Telegraph Co. Ltd v Mullard Radio Valve Co. Ltd (1923) 40 RPC 157).
3. It is legitimate and appropriate to read the body of the specification and the claim together to provide the context in which the claim is to be construed. The specification must be read as a whole. (Decor Corporation Pty Ltd & Anor v Dart Industries Inc (1988) 13 IPR 385 ).
The body of the specification referred to both components of a hook and loop type fastener ("Velcro") as possibly providing the adjustable headband. It also set out that "the plurality of releasable fastening means" is also formed of either component of such a hook and loop type fastener.
Their honours held that a "skilled artisan" to whom the patent was addressed would understand that a "Velcro" fastening means could be used to provide such a plurality. This would be confirmed by that skilled artisan reading the claims with the specification as a whole.
Claim 1, it was held, requires the availability on the material of a means of fastening the material at more than one position, to which the material may be drawn by the wearer. Following on this, their honours held that the two pieces of "Velcro" provided on the material of the "Le Hood" constituted that plurality of fastening means in that they enable the material to be fastened at several positions to which the material may be drawn.
Lewis attempted to make something of the fact that "Le Hood" could not be drawn into all of the arrangements stipulated in the drawings of the patent specification. Therefore, Lewis claimed, the patent had not been infringed. Their honours pointed out that the drawings and their associated description are used to describe the invention 'by way of example only". They are not part of a claim to a monopoly unless a claim incorporates them.
While Hall won through in the end, the whole case could have been avoided if claim 1 had simply included the words "at least one fastening means" instead of "a plurality of fastening means". It follows that it is important that practitioners and inventors alike pay very careful attention to the choice of words and phrases in the claims. If necessary, further independent or principal claims can be used, raising the level of difficulty for opponents. Riding a case like this all the way to the Full Bench is a very expensive process for the sake of a few words.
17 November 2005
Pfizer is the registered patentee of Australian Patent no. 676571, entitled "Pyrazolopyrimidinones for the treatment of impotence". The well-known anti-impotence drug, Viagra, is said to be embodied in the patent. Eli Lilly markets the anti-impotence drug, Cialis, in Australia.
On 17 September 2003, Lilly commenced proceedings in the federal court for the revocation of the patent and sought a declaration that the patent was and always had been invalid. The bases upon which invalidity was alleged included:
1. The invention as claimed in claim 10 did not involve an inventive step.
2. The invention as claimed in claim 10 was not fairly based on the matter described in the specification.
3. The specification as claimed in claim 10 was not novel.
4. The invention as claimed in claim 10 was not sufficiently described.
5. The specification did not describe the best method of performing the invention as claimed in claim 10.
6. The grant of the Patent was obtained by false suggestion or misrepresentation.
Pfizer cross-claimed against Lilly, alleging that Cialis infringed the patent.
Heerey J. of the Federal Court found that claim 10 was invalid because it did not involve an inventive step. He also found that claim 10 was not fairly based on matter disclosed in the complete specification. Otherwise, he rejected the further contentions of Lilly. Pfizer appealed.
Their honours, French J. and Lindgren J. held that:
1. The invention as claimed in claim 10 did involve an inventive step.
2. The invention as claimed in claim 10 was not fairly based on the matter described in the specification.
3. The invention as claimed in claim 10 was novel.
4. The invention as claimed in claim 10 was sufficiently described.
5. The specification described the best method of performing the invention as claimed in claim 10.
6. The grant of the patent was not obtained by false suggestion.
7. The Lilly product, Cialis, would have infringed claim 10 if that claim were valid.
Her honour, Crennan J. agreed with these except for point 2 relating to fair basing.
It follows that the appeal was dismissed .
The matter hinged on the construction and scope of claim 10, which is worth setting out here:
'A method of orally treating man to cure or prevent erectile dysfunction in man in need of such treatment, which comprises treatment with an orally effective amount of cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity.'
This claim was the result of an amendment ordered by Heerey J. on Pfizer's application made on 19 September 2003.
Grounds of the Appeal
Pfizer asserted that Heerey J. erred in finding that:
1. In claim 10, in the context of the patent as a whole, the term 'cGMP PDEv inhibitor' does not connote an inhibitor which is selective for PDEv.
2. Claim 10 was not fairly based on the matter described in the specification of the Patent.
3. Claim 10 of the patent was invalid because it was obvious.
Notice of Contention
Lilly asserted that Heerey J:
1. Should have held that claim 10 of the patent was not novel.
2. Should have held that the date for determining whether the best method known to the patentee of performing the invention is described in the specification of the patent is the date of filing of the complete specification.
3. Should have held that the specification of the patent did not describe the best method known to the patentee of performing the invention claimed in claim 10 of the patent at the relevant date.
4. Erred in his findings as to sufficiency in relation to the relevant date for determining sufficiency, the construction of claim 10, and the test applied to determining sufficiency.
5. Should have held that there was false suggestion made by the patentee which materially contributed to the decision to grant the patent.
6. Should have held that the importation or sale of Cialis by the respondents would not infringe claim 10 of the patent because it does not "cure or prevent" male erectile dysfunction within the meaning of claim 10 of the patent.
Matters of Construction
The constructional debate was narrowly focussed on two questions:
1. Whether the 'cGMP PDEv inhibitor' in claim 10 refers only to inhibitors which are selective for PDEv.
2. Whether the term 'cure or prevent' in claim 10 covers a method of treatment which temporarily overcomes the effects of erectile dysfunction.
In connection with point 1, their honours found on a reading of the specification that it was important that administration of a selective inhibitor would not unduly affect the functioning of smooth muscles in organs other than the penis. Minimising the risk of adverse smooth muscle effects in cardiac, respiratory, bowel and retinal tissue was an important purpose of the invention.
Thus, reading claim 10 in a way that is consistent with the terms of the specification to which reference has been made and the state of common general knowledge at the time and with an eye to its utility yielded the narrower construction advanced by Pfizer.
In connection with point 2, Lilly submitted that use of the expression 'cure or prevent' results in claim 10 extending beyond the functionality of Cialis. Cialis, Lilly submitted, treats male impotence on an ad-hoc basis, whereas the word 'cure' connotes that the man no longer has the problem of impotence.
Their honours looked to the definition of impotence in the specification. They held that impotence as defined in the patent and commonly understood, is an inability to 'perform' from time to time when desired. In their opinion, impotence was not only 'cured or prevented' by a once and for all remedy, but also by the maintenance of an ongoing dosing regimen which is directed to the condition's manifestations from time to time.
Heerey J. held that claim 10 was not fairly based on the specification. This finding found basis in the generality of claim 10 extending to substances outside the group defined as 'compounds of the invention'.
Their honours noted that the specification opening with a statement that the invention related to the use of a particular set of compounds made it clear that the invention related to a particular class of drugs.They also noted that there were repeated references to the use of a compound of Formula (I). Their honours held that claim 10, read as a whole, travelled well beyond the range of compounds which was disclosed in the body of the specification. Thus, they supported Heerey J. in his finding that claim 10 was not fairly based on the specification.
Lack of Inventive Step
By way of background, an invention would lack an inventive step if the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in Australia before the priority date of the relevant claim.
Their honours cited the well known Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 and noted that common general knowledge forms the background knowledge and experience which is available to all in the trade.
Their honours reinforced the position of the High Court that a claimed invention is not obvious if the steps that led to it would have been seen by a person skilled in the art as 'worth while to try' in the light of the common general knowledge at the priority date. Rather, the question is whether the notional research group would, at the relevant date, in all the circumstances, directly be led, as a matter of course, to the invention.
Heerey J, their honours noted, came close to adopting the 'worthwhile to try' approach eschewed by the high court. Furthermore, their honours held that there were too many uncertainties in the evidence of experiments carried out to hold that the person skilled in the art (notional research group) would be led to the invention claimed in claim 10, as a matter of course.
Of interest is the claim by Pfizer that some of the expert witnesses presented by Lilly did not qualify as representative of persons skilled in the art, being from foreign countries. Their honours did not accept this argument and held that that kind of approach would place the fields of pharmacology, medicinal chemistry and urology in Australia in a rather unreal state of isolation from the rest of the world.
By way of background, any document that was publicly available before the priority date of the claim would destroy the novelty of that claim. The test in Australia is known as the 'reverse infringement test' as set out in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228. Their honours cited the case with approval: '...generally one can ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement.'
Citing a number of old British cases (something which is really unnecessary, given our mature source of judicial precedent), their honours noted that if a prior publication is to destroy novelty, it must give a direction, or make a recommendation, or suggestion which will result, if the skilled reader follows it, in the claimed invention.
Their honours had regard to the generality of the discussion in the prior art references cited by Lilly and to the brevity of their references to the use of PDEv inhibitors. They held that it could not be said on any test that the invention as claimed in claim 10 was lacking in novelty.
Sufficiency of Description
Section 40(2)(a) of the Act requires that a complete specification 'describe the invention fully including the best method known to the applicant of performing the invention'.
Their honours noted that the complete specification is the whole document and includes the claims. Thus, the claims can dispel any uncertainty or ambiguity in the description.
The accepted test formulated by the High Court for sufficiency is '...will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?' ( Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 )
Furthermore, in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 212 ALR 1 it was held that it is enough that the disclosure enables the addressee 'to produce something within each claim without new inventions or additions or prolonged study of matters presenting additional difficulty.'
It was not disputed that a range of tests would have to be performed before any compound was administered to a human to determine whether it was efficacious. Lilly therefore submitted that a considerable investment in time and resources were required before any compound could be tested. By forcing the selection of compound, Lilly held that the 'initial difficulty' of Kimberly-Clark was presented.
Heerey J. had held, as a question of fact, that patents incorporated by reference into the patent contained sufficient instructions.He found that there were a number of specifically identified compounds which could be tested and screened by a skilled addressee. This was not challenged by Lilly. Relying on this, their honours held that there was more than adequate basis for Heerey J to decide that the complete specification was sufficient.
As set out above, section 40(2)(a) sets out that the complete specification must describe the best method known to the applicant of performing the invention.
The active ingredient of Viagra is sildenafil monocitrate. This was added to the specification as a result of an amendment subsequent to filing the original international patent application.
Lilly submitted that the 'best method' must be included in the complete specification at the 'filing date' and no later. Pfizer submitted that the date for compliance with the 'best method' requirement is either the date of grant of the patent or the date of commencement of legal proceedings.
Heerey J. held that the date is the date of grant. In support of this, he considered the definition of 'complete specification' as set out in Schedule I of the Patents Act: 'Complete specification means...a specification filed in respect of a complete patent application or, if the specification has been amended, the complete specification as amended'. He saw no reason why the definition did not apply to section 40(2)(a) (supra).
Their honours emphasized that it is indeed the case that the disclosure of the best method must be made in the specification as filed. However, they held that one has to look at the Act's regime for providing for amendment of a complete specification, coupled with the definition of a complete specification. In the examination process, in opposition proceedings and in revocation proceedings it is the specification as amended that must be regarded in order to determine compliance with section 40(2)(a). Furthermore, section 104(1) entitles a patentee to request an amendment of the complete specification for the purpose of removing a lawful ground of objection to it. If the best method is not described, there is a lawful ground of objection. It follows that their honours supported Heerey J.
Lilly's case for false suggestion depended upon a statement in which it was asserted that patient studies had confirmed that one of the especially preferred compounds induced penile erection in males. Lilly submitted that this assertion was calculated to give the false impression that one of the specified compounds identified earlier has been tested and worked. Lilly held that that the assertion was referring to a salt and not to one of the free amines as described in the specification.
Heerey J. held that a person of ordinary skill in the art would not draw a distinction between a compound in its freebase form and the same compound in its salt form. He based this on the evidence of one of the expert witnesses.
Their honours supported Heerey J. when considering cross-examination evidence of one of the witnesses.
In summary, Pfizer succeeded in demonstrating error on the part of Heerey J. regarding his finding of lack of inventive step. However it did not succeed in its challenge to the lack of fair basis finding concerning claim 10.
Bazpat has raised the issue of fair basis in previous posts. This case again emphasizes the need for practitioners always to ensure as close a correlation as possible between the claims and the specification. Also for those considering inventive step, this case indicates the difficulties associated with proving the deficiency of that quality.
28 October 2005
On 21 October 2005, the full federal court of Australia handed down Fresenius Medical Care Australia Pty Limited v Gambro Pty Limited  FCACF 220 .
This case is worthy of study by patent practitioners and patentees alike. Their honours Wilcox, Branson and Bennett JJ provide a good treatise on the construction of claims for the purposes of infringement.
Gambro is the exclusive licensee of Australian patent no. 595423. As such it had the standing to sue Fresenius for infringement, which it did. In the lower court, the judge found that Fresenius had infringed a number of the claims and that the patent was valid. This case concerns the appeal by Fresenius against this judgement. Fresenius' appeal failed.
The reasoning is turgid. However, the full court made some constructive points in connection with claim interpretation for the purposes of deciding infringement and these are discussed below.
The "Essence" of the Invention:
Fresenius objected to the manner in which the primary judge had interpreted the claims. In an apparent attempt to identify essential features of the claims, the primary judge identified some "essence" of the invention, ie " the use of dry powder in a vessel and its dissolution by the introduction of water into the vessel to produce a saturated (and so constant) concentrate fluid that was then withdrawn from the vessel and then dealt with in the customary way by the relevant machines." In order to ascertain the scope of a claim, it is neccessary to determine the essential features or integers of that claim. In support of this strategy, the primary judge cited Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR, where it was held that the interpretation of the specification and claims is to be undertaken having regard to the essence of the invention. His honour decided that the essential integers of a claim are those which are necessary for "the essence of the invention". Other integers were classified as inessential and thus not influencing the scope of the claims.
Their honours held that applying such a principle on its own is erroneous. They held that the subject matter of the claims must be determined. Reference to the specification may be made to understand the context of the claim wording and thus whether or not integers were essential. In this regard, their honours concurred with Gambro in that the claims are to be read in the context of the specification not only when ambiguity exists in the claims. However, their honours did point out that doing so does not permit the adding of integers to the claims.
In Catnic Components Limited v Hill & Smith Limited  RPC 183, the specification is to be read in the light of the common general knowledge before the priority date. The essential features are to be determined in the context of the then existing knowledge, as the patent is addressed to those skilled in the art. The specification serves as a tool for such persons to identify the essential features of the claims.
The analysis of whether or not claim 4 was infringed raised some issues worthy of discussion. The claim included the words: "a vessel containing a powder concentrate, said vessel including an inlet at the top thereof and an outlet at the bottom thereof;... ".
The "outlet" was interpreted, after consulting dictionaries, as an opening or passage by which anything is let out, including a vent or exit. Armed with this interpretation, the primary judge recognised that the Fresenius device did not have an opening at the bottom of the relevant vessel. In short, the Fresenius device is a column within a vessel. Concentrate leaves the column at the bottom of the column, which is at the bottom of the vessel. The concentrate enters a tube that conducts the concentrate to an opening at the top of the vessel. The primary judge held that the precise location of a break in the skin of the vessel is functionally immaterial. He reasoned that there was a fundamental lack of advantage of the Fresenius device over the vessel of claim 4.
In setting out the error in this approach, their honours explained that one does not investigate whether the allegedly infringing article is the same in substance and effect as the disclosures of the specification and claims. The form and wording of the claim are determinative. The primary judge impermissibly construed the claim with an eye to the allegedly infringing article.
Their honours held that when the claim is read in the light of the specification as a whole, including the figures, there can be no doubt that the outlet of the claim is an outlet both located at the bottom of the vessel and an outlet from the bottom of the vessel. By looking at the functionality of the Fresenius device, the primary judge had substituted a mechanical equivalent of an essential integer of the claim. This is not permissible for the purposes of ascertaining novelty or infringement.
For Patentees and Practitioners:
Claims should be drafted very carefully with a clear view of the features of an invention for which protection is sought. The clear meaning of the words in the claim will be taken as defining the scope of protection sought. Whether or not particular features are essential or not cannot be decided based on the functional "essence" of the invention. Rather, a reading of the specification with reference to the drawings in the shoes of the nominally skilled person is determinative of whether or not particular features are essential.
15 October 2005
On 26 September 2005, the Deputy Commissioner of Patents handed down his decision in an opposition proceeding against Sheiman Ultrasonic Research Foundation Pty Limited by Novapharm Research (Australia) Pty Ltd. .
The Patent Application
Sheiman filed an international patent application on 17 February 1999, claiming priority from an Australian provisional patent application. Acceptance of the application in Australia was advertised on 31 October 2002. The matter came to a hearing on 29 August 2005. Sadly, this is an indication of the sort of time periods litigants, even in lower courts, can expect. .
The claims of the patent application included two independent claims. These were:
1. A sterilisation apparatus comprising:
an aerosol generator being adapted to generate an aerosol of a sterilising agent; and
a sterilisation chamber operatively coupled to the aerosol generator so as to receive a recirculatory flow of the aerosol, the aerosol generator being adapted to produce said recirculatory flow and the sterilisation chamber being designed to receive an article requiring sterilisation whereby in operation the recirculatory flow of the aerosol through the sterilisation chamber is effective in sterilising the article..
12. A method of sterilisation comprising the steps of:
providing a sterilisation apparatus including an aerosol generator and a sterilisation chamber operatively coupled to each other;
locating an article requiring sterilisation in the sterilisation chamber; and
providing a recirculatory flow of an aerosol of a sterilising agent through the sterilisation chamber said recirculatory flow being produced by the aerosol generator whereby in operation the recirculatory flow of the aerosol through the sterilisation chamber is effective in sterilising the article.
22 September 2005
King filed patent application no. 754492 on 4 December 2000. After some initial confusion, it was established that the patent application had a priority date of 4 January 1999. The application was duly accepted and advertised for opposition purposes. KMJ opposed the application on a number of grounds, including lack of novelty and inventive step.
The broadest claim (claim 1) of the patent application read: "An adjustable latching device for use with a spring actuated self-recoiling reeling assembly, said latching device including:-
a rotatable reeler drum; a reeler casing located adjacent said rotatable reeler drum, with said rotatable reeler drum being rotatable relative to the reeler casing;
a slotted cam plate supported by said reeler casing, which cam plate:- provides at least one latching slot, with the length of said at least one latching slot being selectively variable, and
at least one latching pawl, which is pivotally mounted to the reeler drum and which is adapted to enter into the latching slot in the cam plate and thereby arrest rotatable movement of the reeler drum relative to the reeler disk,
wherein the length of the slot can be selectively varied to determine the ease with which the latching pawl can arrest rotatable movement of the reeler drum relative to the reeler disk."
Disclosure in Meetings
Initially, KMJ attempted to show that there had been disclosure of the invention in certain meetings before the priority date. The Delegate accepted that these meetings had taken place, but could find no corroborating evidence for what had transpired at those meetings. The importance of adequate and corroborating evidence was emphasised. The Delegate referred to Paul Andrew Cronk v The Sunnyfield Association 2003 APO 27, where it was held that in order to be invalidating, the prior use must be "informative" in the sense that all the essential features of the invention are made available to the public. In Windsurfing International Inc v Borsimex Pty Ltd, (1984) AIPC 90, Waddell J set out that it is essential that an allegation of prior public use should be strictly proved. Evidence which is uncorroborated is undoubtedly suspect and should be scrutinised with particular care. The Delegate was not presented with any corroborating evidence supporting statements made by KMJ. Accordingly, the Delegate held that the onus on KMJ to present such evidence had not been discharged, and that the claims of the application did not lack novelty as a result of disclosures made during the meetings.
Unfortunately for King, KMJ produced drawings which (supported by King's assertions) were handed to KMJ before the priority date of the patent application. The drawings were very similar to the drawings of the patent application. Furthermore, one of King's assertions was that he approached KMJ with a fully developed latching system. The drawings were dated before the priority date and had no markings indicating that they were to be regarded as confidential. In this regard, the Delegate referred to Stanway Oyster Cylinders v Marks (1996) AIPC 91 in which it was held that information which is publicly available includes that information disclosed to a person such that the person is free in law and equity to make use of the information. The Delegate held that the drawing sheets were disclosed "without inhibiting fetter" and that there was "no inkling" in the evidence that confidentiality existed in the disclosure of King to KMJ.
The case illustrates two important points: Firstly, it is extremely difficult to show that novelty is destroyed by mere verbal disclosure. Secondly, it would appear that the bar for what can be regarded as confidential information is rather low. By default, inventors should mark all drawings as confidential, especially before a patent application is filed.
08 September 2005
This matter concerned Australian patent no. 702106 entitled: "Use of Carbazole Compounds for the Treatment of Congestive Heart Failure". The patent is owned by Roche. The case is effectively two proceedings. Since the isues are similar in both, the parties agreed that the issues could be dealt with together. In the first proceedings, Hexal claimed that the patent is invalid. Roche filed a cross claim alleging that Hexal intended to apply for a listing of a product known as Carvehexal on the Australian pharmaceutical benefits scheme ("PBS"). Roche alleged that would constitute an infringement of the patent. This particular matter arose when Roche filed a notice of motion seeking interlocutory relief to restrain Hexal from making the application to list the product in the PBS. In the second proceedings, Roche claimed that Alphapharm intended to apply for the listing of a product known as Dilol on the PBS. Roche also sought interlocutory relief against Alphapharm.
The patent contains both manufacture and method claims. The manufacture claims include independent claim 1 which reads:
"The use of carvedilol for the manufacture of a medicament for decreasing mortality resulting from congestive heart failure in mammals, alone or in conjunction with one or more other therapeutic agents, said agents selected from the group consisting of an angiotensin converting enzyme inhibitor, a diuretic and a cardiac glycoside."
The method claims include independent claim 14 which reads:
"A method for decreasing mortality resulting from congestive heart failure in mammals comprising the administration of carvedilol, alone or in conjunction with one or more other therapeutic agents, said agents selected from the group consisting of an angiotensin converting enzyme inhibitor, a diuretic and a cardiac glycoside, to a subject in need thereof."
Carvedilol is a beta-blocker compound.
Interlocutory relief appears to have been sought by Roche because of a 1 September 2005 deadline for lodgment of applications for listing on the PBS. Roche operated under the assumption that Hexal and Alphapharm were intending to apply on that date.
The grounds for interlocutory relief are well established. Roche needed to demonstrate:
1. There is a serious question to be tried or a prima facie case such that there is a probability that at a final hearing Roche would be entitled to relief.
2. That Roche would suffer irreparable harm for which damages will not be adequate unless an injunction is granted.
3. That the balance of convenience favours the granting of an injunction.
Stone J. mentioned that while each of the elements does need to be satisfied, the strength, or otherwise, of Roche's case for infringement can effect the balance of convenience. Her honour also pointed out that the onus is on the party asserting invalidity to show that the assertion is a triable issue. However, an interlocutory application is not an appropriate forum to carry out an effective preliminary trial.
In its application, Roche submitted that if Hexal or Alphapharm manufactured their respective products in Australia, there would be an infringement of claim 1. However, there was no probative evidence of any intended manufacture in Australia by Hexal. Her honour thus held that there was no serious question to be tried in relation to manufacture by Hexal. Counsel for Roche attempted to base an assertion that Alphapharm would manufacture on the basis of Alphapharm's manufacturing licence in Australia. However, her honour was not convinced.
Roche's primary assertion of infringement was that of claim 14. Counsel for Roche relied on section 117 of the Patents Act. This section deals with infringement by supply. In short, if the use of a product would infringe a patent, the supply of the product is an infringement, subject to a number of provisos. One of the provisos is that if the product is not a "staple commercial product" any use of the product would be an infringement if the supplier had reason to believe that the person would put it to such use. It appeared that there was no judicial precedent to assist with the definition of "staple commercial product". In any event, her honour held that this was not the forum to decide questions of law such as that. However, she did hold that there was a serious issue to be tried in relation to infringement, subject to her opinion on the validity of the patent.
Hexal and Alphapharm contended that the patent was invalid. In support of this, they relied on an article by one David T Kelly. The article concluded that "Carvedilol may have beneficial effects in patients with chronic heart failure secondary to coronary heart disease". Hexal and Alphapharm did not provide evidence that was sufficient to show that the Kelly article was available before the priority date of the patent. In any event, her honour considered the evidence of one Dr Keogh which diminished the importance of the Kelly article. Dr Keogh testified that she would not have been led to use Carvedilol in the treatment of congestive heart failure even if she had been aware of the Kelly article before the priority date. The prevailing view at that time was that beta blockers were contraindicated for congestive heart failure. Thus, her honour held that she could not conclude that a skilled person would be directed by the Kelly article, as a matter of course, to try the claimed invention in the expectation that it would produce a useful or desired result. In support of this, she referred to The Welcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262. However, she did hold that there was a serious question to be tried in relation to novelty and obviousness.
Roche failed to show that it would suffer irreparable harm unless an injunction were granted. Her honour held that if Hexal and Alphapharm failed to have the patent revoked and were found to have infringed the patent, any dilution of the investment made by Roche would be essentially negligible as Roche would regain the monopoly on the market.
In refusing interlocutory relief, her honour held that the case involved serious questions to be tried both in respect of infringement and in respect of invalidity, but that the concerns about invalidity had more weight. She took into account the comparatively long delay to Hexal's and Alphapharm's plans, the fact that loss caused by interference with those plans was difficult to assess and the fact that any loss to Roche would be easy to quantify.
Bazpat will keep an eye out for the main decision.
01 September 2005
In this matter, Neurizon applied to make an amendment to the claims in the light of anticipatory material presented by Jupiters. For the purposes of this post, it is only necessary to point out that there should not be undue delay in seeking an amendment. Thus, once a patentee or applicant is aware of a claim that is overly broad, he or she should seek to amend the claim within a reasonable time. The purpose of this requirement is to ensure that the public is not prejudiced by an excessively broad patent on the register. In this case, her honour held that Neurizon only became aware of the need to make the amendment after the Full Federal Court decision. In fact, it was found that Neurizon had earlier canvassed the possibility of amending with its patent attorney, who advised that the amendment was unnecessary. Her honour allowed the amendment.
The inventive step requirement of our Patents Act is governed by Section 7(2) which states that: "For the purposes of this Act, an invention is taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, ... ".
Her honour briefly referred to Aktiebolaget Hassle v Alphapharm P/Limited (2002) 212 CLR 411 (Aktibolaget), which warns against the use of hindsight when making a determination of inventive step. In the Full Federal Court it had been found that a system used by Jupiters anticipated the invention claimed by Neurizon. However, Jupiters had been unable to show that there had been an enabling public disclosure of the anticipation. Her honour thus held that the Jupiters system did not form part of the common general knowledge and therefore could not found an attack based on lack of inventive step. In particular, her honour held that the witnesses relied upon by Jupiters were not able to give evidence about the process by which the Jupiters system was derived, the paths taken and the problems solved. In other words there was insufficient evidence about the origin of the Jupiters system to make it relevant.
Her honour held that witnesses presented by Jupiters not only lacked the necessary skill to qualify, but also developed their evidence using hindsight. Furthermore, where Jupiters did present a witness who could have qualified as a person skilled in the art, that witness relied on material which was held not to form part of the common general knowledge.
This case emphasizes the difficulty of "getting up" on a lack of inventive step argument. Not only is the relevant party confronted with the difficulty of framing witness questions to avoid hindsight, but also has to be very careful when selecting material to form part of the common general knowledge.
22 August 2005
The matter arose out of an opposition by Monsanto to the grant of a patent to Novartis on Australian patent application no. 720095. The matter is interesting in that it sets out an example of an insufficient description of a preferred embodiment of an invention. Section 40 (2)(a) of the Australian Patents Act 1990 sets out that a complete specification must describe the invention fully, including the best method known to the applicant of performing the invention. The matter also canvassed the issues of novelty and inventive step.
The relevant claims are extensive and Bazpat will not repeat them here. In short, claim 1 is directed to a process for the control of weeds, where the process is characterised in that a "synergistic amount" of at least one herbicide is added to "a phospho-herbicide selected from the group comprising glufosinate and glyphosate". A further independent claim 14 is directed to a composition of "...glufosinate and a synergistic amount of at least one further herbicide selected from...". Yet a further independent claim 15 is directed to a composition of "...glyphosate and a synergistic amount of at least one further herbicide selected from ...".
The Delegate interpreted the claims as having "a synergistic amount" of the co-herbicide as an essential feature. The Delegate held that: "Synergy is established by comparing the effect of each of the components individually with the effect of the mixture of components. If the effect of the mixture is greater than the sum of the individual components, then there is synergy."
The Delegate pointed out that the specification indicated that the proportion of the active ingredients is preferably in the range of 1:100 to 1:0.001. There was no suggestion in the specification whether any ratio in that large range was more likely to be synergistic. No examples of a synergistic amount were given. In the words of the Delegate: "A person seeking to work the invention is confronted with the need to undertake a potentially huge amount of experimentation in order to find a suitable composition".
The specification was held to leave the reader without guidance of where success is likely, or even where success is possible. Thus, the Delegate held that the specification clearly failed to disclose a manner of carrying out the invention, and consequently did not fully describe the invention.
14 August 2005
"An asset protection method for protecting an asset owned by an owner, the method comprising the steps of:
(a) establishing a trust having a trustee,
(b) the owner making a gift of a sum of money to the trust,
(c) the trustee making a loan of said sum of money from the trust to the owner, and
(d) the trustee securing the loan by taking a charge for said sum of money over the asset."
The matter was an appeal from a decision of the delegate of the Commissioner of Patents. The Applicant argued that the invention was patentable because it concerned a method of creating an artificial state of affairs and had economic utillity in practical affairs. The argument was based on the well-known National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) case. The Applicant quoted that judgement as setting out:
'... the method the subject of the relevant claims has as its end result an artificial effect falling squarely within the true concept of what must be produced by a process if it is to be held patentable ... It is a "product" because it consists in an artificially created state of affairs, discernible by observing over a period the growth of weeds and crops respectively on sown land on which the method has been put into practice. And the significance of the product is economic; for it provides a remarkable advantage ... for one of the most elemental activities by which man has served his material needs, the cultivation of the soil for the production of its fruits.'
However, the Delegate noted that the concept of manner of manufacture has consistently involved either the discovery of laws of nature or the application of a technology based on the laws of nature. He set out that the invention was " a discovery in relation to the laws of Australia, useful in the affairs of the populace." As such, the Delegate concluded that the invention did not result in an "artificially created state of affairs " in the sense discussed in NRDC.
Branson J. supported the delegate's conclusion, but varied in her reasoning. She cited the NRDC case: "any attempt to state the ambit of s6 of the Statute of Monopolies by precisely defining "manufacture" is bound to fail ". She held that it would be wrong to see NRDC itself as defining a manner of manufacture as resulting in an artificially created state of affairs of economic significance.
As part of her reasoning Branson J. went back to the Statute of Monopolies upon which our interpretation of patentable subject matter is founded. In that statement any manner of new manufacture should not be " contrary to the law nor mischievous to the state, by raising prices of commodities at home, or hurt of trade, or generally inconvenient." Thus, this was intended to allow the grant of monopolies for a limited time where the public benefit might be expected to outweigh the public cost of the resultant interference with free trade. Branson J. reiterated the principle that applying the Statute of Monopolies involves more than just identifying classes of invention which have in the past been found to constitute a manner of manufacture. Our courts have repeatedly held that advances in science and the development of new technologies render this approach unsound.
Her honour applied the principle derived from the Statute of Monopolies that an invention should only enjoy the protection of a patent if the social cost of the resulting restrictions upon the use of the invention is counterbalanced by resulting social benefits. She cited NRDC in which it was set out that the invention " must be one that offers some advantage which is material, in the sense that the process belongs to a useful art as distinct from a fine art -- that its value to the country is in the field of economic endeavour." Her honour held that the value of the invention was only to those whose assets are ultimately protected - and possibly to their professional advisers. She held that the performance of the invention will not add to the economic wealth of Australia or otherwise benefit Australian society as a whole. For that reason, in her view, the invention was not proper subject matter for a patent. Her honour went on further to state that the claimed invention is a method by which the owner may be insulated from the operation of laws intended to serve the public interest. She held that a court of law must assume that the performance of the invention will not advance the public interest but merely advance private interests. Finally, her honour held that the social cost of conferring on the invention the protection of a patent would not be counterbalanced by any resultant benefit to the public.
03 August 2005
On 25 July 2005, Lindgren J. handed down Emperor Sports Pty Ltd v Commissioner of Patents  FCA 996. This is the first time that the Australian Federal Court has been required to consider section 97(2) of the Patents Act 1990, which provides for post-grant re-examination of a patent.
By way of background, the relevant section provides that the Commissioner must re-examine a complete specification if asked to do so by the patentee or any other person.The regulations provide that the request must identify the documents on which an assertion of lack of novelty or inventive step (obviousness) is made. The request must state the relevance of the documents. The Act directs the Commissioner to ascertain and report whether, to the best of his or her knowledge, the invention is not novel and does not involve an inventive step. If the Commissioner makes an adverse report the patentee may dispute the whole or any part of the report, whether or not steps are taken to amend the specification. If the Commissioner has given the patentee a reasonable opportunity to be heard and given the patentee a reasonable opportunity to amend the the specification and the patentee fails to do so, the Commissioner must revoke the patent.
In brief, the relevant claim covered: "A device for use in sport, including one or more indicia, the, or each, indicium being adapted for removable attachment to a user's garment, such that in use and when attached to a user's garment, the removal of the, each, or one or more of further indicia indicates a predetermined result." In making the request for re-examination, the Australian Football League (AFL) identified eight US patents together with a statutory declaration. During the proceedings, Emperor attempted to amend the claim as follows: "A device for use in sport when used in the game of Rugby League or Australian Rules football, the device including one or more indicia...further indicia takes the place of a tackle in the game."
The Commissioner's Decision
The delegate of the Commissioner decided that the amendment was not allowable and that the patent should be revoked. The procedure followed by the delegate was flawed in that the issue of the amendment should have been settled first before the decision to revoke. However, the parties agreed that no injustice had occurred and Lindgren J. thus dealt with both the application for amendment and the decision to revoke together.
The Court's Decision
In connection with the amendment, the wording of the Act is important and, in particular, section 102(1) provides that an amendment of a complete specification is not allowable "if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed". The court held that the amendment was allowable. In coming to this conclusion Lindgren J. raised an interesting point concerning interpretation.
One of the reasons provided by the delegate for refusing the amendment was that by amending "a device for use in sport..." to "a device when used in...", the claim was being amended from a device claim to a method claim and there was no disclosure in the specification of a "method of playing Australian Rules football". Lindgren J. held that the delegate was putting too fine a point on it and held: "I regard all of the original claims as, in substance, method or process or means claims, rather than pure device claims."
The revocation decision was considered by Lindgren J. with the claims in the notionally amended form.
In having to decide the issue of inventive step, the delegate and the Court had to make a decision as to whether information in cited documents (a) formed part of the common general knowledge of a coach, referee or administrator; or (b) is information which such a person could be reasonably expected to have ascertained, understood and regarded as relevant. Lindgren J. held that it is not possible to make such a decision in the absence of evidence. In the absence of evidence " resolution of these issues is a matter of mere speculation." His honour based this contention on well known judicial precedents, such as Minnesota Mining and Manufacturing Co. v Beiersdorf (Australia) Ltd (1980) 144 CLR 253. While that may be, the problem is that post grant re-examination proceedings are ex parte. In other words, the Commissioner cannot hear evidence from coaches, referees or administrators.
His honour thus concluded that "the Commissioner was not at liberty to decide whether a hypothetical person skilled in the art would have ascertained the existence of the Cited Documents. In the absence of evidence, the Commissioner was relegated to speculation. The Commissioner did not give effect to the opening words of s 7(2) of the Act... ".
The decision has serious ramifications for pre-grant examination, which is also ex-parte. In fact, immediately preceding the above passage, his honour stated that he saw no reason why the approach taken in pre-grant examination should not be taken in relation to post-grant re-examination. As any practitioner knows, the Commissioner regularly makes decisions regarding inventive step.
Lindgren J. went on to state that he appreciates that his conclusion may signify that post-grant re-examination may not readily lead to revocation on the ground of lack of inventive step. His honour then made some surprising statements, to say the least:
a) "The procedure has a greater role to play in relation to novelty."
b) "It always remains open to a third party requesting re-examination to bring a revocation proceeding."
c) "The re-examination procedure may have the beneficial effect of leading to amendments."
It is not clear to Bazpat how his honour comes to the conclusion in (a). The statement (b) undermines the purpose of the post grant re-examination procedure. The statement (c) is in Bazpat's view a specious argument.
It will be interesting to see what, if any, fall out there is from this decision. Bazpat will be keeping an eye out.
19 July 2005
In this case, the court held that the primary source of reference for the meaning of words in a claim should be the specification rather than extrinsic references, such as dictionaries. The basis lies in the US statutory requirement that the inventor provide a "full" and "exact" description of the claimed invention. In spite of this, however, it is important to bear in mind that the court held that each patent still had to be treated individually. In other words, there may be cases where such a rule may not be appropriate. An interpretation must always be carried out in the shoes of a person of ordinary skill in the field of the patent. Such a person may find that the wording of the patent precludes limitation of the claims by a specification.
In Australia, Section 40 of our Act holds, inter alia, that a complete specification must describe the invention fully, including the best method known to the applicant of performing the invention. Proper claim interpretation requires that the description and the claims be read as a whole. This allows the description to set up a dictionary for the claims. However, our courts have held that the description must be read as a technical document, while the claims must be read as a legal document. Furthermore, if the claims are clear and unambiguous, the description should not be used to read meanings into the words of the claims. Only if the words are not readily understandable should reference be made to the description.
Given that many Australian-prepared patent specifications form the basis of US patent applications, practitioners should remain aware of developments such as these in the US.
18 July 2005
Many in the Australian ICT industry do not place sufficient value on software patents. This is both short-sighted and dangerous. It is important to understand that according to our law, software patents are fully recognised and enforceable. Furthermore, for the purposes of litigation, patents are presumed valid and the onus is on a defendant to prove that the patent is invalid. Those practitioners who have experience with software patents will agree that such an onus could be extremely difficult and expensive to discharge.
Most Australian investors are beginning to rely on patents for some degree of comfort. However, apart from the obvious reasons associated with the ability to protect their investment, there are other, perhaps even more significant reasons. These relate to identification of the intellectual property.
An effective agreement must define the intellectual property. Without a patent application, a software product can usually only be defined as a set of instructions stored on computer readable media. It follows that there is no inherent breadth in the definition. This can limit the effectiveness of an agreement. In other words, it may be impossible to expand the reach of a license agreement beyond a reference to a particular set of instructions. On the other hand, if a software product is defined in a patent application, then the license agreement can refer to the patent application and automatically cover a broad definition of the software product.
Software producers in Australia need to stake their claim. Software is an ever-developing field. However, Bazpat is certain that there will come a time when our industry will start clashing with organisations such as Microsoft. Without a patch of patent land, the results of such a clash could be catastrophic.