Patents

Pharmaceutical patents

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The European Commission has published its preliminary report into its inquiry into the state of competition in the pharmaceutical industry in the EU – comment and links via IPKat.

The IPKat also has links to what they describe as “the powerful speech” delivered by Sir Robin Jacob (aka Jacob LJ) in the Commission’s public meeting on the issue.

Meanwhile, the developing countries are developing a proposal which envisages greater involvement of WHO; see here, while there are also reports of the Director General of the WTO appearing to acknowledge some significance to the issue.

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Patent appeals from the Commissioner

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Merck & Co. had successfully opposed Sherman’s application for a patent.  Sherman appealed to the Federal Court from that rejection.  Merck subsequently withdrew from the proceeding in the Court and the Commissioner was added as a party.  The Commissioner filed an affidavit exhibiting a copy of the delegate’s decision upholding the opposition and the declarations which Merck had relied on in the opposition.

The trial judge ruled these materials were inadmissible.  The Full Court (Heerey, Kenny and Middleton JJ) upheld the Commissioner’s appeal against this exclusion of material. 

When an appeal is brought in the Federal Court from the Commissioner (or the Registrar of Designs or of Trade Marks), FCR O 58 r8 provides that evidence before the Commissioner may, with leave of the Court and saving all just exceptions, be admissible in the Court.

Unlike the usual situation in “appeals” of this kind where the parties to the opposition may be relying on the statutory declarations they had filed in the Office, Merck had withdrawn and so the statutory declarations of its witnesses were hearsay – presumably, the Commissioner did not intend, or was unable, to call them.

The Full Court confirmed that the rules of evidence still apply to the evidence sought to be “uplifted” so that, if there are objections such as that the evidence is hearsay, evidence which was before the Commissioner may be excluded before the Court.  However, the Full Court went on to find that both the decision and the declarations were admissible.

The delegate’s decision itself was relevant on two bases (at [37]):

First, the fact that it was made was a fact on which the jurisdiction of the Court depended.

Secondly (and more substantively), the Commissioner’s decision and the reasons for it were admissible before the Court as a form of expert evidence because (unlike the Court) the Commissioner (and the various Registrars) is credited with having some technical expertise which the Court is entitled to take into account.

As the decision itself was relevant and admissible, the Full Court went on to hold that so too were the materials on which it was based.

The weight actually to be accorded to the Commissioner’s decision ultimately would depend on what other evidence was adduced before the Court.

Depending on the extent to which the evidence before the Commissioner and the Court overlaps, the decision-maker’s opinion on these matters carries some weight in the Court’s assessment. Viewed in this way, the decision of the delegate is plainly not inadmissible on the ground that it is irrelevant. 

The Full Court noted that, because the declaratory evidence was admissible on the grounds that it was relevant to an understanding of the Commissioner’s decision, it was admissible for all purposes.  Further, however, the Full Court agreed with Lindgren J’s analysis in Alphapharm v Lundbeck (at [762 – 770]) of why articles cited by an expert were admissible even though hearsay.  

The Court did not address Heerey J’s earlier decision in Cadbury v Darrell Lea (No. 3) in which market survey reports were excluded as ‘double’ hearsay.  It would seem that the difference is that in Sherman and Lundbeck the materials were adopted or referred to by the expert as the basis for the expert opinion.

Commissioner of Patents v Sherman [2008] FCAFC 182.

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Gene Patenting Inquiry

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The Commonwealth Senate has launched an inquiry into the patenting of genes.

According to the terms of reference:

The impact of the granting of patents in Australia over human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in an isolated form, with particular reference to:

(a)     the impact which the granting of patent monopolies over such materials has had, is having, and may have had on:

(i)     the provision and costs of healthcare,

(ii)    the provision of training and accreditation for healthcare professionals,

(iii)   the progress in medical research, and

(iv)   the health and wellbeing of the Australian people;

(b)     identifying measures that would ameliorate any adverse impacts arising from the granting of patents over such materials, including whether the Patents Act 1990 should be amended, in light of the any matters identified by the inquiry; and

(c)     whether the Patents Act 1990 should be amended so as to expressly prohibit the grant of patent monopolies over such materials.

The terms of reference do not say so but, presumably, the inquiry has been triggered by the recent controversy when Genetic Technologies announced it was going to commence enforcing its exclusive licence to patents relating to breast cancer detection.  It would seem, however, that the company rescinded its threat.

The Senate Community Affairs committee is due to report by the last sitting day of 2009.  Written submissions have been sought, however, by 19 March 2009.

Anyone else looking forward to learned consideration of TRIPS art. 27, 30 and 31 after all that hard work that’s been done by the ALRC.  See now ACIP’s review of patentable subject matter (pdf) which includes some notes on the AUSFTA obligations.  Then, of course, there is always Patents Act s 163.

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Business method patenting?

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The US Federal Circuit (9 panel bench) has handed down its decision ruling that Bilski’s method of hedging risks in commodities trading was not patentable.

As summarised by Patently-O, the majority opinion substantially retreats from State Street.

a process claim [must be] tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.

Judge Newman would have found the invention patentable; Judge Rader would have rejected the patent, without the need to develop a new principle, on the grounds that all that was claimed was an abstract principle.

Read Patently-O’s summary, which also has a link to the decision itself.  Compare our Full Federal Court in Grant.

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Patenting software in the UK (Europe)

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The UK Court of Appeal has apparently broadened the scope to patent computer software:

Symbian Limited v. Comptroller General of Patents [2008] EWCA Civ 1066

Paul Cole guest posts at Patently-O. IPKat extensively here.

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Contributory patent infringement

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The High Court has allowed the Northern Territory’s appeal against the finding that it infringed the Collinses’ patent under section 117 of the Patents Act 1990 (Cth) by granting a statutory licence to ACOG to harvest certain trees from Crown land.  It was alleged ACOG then used oil extracted from the trees to make blue cypress oil by a process protected by the Collinses’ patent.

From a quick skim of the judgments (there are several), it appears that the Northern Territory escaped liability because the trees were a staple commercial product and so it was necessary to show that the Northern Territory had given instructions or inducements to use the product by means of the patented process (not merely ‘facilitated’ it).

It also looks like the High Court rejected the Northern Territory’s argument that Rescare set out the correct interpretation of s 117; not Bristol-Myers Squibb v Faulding.

Northern Territory v Collins [2008] HCA 49.

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Troubles with the grace period

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The Patents Act was amended (in relatively controversial circumstances) to include a 12 month grace period (somewhat a la the USA) so that use or publication of the invention in the 12 months before the complete specification was filed could not be relied on to destroy validity: see s 24(1)(a) and reg.s 2.2(1A) and 2.3.

Assume that a complete application for a standard patent was filed on 13 May 2005.  Then a complete application for an innovation patent, as a divisional from the standard, was filed on 22 November 2006.

Assume further that the first publication of the invention the subject of both applications was in October 2004.

Which complete application does time run (backwards) from?

If the standard application, the innovation patent will be valid; if not, it will be invalid.  If time runs from the date of the complete application for the innovation patent, however, the divisional status of the innovation application will not have all the usually expected effects.

Stone J has found that the relevant application, on the basis of the specific wording of the legislative provisions, is the complete application for the innovation patent:

10 There does not appear to have been any previous judicial consideration of the present question. Both parties submit that, having regard to the context in which they appear, the ordinary and natural meaning of the provisions supports the construction for which they respectively contend. For reasons given below I have concluded that the construction for which the respondent contends is correct, namely, that where the specification filed in respect of a parent application discloses the invention claimed in a divisional application based on the parent, the “complete application” to which cl 2.2(1A) refers is the divisional application. Consequently I would answer the question for determination as follows:

For the purpose of determining the validity of the Australian Innovation Patent No 2006100978 (Innovation Patent), and on the facts stated in the orders made by Bennett J on 11 December 2007, “the filing date of the complete application” within the meaning of reg 2.2(1A) of the Patents Regulations 1991 (Cth) is the filing date of the complete application for the Innovation Patent on 22 November 2006.

28 I reject the applicant’s argument that the respondent’s construction creates an anomaly by providing the innovation patent with the benefits of divisional status whilst depriving it of the grace period benefits otherwise accruing to that status. As the respondent correctly submits, the consequence of its view is that the grace period simply runs from a later date, which may or may not extend past the priority date based on the filing of the parent application. This is said to reflect:

… a decision not to allow divisional applications to benefit more than they already do from the earlier priority date in circumstances where the divisional application is filed more than a year after the parent application.

Be very, very very careful if you have to rely on the grace period!

Mont Adventure Equipment Pty Limited v Phoenix Leisure Group Pty Limited [2008] FCA 1476.

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Patent application searching

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IP Australia and the US PTO have reached agreement to permit some international searching for US patent applications to be undertaken by IP Australia.

According to IP Australia:

The arrangement, which comes into effect on 1 November 2008, will allow applicants from the US to choose IP Australia to undertake the initial search and examination of their patent application under the Patent Cooperation Treaty (PCT). Applications that may not be covered under the arrangement are certain international applications relating to particular mechanical engineering or analogous fields of technology.

The arrangement starts on 1 November 2008.

A bit more detail here.  Nothing on USPTO site as yet.

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Manner of manufacture

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The hyper-driven David Brennan is also doing a free lunch time presentation at Allens Arthur Robs in Melbourne on 14 November.

Registration and more details here (pdf).

Attempt to patent the new (?) science of subronics here and check out Prof. Lemley’s take on the issue or bone up on the ACIP review via here.

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Innovation review

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I’m still wading my way through the Innovation Review.

Meanwhile Duncan Bucknell is highly critical, particularly of recommendation 7.2:

Recommendation 7.2: Patent law should be reviewed to ensure that the inventive steps required to qualify for patents are considerable, and that the resulting patents are well defined, so as to minimise litigation and maximise the scope for subsequent innovators.

As Duncan points out, what does this actually mean?  Well, Ben Roxborough at IPRoo thinks we should pay much more attention to this recommendation as it appears to be, or be very close to, what IP Australia thinks should happen.  Follow Ben’s link from here.

If that is right, then there must be a very good chance that, whatever it means, it is going to happen.

One certainly can’t quibble with the idea that patents should be certain and clear in scope.  Indeed, Besson & Meurer contend that one of the main reason why the patent system in the USA is not working properly is precisely because patents there are not clear and certain in scope. (Blog summaries here and here.)

Given Australia’s role as an IP importer, and bearing in mind we have the innovation patent too, one can’t really quibble with the idea that we shouldn’t be granting standard or “real” patents for things that wouldn’t get patented overseas – well, I suppose one can quibble, but I’m not at all sure what would be the justification for allowing patents in Australia which are not patentable elsewhere.  

(As an aside, I wonder how requiring more inventiveness, if it can be defined, fits in with having innovation patents – which are certainly real – but for rather more limited, limited terms.)

In the Alphapharm case (see esp. [80 -81], however, the majority of the High Court pointed out that there didn’t seem to be a “standard” international approach.  On the other hand, there is some evidence emerging that it may be easier to get patents in Australia than Europe and Japan but, possibly, not the USA.

If that is what the evidence does suggest, one might then have to go on to ask (amongst other things) how much of the difference is due to, say, EU-centric rules like no patents on computer programs as such?

Now, I have previously mentioned that Prof. Mark Lemley provides one of the clearest explanations I have come across on whay that is not a good idea (listen to podcast #62).  And that was in the context of considering patentable subject matter.

And guess what, that is the subject of another Australian governmental review.  So, it looks like change is coming.  Perhaps, you should get involved?

On recommendation 7.3:

Recommendation 7.3:  Professional practitioners and beneficiaries of the IP system should be closely involved in IP policy making.  However IP policy is economic policy. It should make the same transition as competition policy did in the 1980s and 90s to being managed as such.

I can’t do better than quote the new DG:

In this regard, it is useful to remember that intellectual property is not an end in itself. It is an instrumentality for achieving certain public policies, most notably, through patents, designs and copyright, the stimulation and diffusion of innovation and creativity on which we have become so dependent, and, through trademarks, geographical indications and unfair competition law, the establishment of order in the market and the countering of those enemies of markets and consumers: uncertainty, confusion and fraud. In the end, our debates and discussions are about how intellectual property can best serve those underlying policies: whether modifying the international framework will enhance or constrain innovation and creativity and contribute to their diffusion, and whether it will add confusion, rather than clarity, to the functioning of the market.

Unfortunately, that doesn’t tells us in any particular case whether more protection or better exceptions are required.  It does, however, remind us what the rules are trying to balance.

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