Wednesday, 7 October 2015

Section 73(1A) Revocations - An Update

To follow up from my previous posts (here, here and here) on the subject of revocation following request for an opinion on validity, this  is to provide a little update on where things currently stand. At the time of writing revocation proceedings have been initiated in three cases. These are:

GB2497956 (JCB): Proceedings were initiated on 7 August 2015, with an initial deadline of 7 October to file observations and/or amendments. This has now been extended to 9 December 2015.

EP1837182 (Fujifilm): Proceedings were initiated on 16 September 2015, providing a deadline of 16 November 2015 (extendable by two months).

GB2487996 (Jemella): Proceedings were initiated on 18 September 2015, providing a deadline of 18 November 2015 (extendable by two months).

Two further opinions, 07/15 and 10/15, look likely to result in initiation of revocation proceedings. The proprietors have until 11 November and 24 November respectively to request a review of the opinion under section 74B.

Thursday, 1 October 2015

Kadcyla & Crown Use

An article in the Grauniad today reports a letter written by The Coalition for Affordable T-DM1 to the Health Secretary Jeremy Hunt.

The letter asks Mr Hunt to "authorise the domestic manufacture and/or importation, use and sale of biosimilar versions of trastuzumab emtansine (T­DM1) used in the treatment of breast cancer, to be supplied to the government for use and sale in the UK", which they argue can be done under the Crown Use provisions of the UK Patents Act 1977 (sections 55 to 59). This is apparently necessary because the medicine is very expensive and unaffordable to patients in the UK, costing in the region of £100k for a year's treatment.

The letter does not indicate what patent would need to be authorised for use, which seems to me a bit strange. I have, however, found one that seems to fit the bill: EP1689846B1, which was granted in March 2013 to ImmunoGen, Inc., claiming a cell-binding agent maytansinoid conjugate with the formula shown above, where Ab is trastuzumab.

T-DM1, more commonly known by its trade name Kadcyla, is an antibody-drug conjugate, being a combination of the monoclonal antibody trastuzumab (trade name Herceptin) with a cytotoxic agent DM1, a maytansinoid. The drug can apparently be of some use in treating HER2-positive metastatic breast cancer, although is not a cure and results show that it might be able to extend life by typically a few months. The National Institute for Health and Care Excellence (NICE) have indicated that the drug is not worth funding, finding last year that it is not recommended for treatment because it was not a cost-effective use of NHS resources.

To my knowledge, the Crown Use provisions in the UK Patents Act 1977* have never been applied to the provision of drugs (although I would be happy for someone to prove me wrong). It would be interesting to see whether this case will establish a precedent, but I strongly suspect that it will not.

*As pointed out in the comments below, Crown Use provisions in the 1949 Act were used. However, apart from the case of Henry Brothers v MOD [1997] RPC 693, which was not about drugs, I am not aware of any cases under the 1977 act relating to sections 55 to 59 and do now know of any patents that have been the subject of an order under section 55. Making an order in this case would therefore seem to be setting a precedent, which I suspect the current government would be very unwilling to do.

Thursday, 13 August 2015

Partial Priority - Questions for the Enlarged Board

Back in January I wrote about an appeal case at the EPO where a referral to the Enlarged Board on the question of partial priorities was going to be made. The Board in T 557/13 has now finally issued their decision, which is available here. Although it has taken them over six months to get there, I can see why it has taken so long, since the decision runs to 64 pages and is very comprehensive (as you might expect for such an important case).

In brief, European patent EP0921183 (which, by the way, expired in June this year) was opposed for lack of novelty, among other things. The opposition division concluded that claim 1 as granted was a generalisation of a more specific disclosure in the priority document, which had also published as an EP application. The priority document therefore became prior art under Article 54(3) EPC. Since, in the opposition division's view, the granted claim did not give rise to the claiming of a limited number of clearly defined alternative subject matters (referring to G 2/98), the claim was not entitled to priority and lacked novelty over the priority document.

On appeal, the patent proprietor argued that the claim was novel because a divisional application could not have a different priority date from its parent, backing its arguments up with various documents, which included a post from this blog (mentioned as D22 in the decision). The proprietor also cited the FICPI memorandum that was referred to in G 2/98, and proposed various questions to be referred to the Enlarged Board (which were mentioned in my previous post). The Board indicated that the issue of novelty might hinge on whether a patent could validly claim a right of priority when claiming more generically than a priority disclosure, and drew the parties attention to decision T 571/10, which is quite clear on the subject.

Following oral proceedings, which were held on 17 December 2014, the Board decided that it would refer questions to the Enlarged Board, the form of which were to be decided. This decision now sets out the reasoning behind the questions being referred. As the Board states at point 8.4 of the reasons, "the decision on novelty of the subject-matter of Claim 1 may depend on what approach is adopted in assessing entitlement to partial priority for a generic "OR"-claim. The concrete question to be resolved here is whether Claim 1 enjoys partial priority to the extent that the use of the product of Example 1 as disclosed in D16 is encompassed by the more generic definition of Claim 1, rather than being spelt out in it". In my view, this is the core of the issue, and one that has been much debated here and elsewhere. The question is in effect one of whether it is correct to take a broad or narrow view of the "limited number of clearly defined alternative subject-matters" as defined by G 2/98.

The Board goes into a lot of detail discussing the background to the issue of claiming partial priorities. They refer to the FICPI memorandum, and note that it was "an essential element in the process of drafting the EPC provision allowing the claiming of multiple priorities for one and the same claim which was finally adopted" (point 11.7). This seems to disagree with comments from some who have accused me of putting too much emphasis on the memorandum. In my view the memorandum is key, and has to play a very important role in resolving the issue if G 2/98 is to be followed at all (which, of course, it might not be). The Board also discuss the conflicting case law of the EPO, as well as two relevant judgments from the England and Wales High Court (Nestec v Dualit and HTC v Gemalto) where partial priority made an appearance. All of the issues should already be familiar to readers of this blog, so I won't go into the details again.

In a preamble to the actual questions themselves, the Board outline the main issues and comment on the fundamental importance of the point of law. At point 17.2.2 the Board states:
"The right of priority being one of the cornerstones of the patenting system, the Board considers that clarification of issues arising in the present connection is of fundamental importance. As argued by the appellant, the way in which entitlement to priority is assessed in cases of generic "OR"-claims is of great practical importance for claim drafting and filing strategies. "
The Board refers to another pending appeal case, T 624/14 concerning EP2157457, where a request for a referral has also been made. They also draw attention to two further publications, one of which is an article I wrote (in my real life persona) with Renaud Fulconis for the CIPA journal in December 2013 (cited as D30 and available in preprint form here), setting out the two opposing views on partial priorities. The Board mention that the jurisprudence before and after G 2/98 has not been applied uniformly in the assessment of partial priority for generic "OR"-claims, resulting in two divergent approaches developing. Clarification from the Enlarged Board is therefore needed. Given the fundamental nature of the issue, the questions have been formulated in broader terms than those suggested by the parties, and are as follows:
1. Where a claim of a European patent application or patent encompasses alternative subject-matters by virtue of one or more generic expressions or otherwise (generic "OR"-claim), may entitlement to partial priority be refused under the EPC for that claim in respect of alternative subject-matter disclosed (in an enabling manner) for the first time, directly, or at least implicitly, and unambiguously, in the priority document? 
2. If the answer is yes, subject to certain conditions, is the proviso "provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters" in point 6.7 of G 2/98 to be taken as the legal test for assessing entitlement to partial priority for a generic "OR"-claim? 
3. If the answer to question 2 is yes, how are the criteria "limited number" and "clearly defined alternative subject- matters" to be interpreted and applied? 
4. If the answer to question 2 is no, how is entitlement to partial priority to be assessed for a generic "OR"-claim? 
5. If an affirmative answer is given to question 1, may subject-matter disclosed in a parent or divisional application of a European patent application be cited as state of the art under Article 54(3) EPC against subject-matter disclosed in the priority document and encompassed as an alternative in a generic "OR"-claim of the said European patent application or of the patent granted thereon?
The questions posed look very comprehensive to me, and very thoroughly thought out. I suspect the answer to them is not going to be a straightforward "no" to question 1, as that would be too easy (although would seem to me to be the correct one; see here for my reasons why). The key part is likely to be question 3, which is where the FICPI memorandum will come into play, unless the Enlarged Board decides to throw out that part of G 2/98 and start afresh (which they can do).

What happens next is the interesting part. I suspect the EPO will invite observations on the questions being referred, and then in a year or two we should get the answer. Let's hope it's the right one.

See further analysis from PatLit here and the IPKat here.

Friday, 7 August 2015

Opinions and Revocation - JCB is the Guinea Pig

Following my earlier posts here and here about the new provision under section 73 of the UK Patents Act for automatic revocation following an opinion, I have noticed that the first step has been taken today in relation to Opinion 25/14. As mentioned in my post here, this opinion found GB2497956 to lack novelty over a patent cited by the requester. The period for requesting a review expired on 11 May 2015 with no request being filed. After taking nearly three months to think about it, the UK IPO has now written to the proprietor, stating the following:
"Under Section 73(1A) your patent has been reviewed by a Deputy Director on behalf of the Comptroller who considers that claim 1 is not novel in view of US 3485037 and also not inventive, in particular in view of US 2007/175209 and EP1439310.
Before beginning revocation proceedings, you are invited to amend your patent and/or to comment on the citations before [7 October 2015]."
This is the first time the new provision under section 73(1A) has been used to initiate action. The proprietor, JC Bamford Excavators Limited, now has two months to decide what to do to try to avoid getting their patent revoked. I will, of course be keeping a close watch to see what happens.

Saturday, 25 July 2015

An Analysis of TKDL at the EPO

Following my recent post on the IPKat here about (at least partly) false claims made by the Indian government regarding the relevance of the Traditional Knowledge Digital Library (TKDL), I thought I would have a good look at a bigger sample of the recent claims that have been made. These are listed on the TKDL website here as 'major milestones'. Another list is available here on the TKDL website indicating all instances where the TKDL has been used in third party observations, but without any claims to the relevance of the observations.

The major milestones page claims that things have happened, such as applications being refused or withdrawn, "based on the TKDL evidences". Based on the cases I have seen so far, these claims have turned out not to be true. The recent announcement by the Indian government to have "foiled an attempt by consumer goods giant Colgate-Palmolive to patent a mouthwash formula containing herb extract by citing ancient texts that show it was traditionally used in ancient medicinal practices" was just one recent example, as I showed in my recent post.

I wondered whether there had been any cases where the TKDL had been actually relevant in determining the outcome of an application. The only way to find out was to look at each of the cases and see what actually happened. The table below, which is derived from the TKDL's own list, shows for each European application in the list a summary of what happened, and whether the claim is true or false (or perhaps somewhere inbetween). You don't need to take my word for it though, as links are provided in each case for verification if needed.

Where I have indicated that the TKDL claim is false, this is based on there being no objections raised by the examiner in relation to the TKDL documents or, in some cases, that the examiner has specifically stated that the references were not as relevant as those already cited, and therefore could not possibly have made any difference. Where I have indicated that the claim is true, this is where either the examiner has specifically raised objections and/or the applicant has responded to the references by amendment. Whether any subsequent deemed withdrawal has anything to do with the TKDL citations is, of course, unknown, but I have given the TKDL the benefit of any doubt where any objections have been raised during prosecution.

TKDL Claim
Evidence from EP Register
True or False?
BASF Beauty Care Solutions France SAS, France has amended the claims of the application no. EP2157966 for "MC-1R, MC-2R, and/or [mu] opioid receptors simulation" based on the TKDL evidences.
No mention of TKDL evidence in summons to oral proceedings dated 9 Jan 2015. Applicant responded to TKDL evidence with no amendments.
Based on TKDL evidences, MORINAGA MILK INDUSTRY CO., LTD. 33-1, Shiba 5-chome Minato-ku, Tokyo 108-8384 / Japan has amended the claims of application no. EP1941899 for "Agent for promoting glucagon-like peptide 1 secretion, food or drink for promoting glucagon-like peptide 1 secretion, agent for inhibiting postprandial increase in blood sugar level and food or drink for inhibiting postprandial increase in blood sugar level" and then the application was deemed to be withdrawn.
Last examination report dated 8 Jan 2015 cites two documents, neither from TKDL. No response filed, application deemed withdrawn.
Based on TKDL evidences, Phenolics, LLC, P.O. Box 2439, 846 San Carlos Avenue, El Granada, CA 94108-2439 / United States has amended the claims of application no. EP1572219 for "Efficient method for producing compositions enriched in total phenols" and then the application was deemed to be withdrawn.
TKDL observations mentioned in examination report dated 13 Jan 2011, but documents already cited by examiner used in novelty/inventive step objections.
Based on the TKDL evidences, Application no. EP2328598 (Phenolics, LLC United States) for "Novel compositions containing isolated tetrameric type a proanthocyanadin and methods of use and manufacture", is deemed to be withdrawn.
Inventive step objection based on document D1 cited by examiner in last examination report dated 7 March 2014. TKDL observations also mentioned. Application subsequently deemed withdrawn due to no renewal fee payment.
TRUE (partially)
Based on the TKDL evidences, application no. EP2464363 (M/S Medasani, Munisekhar / India) for "Natural extract from whole banana fruit (Musa Spp.)", is refused.
Decision to refuse dated 20 March 2015 based on objections in examination report dated 17 March 2015, cites document D8 (WO 2004/069143) as main reference for novelty & inventive step, D10-12 & D18 used in inventive step. None of cited documents from TKDL.
Based on the TKDL evidences, Application no. EP2689806 (Colgate-Palmolive Company/ United States of America) for "Oral compositions containing extracts of myristica fragrans and related methods", is deemed to be withdrawn.
Last examination report dated 6 October 2014 cites document not from TKDL as main reference.
Avon Products / U.S. has amended the claims of the application no. EP1827362 for "Compositions and methods of their use for improving the condition and appearance of skin" based on the TKDL evidences.
Examination report dated 7 Aug 2014 cites TKDL observations in novelty & inventive step arguments. Applicant subsequently amends claims.
Based on the TKDL evidences, Nestec S.A. / Switzerland have withdrawn their Application No. EP2243383 for "A method and composition for nutritionally improving glucose control and insulin action."
Summons to oral proceedings dated 1 Aug 2014 specifically mentions third party observations not being more relevant than documents already on file.
Based on the TKDL evidences, Application no. EP2266586 (Lifeline Nutraceuticals Corporation 6400 South Fiddler's Green Circle, Suite 1970 Englewood, CO 80111 / United States) for "Compositions and method for alleviating inflammation and oxidative stress in a mammal", is deemed to be withdrawn.

Application was closed on 18-Mar-15.
TKDL evidence mentioned in last examination report dated 30 April 2014, but examiner cited documents used in novelty & inventive step objections.
Nestec S.A. Avenue NestlĂ© 55 1800 Vevey / Switzerland has amended the description of the application no. EP1750651 for "Composition for improving skin, hair and coat health containing flavanones" based on the TKDL evidences.
Novelty objections raised in last examination report based on examiner cited documents and TKDL evidence. Examiner also raises novelty objection citing orange juice with pulp as prior art.
 TRUE (partially)
M/S Indena S.p.A. / Italy has amended the claims of the application no. EP2046324 for "Treatment and prevention mucositis by anthocyanidin derivatives.
Novelty & inventive step objections raised in last examination report based on 35 documents cited by examiner. TKDL evidence not used.
N/A (no claim made)
Based on the TKDL evidences, Application no. EP1558271 (Metaproteomics, LLC / United States) for "Compositions that treat or inhibit pathological conditions associated with inflammatory response", is deemed to be withdrawn.

Application was closed on 09-Jan-15.
Examiner considered claims to be new and inventive over cited documents and TKDL documents in examination report dated 3 March 2014. Minor clarity objections raised. No response filed, application deemed withdrawn.
Based on the TKDL evidences, Application no. EP2419508 (Somalabs, Inc., 40 Allen Road, South Burlington, VT 05403 / United States) for "Method for the induction of a reward response by modulation of dopaminergic systems in the central nervous system", is deemed to be withdrawn.

Application was closed on 12-Nov-14.
TKDL observations used in examination report dated 7 March 2014 for inventive step argument. Application then deemed withdrawn due to missing renewal fee.
Unitika, Ltd./ Japan has amended the claims of the application no. EP2226071 for "Composition for oral administration" based on the TKDL evidences.
Novelty objection in examination report dated 20 Feb 2015 based on document cited by international examiner. TKDL evidence not mentioned.
Based on the TKDL evidences, Unigen, Inc. / US, have amended the claims of application no. EP1881839 for "Compositions of Bakuchiol and methods of making the same" and then the application was withdrawn.

Application was closed on 12-Nov-2014.
Intention to grant issued 17 Feb 2014. No response filed, application deemed withdrawn. TKDL references stated to be not relevant in examination report dated 11 March 2010.
Laboratoires Expanscience / France has amended the claims of the application no. EP2506724 for "Vigna unguiculata seed extract and compositions containing the same" based on the TKDL evidences.
Inventive step objections in examination report dated 12 March 2014 based on TKDL evidence. Claims amended in response.
New Chapter, Inc. / US has amended the claims of the application no. EP2435057 for "Compositions and methods for modulating lipid composition" based on the TKDL evidences. Application was refused on 17-Jun-2015.
Amendments made in response to documents cited by examiner. Examination report dated 7 March 2014 indicates that "third-party observations has been taken into account", but novelty & inventive step objections based only on examiner cited documents. Reasons for refusal in summons to oral proceedings dated 10 March 2015 made no mention of TKDL references.
Mimozax Co., Ltd. , 4291-1, Miyauchi Hatsukaichi-shi, Hiroshima 738-0034 / Japan has amended the description of the application no. EP2052731 for "Composition for preventing and/or treating itching containing component originating in the bark of tree belonging to the genusacacia." based on the TKDL references.
No third party observations have been filed.
Nanyang Polytechnic/ Singapore has amended the claims of the application no. EP2416793 for "A plant extract comprising statins and preparation techniques and uses thereof" based on the TKDL evidences.
Search opinion dated 25 July 2013 invited applicant to comment on TKDL references. Applicant responded on 6 June 2014 with amendments.
Based on the TKDL evidences, Application no. EP1901701 (Ott, David M., 777 Panoramic Way, Berkeley, CA 94704 / US) for "Personal care and medicinal products incorporating bound Organosulfur groups", is deemed to be withdrawn.

Application was closed on 14-Aug-14.
Examination report dated 9 October 2013 raised novelty objections relating to examiner cited documents. Third party observations mentioned, but no specific objections raised. No response filed, application deemed withdrawn.
Based on the TKDL evidences, Application no. EP2293689 (Mars, Incorporated / US) for "Food product", is deemed to be withdrawn.

Application was closed on 04-Aug-14.
Examination report dated 22 November 2013 considered third party observations to be relevant for inventive step. No response filed, application deemed withdrawn.
Based on the TKDL evidences, Application no. EP2269598 (Metaproteomics, LLC/ United States) for "Curcuminoid compositions exhibiting synergistic inhibition of the expression and/or activity of cyclooxygenase-2", is deemed to be withdrawn.

Application was closed on 18-Jul-14.
Search opinion dated 23 May 2011 cited TKDL references mentioned in third party observations, raising novelty objections based on these. Subsequent deemed withdrawal due to non-payment of renewal fee.
Based on the TKDL evidences, Application no. EP1993522 (Kao Corporation 14-10, Nihonbashi-Kayabacho, 1-chome Chuo-ku Tokyo 103-8210 / Japan) for "Resveratrol and/or grape leaf extract as i.a. endurance improver, anti-aging agent, muscle strength improver", is deemed to be withdrawn.

Application was closed on 23-May-14.
Examination report dated 29 March 2011 mentioned third party observations, but considered documents already cited by examiner to be more relevant. 
Universiti Putra Malaysia, UPM Serdang, 43400 Selangor Darul Ehsan / Malaysia has amended the claims of the application no. EP2349302 for "Cardioprotective effects of nutraceuticals isolated from nigella sativa seeds" based on the TKDL evidences.
Search opinion dated 10 July 2012 indicated that TKDL references were not considered to be as relevant as examiner cited documents. 

Out of a total of 23 cases where a claim has been made that something happened "based on the TKDL evidences", 15 turn out to be completely false. There are no cases where an application has been refused based on TKDL evidence, but several where an application has lapsed for one reason or another after TKDL evidence has been submitted. It looks to me like the TKDL is a potentially useful source of prior art in limited circumstances, but is nowhere near as significant as it is made out to be. Perhaps the Indian government could be a little more honest and make claims where they are actually justified.

Friday, 10 July 2015

Don't let your patent go up in smoke

Renewal fees are payable to the UK IPO on GB and EP(UK) patents each year, by the end of the month in which the anniversary of the filing date falls (rule 37). If this is missed, an extra six months is allowed for paying the fee, with surcharge (section 25(4)). If, after this period passes, the renewal fee is still not paid the patent lapses. It is possible to have such a lapsed patent restored, but only if it can be shown that the proprietor unintentionally failed to pay the fee (section 28). This is usually a fairly low hurdle to get over, and it is quite common for proprietors to be able to get their lapsed patents restored provided they can show that there was an underlying intention to keep it. An important point to note, however, is that although anyone can pay a renewal fee it is the proprietor who must be shown to have the intention to pay.

EP1409166, relating to processing of waste material, and originally applied for in the name of Strumat Limited, was granted to Globally Greener Solutions Limited in 2010, after recordal of a transfer was made during prosecution. The patent then lapsed in the UK due to failure to pay the renewal fee that was due by the end of July 2012. Unfortunately, as it turns out, the transfer to GGSL was apparently made by one of the directors of Strumat without the permission of the others. Following dissolution of GGSL, which seems to be connected to a large fire at their premises involving 5000 tonnes of stockpiled waste material, and which resulted in two of GGSL's directors being jailed for failure to comply with environmental regulations, ownership of GGSL's assets passed to the Crown, under section 1012 of the Companies Act 2006. As an aside, very large fires at recycling plants seem to have been quite a common occurrence recently, a few examples being in Linconshire, Salford, Wrexham, Rainham, Swindon, Melton and Smethwick (the large plume of smoke from which was visible from my office).

To return to the issue in question, since the Crown was the proprietor at the time the patent could have been renewed, on the face of it the intention that would count regarding whether the patent could be renewed would be theirs. Unfortunately, the Crown makes no effort to maintain patents that are acquired as a result of them being bona vacantia, so the intention test would never be met. This was clearly a problem for Strumat, who claimed that the application had been transferred fraudulently and should therefore never have been recorded as being in the name of GGSL. They applied under section 37 to have the question of entitlement resolved by the comptroller, but the comptroller declined to deal with the issue (see the decision here), as it was one that related only to non-patent law issues. Strumat then went to Court, and were granted a Vesting Order which ordered:
the Patent Number EP02747559 granted as EP1409166 be and is hereby vested in Strumat Limited for all the estate and interest therein which immediately prior to its dissolution were vested in Globally Greener Solutions Limited”.
Strumat argued in their application for restoration that this meant they had always been the proprietor and it was therefore their intention to maintain the patent that counted. The hearing officer disagreed because it was quite clear that the order took effect as of its date, and was not retrospective. As a result, only the intention of the Crown could be relevant, and they had no intention to maintain the patent. The application for restoration therefore had to be refused (see decision BL O/248/15).

The case is quite an unusual one, but does suggest at least one lesson to be learned, which is to keep an eye on your own patents if they are important to you. If the issue had been spotted earlier, which it could easily have been (the transfer took place in 2007, long before the patent was granted), the patent might have survived. Getting others to look after them might save you some time and effort, but it's always worth doing a quick check now and then to make sure your patent is not about to spontaneously combust.

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.