Wednesday, 17 June 2015

Opinions & Revocation - Continued

Earlier this year I wrote about the first couple of Patent Office opinions under section 74A that issued under the new provisions of section 73(1A)&(1B), where the comptroller now has the option of initiating revocation if an opinion finds a patent to lack novelty or inventive step.

The question I had at the time was how the comptroller would decide where initiating revocation proceedings would be justified. The two opinions issued so far seemed to me to be fairly "clear cut" (in the words of the Office's own guidance on the matter), since both found claim 1 of the patent to lack novelty over a prior publication. I therefore expected that we should see the first action to initiate revocation shortly after the 3 months period for requesting a review expired on the first one, which was in April (no review was requested).

After a couple of months to think about it, the Patent Office has now written to the proprietor in a letter dated 12 June that states in part:
"Whilst opinion [23/14] did conclude that your patent was invalid the comptroller does not consider it appropriate to initiate revocation proceedings against your patent.  
You should note that the decision not to initiate action under section 73(1A) does not alter or set aside the conclusion in the opinion. You may still wish to amend your patent."
The opinion, which was written by a senior examiner, was quite clear in finding that claim 1 lacked novelty over a prior published Chinese utility model publication. This makes me wonder what it would take for the comptroller to decide when a case met the "clear cut" criterion. How clear cut does it have to be? There is no real further guidance in the Manual of Patent Practice, which simply states that the group Deputy Director (DD) "should consider whether action under section 73(1A) is necessary. Action under this section should only be initiated if the DD considers that the patent is clearly invalid due to lack of novelty or inventive step. The opinion should be considered but the DD is in no way bound by it". Based on this, it appears that the comptroller could decide not to take action for any reason at all, however subjective it might be. This does not sound to me like a good way to implement the new provisions.

Perhaps we will know more when a decision is made regarding the second opinion that resulted in a finding of invalidity, which should issue soon. The situation at the moment does appear to be in need of some clarification.

Friday, 17 April 2015


Those of you who are already up to date on the issues surrounding partial priority and poisonous divisionals (the latest state of play on which is summarised here) can safely ignore this post. Others who have a more masochistic disposition may wish to read on.

The issue of poisonous divisionals was first raised by Malcolm Lawrence in 2011 a few years ago while he was at HLBBshaw (since rebranded as Avidity). The original paper on the subject was published in issue 2/11 of epi information (which is available here). It has since prompted a lot of discussion, mostly among patent professionals in Europe. I have written about it a few times over the past few years, and have proposed a general solution that is in line with two decisions from the EPO Boards of Appeal. Since the latest development of a referral to the Enlarged Board, there has been nothing further to note on the subject, as we can now wait for the questions to be raised and then answered by the Board before we see what can or should be done about the issue. Or so I thought.

Mr Lawrence, however, thinks there is a lot more to say on the subject, and to prove it has written another article in this month's epi information (available here). This runs to just over 12 pages, and is (as usual) not an easy read. I would not bother to comment, as it doesn't seems to be actually saying anything new, but it does make lots of references to an article I co-wrote in the December 2013 issue of the CIPA journal (a preprint copy of which is available here; the relevant points made are also detailed in these two posts: here and here), which put forward opposing viewpoints on the partial priority issue in light of G 2/98. In essence, the issue boils down to whether you take a narrow or a broad view of the requirement stated in reason 6.7 of G 2/98, which states that multiple priorities are allowed "provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters". The narrow view is that there needs to be basis for each of the alternative subject-matters, in a similar way as this would be required if the claim were to be split up into separate claims, and that a limited number would probably not apply to continuous ranges. This view inevitably gets bogged down in all kinds of complications about disclaimers and what is actually disclosed in the as-filed application. The broad view (being my own view), which takes support from the FICPI memorandum cited in G 2/98, is that it doesn't make sense to get involved with basis for amendments and disclaimers because no amendment is necessary, which I pointed out in my earlier post about imaginary claims here. As I stated in my article:
"The only criteria required would be: i) that the claim scope entirely encompasses the priority disclosure; and ii) that there is no issue regarding public disclosures between the priority date and the date of filing of the application. Provided such criteria are met, and of course all other requirements of the EPC are met for the claim scope (in particular Article 83 EPC, as the broader scope would need to be justified by the application as a whole), the validity of a partial priority would defuse any possibility of the priority application, if published, becoming Article 54(3) prior art. This is because the published priority application would not be prior art for the portion of the claim scope having a valid claim to priority, while the rest of the scope of the claim would inevitably be novel. It must be emphasised, however, that this is only applicable when there are no intervening public disclosures within the scope of the later broader claim but outside of the scope of the earlier disclosure, since the only solution to this would be to amend the scope of the later claim."
To me, this seems pretty straightforward. Provided these criteria are met, the issue about poisonous priority simply goes away, and should never have been an issue in the first place. Mr Lawrence, however, seems to think otherwise, and apparently disagrees with me, stating in footnote 33 to his article (he is very keen on footnotes; there are 62 in all) that the above solution is not correct, but fails to explain how. He also considers that too much weight is attached to the FICPI memorandum in my article (see point 1.1.5), but again fails to explain why this is wrong, other than offering an assertion. He goes on to provide some examples, one of which is illustrated using a hypothetical chemical case (see the figure and table on the right, taken from page 29 of the article). Why it has to be chemicals is a bit beyond me, as the point would seem to be the same with any numerical values. It then all gets a bit complicated, with lots of talk about different domains, targets and missiles, which all seem to be deliberately designed to confuse the reader. While there might be a valid point in there somewhere, I'm afraid I am currently at a loss to see how he has shown that my general solution is wrong. The concluding remarks in the article, referring to "challenging algebraic thinking" suggest that the author thinks the issue is indeed a lot more complicated that I might have thought. I cannot see how this is the case, but perhaps I'm just not clever enough. Can anyone illuminate further?

Thursday, 19 March 2015

Time-Lapse IVF & Article 53 revisited

I wrote a while back about a journal article and subsequent opposition to European patent EP2430454, which claims a method of assessing competence of a human embryo through measurements of time intervals between the first few cell divisions (an illustration of cytokinesis is shown on the right, taken from this web page). The opposition, filed jointly by the European Society of Human Reproduction and Embryology and the authors of the journal article (one of whom happens to be a European Patent Attorney), argued that the patent claimed a diagnostic method that was excluded under Article 53(c) EPC. The problem with this, as I explained at the time, was that the Enlarged Board of Appeal determined in G 1/04 that for a claim to fall within the Article 53(c) exclusion (which at the time was Article 52(4)), it required all of the following features to be present:
(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.
Step (i) of the requirements is clearly missing from the claimed invention, so it seemed fairly clear to me at the time that the opposition would inevitably fail, for the obvious reason that an opposition division would not make a decision that was clearly contrary to a decision of the Enlarged Board.

Following a response from the patent proprietor and a further response from the opponent, the opposition division has now decided to hold oral proceedings at 09:00 on 30 November 2015 at the EPO in Munich (which will be open to the public). The proceedings are expected to last two days.

The opponent's main argument is explained in my earlier post here, and is set out in their opposition here, as well as in the journal article here (to which I responded in a letter in the same journal here, to which the authors responded here, all of which are mentioned in the opposition proceedings as document D12). The opponent has, however, since then expanded on their reasoning as to why they consider the exclusion should apply. Their letter explaining this is available here on the EP register. Some of the argumentation is unusual, to say the least. In response to the argument that G 1/04 required there to be a diagnosis for curative purposes, the opponent has stated:
We accept that these requirements might possibly be inferred from opinion G-1/04. However, to the extent that that may be the case, we respectfully submit that the Enlarged Board erred in suggesting these requirements and we ask the opposition division to hold that these are not in fact requirements for a claimed method to be to an excluded method of diagnosis.
They then go on to explain why G 1/04 was wrong in deciding that a diagnosis would need to be made for curative purposes. In support of this, they have obtained signed statements from 29 physicians across Europe, who have all stated that there can be a medical diagnosis in a human subject without that condition being a disease condition, and even if no curative treatment is known.

The opponent seems to acknowledge that their chances of success are slim, as they then go on to state that "Whichever way you decide, an appeal will almost certainly be filed, and at the appeal stage we fully expect that a referral to the Enlarged Board will be sought. Addressing the Art. 53 EPC point now thus offers to expedite the final disposition of the opposition". How they think a referral to the Enlarged Board would be justified, given the decision in G 1/04, is beyond me but they are of course welcome to have a go. I would guess that any question would have to be along the lines of whether a "diagnosis for curative purposes" requires there to be a condition for which it is possible to determine a treatment.

For what it's worth, my prediction is that on 30 November the opposition division will decide to reject the A53(c) ground. If the opponent appeals the decision, the Board of Appeal will then, after about 2 or 3 years, decide to dismiss the appeal on the grounds that G 1/04 was quite clear on this point, and will not refer any question to the Enlarged Board. The patent might, however, be revoked on the more conventional grounds anyway, so this issue will probably not be up for discussion if the patent does not survive the novelty and inventive step attacks.

UPDATE 20 March 2015: Now that the summons itself has appeared on the register (here), it appears I was jumping the gun a bit in originally saying that the OD would only be considering the A53(c) objection at the summons. They will in fact be considering all grounds of opposition raised. The post above has consequently been edited a bit compared to the original version published yesterday. Interestingly, the OD will also be considering the additional ground of A53(a) of their own volition,  because neither opponent has raised it. The OD states that the claimed invention "may be regarded as involving the use of a human embryo for industrial or commercial purposes" (point 3 of the annex to the summons), and raise this for discussion without coming to an opinion one way or the other. It is surprising this was not picked up by the second opponent, although I can see why the first one would not want to raise it even if they had considered it. The preliminary view of the OD appears to be that the A53(c) exception does not apply, given the narrow scope indicated by G 1/04, but that A53(a) might.

Thursday, 12 March 2015

Opinions & Revocation

Since 1 October 2014, when section 16 of the Intellectual Property Act 2014 came into force, amending section 73 of the Patents Act 1977, it has been possible for the comptroller to revoke a patent following an opinion finding the patent to lack novelty or inventive step. This has substantially extended the comptroller's power to take action on his own initiative, which previously was only possible to prevent double patenting. Under the law as it stood prior to October 2014, the only other way to get a patent revoked would be to apply for revocation, either to the patent office or the court. Applying for revocation, however, is a tricky business and can lead to all kinds of complications, not least of which are high costs to pay for lawyers, together with potential exposure to at least some of the other side's costs if the case does not go your way. It is therefore not something to be taken lightly, even if your case seems to be watertight and the patent clearly invalid.

Under new section 73(1A)-(1C), if an opinion is issued that finds a patent to be not novel or to lack inventive step, the comptroller may revoke the patent. He must, however, wait until the patent holder has had an opportunity to request a review of the opinion, which can be done within 3 months of the opinion issuing, and cannot proceed until any review, and any subsequent appeal, has been disposed of. If, of course, the review finds the opinion to be wrong, it will be set aside and no action will be taken.

Once the comptroller decides to take action to revoke the patent, he has to give the patent holder an opportunity to make any observations and to amend the patent. Importantly, this procedure happens only between the Patent Office and the patent holder. The person who made the request for an opinion is no longer a party to the proceedings. They can, however, oppose any amendments requested under section 75, which are always advertised before they are made (although typically with a very limited 2 or 4 week period to file any opposition).*

The upshot of all this is that a person who has what they think is a solid case for knocking out a patent in the UK now has potentially an entirely risk-free way of getting rid of the patent by simply requesting an opinion on validity and waiting to see what happens. If the examiner agrees with the requester, the patent could then be knocked out, or at least amended, without any further action needed by the requester of the opinion and with no potential for a costs decision being made against them (even if the patent is only limited and not revoked in full). For those who do not want to get into an expensive procedure just to get rid of an inconvenient, but clearly invalid, patent, the new law seems to be a very good option indeed.

At the moment, we do not yet know how the new procedure will work in practice. The IPO have indicated that they will only act "in clear-cut cases where the patented invention clearly lacks novelty or an inventive step". What does "clear-cut" mean though? What is the difference between a patent lacking novelty and clearly lacking novelty? We may find out over the next few months, as two opinions have now issued that have found patents to lack novelty and inventive step.

The first of these, Opinion 23/14, was requested on 24 October 2014, and issued on 21 January 2015. The request was made regarding validity of GB2493904, granted to Actegy Limited and relating to an "apparatus for electrical stimulation of a foot" (or more likely a pair of feet, as seems to be clear from the illustration of the product shown on the right, and available here). The examiner found the  patent to be not novel over published Chinese utility model CN200973920Y relating to a "foot-care and body-beautifying machine with electromagnetic waves". According to Rule 98(1), the patent holder has until 21 April 2015 to request a review of the opinion. If no review is requested, or if any review does not result in the opinion being set aside, the comptroller may decide to revoke the patent.

The second is Opinion 25/14, which was requested on 13 November 2014 and issued on 11 February 2015. The request was made regarding validity of GB2497956, granted to J. C. Bamford Excavators Limited (more widely known as JCB, famous for making machines like the one shown on the left) and relating to a hydraulic system with kinetic energy recovery and storage device. The examiner found that the independent claims of the patent were not novel over US3485037 and were obvious over other documents cited by the requester. The patent holder has until 11 May 2015 to request a review.

In each case, the examiner's finding seems to be pretty clear in finding a lack of novelty of at least the independent claims of the patent. If the opinions are not set aside following a review, I would have difficulty seeing how either case could be anything other than "clear-cut" cases where revocation under section 73(1A) would be inevitable. We will, however, have to wait and see to find out whether the comptroller agrees.

*This turns out not to be correct. Any amendments made as a result of objections under section 73 are not advertised and are not subject to opposition. Only proposed amendments under sections 75 and 27 are advertised.

Saturday, 21 February 2015

Missing bits

Electronic filing is now the standard way to do most things at the European Patent Office, apart from the obvious exceptions where an appearance in person is required. The EPO's online filing software platform, although not perfect, is generally pretty good. Provided you can get around the extremely picky technical requirements for what documents it will accept, it is fairly straightforward for a reasonably IT-competent person to prepare and file an application, examination report response, opposition, appeal or whatever else takes your fancy. Secretarial support is often useful, and can save time in dealing with the mechanics of creating and uploading documents and entering details, but it is of course critically important to remember that it is the patent attorney who remains ultimately responsible for what is uploaded and sent using the software.

A key feature of the EPO's online filing software is the use of a smart card (like the one on the right). These are issued, free of charge, to attorneys and their support staff. Only attorneys are able to sign documents using the software, but support staff can use smart cards to send documents that have already been signed. The EPO have this to say about why they use smart cards and how secure they are:
Smart cards are credit card-sized plastic cards that contain a microprocessor and a small amount of memory.

The EPO decided very early on in the planning process for its online services that the certificates which would allow users to conduct secure transactions with us would be stored on smart cards. Unlike passwords, smart cards allow us to provide the more secure two-factor authentication, comprising something that is held (the card) and something that is known (the PIN.) Two-factor authentication means that PINs can be simpler and therefore easier to remember than with a password, since, without the card, the PIN is useless, and vice versa. Also, the simpler PINs are not susceptible to brute-force attacks because the smart card locks out after several unsuccessful attempts to enter the PIN.

In addition to being small and portable, smart cards afford a much higher level of secure storage for certificates than, say, if they are stored on a hard drive. They offer tamper-proof storage of the user's private keys and digital certificates, are highly resistant to unauthorised deletion or copying of the certificates and keys, and any attempt to tamper with them requires significant effort which would invariably result in physical damage to the cards themselves. Also, it is easier to spot the loss or theft of a card than of a certificate stored on a computer.
It helps here to know a little bit about how public-key cryptography works. When you want to send an electronic document securely to another person, but the transmission path is insecure (for example over the internet), the document needs to be encrypted somehow. If you and the recipient have a code that only you and they know, you can use this code to encrypt the document and the recipient can use the same code to decrypt the document at the other end. Someone obtaining the encrypted document along the way would only be able to get at the document if they either know or can work out the key. This is known as symmetric cryptography. The downside of this is that the key for encryption and decryption needs to be kept secret, as well as being shared by the sender and recipient. This is obviously difficult to achieve, particularly when the parties are far away from each other. A better way is to make the encryption and decryption asymmetric, where a different key is required to encrypt and decrypt. The sender can then encrypt the document using a public key, and the recipient can decrypt it with their private key. The encryption key can safely be made public, since knowledge of one cannot easily result in knowledge of the other (unless perhaps you know an easy way of factoring large numbers into primes; fame and fortune awaits if you can do it). The advantage of this is that anyone can find out a public key, and can encrypt and send documents to the recipient without needing to share anything with them beforehand.

The EPO's online filing software uses asymmetric cryptography, but in a different way. Instead of using a public key to encrypt an electronic document, the sender (i.e. the patent attorney) uses a private key, which is accessible via their smart card in combination with a secret PIN, to sign (i.e. encrypt) the documents to be sent to the EPO [this is not quite how it works, as explained in one of the helpful comments below, but the general principle is the same]. Since these documents can only be decrypted by the other (public) key, this provides an assurance that the documents were signed by the person authorised to do so. This is known as non-repudiation, and is of course an essential feature in ensuring that whoever signs is taking responsibility for what is being sent. Another feature inherent in this system is that the signed documents can only be sent in their entirety, and cannot be amended in any way once they have been signed. This allows another feature of the EPO's online filing software to work, which is that an electronic receipt is issued once a signed set of documents is successfully received by the EPO. This receipt always includes a "Message Digest", which is a string of hexadecimal codes that is uniquely derived from the content of what was transmitted, presumably the result of a hash function performed on the signed documents.

All this should be fairly simple for a patent attorney to understand, particularly if they deal with anything computer-related in their day to day work. Once the basic principles are understood, it should be clear that electronic filing, as well as providing a convenient way to transmit documents to the EPO, provides much greater assurance to the sender that what was sent has actually been received. Compared to the old way of doing things, where a set of paper documents would be signed off by the attorney and then be passed through several pairs of hands before arriving at the EPO, electronic filing provides much more assurance to the nervous attorney who might be worried about getting things done correctly.

All this is by way of introduction to a recent EPO Boards of appeal decision T 1101/14, which I noticed on the PatLit blog here. The case relates to EP application 08743225.8, which was refused by the examining division in December 2013. The applicant then appealed the decision, their attorney filing a notice of appeal the following month. The attorney then filed a statement of grounds of appeal, together with several sets of claims as main and auxiliary requests. Shortly afterwards, the EPO issued a formalities report, indicating that the grounds of appeal had not actually been filed. What had been sent was only a one page cover letter, and the statement of grounds with the supporting arguments had not been included. The attorney then requested re-establishment of rights, arguing that the missing grounds had been the result of "an isolated error of a suitable experienced and normally reliable secretary". The attorney had not noticed that the grounds were missing, but argued that "the two errors were uncharacteristic and isolated mistakes in an otherwise secure system". The board indicated that they had no doubts regarding the professional qualifications of the secretary, nor of the quality of supervision by the representative, but considered that "signing the wrong documents is incompatible with all due care unless special circumstances are invoked which could justify the representative's mistake in a particular case, thus following the cited reasons of T 1095/06" (point 6.5 of the reasons). In this case, there were no such special circumstances, and the request for re-establishment was refused.

Among the arguments submitted by the attorney was one that struck me as being quite odd. This was summarised in point 2.3 of the reasons, relating to why the attorney had not noticed the error when the filing receipt indicated only two pages in the letter of appeal and did not indicate the presence of a 12 page document. The board stated:
The representative has however argued that she does not - and is not required to - check the electronic acknowledgement of receipt, as this is a secretarial task. She explained that, according to the procedure for elec­tronic filing used in her office, the primary pur­pose of the acknowledgement of receipt is to confirm that the documents received at the EPO tally with the trans­mitted ones so that, in the case of a transmission problem, some or all of the documents can be sent again.
Given the explanation I have provided above of how the online filing software works, this seems to me to indicate such a basic lack of understanding that the error resulting in the missing grounds of appeal was almost bound to happen at some point. Contrary to the view expressed by the attorney, it would never be the case with online filing that only some of the documents would be sent. Instead, it can be either all or nothing. If a filing receipt is issued, this is a definite indication that what was signed was received by the EPO. Electronic filing does not work in the same way as operating a fax machine, where sometimes pages can be skipped so it is always essential to check that the correct number of pages has been transmitted.

So what lessons should be learned from this? The main one, to my mind, is that when using online filing it is of utmost importance that the attorney checks the documents that are going to be sent on screen, and not in the form of a printout. Many attorneys still prefer to check printed documents, but this cannot provide assurance, regardless of how reliable your secretary is, that what is being checked is the same as what has been uploaded. Another lesson, however, which shouldn't really need to be learned by any attorney, is that the patent attorney is the one that has to take ultimate responsibility for what is signed and sent to the EPO. Blaming secretaries is not usually going to work.

Friday, 13 February 2015


It is well known that while a drug is protected by a patent, its price will be higher than it would otherwise be. This is, of course, the reason for having a patent. Sometimes this price can be very high indeed, for example where a patented drug is very much more effective than anything else currently available, for which people will be prepared to pay a lot more. In a free market, the price of any patented drug would be determined simply by how much the patent holder could get away with charging. The optimum price for the patent holder will be the one that maximises profits, which will of course not necessarily be the maximum price they can get away with. The market in drugs, however, doesn't always work like that, and in some cases the market is, for various reasons, not free at all. Whereas in the US, pharmaceutical companies can charge pretty much whatever they like and see what the market can bear, in Europe the situation is much more complicated. In the UK, the NHS will strike a deal with pharmaceutical companies to get the best price they can, and there is an incentive for the patent holder not to charge too much because otherwise the patented drug will not be considered cost effective by NICE and will therefore not be generally prescribed.

It is obvious that there are many factors in play when a patent holder decides what to charge for their drug in each country they wish to sell it in. In some countries it might not be possible to even get a patent for the drug. A decision will then need to be made on whether to market the drug in that country at all, if the price that can be charged is not worth it. In other countries where a patent is possible, a patent holder may need to charge the same price throughout an entire region, in order to prevent parallel importation from becoming a drain on profits. This is the case in Europe, where different deals may be struck in different EU countries, resulting in different prices being charged. Sometimes the price being demanded is so high that complaints start to be raised.

A recent complaint about high pricing relates to the price Gilead are currently charging for their patented drug Sofusbuvir (trade name: Sovaldi or Virunon), a new drug for treating hepatitis C virus (HCV) infections. In the UK, a price of £35,000 for a typical 12 week treatment course has been quoted (see the Wikipedia link above). NICE have as yet not issued any guidance as to whether Sofusbuvir should be funded on the NHS, although a decision is expected this month (see here).

In France, the issue has been raised by the charity Médecins du Monde, which describes itself as "an international humanitarian organisation providing medical care to vulnerable populations affected by war, natural disasters, disease, famine, poverty or exclusion". It has recently, however, apparently extended its remit to cover objecting when high prices are charged for patented drugs. A press release of theirs, issued on 10 February, states:
Today, Doctors of the World - Médecins du Monde (MDM) has filed a European patent challenge against the Hepatitis C virus (HCV) drug, sofosbuvir. In recent months, Médecins du Monde and its partners have raised the alarm around the problems caused by the cost of new treatments against hepatitis C and of sofosbuvir in particular. The U.S.-based pharmaceutical company Gilead holds a monopoly for sofosbuvir and is marketing a 12-week course treatment at extremely high prices – 41 000 euros in France and 44 000 euros in the United Kingdom – thereby hindering access to the drug for People Living with HCV.
A patent challenge is a legal procedure by which the validity of a patent is questioned. While using sofosbuvir to treat hepatitis C represents an important step forward, the molecule itself is not sufficiently innovative to warrant a patent. If successful, it can encourage competition from generic versions of sofosbuvir, which can drive price reductions closer to the cost of production. According to experts, this cost for sofosbuvir may be as low as $101 USD for a 12-week course.
Since Gilead is prioritizing its private rights over human rights, imposing unconscionable prices for healthcare systems, Doctors of the World – MDM has decided to challenge Gilead. This is the first time in Europe that a medical non-governmental organisation (NGO) uses this procedure to improve patient access to drugs. MDM believes that the price of sofosbuvir is unjust in part because public funds were used to research and develop the drug.
We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,” explains Dr Jean-François Corty, MdM’s French Programmes Director.“Even in a ‘rich’ country like France, with an annual medicines budget of 27 billion euros, it is difficult to meet this cost. We are seeing an arbitrary rationing approach that excludes patients from care, and this is unacceptable.”
According to the World Health Organisation (WHO), an estimated 130 to 150 million individuals are living with chronic hepatitis C. Within the European Union, it is estimated that between 7.3 and 8.8 million people are living with the virus. In France, 230, 000 people are reportedly chronic carriers of hepatitis C.
Patent challenges have already been used by civil society in India, Brazil, the United States and around the world to remove weak or unmerited patents for drugs and to make low-cost generic versions available,” explains Olivier Maguet,MdM board member delegate for hepatitis C. “This has led to a substantial reduction in the cost of treatments, enabling access to drugs of patients who would otherwise be deprived of life-saving medicines.” Doctors of the World - Médecins du Monde is taking up the fight to promote universal access to treatment against HCV in Europe and the rest of the world. MdM is also launching a public debate in France on the drug pricing mechanism and its impact on the healthcare system.
MdM do not actually indicate what patent is being opposed, but a copy of the opposition itself is linked to on this page, and states that the patent is EP2203462 (EP register here), which was granted on 21 May 2014. The deadline for filing oppositions does not end until 21 February 2015, so there is a chance that others may join in over the next few days, possibly making MdM's politically motivated contribution irrelevant. Given the very high value of the patent in question (which appears to be of the order of billions of whatever currency unit you favour), I think there is a very high probability of this happening. I suspect this one will run for a very long time, regardless of MdM's opposition.

UPDATE 20/2/15: As expected, more oppositions have been filed. Two further notices of opposition were filed yesterday: one by Dr. Holm Herbert Fleischer, a German doctor, and another by Ellis IP Limited (presumably acting as a straw man on behalf of an unidentified opponent). There seems to be a consistent theme among the three oppositions so far filed that there is an issue regarding the patent claiming the two stereoisomers of sofosbuvir, and in particular whether this is directly and unambiguously derivable from the application as filed (Article 123(2) EPC), whether the application discloses the invention sufficiently (Article 83 EPC) and whether the claimed invention has a valid right to priority (Article 87 EPC).

UPDATE 24/2/15: Four further oppositions have now been filed, making a grand total of seven now that the opposition deadline has passed. These extra four have been filed in the names of Actavis Group PTC ehf, STADA Arzneimittel AG, ZBM Patents and IPS. the latter two being apparently further strawmen oppositions. The six other oppositions, which were presumably made for sound commercial reasons rather than being politically motivated, make the MdM opposition seem a bit of a wasted effort.

UPDATE 5/3/15: The EP register now indicates a total of ten opponents, another three apparently getting in at the last minute. These are:

2. Fleischer, Holm Herbert
4. Pharmaceutical Works POLPHARMA
5. Generics [UK] Ltd (trading as Mylan)
6. Teva Pharmaceutical Industries Ltd
7. Intellectual Property Services (IPS)
8. STADA Arzneimittel AG
9. ZBM Patents - Zea, Barlocci & Markvardsen
10. Actavis Group PTC ehf

It looks like Gilead's representative (Sheila Wallace of Marks & Clerk) will be kept quite busy for some time.

In a related matter, a commenter has kindly pointed me to this article in the Grauniad. According to the author, who was lucky enough to have been successfully treated with sofusbuvir, socialism would be the answer to the problem of big pharma charging high prices for new drugs. He neglects, however, to explain how this would help in discovering these new drugs in the first place.

Thursday, 15 January 2015

Enforcing Second Medical Use Claims

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

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

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

Claim 1 of the patent, as recently limited, reads:
Use of (S)-3-(aminomethyl)-5-methylhexanoic acid or a pharmaceutically acceptable salt therof for the preparation of a pharmaceutical composition for treating pain. 
The scope of this claim would appear to be sufficient to cover at least manufacturers and suppliers of pregabalin, provided there was a clear indication of using the substance for the treatment of pain. Including instructions to this effect together with the product would presumably be enough. The patent could not, however, cover the sale of pregabalin where there was no indication that it could be used for treating pain.

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

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