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". 

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 M├ędecins 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?