Wednesday, 8 February 2017

UNION-IP Round Table: Literal Infringement and Doctrine of Equivalents

A long time ago, while I was training to be a patent attorney I was briefly involved with an application that faced a difficult problem, which was how to ensure that the claims of the application covered a possible infringer. The application (or rather its parent application, as the one I was dealing with was a divisional) was originally drafted as a US patent application, and described a type of device known as a PFO occluder (specifically this one). A patent had already been granted, EP0808138B1, covering the basic form of the device, claim 1 of which read:
A collapsible medical device (60) comprising a metal fabric formed of braided strands, the device (60) having a collapsed configuration for delivery through a channel in a patient's [body], and has a generally dumbbell-shaped expanded configuration with two expanded diameter portions (64) separated by a reduced diameter portion (62) formed between opposed ends of the device, characterized in that clamps (15) are adapted to clamp the strands at the opposed ends of the device.
The Amplatzer PFO Occluder
The claim covered a type of device known as the Amplatzer PFO occluder, marketed by St. Jude Medical. A key feature of the device is that clamps are provided at each end, which serve to keep the strands of wire together.

The Occlutech alleged infringement.
The alleged infringing device, made by Occlutech GmbH, was in most ways similar to the Amplatzer device but a key difference was that this device (also shown here) did not have a clamp at its distal end. This is because the device was made using a different technique that, rather than making the device from a continuous tubular braid, formed it as a closed-end sock shape, with the wires at the distal end crossing over and turning back on themselves. No physical clamp was therefore necessary at the distal end.

The question, which was put before courts in the UK, Sweden, the Netherlands and Germany (see also here for a summary of the cases), was whether the claim above could be construed to cover the Occlutech device. On a straightforward literal interpretation it clearly couldn't, because the Occlutech device didn't have a clamp at both ends, but only at one end. Could it, however, be infringed based on a doctrine of equivalents? This is the subject of an upcoming "Round Table" session organised by UNION-IP, to be held in Munich on 24 February (regular readers will recall that I attended and presented on partial priority at the event last year, which I reported on here). Details of this year's session are provided below.

For more information and how to book, please see the UNION-IP website.

UNION-IP Round Table Program, February 24, 2017 
Literal infringement and the doctrine of equivalence from a European perspective - How should one draft patents that are infringed? 

The landmark decision "Occlusion device", rendered by the BGH, started intense discussion amongst practitioners as to how to draft patents that can be successfully enforced. UNION-IP picks up this discussion, and connects together the jurisprudence which has been developed since the Occlusion device decision regarding the questions of literal infringement and doctrine of equivalence when drafting patents with a European perspective.

What lessons need to be learned? What are the pitfalls to be avoided? In brief, how does one draft a patent that can be infringed? We will hear views from experienced judges, litigators and patent attorneys on these points.

08:15 - 08:45 Registration
08:45 - 09:00 Welcome words
Luigi Franzolin, President UNION-IP, Mr. Rothe GPTO 
09:00 - 09:45 Do's and Don'ts under Dutch Case Law Experiences from the judge's bench
Edger F. Brinkman, Senior Judge IP Court of The Hague, NL 
09:45 - 10:30 Do's and Don'ts under German Case Law Experiences from the judge's bench
Judge Dr. Hermann Deichfuß, Federal Court of Justice, DE 
10:30 - 10:50 Coffee Break
10:50 – 11:35 Pitfalls and lucky punch Practical insight from the perspective of the telecommunication industry
Thomas Burchardi, Senior Patent Attorney, Ericsson GmbH 
11:35 – 12:20 Pitfalls and lucky punch  - Practical insight from the perspective of the pharmaceutical industry
Marco Riensche, Principal Patent Attorney, Novartis AG and Marco Fachini, Senior Patent Attorney, Sandoz Inc. 
12:20 - 13:05 Pitfalls and lucky punch The attorney's view
Sabine Agé, Veron & Associés, Lawyer, FR 
13:05 - 13:30 Q&A and closing remarks
Jochen Kilchert, Meissner Bolte, President Patents Commission UNION-IP, DE 
13:30 - 15:00 Get Together

Thursday, 2 February 2017

G 1/15 - The Wait is Over

Back in 2011 I wrote about a potential problem that had been identified to do with priority and EP divisional applications. This problem was confirmed a couple of years later, after which I had a think and came up with a solution. This turned out to be similar to a solution that was considered by the EPO Boards of Appeal in T 1222/11. This was not, however, the end of the story.

The problem, put simply, is that if a European application claims an invention more broadly than is disclosed in a priority application, can partial priority be allowed for what is disclosed in the priority application. If not, then the priority application, if it also publishes as a European application, becomes A54(3) prior art and knocks out the claimed invention. If partial priority is allowed, then the problem goes away (for reasons given here). The Enlarged Board in G 2/98 set out a proviso regarding when partial priority would be allowed under A88(2), which was only if it gave rise to a "limited number of clearly defined alternative subject-matters" (point 6.7). The meaning of this has been argued over for the past few years and a referral was made in August 2015 to the Enlarged Board in T 557/13, which asked the following question:
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?
The referral, which was numbered G 1/15, generated a lot of interest, as evidenced by the number of amicus briefs filed, as well as the number of comments received on this blog. Most of the briefs recommended a 'no' answer to question 1, which would cause the problem to go away. Following a hearing in June last year, the Enlarged Board issued an order that gave the following answer to the question:
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 far as I could see, this made the problem go away. There would no longer be any issue over partial priority and possible collisions between a priority document and a European application. Simply answering the question, however, was not the full story. The Enlarged Board has now issued their full reasoned decision, which has just appeared on the EP register here.

The decision goes over all of the arguments put forward along the way, which regular readers will already be well aware of (see the links above to previous posts). What the key question concentrates on is what was meant in G 2/98 by "a limited number of clearly defined alternative subject-matters", and how this could be aligned with the EPC and with the famous FICPI Memorandum that apparently expressed the legislative intent behind A88(2). I have tried to make it clear on this blog that the examples in the Memorandum must be consistent with any interpretation of A88(2), and partial priority should be assessed accordingly. Others, including the respondent in G 1/15 have effectively argued that this does not need to be the case.

The reasoning in G 1/15, as you would expect, starts from basic principles of priority, and develops towards the principles of partial and multiple priorities, leading up to the Memorandum, which defined examples where multiple priorities should be allowed in a single claim. The Enlarged Board thankfully make it quite clear that the Memorandum is indeed consistent with A88 and the Paris Convention, and then lead up to the inevitable consequence that the proviso in G 2/98 "cannot be construed as implying a further limitation of the right of priority" (point 5.3). This is enough in itself to reach a 'no' answer to question 1, but the Enlarged Board go on to lay out in clear terms how partial priority should be assessed. This is laid out at the end of the reasons for the decision, at points 6.4 to 6.7, which state:
In assessing whether a subject-matter within a generic "OR" claim may enjoy partial priority, the first step is to determine the subject-matter disclosed in the priority document that is relevant, i.e. relevant in respect of prior art disclosed in the priority interval. This is to be done in accordance with the disclosure test laid down in the conclusion of G 2/98 and on the basis of explanations put forward by the applicant or patent proprietor to support his claim to priority, in order to show what the skilled person would have been able to derive from the priority document. The next step is to examine whether this subject-matter is encompassed by the claim of the application or patent claiming said priority. If the answer is yes, the claim is de facto conceptually divided into two parts, the first corresponding to the invention disclosed directly and unambiguously in the priority document, the second being the remaining part of the subsequent generic "OR"—claim not enjoying this priority but itself giving rise to a right to priority, as laid down in Article 88(3) EPC.

This also corresponds, logically and exactly, to the scheme described in the Memorandum (see point 5.2 above): "If a first priority document discloses a feature A, and a second priority document discloses a feature B for use as an alternative to feature A, then a claim of the application directed to A or B will in fact consist of two distinct parts A and B respectively, each complete in itself...", and further: "... it would be appropriate to claim a partial priority in situations corresponding to the "OR"-situation under "Multiple Priorities", the European patent application itself taking the place of the second priority document".

The task of determining what is the relevant disclosure of the priority document taken as a whole, and whether that subject—matter is encompassed by the claim in the subsequent application, is common practice in the EPO and among practitioners of the European patent system and as such should not pose any additional difficulty. Nor does it create uncertainty for third parties, as argued by the respondent and in some amicus curiae briefs. Although it can be a demanding intellectual exercise, the decisions reached in cases T 665/00, T 135/01, T 571/10 and T 1222/11 all show that it can be carried out without any need for additional tests or steps.

From this analysis it follows that the assessment of entitlement to partial priority right does not show that any additional requirements are needed.

Just to make it clear, here is a simple flowchart I have created that defines the process to follow when considering whether partial priority should be allowed.
It should go without saying, but I'll say it anyway, that this is what I have been arguing in favour of all along. It should also go without saying that this decision really does put the final nail in the coffin for poisonous divisionals and poisonous priority. Conventional best drafting practice is still acceptable, and we can carry on as before.

Tuesday, 24 January 2017

Why amend an expired patent?

The maximum term of a UK patent, according to section 25 of the UK Patents Act, is 20 years from the date of filing of the application. If renewal fees continue to be paid, the last day of a patent's life will be on the day before the 20th anniversary of the date of filing. In the case of EP0736030, which was filed on 20 December 1994 and granted in 2001, the patent expired on 19 December 2014. The patent, titled "Tetrahydrofuran Antifungals" claimed the compound shown here on the right (with some optional features for X and R1).

The compound was apparently worth protecting a bit more, so a Supplementary Protection Certificate was applied for, and granted. SPC/GB06/007, granted in 2007, extended the protection by the usual five years beyond the expiry date of the patent, i.e. until 19 December 2019.

In April last year, two requests for an opinion were filed in relation to the patent and the related SPC, the requester alleging that the patent was invalid due to lack of novelty or inventive step. The requests were dealt with together, since validity of the SPC depended on validity of the patent, and resulted in opinion 09/16 & 10/16, issued on 31 May 2016. The examiner found that claims 1 to 4 of the patent were lacking novelty, but that claims 6 to 19 were novel and inventive. As is now allowed under section 73(1A-C), the comptroller initiated revocation proceedings on the patent, giving the proprietor (Merck Sharp & Dohme Corp.) until 21 December 2016 to respond. The proprietor responded, stating that they were "somewhat surprised" that the comptroller might consider revoking their patent, since it had already expired and that third parties were "unaffected by the validity, or otherwise of an expired patent", and suggesting that the only reason for amending an expired patent would be bureaucratic. They also questioned whether "otiose actions of this kind were in the mind of Parliament when S.73(1A) of the Patents Act was enacted". They did, after all this protesting, nevertheless submit amendments that limited the patent to the claims that were found to be allowable, and which also still covered the product covered by the SPC.

What I find surprising about this case is not the fact that revocation was initiated on an expired patent, but that the proprietor was apparently surprised by this possibility. An expired patent can still be used against third parties, since it could be used to claim damages for past infringements that took place while it was still alive. It can also be used to support an ongoing SPC, as in this case, so initiating revocation proceedings would be very relevant, particularly if they resulted in the SPC being knocked out as a result of the patent being found invalid. The fact that in this case the patent could be amended so that it was found to be both valid and still capable of covering the product protected by the SPC is something of a lucky break for the patent proprietor, but I don't think that this means the action was otiose at all.

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 𝛽-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".