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 ­ŁŤŻ-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". 


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?