22 September 2005

Latching Device Lacks Novely

On 8 September 2005, the Delegate of the Commissioner of Patents handed down William King v KMJ Corporation Pty Ltd [2005] APO 37.

Background

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 Invention

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.

Drawings

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.

Conclusion

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

Balance of Convenience Tips Against Roche

On 31 August 2005, the Federal Court of Australia handed down Hexal Australia Pty Ltd v Roche Therapeutics [2005] FCA 1218.

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

Jupiters Misses the Jackpot (Again)

In my post of 16 June 2005, I discussed the matter of Jupiters Ltd v Neurizon Pty Ltd [2005] FCAFC 90 . That matter was referred back to the Federal Court in Neurizon Pty Ltd v Jupiters Limited [2005] FCA 1177 for the determination of lack of inventive step asserted by Jupiters Ltd. Her honour, Kiefel J, handed down the decision on 25 August 2005, holding that Jupiters could not show lack of inventive step.

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.