Friday 16 December 2016

Sofosbuvir - a $2.54bn infringement in the US, but not in Europe

It is a common misconception among inexperienced (typically would-be) patentees that getting a patent for their invention will give them the right to commercialise it. As I have had to explain quite often to new clients, there is a big difference between these two things. A patent only gives you the right to stop others from doing what the claims cover, while being free to put your invention into practice is dependent on not being found to infringe anyone else's patent.

A good recent example of this difference is the verdict from the case of Idenix Pharmaceuticals LLC v Gilead Sciences Inc, as reported here and many places elsewhere. Gilead were found to have infringed US 7,608,597, and have been ordered to pay $2.54 billion in damages. Gilead have their own patent on the infringing drug, known as Sovaldi and Harvoni and with the generic name sofosbuvir, which I have written about here and here in relation to the European patent. Gilead do, of course, have a corresponding US patent for the drug, but this did not help them in their case against Idenix.

What is also interesting about this case though is the contrast that it shows between what can be achieved in the US and what can be done with the same starting material in Europe. Claim 1 of the US patent is very brief, and reads as follows:
1. A method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine ūĚõĹ-D-2'-methyl-ribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.
Claim 1 of the only corresponding granted European patent EP2319856B1, however, is very very long indeed, much too long to be reproduced in full here. It starts off in a similar vein, defining a pharmaceutical composition for use in a method for the treatment or prophylaxis of a Hepatitis C virus infection in a host, but then goes on for a further two pages with various structural features and alternatives. What was possible in the US therefore seems to be impossible in Europe in this case. Not only would sofosbuvir alone not be an infringement of the European patent (I am fairly sure about this, but happy to be proven wrong), but also European courts do not go for such huge damages as are found in the US (although the headline $2.5 billion figure is very likely to be whittled down on appeal).

Another interesting feature of this long-running story is that an infringement action has already been tried by Idenix against Gilead in Europe, but this ran aground when Mr Justice Arnold at the England & Wales High Court found that Idenix's patent EP1523489B1 was invalid (see the IPKat post here), and this was upheld on appeal. So, at the moment at least, it looks like Gilead have done very well in Europe to keep their patent on sofosbuvir and also avoid it infringing anyone else's, but the story is very different in the US. This seems to be largely down to more thorough examination in Europe, both at the EPO and the courts (although this does not always apply: see my recent post here), compared with the generally far more lenient USPTO and more patent friendly court system in the US.

Wednesday 14 December 2016

Confusion around G 1/15 & conceptual splitting

Since I reported a couple of weeks ago about the order issued by the Enlarged Board in G 1/15, there have (at the last count) been 69 comments on the post, which for me is quite a lot. There is a similar, though not quite as lengthy, discussion on the IPKat here. It seems that the EB's order has not yet settled the issue around partial priorities, and there remain some questions about how it should be interpreted. We should, of course, get some clarity once the reasoned decision comes out. For now though, there seems to be quite strong disagreement among some commenters about how to assess partial priority.

The disagreement seems to boil down to whether conceptual splitting of a generic OR type claim can result in different priorities for different parts of a generic claim. Some anonymous commenters have said that this cannot be correct, as it cannot be right to assign a priority to a part of a claim that has not been disclosed. Others, however, have said that conceptual splitting is not even needed, since the only requirement is based on what is disclosed in the priority document. My personal view is that the conceptual splitting approach makes more sense, and avoids problems with Article 4C(4) of the Paris Convention, even though it does result in assigning a priority date to a part of a generic claim that is not literally disclosed in a priority document. It is plausible that the EB could come to a different interpretation, although in my view this interpretation is already covered by the words "at least implicitly" in the order.

The issue can probably be best explained by reference to one of the examples in the FICPI memorandum which, as you will recall, was the basis for the decision on partial priorities in G 2/98 and which was totally ignored by decisions from the boards of appeal that went down on the side of literal interpretation of point 6.7 (the "limited number of clearly defined alternatives" bit). The example reads as follows:
b) Broadening of range (temperature, pressure, concentration, etc.).
     Let us assume that a first priority document discloses a temperature range of 15-20° and a second priority document discloses a temperature range of 10-25°. 
     If multiple priorities for one and the same claim are allowed, it will suffice in the European patent application to draw up a claim directed to the temperature range 10-25°. 
     If multiple priorities for one and the same claim are not allowed, the applicant will have to draw up two parallel claims, one directed to the temperature range 15-20° and enjoying the first priority, and another claim directed to the temperature ranges 10-15° or 20-25°, which claim will then enjoy the priority of the second priority document which was the first one to disclose these temperature ranges. 
It should be clear from this example that there is no need to have literal basis for the ranges 10-15° and 20-25° in the second priority document (let's call it P2) to allow priority for these portions to be validly claimed in the later filed European application (let's call it EP). This, to me at least, suggests that the conceptual splitting approach is correct, where priority for the narrow range of 15-20° is from the first priority document (P1) and for the other parts of the range from P2.

I would guess that the reasoning in G 1/15 will need to go over in detail each of the examples in the memorandum (which G 2/98 did not) to establish clearly what they mean by assigning partial priorities. Unless they do, the argument about whether conceptual splitting is allowed or not will continue to rumble on. My prediction, for what it is worth, is that they will go over each of the examples, and find that conceptual splitting is a necessary feature of assigning partial priorities to a generic OR type claim, particularly in cases where priority is claimed from more than one document, such as in the example above. I might, however, be wrong.

Wednesday 30 November 2016

G 1/15 - The answer is NO

As I mentioned in my report of the oral proceedings back in June this year, the Enlarged Board in the case of G 1/15 (partial priority) promised that a decision would be made by November this year. True to their word (but only just), an order has just appeared on the EPO register today, which is dated yesterday. The order states in full:
Under the EPC, entitlement to partial priority may not be refused for a claim encompassing alternative subject-matter by virtue of one or more generic expressions or otherwise (generic "OR"-claim) provided that said alternative subject-matter has been disclosed for the first time, directly, or at least implicitly, unambiguously and in an enabling manner in the priority document. No other substantive conditions or limitations apply in this respect.
As readers may recall, this is a response to the first question referred to the Enlarged Board, which was:
Where a claim of a European patent application or patent encompasses alternative subject-matters by virtue of one or more generic expressions or otherwise (generic "OR"-claim), may entitlement to partial priority be refused under the EPC for that claim in respect of alternative subject-matter disclosed (in an enabling manner) for the first time, directly, or at least implicitly, and unambiguously, in the priority document?
In other words, the answer to question 1 is a clear "no". All the other questions were dependent on question 1 being answered in the affirmative, so they now all fall away and need not be answered.

No reasoning has yet been provided behind the order, but this will apparently be issued "as soon as possible", according to the accompanying letter to the EPO president. For now, we can at least be satisfied that the problem of poisonous priority and poisonous divisionals has finally been laid to rest and the flawed case law from the technical boards, as well as in some court decisions (such as this one, which I wrote about here), can be set aside.

Just for the record, I would like to say that I was right all along.

Wednesday 16 November 2016

The EPO issues invalid patents too

The European Patent Office makes a big thing about quality. There is even a section of the EPO website about it, with several entries illustrating how well they are doing on various measures. The EPO President remarked recently that the EPO scrutinizes applications more closely than the USPTO, resulting in patents that were more legally sound. In general, based on my own experience, I would tend to agree. Sometimes, however, even the best organised systems can fail. An example I have just found out about (hat-tip to @JeremyNicholls) is European patent EP2700769B1, granted with effect from 31 August 2016. Claim 1 of this patent reads:
1. A hairdressing salon (1) comprising at least one styling station (3), which is embodied in a room (5), wherein the room (5) is arranged in a mobile structure (7), which can be displaced by means of a lifting tool, characterized in that the mobile structure (7) has at least one window (13).
The sole drawing of the patent is shown here on the right. Basically, the patent claims a hairdressing salon in a shipping container (or some other kind of mobile structure) with a window cut into it. This is not, however, even the broadest claim. Claim 9 defines "A mobile structure for a hairdressing salon according to one of claims 1 to 7". According to the usual EPO interpretation of the word "for", this would cover any shipping container (although, as a commenter notes below, it might have to have at least a window).

How this application got through the EPO system is at the moment quite beyond me. From a quick review of the prosecution file though, it seems that the examiner was persuaded that adding a window made the invention allowable over US 2006/137188 A1. Just in case anyone has any doubt about whether the invention is novel, let alone inventive, there is prior art in the form of shipping containers repurposed as hair salons such as this article from 11 June 2011 (before the 23 August 2012 priority date of the patent), which describes the popular practice of converting shipping containers to new uses in South Africa. For further avoidance of doubt, the internet archive wayback machine (which is normally accepted by the EPO as evidence of publication date) confirms that the article was available on 16 June 2011. One of the photographs in the article, shown below, seems to have everything required according to claim 1. Incidentally, the search that led me to this took about five minutes.

The EPO will certainly not be able to do anything about this particular patent, at least not unless someone bothers to make the effort of opposing the patent (which they have until the end of May next year to do). The EPO might, however, like to take a look at how such an obviously invalid claim could get through a system that is considered to be the highest quality in the world.

UPDATE 22/11/16: Thank you to the anonymous commenter who has done a bit more research and come up with the following additional pieces of prior art, which at least demonstrate that the claimed invention can be considered to cover more than just shipping containers.

The first piece of prior art is Elizabeth Taylor's trailer for the 1963 film "Cleopatra". A report on this from 21 November 2011 is available here, from which the picture below is taken. The trailer obviously had a hairdressing salon, and windows. It was sold in 2012 for over $50k, according to this report, although it cost a lot more when it was made.

The second piece of prior art is a ship, specifically the "Radiance of the Seas", as shown in the video below being brought into drydock in the Bahamas. According to this article, the ship has a salon for "hair styling, facials and other beauty treatments". 

UPDATE 27/10/17: Since the opposition period has expired, and the patent has not been opposed, I have decided to request a UK Patent Office Opinion on validity. A copy of the opinion request, which was filed today, can be accessed here. I will, of course, provide updates on further progress as I hear of it.

UPDATE 3/11/17: The opinion request is now up on the IPO website, and has been allocated the number 18/17. The deadline for filing any observations is 19 November 2017.

Tuesday 25 October 2016

New EPO Enlarged Board referral: does the gold standard apply to a bitten apple?

If claim 1 of your application or patent encompasses subject matter in the prior art, you have to do something about it. Usually this means limiting the claim using subject matter found from somewhere in the application as filed. If the prior art only counts under Article 54(3) EPC, you only have to make the resulting claim novel. Any amendment though has to comply with Article 123(2) EPC, in that it must not contain subject-matter which extends beyond the content of the application as filed. A usual way of limiting a claim would be to add a narrowing feature, making something in the claim more specific. Sometimes though, the only option is to disclaim a part of the invention by explicitly stating that a certain portion is excluded.
"Gold bitten apple" by Teodor Dukov 

The Enlarged Board in G 1/03 decided disclaimers that did not have basis in the application as filed were in some cases allowable, but only where a disclaimer was required to: i) restore novelty over an A54(3) document; ii) restore novelty over an "accidental" prior art document, where anticipation was "so unrelated and remote that the person skilled in the art would never have taken it into consideration when working on the invention"; or iii) disclaim subject matter that was excluded from patentability for non-technical reasons. This allowed disclaimers to be made that would otherwise fall foul of A123(2), but only in quite limited circumstances.

A further Enlarged Board decision in G 2/10 related to disclaimers, but instead to those that were disclosed in the application as filed. The Board did, however, state that the test to be applied is "whether the skilled person would, using common general knowledge, regard the remaining claimed subject-matter as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed" (point 4.5.4 of the reasons). This test was, according to G 2/10, the generally accepted "gold standard" for assessing any amendment for compliance with A123(2) EPC.

The question then arises whether the gold standard must also be applied to the type of undisclosed disclaimers that would otherwise be allowable under G 1/03. This situation has arisen in the appeal case, T 437/14, for which a decision has recently issued. The Board has decided to refer the following questions to the Enlarged Board (which will presumably be numbered G 1/16) to decide the issue:
1. Is the standard referred to in G 2/10 for the allowability of disclosed disclaimers under Article 123(2) EPC, i.e. whether the skilled person would, using common general knowledge, regard the subject-matter remaining in the claim after the introduction of the disclaimer as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed, also to be applied to claims containing undisclosed disclaimers?

2. If the answer to the first question is yes, is G 1/03 set aside as regards the exceptions relating to undisclosed disclaimers defined in its answer 2.1?

3. If the answer to the second question is no, i.e. if the exceptions relating to undisclosed disclaimers defined in answer 2.1 of G 1/03 apply in addition to the standard referred to in G 2/10, may this standard be modified in view of these exceptions?
The issue in this case related to a claim to a range of chemical compounds, in which two disclaimers were introduced during opposition and appeal proceedings. These disclaimers were made to confer novelty over two cited documents, but there was no specific basis in the application as filed for them. Following the test in G 1/03, the Board concluded that the disclaimers did meet the accidental disclosure test, and that the resulting claim was novel, inventive, sufficient and clear. The only question remaining was whether the gold standard mentioned in G 2/10 should also be applied. In some previous cases only G 1/03 was applied, while in others the gold standard was used, resulting in an inconsistency that needed to be resolved.

In the Board's view, applying the gold standard of G 2/10 regarding A123(2) would result in the disclaimers not being allowable for the case in point (point 10.2 of reasons). The disclaimers would only be allowable if either only the G 1/03 standard was to be applied to disclaimers due to accidental disclosures or if some modified form of the gold standard test was to be applied.

The Board gave a simple example to illustrate their reasoning. If one takes a bite out of an apple, what remains is recognisably no longer the same apple as the original one. Even though it is still an apple, the apple with the bite taken out of it cannot be regarded as explicitly or implicitly, but directly or unambiguously, "disclosed" in the original apple (point 8.1 of the reasons). The strong suggestion from the Board therefore is that the test in G 1/03 alone is not enough.

Thankfully I do not have to deal with chemical cases where these kinds of issues most often arise, which is largely due to the way that chemical compounds are often very broadly defined in claims. It has, however, always struck me as a bit odd that an amendment could be made to a claim that had no basis at all in the application as filed. I wonder whether the Enlarged Board will think it odd as well that such a decision could have been made, and set aside G 1/03.

Thursday 13 October 2016

Sofosbuvir EP opposition - an update

As I reported in February last year, Gilead's European patent EP2203462B1 to sofosbuvir (Sovaldi) was opposed by various organisations, the first of which was Médecins du Monde (MdM). Their main reason for opposing the patent seemed to be that Gilead was charging a high price for the drug, which is effective for treating Hepatitis C. The opposition has recently concluded, following oral proceedings earlier this month. A press release issued on October 5th indicated that MdM's opposition was partially successful, and that "the quality of the patent was weak". Details of how exactly the patent fared as a result of the opposition were, however, missing, except for a mention that "the patent extended beyond the content of the patent application as filed" (suggesting an Article 123(2) issue). Another report from IP Watch did not provide much in the way of further illumination, and as yet there has been no word from Gilead or the EPO on the outcome.

The decision and minutes of the oral proceedings have not yet appeared on the EP register for the case, and are unlikely to do so for some time. It can, however, be inferred from what has already been said, and in particular a document that has appeared on the register, what actually happened.

In their preliminary opinion, issued on January 28, 2016, the opposition division indicated that claim 1, corresponding to the racemate (shown here), had been specifically disclosed in the application as filed. Claims 2 and 3, however, which were directed to the enantiomers (or diastereomers - see the comment below), did not appear to be disclosed. Whether the disclosure was sufficient to disclose the enantiomers was something that was due to be discussed at the oral proceedings.

Gilead filed a large number of auxiliary requests, the first of which had a set of claims that had been amended to define the enantiomers instead in terms of the slow and fast eluting isomers obtainable by a specific method that was disclosed in the application. The clue that this succeeded at oral proceedings is this document, issued shorty after the proceedings, that contains amendments made to the summary of the invention, and indicating that this corresponds to the first auxiliary request. This shows that claims 2 and 3 have been removed from the application, clearly indicating that claim 1 survived, but that the specific claims to the enantiomers did not.

As a result, the patent seems to me to have survived pretty well, and not really limited in any substantial way. It will, of course, be irritating to Gilead that the specific claims to the enantiomers have gone, but the patent as amended would still protect the drug. Reports (such as this one, for example) that suggest generics may be able to enter the market sooner than expected, therefore seem to be a bit wide of the mark.

UPDATE 3/11/16: The grounds for the decision have now appeared on the EP register. As expected, claim 1 to the racemate stands, and the claims to the enantiomers/diastereomers have gone.

Tuesday 6 September 2016

Sofosbuvir revisited - a chemical puzzle

I last wrote about the blockbuster drug sofosbuvir in February 2015, around the time when a few oppositions were being filed against Gilead's European patent for the drug. The oppositions are currently going through the usual procedures at the EPO, and oral proceedings have been scheduled for 4-5 October 2016. From a quick look at the preliminary opinion of the opposition division, it looks like the patent will be upheld. With ten opponents and a huge amount of material on record, however, it still looks like a Herculean task for the patentee.
Chemical structure of sofosbivir (Wikipedia).

In the meantime, however, I noticed a recent article about a claim being made in the US that a patent owned by the University of Minnesota is infringed by the drug. The article does not mention the patent by number, but after doing a bit of simple searching I think it could be US6475985, titled "Nucleosides with antiviral and anticancer activity", which was granted to the University in 2002 (and was, incidentally, not cited as prior art in the EP oppositions), considerably before the earliest priority date for the sofusbuvir patent in 2007. Claim 1 of this patent reads as follows:

There are other independent claims that are directed to a chemical compound, rather than to a therepeutic method, but claim 1 does seem to have at least the use of sofosbuvir within its scope. It is, however, a bit of a complicated puzzle to figure out whether it does. Can anyone confirm this?

Tuesday 19 July 2016

Negative IPO Opinions - The Story So Far

Since 1 October 2014, when section 73 of the UK Patents Act was amended to allow for revocation to be initiated by the comptroller following a negative opinion on validity, a total of 13 opinions have issued where an examiner has concluded that a patent is either lacking in novelty or inventive step. This is out of a total of 42 requested opinions that reached a conclusion, 25 of which related to validity.

A first point worth noting is that these numbers are quite small, suggesting three possible reasons: i) people are reluctant to use the opinions service, possibly due to the public nature of the procedure; ii) the service is still not well known, even though it has been around for several year now; and iii) that there is just not very much contentious action around in the UK. I suspect the main reason is the first one, as many will be unwilling to put questions of validity or infringement before an examiner and have it decided on the papers alone, with the result being publicly available, even if the resulting opinion "shall not be not binding for any purpose" (section 74A(4)).

A second point worth noting is that the hit rate of a finding of invalidity, with 13 out of 25 opinions finding the patent to be invalid, is about 50%. If you are looking to use an opinion as a card to play in negotiations, this is not a bad hit rate. Sometimes, of course, a positive opinion can be useful too, particularly if the question is framed in the right way, as I know from personal experience relating to this one.

According to section 73(1A), the comptroller may revoke a patent if an opinion finds that section 1(1)(a) or (b) is not satisfied, i.e. if the claimed invention lacks novelty or an inventive step. He cannot, however, do so until any review under section 74B has been concluded, or once the three month period for requesting a review has passed.

It has now been nearly two years since the new procedure started, so how many patents have actually been revoked using section 73(1A)? Of the 13 negative opinions issued to date, only two have resulted in the patent in question being revoked (EP1837182 and GB2508152), although another one (EP2160936) should be revoked shortly, which I wrote about here [UPDATE 17 August 2016: it has now been revoked, confirmed by this letter from the IPO]. Three other opinions (relating to GB2493904, GB2487996 and EP2124945) resulted in the Office deciding to take no action, with no amendments being made to the patent, while for two others (EP1657072 and GB2503963), no action was taken following amendments being made. The remaining five (relating to GB2493904, GB2480275, EP0736030, EP1472164 and EP2018153) are currently awaiting a decision, four of these being within the 3 month review period, with the other one (GB2493904, which I have posted about before here) having been delayed due to arguments and extensions of time.

Although the overall count may change over the next few months once a few more decisions are made, the impression I get so far is that automatic revocation is likely to remain a rare option for the Office to take, and an option that is only taken when the case is very strong and/or if the patentee does not put up any fight. If the case for revocation is strong, a sensible patentee will be well advised to consider making amendments, either before the UK Office or, if applicable, centrally at the EPO. If the case is less strong, the advice would probably be to put up a fight to try to get the Office to back down, which they seem likely to do in most cases.

Tuesday 12 July 2016

Partial Priority - An Alternative View

I have written a lot about partial priority over the past few years (to see all of my posts on the subject, click here), and have always allowed conflicting views to be expressed about the subject, for example in various comments on the subject as well as in this post that expresses a view opposed to my own. The discussion to date has, however, been largely about which side should be taken on the issue of whether partial priority should be allowed for a generic claim, i.e. whether a broad or narrow view should be taken, and always within the framework of the EPC and associated case law. This will, of course, determine the outcome of the currently pending G 1/15 case. There are, however, other perspectives that can shed different light on the subject, one of which has been recently published in epi Information.

The article, titled "The History of Partial Priority System of the Paris Convention", by Kazuo Shibata, a Principal Examiner at the Japan Patent Office, goes through the long history of claiming priority for patent applications, going back to the Great Exhibition of 1851 in London. The author then provides details of the various legal developments, and reasoning behind them, that occurred throughout the world up to the establishment of the European Patent Convention in 1973. A key theme of the article, and what appears to be a favourite subject of the author, is what is described as the "umbrella theory" of priority (illustrated by the picture here, taken from the article). This theory, which apparently originated in Germany, was intended to protect an application from being affected by disclosure of the content of its priority document if it covered a combination of features that included subject matter in the priority document. Interestingly, this protects a combination of A+B as well as A OR B from being attacked by disclosure of A in the priority document.

As the author notes, umbrella theory has not been widely taken up, and appears now to be inconsistent with UK and EPO case law. It does, however, provide an interesting different perspective on the question of whether an invention can enjoy partial priority. The author ends with a scenario that he asks the reader to consider, which is similar to some of the scenarios considered in G 1/15. I my view, the scenario makes sense whether the broad view of partial priority is taken or the umbrella theory view is taken, but the author does not yet have an answer himself. I wonder if anyone else can take a view? Is umbrella theory simply outdated and no longer relevant, or does it have a part to play?

Tuesday 7 June 2016

G 1/15: The wait is nearly over

The EPO Isar building in Munich on a lovely sunny day. 
As I mentioned in an earlier post a couple of months ago, I arranged to get out of the office to attend the oral proceedings for the Enlarged Board (EB) case of G 1/15 on partial priority that were scheduled for 7 & 8 June 2016. As it turns out, the second day is not now going to be needed, because the EB concluded the proceedings at just before 3pm today, following just a few short hours of submissions and brief discussions from each side.

Although the EB did not give any clear indication of how they were going to decide the matter (unlike in lower board of appeal cases, where a decision is normally announced at the end of the proceedings), there were some clues as to how things might turns out. What follows is a brief, and necessarily biased, view of how the proceedings went. It is biased, not only because I have a clear opinion on how the issue should be settled, but because the respondent spoke only in German, with interpretation not being provided for attending members of the public (I even asked, and was bluntly refused, even though there were several spare headsets available), and my understanding of German was just not good enough to closely follow the respondent's speeches. Thanks to other attendees, however, I managed to get at least the gist of what the respondent's arguments were, and they did not seem to be much different to what had already been presented in written arguments and elsewhere. Following several years of discussing the various arguments regarding partial (and poisonous) priority, there was in any case unlikely to be anything that came up today that hadn't already been said somewhere.

The issue, just to remind those that haven't been following this for the past few years, is about whether a claim in a European patent (or application) that does not have a full right to priority can be knocked out by publication of the priority application as another European application. If the European application claims something more broadly than is disclosed in the priority application, can this narrow disclosure be Article 54(3) prior art for the later application? The issue was first set out in 2011, and has been discussed many times on this blog, so I won't say any more about it (you can in any case view all of the relevant posts here if you want to catch up).

Following submissions on the case that were provided by the appellant (Infineum), the opponent/respondent (Clariant) and on behalf of the EPO President, along with quite a few amicus briefs, all of which are summarised in my earlier post here, the EB invited all these parties to the hearing to set out their case. They did not, however, set out any preliminary opinion or agenda of things they wanted to discuss, which was fairly unusual for any Board of Appeal case. Whether this meant that they had already made up their mind and were just going through the motions is impossible to tell, but might I suspect be fairly close to the truth, given how things turned out on the day.

The EB was made up of seven members, with F. Blumer and I. Beckerdorf as legally qualified members, W. Sieber and H. Meinders as technically qualified members, P. Carlson as an external legally qualified member, C. Vallet as a further legally qualified member and rapporteur, and W. van der Eijk as chairman. The chairman kicked off proceedings just after 9am by reading the questions that had been referred to them in decision T 557/13 of 17 July last year (which I wrote about here). These are:
1. Where a claim of a European patent application or patent encompasses alternative subject-matters by virtue of one or more generic expressions or otherwise (generic "OR"-claim), may entitlement to partial priority be refused under the EPC for that claim in respect of alternative subject-matter disclosed (in an enabling manner) for the first time, directly, or at least implicitly, and unambiguously, in the priority document? 
2. If the answer is yes, subject to certain conditions, is the proviso "provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters" in point 6.7 of G 2/98 to be taken as the legal test for assessing entitlement to partial priority for a generic "OR"-claim? 
3. If the answer to question 2 is yes, how are the criteria "limited number" and "clearly defined alternative subject- matters" to be interpreted and applied? 
4. If the answer to question 2 is no, how is entitlement to partial priority to be assessed for a generic "OR"-claim? 
5. If an affirmative answer is given to question 1, may subject-matter disclosed in a parent or divisional application of a European patent application be cited as state of the art under Article 54(3) EPC against subject-matter disclosed in the priority document and encompassed as an alternative in a generic "OR"-claim of the said European patent application or of the patent granted thereon?
The chairman noted the importance of the questions raised, which was emphasised by the submissions provided by the parties and the fact that there had also been 33 amicus briefs filed (which thankfully matches my last count of 36 in all). The EB had studied the submissions and taken note of them, so didn't want to hear all of the arguments again but wanted to hear anything that had not been already set out. This might have made the proceedings very brief indeed, as there really wasn't anything else to say that had not already made it to the file, but all sides had a go anyway, as you might expect.

An important point to note is that the Chairman made it clear the referral was considered to be admissible, because it related to a point of law of fundamental importance and on which there was a clear divergence in the case law. There was therefore no need to discuss the question of admissibility (unlike, for example, the case of G 3/08, which I was to a small extent involved with), and none of the parties raised this in their arguments.

The submissions started with Infineum, whose representative Richard Hart went through the various key points as he saw them relating to the questions. One of the more general points raised was that, from the industry context, it had to be recognised that inventing was difficult and did not stop with the first filing. It was therefore very common for an invention to change, and possibly broadening, during the priority year. Having an effective bar to being able to broaden the resulting claims in a patent would result in the patenting system being far too harsh on the applicant, who typically would have spent a lot of effort getting to the point of filing a patent application, and would have done much else that did not result in one. A strict approach to partial priority could therefore act against the interests of the system, as well as being unreasonable in allowing a patent to act against itself. There was a general principle that the scope of a patent should be commensurate with the contribution. If a broader contribution, backed up by further work in the later filed application, could not be protected, this pulled in the opposite direction.

On the substantive legal points, Mr Hart set out the usual arguments starting from Article 88 EPC, which should be interpreted according to the travaux preparatoires, mentioning the now famous FICPI Memorandum, which set out the legislative intent behind Article 88(2), second sentence. Using the memorandum was one way of figuring out how to interpret the legislation, while another way was to consider indirect interpretations based on the Paris Convention, which the EPC was a special agreement within. Article 32 of the Vienna Convention specified supplementary means as a way of interpreting, which the memorandum certainly was. A key point relating to this is that the examples in the memorandum could only be reconciled with the conceptual approach to partial priority, whereas the strict approach could not. There was then a lot of discussion about Articles 4F and 4G of the Paris Convention and commentary by Professor Bodenhausen, during which the EB appeared to be getting a bit bored, and which I will not bore you further with.

The key points to Mr Hart's submissions appeared to be, as we have seen before, that the conceptual approach is the only one that can be made consistent with everything else, including the concept that the test for novelty is essentially the same as the test for priority. If the tests were to be different, which they would need to be if the more strict literal approach were to be taken, then the test applied for assessing priority would result in nonsensical results for novelty. The proper test was, as with that for novelty, to compare the disclosures and determine the boundary of the claim, then determine what falls within the scope of the claim. The decision in G 2/98 could be viewed, as the respondent had done, that a new more restrictive test was being laid out on partial priority, or that it wasn't. It was, in Mr Hart's view, more likely that the EB in that case were not trying to set out a new test, and that later decisions were simply a misunderstanding of what was meant by "a limited number of clearly defined alternative subject-matters" in point 6.7 of the reasons. The later decision of T 1222/11 was the first one to have properly considered how this should be aligned with the EPC, setting Article 88(2) in its proper context.

After a short break, the opponent/respondent, represented by Mr Mikulecky, was given his turn to set out his case. As I mentioned above, I was not able to follow his arguments very closely, but the gist of his case was that the more strict approach to partial priority should be followed because G 2/98 had set out a new test to be met. The fact that this could not be reconciled with at least some of the examples in the memorandum was, in Mr Mikulecky's submissions, a sign that, although the legislative intent was clear when the EPC was first drafted, times change and the intent changes with them. If I am understanding this correctly, this seems to me like a very strange argument, because if G 2/98 was trying to set out a new interpretation of Article 88(2) EPC it would have said so rather than just referring to the memorandum as expressing the legislative intent without making it clear that this was no longer the case.

Another point made by Mr Mikulecky related to the consequences of taking the strict literal approach. In his submission, these consequences were just a feature of the system, and had to be dealt with by better drafting. If the invention had been broadened out during the priority year, the applicant just had to take more care when preparing the later application to make sure that there was sufficient basis for all separable embodiments. In my view, this is a more sensible argument, although still wrong because it would inevitably lead to applicants having to include ever increasing amounts of what effectively amounts to boiler plate language to make sure that all embodiments were either claimed or disclaimed. This was surely not what the legislator intended, and is definitely contrary to the memorandum, which makes it quite clear that the main reason for allowing multiple priorities is to prevent this sort of thing being necessary.

The EB then gave the EPO President a chance to express his views. Unfortunately, whether out of time pressures or fears for his own safety, the President himself could not be there. He did, however, send a couple of representatives, who did the job for him. As with the written submissions, the President did not make it entirely clear which side of the fence he was on, although it seemed that he was more in favour of the conceptual view than the strict literal view. Apart from some comments about the EPO requiring an approach that was practical and not over complex, and that not allowing priority for a part of a claim that was not spelled out as such was contrary to common practice, the President did not have much further to say of substance. There was, however, a comment about the adverse consequences of following the literal approach, which would inevitably lead to increased complexity in applications and a consequential increase in legal uncertainty for third parties.

After lunch, each of the parties were given an opportunity to respond to what the others had said earlier. Not much of interest was raised at that point, but there was an odd discussion about what would be the consequences of leaving out a chunk of the priority document in a later filing, on which priority depended. I suspect this is not going to be a key feature of the EB's reasoning, so I will leave it there.

Finally, after a short break while everybody went outside as a result of a fire alarm (pictured right; it turned out the EPO was not on fire, and the alarm was probably just some building work setting it off), the EB had a chance to ask some questions. Only five of the members asked any questions, and this took up the final 20 minutes or so of the proceedings. The impression I got from this was that the EB did not really need to know any more from the parties, and had therefore probably already made up their minds. The most interesting question, in my view, came from the Chairman, who asked the respondent how the intent of the legislation could have changed over the 40 or so years since it was prepared. What had made this intent change? The questions, along with the body language of the EB members, which seemed to express boredom with the appellant and annoyance at the respondent, gave me the general feeling that they were largely sceptical of the respondent's arguments.

At the end, the Chairman announced that a decision would be made "as soon as possible" (which raised a small ripple of laughter from the audience), but that this would be by November this year. This fits with the impression I have gathered previously from discussing the issue with people from the EPO, who think that this is an important issue that needs resolving soon. I might as well stick my neck out now and say that I think the decision will be in favour of the appellant, and the answer to question 1 is likely to be either a clear "no" or possibly a "no" with some very limited caveats. The answer to question 5, which I suspect the EB will deal with at least partly as a separate question and not necessarily dependent on question 1, will be a clear "no", regardless of how the answer is arrived at. We now only have a few months to wait. I will, of course, write about it as soon as I hear.

Any comments on the above would be gratefully received, particularly if they go over any points that were raised at the hearing but that I have not covered.

UPDATE 9/6/16: Here's a tweet from me asking for your opinion on what the answer to question 1 is going to be. Just a bit of fun, but it would be interesting to see what your view is. Please vote!

UPDATE 22 June 2016: The minutes of the oral proceedings have now appeared on the EP register here. They are a bit more brief than my report, and the only useful piece of information is the confirmation that the EB will be issuing their decision by November.

UPDATE 25/11/16: An unusual third party observation has just appeared on the register, although it was filed a month ago. It says:
"Die Gro√üe Beschwerdekammer hat in mit dem vorliegenden Verfahren √ľberlappender Besetztung in ihrer Entscheidung Art. 23 1/16 vom 16. Juni 2016, Abs√§tze 39-45 festgestellt, dass sie Drohungen des Pr√§sidenten des Europ√§ischen Patentamtes ausgesetzt sei, die alle Mitglieder betr√§fen,die sie darin gehindert habe, bestimmte Entscheidungen treffen zu k√∂nnen. Auch der Verwaltungsrat habe diese Bedenken nach Ansicht der Gro√üen Kammer nicht ausger√§umt. Auch im vorliegenden Falle war der Pr√§sident durch seine Vertreter in der m√ľndlichen Verhandlung am Verfahren beteiligt, obgleich nicht Partei. Besagte Entscheidung wurde entgegen der ausdr√ľcklichen Anordnung der Gro√üen Beschwerdekammer bis dato nicht ver√∂ffentlicht, ist aber der √Ėffentlichkeit anderw√§rtig zug√§nglich. Ein Organ, das Drohungen ausgesetzt ist, das sich nicht in der Lage sieht seine Verhandlung entgegen anderslautender Absicht √∂ffentlich zu f√ľhren und ihre Entscheidungen der √Ėffentlichkeit zug√§nglich zu machen, ist auch im vorliegenden Falle nicht im Stande eine unvoreingenommene Entscheidung zu treffen. Gegen die gesamte Gro√üe Beschwerdekammer besteht auch im vorliegenden Falle der begr√ľndete Verdacht der Befangenheit, der solange fortbesteht, wie sie disziplin√§r dem Pr√§sidenten bzw, des Aufsichtsrates unterstehen. Sie k√∂nnen in Folge keine wie immer gerartete richterliche Funktion wahrnehmen."
As I understand it, the gist of the argument is that the EB is unable to make an unbiased decision because they have been subject to threats from the President and may therefore be biased. I can't see it having any effect on the decision, which is due to appear any time now, as it hasn't been raised previously, but we shall see.

Latest tweets on G 1/15:

Wednesday 25 May 2016

T 1785/15 - If you're reading this it's too late

The end of the examination procedure at the EPO starts with a communication under Rule 71(3) EPC, which informs the applicant that the examining division is prepared to grant the application on the basis of an accompanying version of the application text. The text intended for grant (a.k.a. the druckexemplar) is typically an assembly of the originally filed application, together with any amendments the applicant has made along the way, and usually with further amendments made by the examiner. Examiners often make amendments to tidy up the application so it complies with the EPC, such as inserting a characterising clause to comply with Rule 43(1)(b), mentioning a relevant document to comply with Rule 42(1)(b) or amending the description to conform with the claims (Article 84 EPC). Normally the examiner's amendments are fairly easy to identify and a decision on whether to approve them is straightforward. If any are not acceptable, for example if the examiner gets something wrong, it is always possible to respond with a request under Rule 71(6) to have them changed. If the changes are minor and unlikely to be a problem, the right to receive a further communication under Rule 71(3) can be waived, and the application can then go on to get granted without further ado.

All this is straightforward and well known, at least to European practitioners. An important point to note is that the communication under Rule 71(3) is the applicant's last chance to get things right before the application gets granted. Approving the text for grant is therefore not something to be taken lightly. Examiners, applicants and even patent attorneys can make mistakes and this is the opportunity to correct any that might have been made. An applicant that responds to a Rule 71(3) communication without first checking carefully that everything is how they want it to be is running the risk of not getting what they want and not being able to do anything about it afterwards. As the Enlarged Board decision of G 1/10 made clear, errors made by the applicant during prosecution cannot be corrected after grant, which can prove fatal to the resulting patent. Possibly more importantly, errors made by the examiner that have been approved by the applicant at the Rule 71(3) stage also cannot be corrected after grant. As stated in G 1/10, the responsibility for any errors remaining in the text after grant is the applicant's alone, whether the error was made by them or by the examining division.

A recent decision, T 1785/15, has emphasised the need to be careful when considering whether to approve the text for grant. The application, 09756869.5, entered the European regional phase in 2012 and the applicant made some amendments to the claims the following year in response to the international written opinion. The examining division then issued a communication under Rule 71(3) in February 2015 with a clean and marked-up version of the text. Substantial changes were made to the claims, together with a few formal changes to the description. The applicant then paid the grant fee and filed translations of the claims into French and German within the usual four month period. Only after a decision to grant was issued did the applicant point out to the examiner that the claims contained errors. By that point, however, it was too late to do anything about it. The applicant's attorney, who somehow got the impression from the examiner that the decision to grant could be appealed, filed an appeal against the decision to grant.

The Board first pointed out that appeals could be filed by any person adversely affected by a decision (Article 107 EPC). By approving the text for grant, the applicant had signalled its approval, leaving no room for the notion that they were adversely affected by the decision to grant. Rule 140 EPC allowed obvious mistakes in decisions to be corrected but, as G 1/10 set out, this was not available for correcting the text after approval by the applicant. The applicant's request for a correction was therefore inadmissible. Normally this would not mean that the appeal fee was refunded, since the applicant should have known that the appeal was hopeless. They had, however, been given the impression that an appeal could be validly filed after speaking with the examiner. The Board therefore decided that the appeal fee could be refunded, even though the appeal was rejected as inadmissible.

This case is another warning, as if it were needed, that the communication under Rule 71(3) should be taken very seriously and the text for grant should be carefully checked before it is approved. The responsibility for this is with the applicant, but applicants are often unaware of the importance of getting things right at this stage and may simply wave an application through, not wanting to spend any more time and money than necessary to get the application granted. The responsibility is then in practice down to the patent attorney, who should always carefully check the text for grant and point out anything that might be a problem, even if this means adding a bit more to the bill, or having to write off some time. Obvious errors or mistakes can then be spotted and corrected before it becomes too late.

Wednesday 11 May 2016

G 1/15 (partial priority) - an update

My post on the G 1/15 amicus briefs, initially written on 3 March, has been amended extensively as the briefs kept on appearing on the EP register. The total, including comments from the EPO President, the patentee and the opponent, has now risen to 37 following a very late submission from Malcolm Lawrence, now of Concerto IP. The drawing on the right is taken from this submission, and is a fairly typical example of how clearly the issue is presented.

As you may recall, Mr Lawrence was in some ways responsible for the whole problem of poisonous divisionals and related issues, which he first raised as an issue in an article for epi information in June 2011, which I commented on here. At the time, no mention was made of Article 88(2) EPC being a solution to the problem, or even being related to it at all. I first raised it as a possible solution in a post in May 2013 here, which has since been given the name "Tufty's Law", although the same reasoning was arrived at a few months earlier in T 1222/11. His latest submissions, which do mention Article 88(2), are typically very wordy, running to a total of 39 pages, including drawings. Thankfully it is only necessary to read the first page to find out what he thinks the answer to question 1 should be, which is a qualified yes. I have not read the remaining 38 pages (as I value my sanity too much, what is left of it) but if anyone reading this has, and finds any interesting points, I would be grateful for any comments pointing them out.

Oral proceedings have been scheduled for 7-8 June 2016 at the EPO in Munich for the Enlarged Board to hear submissions from the parties in the proceedings. A final decision will presumably be arrived at a few months afterwards. Because this is an issue I have been keeping an eye on for several years, I have persuaded myself that it would be good idea to go to Munich to attend the oral proceedings so I can see for myself how the arguments are presented and maybe get an idea of the thinking of the Enlarged Board. A blog post or two will of course be written while I am there. If any readers are going to be there too, please get in touch with me and we can meet up. I can be contacted at tuftythecat at gmail dot com or via Twitter @tuftythecat. I also have a work email address, which is fairly easy to find.

Friday 15 April 2016

Not a Clear Cut Case?

As regular readers will know, I have been keeping a watch on cases where a negative patent office opinion on validity has been issued since October 2014 when section 73 was amended to allow for revocation by the comptroller following an opinion under section 74A finding a patent to lack novelty or inventive step. So far, there has been only one opinion that has resulted in revocation, which I have written about here. Two others resulted in a decision not to revoke the patent, and at the time of writing there are six others that are at various stages awaiting a final decision, including one that in my opinion will inevitably be revoked. One of these six cases involved opinion 10/15, which related to whether the UK part of EP2124945B1 was valid over various documents filed by the requester. The examiner found that the patent was not valid because it lacked an inventive step.

In brief, the invention related to a method of treatment using pirfenidone to treat idiopathic pulmonary fibrosis, the treatment involving a specified escalating dosage regime [as an interesting aside, the very narrow scope of claim 1 of the patent defines the exact dosage regime described in the SPC information for Esbriet (pirfenidone)] . The examiner found that, since everything apart from the specific claimed escalating regime was already known and that there was no proof that the regime had any particular benefits or that there was any technical prejudice against it, the claimed regime was obvious. This finding applied to all of the claims in the patent (of which there were only four). In principle then, the patent stood to be revoked by the comptroller under section 73. The proprietor had, however, the opportunity to request a review of the opinion under section 74B before any action would be taken.

The patent was granted in the name of InterMune, Inc., which was acquired last year by Roche Products Limited in a deal worth apparently £5 billion, and relates to a drug that is a recommended treatment for idiopathic pulmonary fibrosis. It is not therefore surprising that the patent proprietor did not take the opinion lightly and decided to request a review rather than risking the patent being revoked. The result of the review was a decision that issued a couple of weeks ago, BL O/163/16. The proprietor argued that the examiner had got it wrong because he had misapplied the law on inventive step, and in particular by presuming that any new dosage regime would be obvious without there being a clear technical prejudice pointing away from it, referring to this paragraph of the 2008 Court of Appeal decision in Actavis v Merck, which stated that new dosage regimes would nearly always be obvious because it was standard practice to investigate appropriate dosage regimes, and that only in an unusual case, where there was a technical prejudice against the claimed dosage regime, could specifying a dosage regime confer validity on an otherwise invalid claim.

The hearing officer did think that the examiner was wrong in taking the presumption of invalidity as a starting point, but did not think that the opinion was clearly wrong because the examiner had correctly followed the multi-part Windsurfing/Pozzoli test and had carried out a multifactorial analysis based on the material before him. The opinion was therefore not set aside.

What happens now is the interesting question. Given how much money is at stake, the proprietor will presumably not give up and let the opinion stand. To do so would risk getting the automatic revocation process initiated. Instead, I expect they will appeal the decision, which will tie things up for a while. The appeal cannot itself result in revocation but only a final decision as to whether the opinion should be upheld or set aside. If it is upheld, the process could then start all over again, as the patent office will still have the option open to them of initiating revocation of the patent. I wonder though, whether the patent office would decide to do this, given that the patent is one that is clearly worth fighting over, even though it may be (and, I suspect, is) clearly invalid. I suspect the patent office will really not want to get involved in a dispute that could mean having to defend a decision and spend a lot of money doing so. Unfortunately, assuming an appeal is filed, they will be involved anyway. Someone at the patent office might now be thinking that automatic revocation was perhaps not such a good idea after all.

UPDATE 31 May 2016: The IPO has issued a decision stating that no action will be taken to initiate revocation proceedings under section 73(1A). Presumably this means that an appeal has not been filed against the decision to uphold the opinion, which is an interesting approach to take for a patent that is clearly worth a lot of money. Perhaps the patent proprietor managed to find out what the IPO's opinion was on whether action would be taken before they decided not to appeal. Although the patent might not be clearly invalid in the IPO's view, it is at the very least arguably invalid and the negative opinion is there for all to see. I wonder if anyone will now bother to file a proper revocation action?

Thursday 31 March 2016

T 105/11 - A lesson in how not to do it right

A recent decision from the EPO Boards of Appeal, T 105/11, illustrates a couple of points that should serve as a warning to both patent attorneys and EPO examining divisions.

European patent application 05771127.7, in the name of LG Electronics Inc., reached the end of the line as far as the examining division (ED) was concerned, with oral proceedings held on 30 June 2010. The outcome was that the application was refused for lack of inventive step. The ED issued their decision on 29 July 2010, supported by their grounds for the decision. The applicant's attorney wrote back the next month to indicate an error in the decision, noting that the grounds made reference to an auxiliary request that did not exist. The ED then issued what appeared to be a replacement decision on 6 September 2010, with the grounds amended to correct the error. At this point, the question that might immediately come to mind (at least with the benefit of hindsight) is: what was the correct date to take into account for calculating the periods for filing a notice of appeal and the supporting grounds of appeal? Was it the original date of 29 July 2010 or the later date of 6 September 2010 for the corrected version? The patent attorney responsible for the appeal apparently thought it was the latter. Although a notice of appeal was filed on 23 September 2010, which was in due time for both of the dates, the grounds of appeal were not filed until 7 January 2011, which could only be in time for the later date. The EPO initially processed the appeal to indicate that the notice, fee and grounds had been filed in due time, presumably taking the second date as the one to work from. The Board of Appeal, however, took a different view, at least initially. One they got round to finally looking at the case, in a preliminary opinion issued on 27 November 2015 the Board indicated that the ED did not have the power to withdraw a decision and take a new decision, meaning that the second issued decision could not take the place of the first, but could only correct it retrospectively. The appeal therefore appeared to be inadmissible because the statement of grounds was filed late.

In the subsequent appeal decision, the Board cited various decisions (T 1176/00, T 1081/02, T 830/03T 993/06 and T 130/07) where a second decision had been issued incorrectly and had been relied on the the detriment of the parties. In each case the Board had decided that the appeal should be found admissible in view of the principle of the protection of legitimate expectations, given that the parties had in each case been misled into thinking that the date of the decision was different from what it actually was. The Board distinguished this case over the previous cases though, because the appellant had explicitly requested that the written decision be corrected. In the Board's view, "the professionally represented appellant should have been aware that the second decision intended to correct as requested by the appellant itself, the first written decision under Rule 140 EPC" (point 1.8 of the reasons). In other words, the attorney should have known that the second decision was not a replacement decision and did not change the original date. Although it could be argued that the apparent confusion was the result of a legal misunderstanding, it was clear that the second decision was not issued correctly and it was this that the appellant had relied on to count the periods for filing the notice and grounds of appeal. The Board then decided that the grounds were deemed to have been filed in time, although "not entirely without hesitation" (point 1.10).

The reason for the Board deciding in favour of the appellant probably also had something to do with the ED being responsible not only for an incorrectly issued decision but also for a number of errors in the decision itself. Firstly, the ED referred to claims that had been filed on 30 July 2009. The applicant had, however, filed different claims on 25 May 2010 before the oral proceedings. The ED's decision was therefore based on claims that were no longer approved by the applicant. The ED also did not annex a copy of the claims to the decision, as advised in the Guidelines for Examination (E-IX, 5). The ED also did not follow the problem-solution approach in their reasons for finding the application to lack inventive step, contrary to the Guidelines (G-VII, 5), making the decision being insufficiently reasoned in violation of Rule 111(2) EPC. The decision was also, the Board's view, unconvincing in other respects, in particular where they had indicated doubt as to whether the technical problem argued by the applicant actually existed. As the Board noted, it is irrelevant whether or not a problem actually exists in the prior art, as the problem is defined as one given to the skilled person as part of the problem-solution approach. Given the numerous flaws in the ED's reasoning, the Board decided to remit the application to the ED and reimbursed the appeal fee.

Other than spotting that the apparently reissued decision was not the one to be relied on, it is not clear to me what the appellant could have done differently in this case, given the catalogue of errors on the part of the examining division. It looks like this is just one of those cases that will have been very frustrating for the applicant, and one that will probably not be settled for a while yet. Let's hope that the examining division have learned some lessons and do better next time.

Thursday 17 March 2016

T 1727/12 - Biogen sufficiency at the EPO?

As every European patent attorney knows, clarity is not a valid ground of opposition. This does not, however, stop oppositions being filed using sufficiency (Article 100(b) EPC) as a disguise for what would otherwise be a clarity objection. The usual outcome of such an attempt is to cause a bit of trouble for the patent proprietor, but for the opposition division to then dismiss the argument as being unallowable. It is, however, sometimes difficult to separate sufficiency from clarity, as they are to some extent linked together. While clarity relates to the claims being clear and concise and supported by the description (Article 84), sufficiency relates to the application disclosing the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83). If the claims are not clear, and the application does not help to clarify them, then an argument could be made that the skilled person could not reproduce the invention.

In the UK, following the case of Biogen v Medeva in 1996, the law regarding sufficiency is further entwined with clarity, resulting in two types of insufficiency. The first 'classical' type of sufficiency relates to the skilled person being able to reproduce the invention, given the teaching of the application as a whole and the skilled person's common general knowledge. This corresponds most closely with Article 83 EPC. The second type of sufficiency, which is known from the case as Biogen sufficiency, relates to the skilled person being able to reproduce the invention over the whole scope of the claim. Biogen sufficiency is really then about support in the description, which in UK case law relates closely to whether a priority claim is valid. In the disputed patent in the Biogen case, which related to a DNA sequence for causing a cell to make antigens of the hepatitis B virus, the scope of the claim covered the invention as applied to prokaryotic and eukaryotic cells. The priority application, however, only disclosed the invention as applied to bacterial (i.e. prokaryotic) cells. The House of Lords, following Lord Hoffmann's opinion, found that this resulted in the application not being entitled to priority. As a result, the patent was found to be obvious over an intervening disclosure.

It should now be reasonably clear that Biogen sufficiency does not translate well to opposition proceedings at the EPO, because it is tied up with other issues such as clarity and priority. If arguments of the type raised in Biogen v Medeva were raised during opposition, a counter argument would be that these relate to clarity rather than sufficiency and should therefore be dismissed. This did not, however, stop the opposition division in the case of proceedings relating to EP1767375 from raising Biogen sufficiency as a ground for revoking the patent.

The invention in question related to a tape drive for a transfer printer (like the one shown here from Videojet), in which tension on the tape was monitored and maintained between predetermined limits by controlling motors driving a pair of spools. Claim 1 did not specify how the tension was measured, but claim 3 provided means to monitor power supplied to the motors, and claims 4 and 5 provided further detail on how the power was measured. If all this seems vaguely familiar, this is because the case related to a patent that was revoked in the UK in the case of Zipher v Markem in 2008, which was only one of a number of cases involving these parties. The opposition proceedings against Zipher's European patent (since transferred to Videojet Technologies, Inc.), which were initiated around the same time as the court proceedings in the UK, have taken a whopping seven years to complete, with the final appeal decision in T 1727/12 issuing last month.

At the conclusion of the opposition in July 2012, the opposition division's sole ground for revocation was sufficiency, as summarised by the following paragraph in the grounds for the decision:

The patent proprietor appealed against the decision, arguing that it was not clear what the OD meant by 'Biogen sufficiency' (although their representative, being a UK based patent attorney, would obviously know what it meant under English law). More importantly though, they argued that the objection was without  foundation on the facts of the case. Although claim 1 was broader than the specific description, the skilled person would, the proprietor argued, easily be able to realise the invention using the specification and common general knowledge.

As the Board of Appeal put it, the OD had distinguished between 'classical insufficiency' and 'Biogen sufficiency'. They had found the invention to be disclosed sufficiently clearly and completely for the skilled person to carry it out, thereby fulfilling the classical sufficiency requirement under Article 83. What they had considered the invention to lack though was sufficiency in the sense that the skilled person would not be able to carry out the invention over the whole scope of the claim, since the patent did not disclose other ways of carrying out the invention than those defined in the dependent claims. The Board considered, however, that Biogen sufficiency, as defined by the UK House of Lords, related to Article 84 EPC and not to Article 83, given that the underlying purpose was the requirement for support by the description to ensure that the patent monopoly was justified by the actual technical contribution to the art. The Board was not convinced that the OD had justified the use of Biogen sufficiency in relation to Article 83, and concluded that they had not shown that the patent failed to comply with Article 100(b). Since there were other issues that were left open, including novelty and inventive step, the Board remitted the case to the OD to take a look at these.

What made the OD in this case pull Biogen sufficiency out of the hat to justify revoking a European patent is a mystery to me. Even if it was relevant to the case, using a principle of a national court in proceedings at the EPO is to say the least a bit unconventional. It also looks as if the OD did not even understand what the principle was about. As well as establishing that Biogen sufficiency is not something that should be used in EPO oppositions, the case demonstrates that sufficiency arguments at the EPO, whether raised by the opponent or the opposition division, should be a bit more substantive than simply arguing that the skilled person would not be able to do the invention in another undefined way. Such arguments should rightly be dismissed as being invalid grounds of opposition.