Opinions manual

Question 1

1. Introduction to opinions and reviews

Accepted Answer

The opinion service allows anyone to ask the IPO for an opinion on an issue of validity or infringement of a granted patent or Supplementary Protection Certificate (SPC). The procedure is designed to give parties who are involved in a dispute access to an impartial and affordable authoritative assessment of the main issues in contention. An opinion is not binding but rather is designed to help parties focus on the key issues in a dispute and test the strength of their arguments, without committing them to a subsequent course of action. It is intended to help them to resolve actual or potential disputes over validity or infringement before positions become too entrenched.
Anyone is able to request an opinion on any UK patent, any European patent which designates the UK (EP(UK) patent) or an SPC based on such a patent ^{[footnote 1]}. A patent holder may therefore request an opinion on his own patent, or may find that someone else has requested an opinion on a matter connected with his patent (in which case he will have the chance to comment fully). A third party may request an opinion on any patent without having to declare an interest. However, it is important to note that no-one is compelled to use or be involved in the procedures.

1.1 How does the opinions procedure work

The procedure is intended to be relatively quick and simple, and is based on the exchange of written observations on the matter in dispute. The person who asks for an opinion must file a written statement setting out fully the facts that he wishes to be considered. If he seeks an opinion on validity, he may need to include the relevant prior art document(s) which (in his view) raise questions over the novelty or obviousness of the invention. If he seeks an opinion on infringement, his statement must describe the product or process in question. But the person seeking the opinion must make a new case (see Refusal or withdrawal) In other words, he cannot go over old ground, by raising the same arguments that have been sufficiently considered in a previous opinion or during the processing of the patent application, or matters that have been determined in full-blown legal proceedings. So the Office has the power to refuse to give an opinion in such circumstances, in order to stop parties (and particularly patent holders) from being dragged unwillingly into repeated or vexatious opinions requests.
When a request is filed, the Office notifies various interested parties (such as licensees and the patent holder - if he hasn’t made the request himself). The request is also advertised on the Office website. Anyone may make observations on the request within 4 weeks of the advertisement appearing, and the requester and patent holder have a further 2 weeks in which to make any observations in reply. Any observations from the patent holder or anyone else have to be submitted in writing. There are no further opportunities for anyone to make any other observations. Any observations submitted after the observations-in-reply stage will not be considered by the examiner when drafting the opinion (see opinion 28-09, paragraphs (4) to (9)).
A senior patent examiner then considers all the submissions and issues a written opinion on the matter in dispute. This is sent to the interested parties and made available on the website.
Usually, that is the end of the procedure, and it is entirely up to the parties concerned to decide how they want to proceed in the light of the opinion. The parties may find that the opinion forms a basis for negotiation and settlement. Or it may have clarified the real issues in dispute and so - although litigation commences - the opinion reduces the cost and time of that litigation. In certain limited circumstances, an opinion that concludes a patent is invalid because the invention is not new or lacks an inventive step may give rise to action by the comptroller to revoke the patent on his own initiative under section 73 of the Patents Act (see Manual of Patent Practice (for further details).
In most cases, the way to challenge an opinion will be to launch separate legal proceedings either in the courts or at the Office. (If they are launched at the Office, the whole issue will be looked at afresh by a hearing officer who was not involved with the original opinion - so neither party’s position will be prejudiced). Thus, for example, if a third party disagrees with an opinion which states that the patent is valid, he is free to launch proceedings to revoke the patent. And if a third party disagrees with an opinion which states that the patent is infringed, he is free to launch proceedings seeking a declaration of non-infringement. However, in certain limited circumstances the patent holder may be left with an adverse opinion and have no way of challenging that opinion if he believes it to be wrong. So in limited circumstances, a review of the opinion is available. No other parties are compelled to join those review proceedings, although they may do so if they wish.

1.2 How long does the opinion procedure take

An opinion is usually issued no more than 3 months after a request is made.

1.3 What does the procedure cost

The present fee for obtaining an opinion is £200, to be paid by the person requesting the opinion. Others who receive the opinion (such as those who file observations) do not have to pay anything.

1.4 Legislation

The Opinions process is governed by legislation in The Patents Act 1977 (as amended) and The Patents Rules 2007. See the relevant legislation in this manual.

1.5 Case Law

A list of Office Decisions and Judgments of the Patents Court relating to Opinions can be found in Case Law in this manual. Full details of the Office Decisions can be found on the Office’s website. Court judgments can be found at British and Irish Legal Information Institute.

Question 2

2. Requesting an opinion

Accepted Answer

Anyone is allowed to ask the comptroller for a non-binding opinion on an issue of patent validity or infringement. The patent does not need to be still in force.
If an opinion is sought in respect of more than one patent or more than one infringer, then a separate request must be made for each patent or infringer. A single request can however cover both infringement and validity of a patent. A single request can also cover more than one question of validity – for example a single request can cover novelty and sufficiency.

2.1 Who can request an opinion

Anyone can request an opinion. The requester does not need to declare an interest. Also a request can be filed on behalf of a third party without naming the third party.

2.2 Filing a request

A request is made by filing a Form 17/77 together with the appropriate fee (presently £200). The request must disclose any relevant UK or EPO proceedings (underway or completed) of which the requester is aware. The request must also identify any known interested parties (e.g. parties with whom the requester or their client is negotiating or in dispute) in order that those parties can be notified of the request.

2.3 Statements

A written statement must be filed with the Form 17/77. This statement should set out fully the question to be considered in the opinion, arguments or submissions on that question, and include the facts to be taken into account. It is important that the statement includes sufficient detail to enable the examiner to form an opinion. Further guidance on what to include in a statement can be found from previous statements submitted, all of which are viewable online via IPSUM.
It may be necessary to include relevant prior art, a description of the product or process, relevant drawings, formulae etc. A witness statement or other evidence may be filed (e.g. in relation to prior use). All material will be required in duplicate. There is no restriction on the form of the evidence (see opinion 28/09(PDF,732 KB) paragraphs (19) to (23)).
Where a statement refers to samples then these samples should be filed with the request. If only one set of samples is available then the requester should if possible file photographs in duplicate of the samples together with the samples themselves. A copy of these photographs will be sent to any interested party.

2.4 Filing a request electronically

At present there is no facility for filing a request for an opinion electronically although observations and observations in reply can be sent by email (see Observations and observations in reply

2.5 Amending or clarifying the request and/or the written statement

It is usually a simple matter to correct an error on Form 17/77, for example if the “validity” box has been filled rather than the “infringement” box. Amending the statement may be more difficult. In both opinion 1/05(PDF,221 KB) and opinion 05/07(PDF,46.1 KB) the requester was allowed to amend his written statement so as to remove clear errors in the statement. For example, in opinion 05/07(PDF,46.1 KB) it was immediately clear that the wrong claims had been recited in the statement. However some requests to amend the statement have been refused. The requester was refused permission to amend “infringes” to “meets the terms of” in opinion 08/07(PDF, 67.0 KB) a case in which the examiner was being asked if the patent holders own device “infringed” the claims of the patent.
It is important to remember that any observer must be able to comment upon any such amendment or clarification of the request and/or the written statement. It is unlikely that any amendment will be allowed once the period for observations is under way. In the case of opinion 05/07(PDF,46.1 KB) the error (wrong claims) was fundamental and so the period for observations was re-started and the other party informed of the amendment.

2.6 Register entries

As soon as a request is filed a Register entry is made indicating that an opinion in relation to validity or infringement has been requested on a particular date. An entry will also be made on refusal or withdrawal of a request, or on issue of an opinion.

2.7 Notification and advertisement of the request

If the request proceeds, the Office will send copies of the written statement to interested parties. If appropriate it will also send them copies of any other material submitted - evidence or prior art documents for example. The interested parties will include (if they are not the requester) the patent holder (i.e. the proprietor and any exclusive licensee), licensees shown on the Register, any parties mentioned in the request, anyone who has set up a relevant caveat under rule 54 and anyone else that the Office considers is likely to have an interest.
Notification of the filing of a request will also be advertised on the Office’s website so that anyone who has not already been copied the request may request a copy and if it so chooses file observations. The Patents and Designs Journal includes a standard notice every week directing anyone interested in opinion requests to the website.

2.8 Confidentiality

The post-grant opinions procedure is removed from the scope of the confidentiality provisions so that the request, statement and any attachments filed with the statement cannot be kept confidential. Any opinion request and observations will be viewable on the IPO’s online Patent Information and Document Inspection Service (IPSUM).

Question 3

3. Refusal or withdrawal of a request

Accepted Answer

After an opinion request is filed, a preliminary assessment will be made as to whether it should be refused.

3.1 Requests other than in respect of the matters prescribed in Rule 93(6)

Any request for an opinion on a matter not prescribed in rule 93(6) will be refused. The Office refused opinion 05/07(PDF,46.1 KB) because once all of the request, the observations and the observations-in-reply had been considered it was clear that the issue at the heart of the request was one of excluded matter (which at the time was not a matter on which an opinion could be issued), notwithstanding that the request was presented in terms of inventive step.

3.2 Frivolous or vexatious

A request will be refused where it appears that it is frivolous or vexatious, by virtue of rule 94(1)(a). Assessing these matters will require the Office to look at previous requests in relation to the patent and the patent proprietor, as well as substantive issues. It was decided not to refuse opinion 05/06(PDF,59.1 KB) for being vexatious as the observer had requested because the parties and argument in the opinion were found to be different to those in concurrent revocation proceedings.

3.3 Previous Proceedings

An opinion request will also be refused if the issue on which an opinion is sought has already been sufficiently considered in any relevant proceedings (by virtue of rule 94(1)(b)). Relevant proceedings are defined in Rule 92 as proceedings (whether pending or concluded) before the comptroller, the court, or the European Patent Office. The normal pre-grant examination of applications at the IPO or EPO does not constitute a relevant proceeding under Rule 92 (but see below regarding repeating arguments considered during examination). Hearings conducted prior to grant in either the EPO or IPO are likewise not considered to be relevant proceedings, but post grant opposition proceedings before the EPO are.
Both opinion 02/05 (PDF,34.2 KB) and opinion 27/06 (PDF,999 KB) related to infringement of the same patent but different alleged infringers were listed in each respective opinion request, and so opinion 27/06 (PDF,999 KB) was not refused. In the case of [opinion 01/07 (PDF, 130 KB)] (http://webarchive.nationalarchives.gov.uk/20140603093549/http://www.ipo.gov.uk/op0107.pdf) a revocation action was stayed whilst the opinion was sought; and in the case of opinion 22/06 (PDF,43.4 KB) the issues and evidence in the opinion were the same as those that were to go before the court but the issues were settled before the trial, and so the matters were never tested in court.
A request may also be refused where related proceedings (either in the UK or at the EPO) are underway but not completed - although whether it is appropriate to refuse the request would depend on all the circumstances. For example, an opinion issued to parties already involved in proceedings could sometimes be helpful, and the courts may encourage or could direct parties to seek such an opinion.

3.4 Repeating arguments considered during the examination of the patent

The Office will not issue an opinion if for any reason it considers it inappropriate in all the circumstances to do so (by virtue of section 74A(3)(b)). This provision is used to refuse requests which did no more than repeat arguments already considered pre-grant. In decision BL O/298/07 (PDF, 31.8 KB) refusing an opinion request, the hearing officer noted that the request relied on prior art that had clearly been considered pre-grant and therefore did not raise a new question. In decision BL O/370/07 (PDF, 52.2 KB), the hearing officer concluded that a request for an opinion on validity which argues on the basis of prior art that was cited as category “X” or “Y” in the search report, or as part of a substantive objection at any other time in the examination procedure, is, other than in exceptional circumstances, unlikely to clear the hurdle of raising a new question or argument.
However Opinion 21/07 (PDF,247 KB) did consider 4 documents cited as category A in the search report, together with a number of new documents, when assessing validity.
It is therefore likely that any request that merely repeats an argument that was clearly raised by the examiner and answered by the applicant to the satisfaction of the examiner will be refused though each case will of course be considered on its merits.

3.5 Requests in respect of Patentability issues other than Novelty or Inventive Step.

An opinion request on whether the invention relates to other patentability issues, should also raise a new question that has not been considered in previous proceedings before the Office or elsewhere. Whilst each case will be considered on its own merits, it is likely that a request on a case where itis clear that the applicant has overcome an objection raised during the course of examination or has satisfactorily addressed a challenge to the validity on those grounds, will not be considered to have raised a new question.
If however, the applicant can show that there are potentially significant grounds for believing that the assessment is: i) not based on current UK law (where for example a Practice Notice on a change of practice has since been issued by the IPO) or ii) where significant new prior art shows that the contribution for excluded matter was clearly incorrectly assessed (following Aerotel Ltd v Wavecrest Group Enterprises Limited [2008] EWHC 1180 (Patents)) then a request should usually be accepted.
On this basis, it will usually be the case that a request relating to an application granted by the EPO would be accepted if it relates to areas where practice is clearly different under UK law but usually not accepted - where law is aligned . Where an EP(UK) has a UK equivalent reference should be made to processing on the UK equivalent assuming the claims are of the same scope. If such an issue has been considered in prosecution before the IPO then this will be refused.

3.6 Insufficient information

The Office is also free to refuse to give an opinion if the submissions are not sufficiently good enough to enable a sensible opinion to be issued.

3.7 Refusing a request

If a request is to be refused, the Office will inform the requester and give the reasons for refusal. The requester will be entitled to a hearing on the matter under section 101. As is made clear in section 74A(6) no other parties can be involved in that hearing and only the requester has the right of appeal. If a request is refused then the patent holder (who may not have been involved up to this point unless he is the requester) will be informed (patent holder means the proprietor and any exclusive licensee). The request papers and the decision not to proceed will be publicly available on the patent file. A request may be refused at a later stage in the opinion process, after the request has been advertised and other parties have made observations. Refusal can take place at any time before the issue of the opinion, as with opinion 05/07 (PDF, 31.8 KB) (see decision BL O/289/07 (PDF,31.8 KB)). For example, a third party may provide a good reason why the request should be refused. If so, the same procedures will apply, but any party who submitted observations would be informed (as well as the patent holder).

3.8 Withdrawal of a request

A requester may withdraw a request for an opinion at any time, without having to give reasons, as with opinion 01/06 wherein the requester withdrew having seen the observations and thus being clear in his own mind that there was no infringement.
The comptroller will not continue of his own motion when presented with withdrawal. This is different from the practice under revocation proceedings where, if the applicant for revocation withdraws, the comptroller continues in the public interest to consider whether the patent is invalid and should be revoked. Equivalent procedures to those governing refusal of a request apply in terms of notifying third parties, and all the papers will remain public. Since no opinion will have been issued there will be no problems if another party later requests an opinion on the same issue.

3.9 Remission of fees

The Office has the discretion to refund all or part of the request fee if a request is withdrawn or refused. A request for a refund should be made in writing by the requester.

Question 4

4. Observations and observations in reply

Accepted Answer

4.1 Who can respond and when?

Anyone can submit written observations for four weeks after the advertisement of the request appears on the website. This includes parties who have been notified directly.
Once the four week period is over, the requester then has two weeks to respond to all the observations with observations-in-reply. If someone other than the patent holder has filed observations, the patent holder can also respond to those observations, within the same two week period. There are no further opportunities for anyone to make any further observations see opinion 28/09 (PDF,732 KB).

4.2 What should any response cover?

The written observations must

be confined to the issues raised by the request

Thus observations filed at this stage are not allowed to broaden the scope of the opinion by raising unrelated new issues. If an opinion on such unrelated issues is required then a further, separate request for an opinion should be made.

Any observations must focus on the key issue or issues raised by the requester. The opinion process is intended to be quick and cheap. Consequently where an observer wishes to explore a different validity or infringement point then it will normally be necessary for him to file a request himself. Although each case will be different and will need to be assessed on its merits, the following examples may help in deciding what is and what is not allowable as an observation:

example 1: An infringement request asks whether process X infringes patent A. An observation that is confined to issues of claim construction in patent A will probably be taken into account. An observation that indicates that another process, Y, also infringes patent A will probably not be taken into account; instead a new request should be required if that alleged infringement is to be investigated. An observation that questions the validity of patent A is most likely not to be taken into account unless that question has a direct bearing on the infringement issue, for example by throwing light upon how a claim of patent A should be construed.
example 2: A validity request asks whether patent B lacks an inventive step. Asking for an opinion on validity should not open up a free-for-all for any observations going to the validity of the patent, for example questioning the novelty of patent B. If the observation(s), and any citation(s) within the observation(s), add to the argument in the request they should probably be taken into account. If the observation(s) are based on a completely independent argument they should probably not be taken into account.

If the patent holder (i.e. the patent proprietor and any exclusive licensee) wishes to file observations, he must do so at this stage and copy the observations to the requester. Anyone else who files observations must copy them to the requester and the patent holder. If observations have been filed then the requester has two weeks in which it can if it chooses file observations in reply. These must strictly be in reply to issues raised in the observations so again if new issues are raised, a further opinion would need to be requested if they are to be considered. (see review decision BL O/053/08 (PDF,80.0 KB). There are no further opportunities for anyone to make any further observations (see opinion 28/09 (PDF, 732 KB), paragraphs (4) to (9)).

4.3 Extensions of time periods

Any time period mentioned above is extendable at the comptroller’s discretion under rule 108(1). There is as-of-right extension of time. Given that the service is intended to provide relatively quick answer to the question, extensions of time are rarely granted and if they are then only t very short extensions of a few days, and only for very good reasons.

4.4 Confidentiality

The post-grant opinions procedure is removed from the scope of the confidentiality provisions so that any observations cannot be kept confidential. Copies of any observations will be freely available on IPSUM.

Question 5

5. The opinion

Accepted Answer

The opinion will be given by an experienced senior patent examiner. It will be based on a careful consideration of all the material before him and will be issued normally within 3 months of the request. The opinion will be reasoned and a firm view will be stated - rather than, for example, trying to assess the likelihood of invalidity or infringement in percentage terms. Of course the opinion will only be as good as the written statements and observations themselves - and it may be necessary for the opinion to reflect the constraints imposed by those submissions.
Examples of issued opinions can be found on the Office’s website.
A copy of the opinion will be sent to the requester and (regardless of whether they submitted observations or not) to the patent proprietor and exclusive licensee if there is one. A copy will also go to any party who submitted observations. No sooner than 1 week after the opinion has been sent to all interested parties, it will be published in full on the website. This slight delay is to enable representatives to relay the opinion to their clients prior to it being published.
The papers associated with an opinion, such as the request and observations will be open to public inspection and viewable on IPSUM.

Question 6

6. Contesting an opinion

Accepted Answer

Hopefully the parties find that the opinion forms a basis for negotiation and settlement or at least it helps clarify the real issues in dispute and so - although further litigation may be necessary - the opinion reduces the cost and time of that litigation.
If however a party is not happy with the opinion then it may have a number of options to challenge it. In most cases, the best way to challenge an opinion will be to launch separate legal proceedings either in the courts or at the IPO. (If they are launched at the Office, the whole issue will be looked at afresh by a hearing officer who was not involved in giving the original opinion - so neither party’s position will be prejudiced). Thus, for example, if a third party disagrees with an opinion which states that the patent is valid, he is free to launch proceedings to revoke the patent. And if a third party disagrees with an opinion which states that the patent is infringed, he is free to launch proceedings seeking a declaration of non-infringement.
In certain limited circumstances however the patent proprietor may be left with an adverse opinion and have no obvious way of challenging that opinion if he believes it to be wrong. So in limited circumstances, a review of the opinion is available. No other parties are compelled to join those review proceedings, although they may do so if they wish.

6.1 Reviews of Opinions

In certain prescribed circumstances a patent proprietor or an exclusive licensee may request a review of an opinion. Such a review will allow the correctness of the opinion to be considered in full proceedings before the comptroller.

6.2 Grounds for review

The patent holder may apply to have an adverse opinion on validity set aside, and this would include an opinion which suggested that the patent was only partially valid. It is important to provide this opportunity since - in the absence of a third party launching revocation proceedings or committing an allegedly infringing act - the patent holder may have no other way of tackling an adverse opinion on validity that he feels is wrong.
The patent holder may also apply to have an adverse opinion on infringement set aside, but only where the opinion has come to that adverse view as a result of (what the patent holder believes is) an erroneous construction of the patent specification.
It will not be possible to bring review proceedings if the issues raised in the opinion have been decided in other proceedings, since there is no sense in reviewing the status of a non-binding opinion on an issue that has been determined in a binding way by other proceedings.

Question 7

7. Scope of a review

Accepted Answer

A review of an opinion is not a second opinion. This was made clear by Kitchen J. in DLP Limited [2007] EWHC 2669 (Pat) where he noted:

In the case of an appeal under rule 77K, [now Rule 100] the decision the subject of the appeal is itself a review of the opinion of the examiner. More specifically, it is a decision by the Hearing Officer as to whether or not the opinion of the examiner was wrong. I believe that a Hearing Officer, on review, and this court, on appeal, should be sensitive to the nature of this starting point. It was only an expression of an opinion, and one almost certainly reached on incomplete information. Upon considering any particular request, two different examiners may quite reasonably have different opinions. So also, there well may be opinions with which a Hearing Officer or a court would not agree but which cannot be characterised as wrong. Such opinions merely represent different views within a range within which reasonable people can differ. For these reasons I believe a Hearing Officer should only decide an opinion was wrong if the examiner has made an error of principle or reached a conclusion that is clearly wrong. Likewise, on appeal, this court should only reverse a decision of a Hearing Officer if he failed to recognise such an error or wrong conclusion in the opinion and so declined to set it aside. Of course this court must give a reasoned decision in relation to the grounds of appeal but I think it is undesirable to go further. It is not the function of this court (nor is it that of the Hearing Officer) to express an opinion on the question the subject of the original request.

Hence the purpose of a review is not to provide a second opinion but rather merely to decide if the opinion was wrong because of an error of principle or because it reached a conclusion that was clearly wrong.

7.1 Costs in reviews

Reviews of opinions are considered to be inter-partes proceedings even if only one party is involved. Consequently when two or more parties are involved, the losing party may be entitled to an award of costs in line with the comptroller’s usual costs regime. In a review of opinion 11/06 the hearing officer awarded £1500 against the unsuccessful requester of the review. Costs may also be awarded where the party requesting a review subsequently withdraws the request. For example, the hearing officer in BL O/007/07 (PDF,35.5 KB) awarded £1000 against the party who withdrew a request for a review on opinion 03/05 (PDF,48.0 KB.

7.2 Applying for a review of an opinion

Only the patent holder, i.e. the patent proprietor or the exclusive licensee, may apply for a review. An application for a review must be made within 3 months of the opinion being issued. The 3 month period is extendable at the discretion of the comptroller. However it is likely that a very good reason will need to be given before any extension of time is considered.
A patent holder applies for a review using Form 2/77 (which is the form used to launch any proceedings before the comptroller and which is downloadable from the Office’s website). The fee is presently £50. The form must be accompanied by a statement setting out fully the grounds on which the review is sought, and the patent holder must give details of any proceedings which may be relevant to the question of whether the review proceedings can be continued.
All documents including the Form 2/77 should be supplied in duplicate.

7.3 Proceeding with the review: involving other parties

7.4 Subsequent procedure

The Comptroller has a wide discretion to direct subsequent procedure as he thinks fit. Typically the parties have been content to have the matter decided on the basis of the statement and any counterstatement. Occasionally a hearing has been held where parties had the opportunity to make oral submissions.

7.5 Outcome of a review

As with other proceedings before the comptroller, a hearing will be appointed if the parties wish it, or a decision may be reached on the papers. In either case, a reasoned decision will issue in the standard format, and this will either set aside the opinion, wholly or in part, or find no reason to do so.
A review does not create any estoppels. Hence issues determined for the purposes of review proceedings may still be re-litigated in subsequent proceedings.
The review will not come to a binding decision on patent validity or infringement, but is restricted to setting aside the opinion or leaving it to stand. A patent with an adverse opinion, which is subject to a review upholding the opinion, will remain simply a patent with an adverse opinion - although naturally that opinion may carry more weight after the review procedure is completed.
Each party will be sent a copy of the review decision and the decision will be advertised and the Register updated. The Office’s website provides full details of all review decisions.

7.6 Amendment of the patent during review proceedings

Amendment of the patent during a review will not be possible because review proceedings are not considered to be proceedings in which validity may be put in issue. However if the patent holder were to file amendments under section 27 during the course of the review, the hearing officer would be free to stay the review proceedings if that was appropriate.

7.7 Appealing a decision on a review

7.8 Opinions and SPCs

A supplementary protection certificate (SPC) is a special form of IP aimed at providing the owner of a patent for a pharmaceutical or plant protection product with adequate effective patent protection recognising the delay during which market authorisation is obtained. An SPC can extend the effective protection conferred by the patent for a particular product for up to 5½ years.
Insofar as the scope of an SPC is determined by both the scope of the patent and the marketing authorisation placing the product on the market the scope of an SPC may only be a part of the scope of the basic patent. Therefore infringement of the basic patent does not necessarily mean the SPC is also infringed, and insofar as the criteria are quite different, invalidating an SPC does not necessarily mean the basic patent was also invalid. The extension of the opinion service to cover SPCs is intended to “fill in the gaps” where determining infringement or validity of a basic patent would not determine if the SPC(s) was also infringed or valid, some of these circumstances are considered below.
If you wish the IPO to consider the infringement of both the basic patent and the SPC separate requests will need to be filed. Each request should relate to only one SPC, although a single request may cover both the infringement and validity of an SPC. As with a request for an opinion on a patent, the SPC opinion request must raise a new question that has not been considered by the examiner during examination of the SPC.
The criteria for determining the validity of an SPC are found in Article 15 (which itself refers inter alia to Article 3) of Regulation (EC) 469/2009 or Regulation (EC) No 1610/96. Any one of these criteria could form the basis of a challenge on grounds of validity, for example change in the scope of the claims following amendment or limitation may result in the basic patent no longer satisfying Article 3(a) of the Regulation.
Challenge of an SPC on grounds of validity may also be based on the latest interpretations of the criteria of Article 3 resulting from judgments of the Court of Justice of the European Union (CJEU). These judgment have from time to time resulted in a change in office practice; for example such as followed Medeva ^{[footnote 2]} and Actavis / Georgetown ^{[footnote 3]} as regards the interpretation of Article 3(a) and 3(c) respectively. Furthermore, an opinion as regards the validity with respect to Article 3(d) may result from the discovery of an earlier authorisation wherein an opinion may be sought to determine its relevance in light of Neurim ^{[footnote 4]}.

Question 8

8. Drafting and processing opinions

Accepted Answer

8.1 Introduction

This section provides guidance to examiners on drafting opinions. It is not intended to be an exhaustive guide. Rather it seeks to highlight some of the issues that need to be considered.

8.2 Before you start drafting the opinion

It is important that you carefully consider all the material submitted before you start to think about drafting the opinion. If the observations or observations-in- reply raise issues outside of the scope of the request, then these cannot be considered (see for example the opening of opinion 02/06). Those outside issues can be the subject of a later request, if someone chooses. Where the boundaries of the request lie is for you to decide. The opinion should, when necessary, include a short passage stating that you are not going to consider such issues. A very simple example would be a request that asks for an opinion on a patent’s validity with an observation that raises the issue of the patent’s ownership.
In both opinion 02/06 and opinion 03/06 (PDF, 49.9 KB) the requester presented new citations at the observations-in-reply stage. The general position is that if these documents are being used to show flaws in the observations then you may consider them; if they are being used to raise new argument or to further the request then you should not consider them. It is fundamental to the opinions process that the requester raises their best argument at the outset. This allows any observers an opportunity to comment on the entire argument. If argument is introduced at the observations-in-reply stage the observer will not be able to respond.
In opinion 08/06 (PDF, 80.4 KB) the Office refused the observer’s request that the opinion be extended to consider claims not mentioned in the requester’s initial statement.
You should err on the side of keeping the opinion focused on the key issue or issues raised by the requester. The opinion process is quick and cheap and so there is no real hardship in an observer who wants to explore a different validity or infringement point being asked to file a request himself. The following examples may help in deciding what is and what is not allowable as an observation.

example 1 - An infringement request asks whether process X infringes patent A. An observation that is confined to issues of claim construction in patent A probably should be taken into account. An observation that indicates that another process, Y, also infringes patent A should probably not be taken into account; instead a new request should be required if that alleged infringement is to be investigated. An observation that questions the validity of patent A is most likely not to be taken into account unless that question has a direct bearing on the infringement issue, for example by throwing light upon how a claim of patent A should be construed.
example 2 - A validity request asks whether patent B lacks an inventive step. Asking for an opinion on validity should not open up a free-for-all for any observations going to the validity of the patent, for example questioning the novelty of patent B. If the observation(s), and any citation(s) within the observation(s), add to the argument in the request they should probably be taken into account. If the observation(s) are based on a completely independent argument they should probably not be taken into account.

8.3 Scope of the opinion: seeking further observations

In almost all cases you will be expected to base your opinion on the information available to you. There may be rare occasions where it would be helpful for you to seek further information from an observer or the requester before completing your opinion. As a matter of practice you should consider doing this only when there is insufficient information to come to an opinion (probably a very rare occurrence, given that it is always possible to refuse to give an opinion) and there is a strong possibility that contacting the requester or observer will improve matters. This is consistent with how the Office deals with observations on patent applications under section 21 (see MoPP 21.13) However the examiner should always consult with the dedicated opinions DD before such a step is taken - as seeking clarification from (for example) an observer without giving the requester a chance to comment could be seen as unfair.
If you are aware that another examiner has better technical knowledge of the subject matter of the patent then if it is necessary you can seek their advice on any technical points.
Other than in the above situations, you should base your opinion on the material before you. You should not for example do any further searching of your own for relevant prior art.

8.4 Writing the opinion: adopting the right style

It is up to the examiner to decide what the opinion says. However a considerable body of opinions has now been issued. The style of opinions has clearly moved towards that used in hearing decisions as opposed to the less formal style usually adopted in pre-hearing reports. It is important nevertheless that opinions are written so as to be understandable to the informed reader. They should be written straightforwardly, in the active sense and in the first person where possible. Don’t use pompous, passive phrases such as “It now falls to be decided”. Try to avoid using technical jargon or Latin tags unless there is no alternative.
A simple and straightforward approach is best when writing an opinion. Your expertise is technical rather than legal and so your primary interest should lie in the “technical” technicalities ( “does the alleged infringing act fall within the claim?”, “is the claim novel?”, “does the claim involve an inventive step?”) of the request rather than the “legal” technicalities. Once the technical issues are settled their legal consequences are oftentimes relatively simply stated.
An opinion is both reasoned and structured. The template will give you a table to fill in with the various names, an opening stating that a request has been filed on such and such a date and a space to acknowledge any observations. At the end there is a standard closing passage that speaks of the patent holder’s right to a review of the opinion and stating that the opinion is not based on fully-litigated proceedings. If the opinion goes in the patent holder’s favour there is no right of review and you should delete the appropriate part of the closing passage.
What goes in between is up to you, but you must include passages that leave the reader in no doubt regarding “what factors I must consider in order to reach my opinion”, “how I am going to approach my considering of those factors” and “what conclusions I draw from those considerations”. You should address all the issues that arise in the request and any issues in the observations that lie within the scope of the request. Any authorities (RPCs etc) referred to should also, in general, be mentioned - though the mention may be in the form of “I have carefully considered”. but I find no assistance from it in the present circumstances “. It is worthwhile simply setting out any undisputed or non-questionable matters at the start of your opinion, such as the publication date of a patent specification and whether that patent falls into the state of the art by virtue of section 2(2) or section 2(3).
By way of example, Opinions 01/05 (PDF, 221 KB), opinion 02/05 (PDF, 34.2 KB) and opinion02/06 (PDF, 49.9 KB) all open with a brief discussion of the technology of the patent. Note too the usefulness of patent figures in the opinions. These three opinions also deal with issues going beyond novelty, inventive step and infringement. For example both opinion 01/05 (PDF, 34.2 KB) and opinion 02/05 discuss some aspects of the quality of the evidence produced in support of the request. Opinion 02/05 (PDF, 34.2 KB) discusses issues of estoppel and staying proceedings before going on to consider substantive issues. In opinion 02/06 (PDF,49.9 KB the examiner declines to deal with the issues of alleged insufficiency and amendments that allegedly should not have been allowed; the examiner also addresses the relevance of the prosecution history of an equivalent foreign patent.

8.5 Understanding the invention

You are working with granted claims that should, by definition, be clear and supported. However any difficulty in understanding the claims is to be resolved by the usual process of claim construction. It is crucial that you take every care with claim construction. The reviews of opinions 11/06 (PDF,140 KB), opinion 14/06 (PDF,43.3 KB) for example, show instances where the examiner has mis-construed the claims.
Section 125 of MoPP now contains a large section on claim construction. The standard principles of claim construction were set out by Lord Hoffmann in Kirin-Amgen and others v Hoescht Marion Roussel Limited and others [2005] RPC 9 (see paragraphs 32-52). You must put a purposive construction on the claim; interpret it in the light of the description and drawings as instructed by section 125(1); and take account of the Protocol to Article 69 of the EPC.
In simpler language you must decide what a person skilled in the art would have understood the patentee to have used the language of the claim to mean. Jacob J put it in a similar way in Beloit Technologies Inc and Another v Valmet Paper Machinery Inc and Another [1995] RPC 705 (see pages 720-721):

The basic rule is that the monopoly is to be found in the claim. That is the effect of Article 69. The claim is to be construed sensibly in context through the eyes of the skilled man. That is what I think in effect the Protocol says.

8.6 How to treat omnibus claims

For the most part these claims are ignored in hearing decisions, except when they are all that is left. There is no good reason for departing from that practice for opinions.

8.7 How to assess Novelty

This is a very familiar area to examiners. Extensive guidance is provided by section 2 of MoPP and by other well known reference works, such as Terrell and the CIPA Guide. Perhaps prior use will be less familiar and attention is drawn to MoPP 2.27 to 2.29.1 for guidance in this respect.
What will also be less familiar is how to structure an opinion when assessing novelty. It will generally be appropriate to state at the outset what is in dispute and what is not. This will provide a lead in to a more detailed discussion. For instance if the prior art is a patent document there will be no doubt about when it was published and whether or not it forms part of the state of the art, which might not be the case when prior use is described in a witness statement. With novelty the issues in dispute will be one or more of:is the disclosure part of the state of the art? is there an enabling disclosure? what is the extent of the implicit disclosure? does the disclosure destroy the novelty of the claim? what does the claim actually mean i.e. how should the claim be construed?

8.8 How to assess Inventive Step

This too is well known to examiners and extensive guidance is provided by section 3 of MoPP together with the references referred to above.
With inventive step the issues to be addressed will include: is the disclosure part of the state of the art under section 2(2)? what is the inventive concept i.e. how should the claim be construed, and how does what is claimed stand against what the patentee acknowledges as known? who is the person skilled in the art - this person will be unimaginative but will know for instance the common general knowledge in the art at the priority date of the invention? (N.B. common general knowledge is not to be confused with public knowledge; the latter includes everything however obscure which is public; the former is clearly much more restricted; patent specifications are, in general, public knowledge).
A too-often forgotten aspect of obviousness is the collocation. Special consideration is needed when an invention may be to a combination or a collocation - see SABAF SpA v MFI Furniture Centres Ltd [2005] RPC 10.
As with novelty, it important to structure the opinion so that it sets out all the steps of your thinking, and, if appropriate, to set out area(s) of dispute before jumping into the detail.

8.9 How to assess other aspects of validity

The scope of the opinion service was extended in October 2014 to allow opinions on validity issues other than novelty and inventive step. These areas should be very familiar to examiners and as such no further guidance is considered necessary.

8.10 How to assess Infringement

See section 60 of MoPP for guidance on infringement. Explanatory note f) for Form 17/77 has been drafted with a view to concentrating opinions work on primary infringement only. You may have to consider secondary infringement issues, but that should be rare.
By virtue of the wording of section 60(1) it is not a particular product or process that infringes a patent claim, but rather it is any of a range of actions related to that product or process that infringes, such as manufacture, import and sale or disposal. Consequently when writing your opinion it is probably best, and perhaps easier, if you state whether or not a particular product or process falls within or without the scope of the claim(s) in question before you pronounce on infringement.
There should be little or no need to consider complex legal issues such as exhaustion of rights or whether a ship using patented technology infringes that patent if it docks in the UK. If such issues do arise, you should feel free to seek advice.
A request can ask for an opinion on both validity and infringement. Often the question of validity can be taken separately from the question of infringement and so your opinion will be effectively in two parts.
An invalid patent cannot be infringed. Hence if you have decided that the patent is invalid then you might not need to go any further, except to say that the patent is invalid and so cannot be infringed. But it is much more likely that you would put a “However if I am wrong … “ passage into your opinion and then go on to consider infringement.

8.11 Reaching an opinion

You don’t have the opportunities to test evidence that a hearing would afford you. If, for example, you are presented with conflicting views on claim construction (as in opinion 10/06(PDF, 23.6 KB)) you must work through the claim construction process for yourself and see where you land. You may end up agreeing with one side, or neither.
It is particularly important that you are not misled by the reasoning in a request or an observation. For example a request for an opinion on the presence of an inventive step in a patent is effectively unopposed if no observations are forthcoming. The examiner preparing the opinion will have to keep in mind all the alternative arguments that could be made, and would be made, if instead the case was the subject of an Inter-Partes hearing. In general you should treat requests and observations at face value and as genuine statements of a party’s case, but remembering that the case is partial (in the sense of being one-sided) and it might involve some element of spin or gloss.
When drafting opinions you don’t have the pre-grant luxury of being able to “run an objection up the flagpole and see how the Agent responds”. You MUST come to a proper and fully-reasoned opinion if you can. There may however be different reasons why you can’t come to an opinion.
The evidence filed in support of the request may not be detailed enough for you to come to an opinion. One course of action in this situation might be to refuse the request; but if you decide to go ahead you should state that the evidence is not good enough and explain why it’s not good enough, opinion 20/06 (PDF, 40.0 KB) is an example of this. Alternatively it may be good enough for you to come to a decision on inventive step but not on novelty. Again state what the true position is.
The evidence may be supremely detailed but you cannot reconcile a feature of the claim with that evidence with the certainty that you would like. The Kirin-Amgen claim construction procedure can be used to resolve difficulties in understanding a claim. Think also of using phrases such as “On balance …”. You will not give any party the benefit of the doubt. The standard of proof to be used in opinions is that which is used in post-grant work i.e. “the balance of probabilities”. You must not use the pre-grant approach to inventive step for instance of “resolve doubt in favour of the applicant”.
The opinion can only be as good as the written statements and observations themselves - and it may be necessary for the opinion to reflect the constraints imposed by those submissions. In the limit you can come to a conditional opinion, i.e. … if what the requester or another party says is true then it follows that…. However there are considerable risks with this approach. The subtlety of this approach will be lost on those who just look at the outcome of the opinion. The headline will state only that the Office has issued an opinion saying that the patent is, for example, invalid. It follows that this approach, of coming to a conditional opinion, should be a last resort. There is always the option of refusing to give an opinion if the submissions are not good enough to allow you to issue a sensible opinion.

Question 9

9. Relevant legislation

Accepted Answer

9.1 The Patents Act 1977 (as amended)

opinions as to validity or infringement (Section 74A)
reviews of opinions under section 74A (Section 74B)

9.2 The Patents Rules 2007 (as amended) Interpretation (Rule 92)

Decision	Rule
Request for an opinion under section 74A	(Rule 93)
Refusal or withdrawal of a request	(Rule 94)
Notification and advertisement of request	(Rule 95)
Submission of observations and observations in reply	(Rule 96)
Issue of the opinion	(Rule 97)
Review of the opinion	(Rule 98)
Procedure on review	(Rule 99)
Outcome of review	(Rule 100)
Remission of fees	(Rule 106)
Confidential documents	(Rule 53)

Question 10

10. Case Law

Accepted Answer

10.1 IPO Decisions relating to opinions

Review Decisions upholding opinion:

Review Decisions setting opinion aside:

10.2 Decisions concerning refusal of opinion requests

Refusal of opinion requests:

10.3 Other decisions

BL O/007/07 (PDF,35.5 KB) (Costs awarded against the party who requested a review and subsequently withdrew that request)
BL O/053/08 (PDF,80.0 KB) - (Review decision that also considered whether observations were “strictly in reply”)

10.4 Court Decisions relating to opinions

Appeals of review decisions:

DLP Limited [2007] EWHC 2669 (Pat)
Cunningham & Nokia Corporation [2008] EWHC 1174 (Ch)

Question 11

11. Contact us

Accepted Answer

If you wish to point out an error in this Manual, please contact opinions@ipo.gov.uk

11.1 Manual version and date

Version 1.2 updated October 2014

References to patent holder or patent in this guidance should be taken also to refer to SPC holder and SPC unless otherwise stated. ↩
Medeva BV v Comptroller General of Patents , Designs and Trademarks C-322/10 ↩
Actavis Group PTC EHF, Actavis UK Ltd v Sanofi C-443/12 / Georgetown University v Octrooicentrum Nederland C-484/12 ↩
Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents C-130/11 ↩

Cookies on GOV.UK