Enforcing Second Medical Use Claims

The concept of second medical use claims in patents has always struck me as a bit odd, although this is probably partly due to the fact that I do not have a technical background in chemistry and try to avoid such patents at all costs. Those with a chemistry background probably find the concept of computer program claims equally odd. I know enough, however, to see that enforcing second medical use patents will tend to be a bit tricky, especially with the public policy argument about not preventing medical practitioners from doing what they want to do. This public policy is in place quite explicitly in the case of methods of medical treatment, where there are specific exceptions to patentability under Article 53(c) EPC. The same provision, however, also states that this does not apply to products, in particular substances or compositions, for use in any of these methods.

What this means in practice is that a patent can be validly obtained for a new use of a known pharmaceutical substance, provided this new use is not obvious. This is clearly beneficial for pharmaceutical companies, where new developments often occur through unexpected side effects (the unexpected effect of sildenafil citrate during trials for treatment of angina being perhaps the best known example). Enforcing such patents, however, can be more difficult, especially if the substance is already in use and prescribed for an existing condition. Although it might be possible to bring proceedings against another company under section 60(2) of the UK Patents Act for selling or offering to sell a product clearly indicated as being for the new patented use, is it also possible to go after doctors who prescribe an existing generic drug for the new patented use? 

This is apparently what Pfizer are trying to do. In a letter addressed to Clinical Commissioning Groups in the UK (released by Boing Boing here, and further commented on here in the WSJ), Pfizer indicate that their patent EP0934061 on the use of pregabalin for treatment of pain "may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act". This has, predictably, resulted in expressions of outrage from Cory Doctorow and Ben Goldacre, the former being very much against patents and the latter is very much against big pharma in general. 

Claim 1 of the patent, as recently limited, reads:

Use of (S)-3-(aminomethyl)-5-methylhexanoic acid or a pharmaceutically acceptable salt therof for the preparation of a pharmaceutical composition for treating pain. 

The scope of this claim would appear to be sufficient to cover at least manufacturers and suppliers of pregabalin, provided there was a clear indication of using the substance for the treatment of pain. Including instructions to this effect together with the product would presumably be enough. The patent could not, however, cover the sale of pregabalin where there was no indication that it could be used for treating pain.

The question I have arising from this is what legal ground Pfizer has to pursue CCGs for infringement. They could presumably not pursue individual doctors or pharmacists for infringement, since section 60(5)(c) states that "An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if [..] it consists of the extemporaneous preparation in a pharmacy of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner or consists of dealing with a medicine so prepared", but are CCGs any different? It looks to me as though they may be on fairly shaky ground, and making veiled threats to CCGs is perhaps not a great idea. I am, however, not an expert in this area. Any comments would be welcome.

UPDATE 22/1/15: Thanks to a comment from IPKat Darren, a decision from the Patents Court relating to this matter has been brought to my attention. Darren has now commented on this here.

Partial Priority Again - Enlarged Board Referral

I have written a few times in the past about the issue of partial priority under Article 88 EPC, and in particular how it relates to the issue of so-called 'poisonous' divisionals and priority (see here, here, here, here and here; there is also an interesting discussion of the issues on the IPKat here and here).

As I mentioned in my July 2013 post on the Nestec case at the EPO, in my view the only way to resolve the poisonous priority issue would be for a referral to be made to the EPO Enlarged Board. In the Nestec case, the issue unfortunately did not get to the stage of discussing partial priority because the patent was revoked on other grounds. It was, however, inevitable that the same issue would arise in another case, and the clear inconsistency between the Board of Appeal decisions in T 1222/11 and T 1877/08 (among others) about how to interpret G 2/98 would have to be resolved somehow. That case has now appeared.

In appeal proceedings for T 557/13 (Infineum), relating to EP0921183 (see the EP register here), the Board of Appeal have recently decided to refer one or more questions to the Enlarged Board of Appeal. As yet, the only indication of this is the minutes of the oral proceedings that were held on 17 December 2014, and no questions have yet been decided on, although there are some suggestions. The questions will, however, most certainly be about the extent to which partial priority can be claimed and what effect this has on priority applications becoming prior art under Article 54(3) EPC.

The appeal relates to a decision by the opposition division to revoke Infineum's patent (which resulted from a divisional application) based on the claims not being fully entitled to their priority and, as a result, the published parent application becoming Article 54(3) prior art. The opposition division cited G 2/98, and referred to the apparent requirement for the elements of a claim having to be "separable alternative embodiments" (see point 3.1.2 of the ground of the decision; my emphasis). Since this was not the case with claim 1 as granted, the OD decided that the claim was not entitled to priority for its entire scope and was only entitled to the application's filing date. T 1877/08 was cited in support, but the contrary decision in T 1222/11 was not published until the following year. During appeal proceedings, the proprietor made extensive arguments (see here for the grounds of appeal) about the poisonous priority issue, and why it should not happen, but did not refer to T 1222/11 until later on. They did, however, cite one of my posts (this one), which "discusses the issues at the heart of the case and highlighted some of the differing views prevalent among practitioners" (page 6 of the ground of appeal), and which apparently provided them with suggestions for a few helpful arguments.

T 1222/11 was first raised in the proprietor's further submissions in May 2014, together with some further articles on the issue. The Board of Appeal then issued a summons and, in their preliminary opinion, stated that "the issue of novelty apparently may hinge on the question of whether or not [...] the patent in suit can validly claim a right of priority as regards the use of the product of Example 1 as cold flow improver, considering in particular that said use is merely embraced by the more generic definition of the invention according to Claim 1 at issue, rather than being clearly defined as a distinct alternative of the invention defined in Claim 1" (point 4.2.2 of the provisional opinion dated 26 November 2014). The issue in question is therefore clearly one that would be decided differently, depending on whether the approach according to T 1222/11 or T 1877/08 is taken.

The proprietor has already suggested some questions that could form the basis for a referral:

Where a claim of a European patent or patent application encompasses more specific subject matter disclosed in an earlier application from which priority is claimed, for example because the claim in question contains generic term(s) or generic formula(e) encompassing both the subject matter disclosed in the priority application and alternative(s) thereto:

1. Is the expression "provided that it gives rise to the claiming of a limited number of clearly defined alternative subject matters" from Point 6.7 of Enlarged Board opinion G2/98 to be applied as the legal test for entitlement to partial priority under Article 88(2) and (3) EPC? 

2. If the answer to 1 is 'yes', how is the test from Point 6.7 to be applied in this situation, and in particular, how is a claim containing generic term(s) or generic formula(e) to be interpreted as relating to a limited number of clearly-defined alternative subject matters?

3. If the answer to 1 is 'no', what is the legal test for partial priority of a claim containing generic term(s) or generic formula(e), and how is it to be applied to such a claim?

In the situation defined above, where:

(i) the European patent was, or the European patent application is, a divisional application ("Divisional") and the claim in question fails the legal test for partial priority as clarified above;

(ii) the parent European patent or patent application ("Parent") claims the same priority and, as published, discloses specific subject matter also disclosed in the priority application and encompassed by the claim of the Divisional; and

(iii) the Parent and Divisional designate the same EPC contracting states:

4. Does Article 76(1) EPC nevertheless prevent different effective dates being attributed to the claim of the Divisional and the priority-entitled specific subject matter in the Parent?

5. If the answer to 4 is 'no', is the term 'European patent applications' in Article 54(3) EPC to be interpreted as extending to the Parent application, thereby rendering the Divisional lacking in novelty over its Parent ?

Answering these questions would resolve the issue, but we may have a little while to wait before we get the answer.

Surrender

Surrendering a patent, which is possible under section 29 of the UK Patents Act 1977, is an unusual option to take, although it does happen fairly regularly. In the year to date, according to the UK IPO online patents journal, 20 applications have been made to surrender patents. Over the past eight years (the period the journal has been available in electronic form), section 29 has been used 178 times.

The motivations for a patent proprietor to want to surrender their patent are never clear from the outside, and do not need to be stated in an application. There would, however need to be a good reason for a patentee to apply to surrender their patent rather than taking the easier option of simply allowing the patent to lapse by not paying a renewal fee. That reason would in most cases, I suspect, have something to do with either a licence or settlement relating to the patent. If, for example, a patent is being licensed and royalty payments are being made while the patent remains in force, having the patent revoked by a third party could put at risk all of the payments made to date, since revocation has the effect of deeming the patent never to have existed. This would inevitably cause problems for the patentee. A solution would be to surrender the patent, because this would not have a retrospective effect and could merely cause a licence to be terminated rather than put in question everything that has been paid to date.

Any application to surrender a patent must indicate, according to rule 42, whether there is any action pending before the court for infringement or revocation of the patent, and including any particulars. If there is a revocation action pending, this would be a good reason for the IPO not to allow the patent to be surrendered because the patentee should not be able to avoid having their patent revoked by instead surrendering it. Two decisions from the UK IPO this year illustrate the point nicely, with one deciding against allowing the patentee to surrender their patent, at least for the time being, while the other decided in favour of allowing the patent to be surrendered.

In OR Specific Inc.'s patent (BL O/170/14, 16 April 2014), the proprietor gave notice of an offer to surrender their EP(UK) patent EP1237494B,  accompanying this with a statement indicating that an action for revocation was pending before the High Court. The offer was advertised and no notice of opposition was given within the four week period under rule 76(2)(b). The hearing officer considered that the comptroller had no power to decline to deal with an offer to surrender. In a previous decision, however, consideration of an offer to surrender had been stayed and the proprietor ordered to inform the court of the offer (Dyson’s Patent [2003] RPC 24). The hearing officer also referred to Connaught Laboratories [1999] FSR 284, in which Laddie J noted that an order for revocation had a different effect to an offer of surrender and indicated that it was open to the Court to order revocation or to allow the offer to surrender to be processed through the comptroller. In the hearing officer’s view it was appropriate to stay further consideration of the matter to await the outcome of the revocation proceedings. The proprietor was ordered to notify the Court of the offer to surrender and to notify the comptroller of the outcome of the court proceedings, after which the matter would be considered further.

In the later case of Genentech Inc.'s patent (BL O/360/14 11 August 2014), the proprietor also made an offer to surrender their EP(UK) patent (EP1187632B1), including particulars of a revocation action pending before the UK courts relating to the patent, along with two others that were not being surrendered. The patent had been the subject of opposition proceedings at the EPO and an appeal was underway regarding revocation of the patent by the opposition division (see the register here for details). The offer was advertised under rule 75 and no opposition was filed during the four week period under rule 76(2)(b). The office requested further information regarding any response that may have been received from the claimant for revocation regarding the offer. The applicant responded by referring to a judgment from the Patents Court following a pre-trial review of the revocation action, in which the judge referred to there being no reason to continue with the revocation action in relation to the patent that was being surrendered. Following the judgment, the claimant did not pursue the claim for revocation of the patent. The hearing officer considered that the issue to be decided was whether an offer to surrender the patent could be accepted or if the proceedings should be stayed pending resolution of the revocation proceedings. Unlike in the earlier case, surrender of the patent had already been discussed and acknowledged as part of the revocation proceedings and all parties were aware of the offer to surrender. On the basis of the information provided, the hearing officer considered that the patent could be surrendered since: i) the claimant and court were aware of the offer; ii) the offer remained unopposed; iii) the court expressed the view that it should continue; iv) accepting the offer would not adversely affect the revocation action, which now related to two other patents; and v) the claimant and court had proceeded on the assumption that the offer would be accepted and the revocation claim would not be pursued. The order to surrender was accepted.

From these two decisions it appears that offers to surrender a patent are only accepted at the IPO if it is clear that there are either no pending proceedings regarding the patent or, if there are, that the other parties are all happy to allow the patent to be surrendered. This all seems to make a lot of sense, and fits with the general idea that it should not be possible for the patentee to get away with surrendering if the patent should instead be revoked.

Sugru

The UK IPO have recently been promoting via Twitter a video commissioned by them about a company known as Sugru. The company (which is actually called FormFormForm Limited, but I will use the short form) has developed a kind of settable Blu-Tack that can be used for all kinds of fixing and mending jobs. I have bought some myself and can confirm that it does work as advertised and is pretty handy. Most of the little packets of Sugru I have are, however, I suspect destined to live in that drawer everyone has somewhere in the house for things that don't have another place to live.

In the video, the founder of the company Jane Delahanty and her business partner Roger Ashby discuss how and why they went about getting IP protection for their invention. They mention that they had "invested heavily" in intellectual property protection and that a top quality patent attorney was vital. They also mention that their trade mark was a very important part of their IP strategy. Roger points out that a weak patent would be not worth the money involved in getting it. This got me interested in finding out what exactly Sugru had managed to get patented via their top quality patent attorneys, who shall in this post remain nameless despite the rather shameless plugging they get in the video (paid for, of course, by the IPO). I will leave it to the reader to find out who they are.

Looking at the European patent register, there are three applications in the name of FormFormForm Limited: EP06743997 for a "Mouldable Material"; EP06744002 for a "Hand-Mouldable Material"; and EP07824749 for a "Room Temperature Curable Silicone Elastomer Composition". The first two claim priority from two GB applications filed in 2005 and the last one to a GB application filed in 2006. Espacenet shows that there are two distinct patent families here and here, which also cover applications in the US, China and Japan. So far, there are only two granted patents: EP2089465B1 and CN101616979B, granted in 2012 and 2013 respectively, both in the latter family of applications. The other two European applications have been deemed withdrawn, one due to non-payment of a renewal fee and the other due to no response being filed to a notification of allowance. The latter withdrawal seemed strange, so I took a quick look at the allowed claims, which define a two-part silicone elastomer composition. Presumably this is not what Sugru were interested in any more, as the product is a one-part elastomer, so the application was probably dropped for this reason. The first family of applications therefore looks pretty much dead.

The later European application has an interesting history. It was originally filed, as a PCT application, with the following rather brief (and very broad) claim 1:

1. A one part room temperature curable silicone elastomer composition where the uncured composition has a Williams plasticity from 80 mm to 900 mm.

The measure of plasticity seems to be an industry standard, particularly for measuring the plasticity of silicone materials. The test is quite simple, basically involving a measure of how much a pellet of material will plastically deform under a dead weight over a set period of time (using a simple machine like the one on the right, available here). A lower number indicates a greater degree of plasticity. The lower threshold of 80 mm in the claim indicates that the composition would be somewhat resilient rather than being completely plastic, as it does not flow completely away under a load. The upper bound simply indicates that there is some plasticity, as a zero plasticity material would bounce back to its original shape (giving a value of 1000 mm). So far, so good, although such a broad claim would immediately raise suspicions that it might not be novel, given there is a lot of prior art on silicone elastomers, which anyone familiar with the field would be aware of. One might therefore expect to see a lot of generalised fall back positions in the dependent claims and elsewhere. Surprisingly, however, there were only 9 dependent claims in the original application, four of which merely provided further narrowed ranges for the plasticity values.

Unsurprisingly, the EPO examiner found that the invention was not new, citing various prior art documents including this one from Dow Corning (a big player in silicones). In the written opinion of the international searching authority, the examiner found that claim 1 was not new over seven different documents. The applicant, via their attorneys, disagreed and argued that none of the documents in fact showed compositions having plasticity values in the claimed range. The examiner was not convinced by this and issued a summons to oral proceedings (a bit premature perhaps, but probably justified in this case). An interesting feature was that the examiner put the onus on the applicant to show "by appropriate comparison tests that the uncured composition characteristic differences do exist with respect to the Williams plasticity" (annex to the summons, 4 March 2011). The applicant's attorney argued against this, but made extensive amendments to the claims anyway and did not provide any comparison data. After arguing the case at the oral proceedings, with Ms Delahanty accompanying, the examining division finally agreed on the following claim:

1. A one part room temperature curable silicone elastomer composition where the uncured composition has a Williams Plasticity from 80 mm to 900 mm, and where the composition is a non-adhesive composition, the composition comprising:

20-60% by weight of a hydroxy-terminated poly(dimethylsiloxane) of viscosity greater than 350,000 mPa s (25°C) ;

3-66% by weight of a reinforcing filler;

10-60% by weight of a non-reinforcing filler;

2-6% by weight of a crosslinker;

and a suitable quantity of a curing catalyst.

I leave the reader to decide whether this is a claim that is worth spending a lot of money on, which Sugru must have done judging by the size of the EP prosecution history alone. I could certainly find a few fairly straightforward ways of looking at getting around the claim if I wanted to avoid infringing it.

The lessons to be learned from the Sugru case study, in my opinion, are not really those the IPO video would apparently like us to believe, i.e. that it is very important to get patent protection for your invention and worth spending lots of money on it. For Sugru, I think their most valuable IP is their brand, and not their patents. This might not have been obvious from the start, but has become clear over the years as their business has developed. After developing a formulation that works well, they have spend a lot of effort in marketing the product and have so far been very successful in doing it. Jane Delahanty's stated aim of Sugru being one of those things, like Blu-Tack, that everyone has in case they need something fixing, may be a plausible one and would certainly make them a lot of money if it came even partly true. Getting there does not, however, depend on having the patent that they managed to get.

The Mysterious Affair of Partial Priority and Poisonous Coffee

This post is an edited version of a presentation I gave to the CIPA Yorkshire meeting in Leeds on 14 March 2014. It is reproduced here for the benefit of those who didn't attend and to assist those who did and who want to find out more. It covers a subject that will be familiar to regular readers of this blog, but attempts to put it all together in a fairly coherent whole and, purely for entertainment value, with a silly comparison to a Poirot mystery.

Today I will be talking about partial priority and poisonous coffee. Since I am talking to patent attorneys, I suspect most of you will have a good idea of what this is going to be about. Some of you might already be inwardly groaning about yet another presentation on poisonous divisionals. I promise I won’t go into long boring detail about what the issue is, or why we should or shouldn’t be worried about it. Instead, I will be looking at what underpins the whole poisonous issue, which is partial priority under Article 88 EPC, and I’ll illustrate this with one particular example from last year. Along the way I hope to be able to show how both the High Court and successive Technical Boards of Appeal have got it completely wrong.

Two important landmarks happened last year, both of which were causes for sadness and celebration depending on how you look at it, or which side you were on. The first was David Suchet completing the entire set of Poirot mysteries for television, after playing the character for 24 years. In his final case, Curtain, Poirot returns to the setting of his very first case and, after solving the mystery, dies.

The second landmark was the end of Nestle’s monopoly on Nespresso coffee pods, which for some years has been making enormous amounts of money for Nestle. Unusually for a non-pharmaceutical case, Nestle's patents on what are quite straightforward mechanical inventions turned out to have quite high value. A lot of money has clearly been thrown at trying to use them against alleged infringers, and to defend the patents against attack. Despite their best efforts, they were not able to keep their patent protection nor were they able to win the argument on contributory infringement, and had an important European patent revoked first in the UK, and then finally at the EPO Board of Appeal.

Agatha Christie was keen on using poison as a way of killing off her victims, and used it around 30 times in her books in various ingenuous ways (see here for more). She had studied the subject in detail and was therefore very careful to make sure that the details of how the victim was poisoned were absolutely right in her books. She is once quoted as saying: “Give me a decent bottle of poison and I will construct the perfect crime”.

The very first novel Christie had published was The Mysterious Affair at Styles, first published in 1920. This introduced the Belgian detective Hercules Poirot, who became so popular that he was to feature in another 32 novels and short stories. The case involved the apparent poisoning of the victim, Emily Inglethorp, and the main mystery lay in how the poisoning was done. Once this was clear, it was straightforward to tell whodunnit.

Mrs Inglethorp was found at five in the morning convulsing in her bed, and died shortly afterwards. It turned out she had been poisoned with strychnine, which the police assumed had been in her coffee. The coffee cup was found broken on the floor by her bedside, but it was not just broken, it had been ground into the floor, probably by a shoe. She had taken her coffee to bed at around 8 o'clock the previous evening, after having a light meal. The effects of strychnine though are faster acting than this, and would usually take only about an hour to manifest. She had also taken to bed a bottle of tonic and her night-time cocoa in a flask. Although the tonic contained some strychnine, the concentration was so low that it would not have been enough to kill her. 

The question is then: was it the coffee that was poisoned, or was it something else? The answer to this question was key to how the mystery was solved. As we will see, the answer also turns out to be very similar to what happened in the Nestle coffee pods case, so if you know what happened there you should have a good idea of how the mystery was solved.

Now on to the coffee pods. Nestle have sold many millions of coffee pods. Last year nearly 200 million pods were sold in the UK alone, and Nestle accounted for a large fraction. Unfortunately for Nestle, any patents they had on the coffee pods themselves, which is the valuable item, expired a while ago. The earliest one was applied for in 1976, so is long gone. This US patent, showing the same basic construction of capsule, issued in 1979.

It would not have been much use to keep innovating the coffee pods and get new patent protection because any new designs would need to be backwards compatible with older machines, otherwise customers will get upset and stop buying them. So, what to do? Do Nestle simply accept defeat and allow others to start selling copycat coffee pods and chip away at their market. Of course not. Their main weapon is, of course, marketing, and on a big scale, but they certainly didn't give up on trying to keep some kind of patent protection and use it against their competitors.

The only way to keep some patent protection going was to keep innovating the machines rather than the pods. Here is an example of the latest version of Nestle’s ‘Essenza’ coffee machine. To make a coffee, all you need to do is pop a pod into the top of the machine and, after closing the lever, press the button to make the coffee. To eject the used pod and get the machine ready for the next one, you just lift the lever and the used pod automatically drops into a container underneath.

The way the coffee pods are inserted and removed was the subject of a patent application, EP09007962. In simple terms, what happens is that the capsule is inserted vertically into a space between a moveable part and a fixed part. The moveable part is then pushed forward by turning the lever arm, which presses the capsule against the fixed part and pierces the end of the capsule, ready for hot water to be passed through the capsule under pressure. The coffee then passes through a filter in the capsule, through the fixed part and out of the spout. To eject the capsule the lever is brought up again and the capsule drops down into a container.

A key part of the invention was that the axis of the capsule when first dropped into the machine would be offset from the axis of the moveable part. In the figure on the left, the two axes are shown with the capsule in this intermediate position. After the moveable part has been brought forward, the axes are aligned by the capsule being brought downwards so that it passes a pair of flexible stops on either side. This allows the capsule to drop into the container below once the moveable part is brought back. This is effectively what was claimed in the later application, and what was granted in 2010 as EP2103236B1.

The patent was opposed by six companies, who all wanted to sell competing coffee pods, or machines that used Nestle compatible pods, and each saw the patent as a barrier. Whether Nestle had any grounds for stopping others selling compatible pods using their patent is an issue I don’t have time to go into here. What’s of interest here is one of the arguments the opponents used to try to invalidate the patent. Claims 1 and 5 of the patent as granted (in the official English translation) read as follows:

1. Extraction system comprising a device for extraction of a capsule and a capsule (16) which can be extracted in the device; the capsule (16) comprising a guiding edge in the form of a flange, the device comprising

- a first fixed part (2),

- a second part (3) which is mobile relative to the first part,

- a housing (4) to receive the capsule and defining when in a position of closure of the mobile part against the fixed part an extraction position of the capsule about an axis (25) in said housing,

- a part for introduction and positioning of the capsule comprising guiding means (6,7) arranged such as to insert the capsule by gravity and to position said capsule in an intermediate position; the guiding edge being taken charge of in the guiding means (6,7);

said guiding means being introduction slides allowing the engagement of said flange;

- a system of outflow of beverage (19, 53), said mobile second part (3) being configured to displace the capsule (16) from the intermediate position to the extraction position upon closure of the device,

characterised in that the guiding means (6, 7) comprise stopping means (20) configured to retain the capsule (16) in an intermediate position; the flange pressing against these stopping means in the intermediate position, and in that the second mobile part (3) takes charge of the capsule to displace it from the intermediate position to the extraction position about the axis (25) of the capsule in the extraction position in said housing (4) such that in its movement, the mobile part acts on the capsule to bring it down, the flange of the capsule passing beneath the stopping means (20), and to push it about the axis (25) of the mobile part in its extraction position.

5. Extraction system according to claims 1, 2, or 3, characterised in that the stopping means retain the capsule in a inclined fashion with respect to the axis (25) of the capsule in an extraction position in said housing; the capsule tipping slightly with respect to the axis of the capsule in the extraction position (25).

The key parts of the patent are those underlined: the housing to receive the capsule, and the capsule being inclined, which is worth noting is only in claim 5.

In simple terms, the argument goes like this. The priority document, which was an earlier European patent application that also published (as EP1495702A1), disclosed the same coffee machine as in the patent. What it didn’t contain was a detailed description of the machine that was in the later application. There were two things the opponents argued were not disclosed in the priority application.

The first was the option of the housing to receive the capsule being somewhere other than in the second part. As you can see from the drawing above, the housing is only in the moveable part. The patent did not define in the claim that the housing was in either part, which left open the possibility of the housing being in either or both parts.

The second was the extra option mentioned in the patent, but not the priority application, that the capsule in the intermediate position was held inclined relative to the axis when the capsule was in the extraction position.

Both of these issues raised the possibility of the patent not being entitled to priority. If so, the earlier application became prior art under Article 54(3) and made the patent invalid for lack of novelty.

Nestle managed to get their patent through opposition reasonably unscathed by making some amendments, but the parties appealed the decision. While the appeal was still pending, the patent came before Mr Justice Arnold at the High Court and the same issues about priority came up. Unfortunately, Mr Justice Arnold got it completely wrong on both points (see here for more).

I’ll deal with the second point first, as it’s easier to see how it was decided wrongly. This is the diagram presented at the High Court showing the different ways the pod could be arranged relative to an axis. The pod could be offset from the axis, as in the top figure, or it could be inclined as in the middle drawing. It could also be offset and inclined, as in the bottom drawing. The priority document only disclosed that the pod was offset, but the later application and the patent disclosed that the pod could also be inclined.

Justice Arnold reckoned that, because the priority document did not disclose the inclined option the patent covered more options than were present in the priority document and was therefore not entitled to priority. The problem with this logic is that the inclined option was only present in claim 5 of the patent, not in claim 1 (see previous slide). Whether this is Justice Arnold getting completely confused about priority or being misled by Nestec is not clear, but it probably didn’t help that Nestec argued the point that claim 1 covered the three different orientations shown in the drawings, when in fact it didn’t cover the middle one.

The other point was about whether the patent lost priority because the housing was only described as being in the moveable part in the priority document, but the patent didn’t specify which part the housing needed to be in. This is where Justice Arnold got it wrong again, but the reasons are not quite as clear. He referred to the EPO Enlarged Board decision in G 2/98 to figure out when it would be acceptable for a claim to have multiple priorities.

Just to remind you, this is what Article 88 EPC says about multiple priorities:

Multiple priorities may be claimed in respect of a European patent application, notwithstanding the fact that they originated in different countries. Where appropriate, multiple priorities may be claimed for any one claim. Where multiple priorities are claimed, time limits which run from the date of priority shall run from the earliest date of priority.

This is what the enlarged board in G 2/98 said about how to interpret Article 88:

The use of a generic term or formula in a claim for which multiple priorities are claimed in accordance with Article 88(2), second sentence, EPC is perfectly acceptable under Articles 87(1) and 88(3) EPC, provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters. (reasons, point 6.7)

Justice Arnold’s reasoning was that there were three alternatives: the housing could be in the first or second part, or in a third alternative it could be divided between the parts. He concluded that the third option was not a clearly defined alternative to the first two, even though he had just defined it, and the patent was therefore not entitled to priority at all.

Reading the wording of G 2/98, on the face of it you can see how this kind of decision might seem to make sense. However, the enlarged board did not actually intend Article 88 to be so narrowly interpreted. As part of the reasoning in G 2/98, the board refered to a memorandum that led to Article 88 allowing multiple priorities for one claim, and stated that “the memorandum can be said to express the legislative intent underlying Article 88(2), second sentence, EPC”.

The memorandum gave three examples where it should be possible to allow multiple priorities in one claim. The first was where a chemical formula is broadened in a later application, the second where a numerical range was broadened, and the third where a field of use was broadened. In all cases, the memorandum stated that broadening should allow partial priority for the part of the claim that covered the earlier application, while the rest of the scope would be entitled to the later priority date.

The third example in the memorandum was about a priority document disclosing a method of coating the inner walls of pipes, which was then broadened to a method of coating the inner walls of hollow bodies. The later broader scope of claim would be entitled to partial priority for the case of pipes, and to a later priority for the case of hollow bodies other than pipes. So, when G 2/98 stated that multiple priorities were acceptable provided a generic claim gave rise to a limited number of clearly defined alternative subject matters, they must have had this in mind, along with the other examples.

Comparing this example with the one in the Nestec case, it’s quite clear that making the claim scope broader by not specifying which part the housing is in fits quite well. The option of the housing being in the moveable part would be entitled to the earlier priority date, while the other options of the housing being in the fixed part or divided between the parts would be entitled to the later date.

To be fair to Justice Arnold, the same mistake was made in at least three decisions of the EPO boards of appeal, all of which thought they were following the guidance in G 2/98 but none of them referred to the memorandum.

In T 1877/08, the Board rejected a range of numerical values as not corresponding to distinctive alternative embodiments (point 2.4 of the reasons). The same point was made in T 476/09 (point 5.6 of the reasons). This is in direct contradiction to example b) of the memorandum, which specifically refers to numerical ranges being a possibility for multiple priorities in one claim. Both of these decisions must therefore had been wrongly decided on this point.

In T 1127/00, the Board rejected a claim to partial priority for a generic formula encompassing an earlier narrow range in the priority application because, as they said, the claim did not embrace a limited number of clearly defined alternative subject-matters in the form of an “OR” claim which could be split up into groups of different priorities (point 6 of the reasons). This is, however, obviously contradictory in terms of both examples a) and b) of the memorandum.

The only board of appeal decision so far that has actually looked at what G 2/98 actually meant by referring to the memorandum is T 1222/11. In point 11.8 of the reasons, after going through the various examples in the memorandum the board set out in general terms how multiple priorities in a single claim should work. I will paraphrase here, as the board was quite wordy. They said:

In so far as a subject-matter disclosed in a priority document and encompassed by a broader claim of a European application is concerned, the decision on whether priority can be acknowledged for this subject-matter is independent of whether said subject-matter or embodiment disclosed in the priority document is identified in the broader claim as a separate alternative embodiment. Also, when an application on the basis of which a priority date is claimed encompasses a narrower subject-matter already disclosed in an earlier application, the decision on whether the claim to priority on the basis of the later application is valid does not depend on whether the narrower subject-matter disclosed in the earlier application is identified in said later application.

The need to have specific basis for the “limited number of clearly defined alternative subject-matters” in the application is therefore explicitly rejected in T 1222/11. Instead, it is enough for a claim to be theoretically divided up into a first part having a valid earlier priority and a second part having a different priority. For the case of the method of coating hollow bodies, the later application does not need to basis for a claim that states a method of coating hollow bodies other than pipes, because this is already covered by theoretically dividing up the claim into two parts with different priorities.

What should now be obvious, but I haven’t mentioned yet, is how this way of looking at partial priority is the solution to a hypothetical problem that has been discussed for a while. The issue is whether a priority document that is published and becomes Article 54(3) prior art for later filed application can knock out the later application if it claims a broader scope than what is in the priority document. In the Nestec case, the issue was publication of the priority document, which was also a European application. In other cases it might be a divisional application, which could be argued to be Article 54(3) prior art for its parent once it publishes.

Taking the narrow view of partial priority, which Justice Arnold did, means that your own priority document might knock out your patent because it falls within the broader claimed scope of the patent. Taking the broader view, however, it should never be possible for a priority document to be used in this way. This is because the priority document is not prior art for the part of the claim that has a valid claim to priority, while the rest of the scope is at least novel so cannot be knocked out by the priority document alone.

It would be nice if this issue could have been resolved by the board of appeal or the Court of Appeal in the Nestec case. Unfortunately, the EPO board of appeal decided to revoke the patent when they came to hearing the case in October last year and didn’t even get to discuss the issue of partial priority (see here for more). Instead, the board found that the patent failed for added matter, as a result of amendments the proprietor had made during the appeal. The possibility of getting Justice Arnold’s dodgy decision overturned on appeal was then removed, as there was no longer any patent to argue about. 

I can now go back to the question I asked at the beginning: was the coffee poisoned? In the Nestle case, even though the decisions went against them, and the patent was probably invalid anyway for other reasons, I think the answer is that the coffee was not in fact poisoned. It should not have been possible for the priority document to be used against the application. The fact that Justice Arnold and several EPO boards of appeal have found otherwise does not mean that I am wrong, just that the right argument was not presented. If it had been, the conclusion would have been that the coffee was not poisoned and the patent might have survived. In the end though, the patent was killed off by the EPO board of appeal by added matter.

Strangely enough, this is also the answer to the Poirot mystery. If you remember, I mentioned that the victim Mrs Inglethorp was found to have died of strychnine poisoning. Poirot had the coffee analysed and found there was no strychnine in it, which he suspected anyway because if it had been poisoned it would have acted much more quickly. The coffee therefore wasn’t poisoned after all. What was poisoned was her cocoa, and Mrs Inglethorp had done this herself by adding her tonic to it. Although the tonic should have had only small amounts of strychnine, and not enough to kill her, someone else had added bromide to it, which had reacted with the strychnine and made it precipitate out to the bottom of the bottle. The effect was to make the last dose fatal, as it contained most of the poison. The solution to the mystery, as in the Nestec case, was that it was added matter that did it, and not poisoned coffee.

In search of a technical effect

This is a repost of an article that will shortly be appearing in the October 2013 edition of the CIPA Journal. For anyone who doesn't want to know the score before the issue is published, please look away now. Alternatively, read on for a version in which I have incorporated links to the relevant case law and other material. 

Law and practice on what is considered patentable at the UK and European patent offices has been running along parallel lines for as long as the EPC has been in existence. While the direction of travel is always roughly the same, though with occasional diversions, the lines never seem to converge completely. At the risk of a gross oversimplification, this can be largely blamed on the difference between the law of precedent as applied in the UK and at the EPO. On one side, the EPO Boards of Appeal are apparently content to allow "lines of reasoning" to be developed, and sometimes abandoned, as time goes on and technology develops (see for example T 1227/05, commented by me here on the IPKat). Law and practice in the UK on the other hand has followed more of a process of accretion and correction, where previous case law has tended to act as a restraint on any major changes, although changes at the boundary can and do sometimes happen.

There have been six Court of Appeal judgments in the area of patentability under section 1(2) over the period from 1989 to 2013 (see here for a full list). From these, the law in the UK can be considered settled in a way that is roughly based on the four step test put forward by the UK IPO and approved by Jacob LJ in Aerotel/Macrossan from 2006, with various caveats and fudges applied that try to make the test stay in line with earlier Court of Appeal judgments as well as being as consistent as possible with the approach taken at the EPO. To achieve complete consistency between the UK IPO and EPO from the different approaches is, of course, impossible. In an ideal world, the same test would be applied regardless of the office in which an application was being prosecuted, and the same result obtained, not least because the effect of a patent granted by the UK office is the same as one granted by the EPO. This ideal world is not, however, going to appear in the foreseeable future. A change to match the EPO approach in the UK would require abandonment of not just the Aerotel/Macrossan test and related Court of Appeal case law, but also the well-established Windsurfing/Pozzolli test for inventive step. This is because the EPO test for patentability is inextricably linked with the problem-solution approach for assessing inventive step. Barring a highly surprising result from the UK Supreme Court, and ignoring the long-term possibility of the IPO ceasing to grant patents together with UK courts no longer having jurisdiction over UK patents, this is not going to happen. On the other side, it is unlikely in the extreme that the EPO Boards of Appeal would consider abandoning the universally applied problem-solution approach in order to fit with the different approach taken by only one member state. Since a fundamental change in approach is unlikely from either side, the best that could reasonably be hoped for is that outcomes are as closely aligned as possible. As the Enlarged Board of Appeal stated in G3/08 in relation to the exclusion of computer programs, “a uniform understanding of where to draw the line between applications relating to programs for computers as such [...] still cannot be assumed despite considerable convergence in recent court rulings” (point 4.1 of the reasons). However, despite the discrepancies in approach and principles, as Lord Neuberger stated in Symbian, there is clearly a strong desire for the two offices to be “marching together as far as possible”, and “where there may be a difference of approach or of principle, one must try to minimise the consequent differences in terms of the outcome in particular patent cases” (paragraph 61).

Since we can safely assume, at least for the foreseeable future, that the differences in approach and principle are not going to change substantially, the question becomes: how do we ensure that the outcomes are as closely aligned as possible? Now that the heat and antagonism arising from Jacob LJ’s judgment in Aerotel/Macrossan, which claimed that the EPO Boards of Appeal decisions were mutually contradictory, and the resulting response from Herr Steinbrener in T 154/04 accusing the Court of Appeal of missing the point, has dissipated, others have attempted to patch up any differences by using more common language that can be applied to both approaches. A common theme is the unfortunate but seemingly inevitable use of the word “technical”, in particular in the form of tests and checks for whether an invention provides a “technical effect”. Even though no-one has been able to provide a stable definition for what the word “technical” actually means in the context of patentability, this does not seem to matter because decisions from both sides are building up regarding what can and cannot provide a technical effect, while all decisions carefully avoid providing a definition of the exact boundary outside of which there would be no such effect.

In the UK, following the Court of Appeal judgments in Symbian and Aerotel, an attempt was made by Lewison J (as he then was) in Re AT&T Knowledge Ventures LP [2009] EWHC 343 (Pat) to summarise, in the form of a series of useful “signposts”, what aspects of an invention might point towards a relevant technical effect. These signposts are:

i) whether the claimed technical effect has a technical effect on a process which is carried on outside the computer;

ii) whether the claimed technical effect operates at the level of the architecture of the computer; that is to say whether the effect is produced irrespective of the data being processed or the applications being run;

iii) whether the claimed technical effect results in the computer being made to operate in a new way;

iv) whether there is an increase in the speed or reliability of the computer;

v) whether the perceived problem is overcome by the claimed invention as opposed to merely being circumvented.

One benefit of these signposts is that there is no need for the word “technical”; the signposts make just as much sense without it. Hearing officers at the IPO seem to like the signposts, and have used them in practically every decision since AT&T, although in the vast majority of cases to show that a claimed invention does not in fact demonstrate any technical effect. The Court of Appeal, in HTC Europe Co Ltd v Apple Inc [2013] EWCA Civ 451 (see here for my comments) has indicated that these are “useful signposts, forming as they do part of the essential reasoning in many of the decisions to which we must look for guidance. But that does not mean to say they will be determinative in every case”, but considered that the fourth was too narrowly put, which should instead ask “whether the computer is a better computer in the sense of running more efficiently and effectively as a computer” (paragraph 51 of Kitchin LJ’s judgment). This has been recently confirmed in Lantana Ltd’s Application [2013] EWHC 2673 (Pat), where Birss J has simply rewritten the signposts as modified by HTC v Apple.

Although the signposts, which are now firmly established in UK practice, are useful pointers towards what might be patentable, they are non-exhaustive and do not necessarily apply in every case. As Lewison J put it in AT&T, “it is still necessary to consider whether the claimed technical effect lies solely in excluded matter” (paragraph 41). This caveat leaves plenty of room for hearing officers and judges to conclude that an invention would still be excluded from patentability. In practice though there have been no decisions from the IPO where one of the signposts has pointed towards a technical effect but where the hearing officer has nevertheless still considered the invention to be excluded. The possibility therefore remains open, but it seems unlikely to be used in practice.

One of the main problems with aligning the UK approach to patentability with that of the EPO’s is that an assessment of patentability is typically made, according to the Aerotel test, without any real consideration of the prior art. The contribution (step two) is often assessed without looking at where the claimed invention differs from the closest prior art, and sometimes even without a search having been carried out. In some cases an assessment of novelty and inventive step is carried out by the examiner, and the issue of patentability is the only issue remaining to be resolved. In most cases, however, there is no real assessment of novelty and inventive step and patentability is the sole issue in question. This approach is completely at odds with that taken at the EPO, where the assessment of patentability is deliberately intertwined with that of inventive step through use of the problem-solution approach. This approach requires the closest prior art to be established, which in some business method cases might be simply a ‘general purpose computer’ (requiring no actual search to be carried out). The difference over this prior art is then established, and what technical effect this difference has. The objective technical problem is derived from the effect, and finally a judgment made as to whether the skilled person would find the difference to be obvious. The assessment of patentability is incorporated in the steps of assessing what the technical effect is. In line with the leading case on the subject, T 641/00, any differences that are not considered to be technical are moved into the problem to be solved, rather than considered as being part of the solution. In this way, any non-technical aspects are considered not to contribute to the technical character of the invention. As stated in T 641/00, “the problem must be a technical problem, it must actually be solved by the solution claimed, all the features in the claim should contribute to the solution, and the problem must be one that the skilled person in the particular technical field might be asked to solve at the priority date” (point 5 of the reasons), and “an invention in the sense of Article 52 EPC can only be made up of those features which contribute to said technical character” (point 6).

A recent decision from the EPO Boards of Appeal, T 1670/07 (commented on by the IPKat here), has reviewed in more detail what would be considered to be technical. As with T 641/00 (which, strangely, was not cited in the decision), the consideration at the EPO is largely a negative one, i.e. there are certain aspects that are considered not to be technical. Based on this decision, which related to patentability of a method of facilitating shopping using a mobile device, selecting multiple vendors for a shopping order and provision of a shopping itinerary based on a user profile are both considered to be not technical. The Board also considered that there were certain ‘fallacies’ in the arguments presented for a technical effect, which in essence claimed that non-technical aspects could in some circumstances contribute to the technical character of an invention. The Board considered that they could not.

How then, in practice, do these different approaches to patentability work, and do they result in decisions where one would favour patentability for particular types of inventions over the other? The answer appears to be in looking at how a technical effect is defined, rather than the overall approach to be followed. Consideration of a technical effect is now at least common to both approaches, even if it is used at different steps in the process. There is also a degree of convergence in what would be considered to be a technical effect, even though the way to assess what such an effect might be is a positive one in the UK (i.e. deciding whether the effect can be found from a list) and a negative one at the EPO (i.e. whether the claimed technical effect is one that has been previously decided not to be technical). In the end though, if there is a technical effect according to the UK approach, there will always be at least an arguable case for the effect to contribute to the technical character of the invention according to the EPO approach. Decisions may vary according to the facts of particular cases, and to how well arguments are made but in general, despite the differences in approach, the good news at the moment is that there should be no significant difference in result. 

Time-Lapse IVF - A non-patentable method of diagnosis?

Article 53(c) EPC states that European patents shall not be granted in respect of "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body". As far as I am aware, all of the case law relating to this provision relates to methods applied on human or animal bodies in their fully formed state. What does not appear to have been considered previously is whether the provision would apply to methods applied to human or animal embryos. This intriguing possibility has been raised in an article to be published in the journal Reproductive Biomedicine Online, written by Sigrid Sterckx, Julian Cockbain and Guido Pennings. The second of these authors happens to be a European Patent Attorney, while the other two are from the Bioethics Institute in Ghent. The abstract of the article, which is currently available in full online here as a preprint, states:

European Patent No. 2430454 [EP Register here] of Stanford University is open to opposition before the European Patent Office if such opposition is filed by 23 October 2013. This is the European equivalent of the US Patent that raised such controversy in this journal in August 2013 as being a patent on time [the patent is presumably one of these: US7963906, US8323177 and US8337387, although the August 2013 article refers to publication number US 2011/092762. None of these are, of course, patents on time]. The European Patent, which is directed to a method of selecting embryos for implantation using the results of time-lapse microscopy, should, in the present authors’ opinion, be revoked as being directed to a method of medical diagnosis, which is unpatentable under European patent law. The only party currently opposing Stanford’s patent is a competitor, Unisense FertiliTech A/S which is itself seeking to patent similar methods in Europe; the objection that Stanford has patented a method of diagnosis has not been raised by Unisense FertiliTech. We submit that Stanford’s patent should be opposed to safeguard competition and to protect the freedom to operate of clinicians. In this paper we explain how Stanford’s patent should fail under European law.

The argument in the article, which is well worth reading in full, is quite well put and at least plausible, although very probably wrong. The main weakness in the argument seems to me to be whether an embryo can be considered to be a human body. Although there does appear to be support from the CJEU on this interpretation, I think it is possibly a bit of a stretch to apply this to the particular exclusion under Article 53(c). The case law of the EPO Boards of Appeal, in particular the decision in G 1/04 (see this section of the case law book), would also seem to suggest that such a method would not be within the exception because it does not provide a diagnosis for curative purposes. The test would instead only provide an indication of whether an embryo is 'good' or 'bad'. The argument therefore seems to me to be doomed to fail on at least two major points.

The article has, however, already had the desired effect of provoking another opposition. An opposition has recently been filed (here) which, by an amazing coincidence, names the authors of the article and the European Society of Human Reproduction & Embryology as joint opponents. As an aside, I am a bit puzzled as to why the opposition would be filed in this way, rather than using the qualified European attorney as the joint representative.

Regardless of the new opposition, it looks like the patent will probably be revoked, or at least substantially limited, as a result of the opposition that has already been filed, which is very extensive and relies only on conventional grounds of novelty and inventive step. As a point of interest, one of the prior public disclosures cited by Unisense Fertilitec is a YouTube video (see below), which apparently shows the patented method being carried out prior to the filing date. It will, however, be interesting to see how the additional ground for opposition is viewed, and whether it becomes at all relevant or is simply dismissed as being a no-hoper. One to watch for the long term, perhaps, given the long gestation period of EPO oppositions.



UPDATE 5 November 2013: Third party observations have now been filed by Galway Fertility (here) and jointly by the Association of Clinical Embyologists (ACE) & the Royal College of Nursing (RCN) (here), both sets of observations presumably having been prompted by the Sterckx et al article. Both make points based on ethical, rather than legal, grounds, so do not appear to add any further legal weight to the additional opposition. The support by ACE has also been announced on the ACE website here.

UPDATE 20 November 2013: My reply to the paper, which is to be published as a letter in the same journal, is currently in press and available here.

UPDATE 9 May 2014: The patent proprietor's representative has now responded to the oppositions. Their letter of response can be accessed on the EP register here. In brief, they seem to be in agreement with me (unsurprisingly) that the claimed invention is not a method of diagnosis within the meaning of Article 53(c), and for the same reasons. The main points are that i) the method is not a diagnosis of any kind, and ii) it does not result in any kind of treatment. G 1/04 is fairly decisive.