Start date for UPC postponed to 1 June 2023 and sunrise period for opt-out to 1 March 2023

The UPC website has announced today that the start date for the sunrise period (in which European patents can be opted out of the UPC’s jurisdiction in advance of the UPC starting to accept cases) will be delayed until 1 March 2023 to allow users to prepare themselves for the strong authentication required to access the UPC’s case management system (CMS) and to sign documents.  Previously the sunrise period was due to start on 1 January 2023.  This delay means that that start date for the UPC will also be pushed back by two months, to 1 June 2023 (rather than 1 April). The UPC site says that no further delay is anticipated. This June start date would require Germany to deposit its instrument of ratification of the UPC Agreement in February.

This short delay to the sunrise period and UPC start date, may be welcomed by those who are still considering their strategies for the UPC and, in particular, opt-out.  It may also lead to more cases being brought to the court at the start date, given the increased period in which to assess the benefits of the new patent system and prepare for it.

The motivation for the postponement is to allow users to equip themselves with both a client authentication (hard device) and a qualified electronic signature. In order to address concerns from users in regards to suitable providers for the CMS authentication that comply with UPC requirements, the UPC IT team contacted by e-mail all the service providers available in the EU Trusted List. Based on the feedback it received from these service providers, an initial list (downloadable as a pdf on this page) was compiled, sorted by country, with information about the providers’ compliance with UPC requirements. The UPC site page detailing this carries a disclaimer that the list is not exhaustive and that it will be updated regularly; it is “an open ended list which will be amended as additional providers communicate their readiness to the UPC”. The UPC IT team recommends that users contact their chosen provider before ordering certificates to ensure service availability.

The UPC site comments: “As strong authentication is required already for the Sunrise Period the initial timeline seems insufficient in view of the legitimate interests of users who have to find a provider and acquire the required authentication tools.

The site says that no further delay is expected as all secondary legislation needed has been adopted and the judges have been appointed and the Presidium has been formed and the Presidents of both the Court of Appeal and the Court of First Instance have been elected and have assumed their offices. “The Presidium of the UPC has concluded the interviews of candidates for the position of Registrar and Deputy Registrar completing the Court’s administration as of the beginning of next year, in time for the start of the Sunrise period on 1 March 2023. The functionalities of the CMS have been positively tested. The training of the UPC judges and the clerks is under way. No amendments to the roadmap are required in these areas.

Our fully integrated, market leading European patent litigation team is ready to advise on all aspects of the practical and strategic issues you should be considering in preparation for the UPC. Please contact us for further information.

For a short video discussion of how to prepare for the advent of the UPC  – watch/listen to Andrew Wells and Rachel Montagnon discuss how businesses should prepare for the UPC and unitary patent, including strategies to employ, licensing and co-ownership issues, as well as applications for opt-out and unitary effect.

For further background and comment on the UPC, see our recent UPC blog posts and the HSF UP and UPC hub.

Key Contacts

Frederic Chevallier
Frederic Chevallier
Partner, France

Ina vom Feld
Ina vom Feld
Partner, Dusseldorf
+49 211 975 59091
Andrew Moir
Andrew Moir
Partner
+44 20 7466 2773

Sebastian Moore
Sebastian Moore
Partner, London/ Milan
+44 207 466 2801

Laura Orlando
Laura Orlando
Partner, Milan
+39 02 3602 1386
Pietro Pouche
Pietro Pouche
Partner - Milan
+39 02 3602 1394
Jonathan Turnbull
Jonathan Turnbull
Partner, London
+44 20 7466 2174
Andrew Wells
Andrew Wells
Partner, IP
+44 20 7466 2929
Emily Bottle
Emily Bottle
Senior Associate, London/Milan
+39 02 3602 1402
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, IP
+44 20 7466 2217

The UPC and unitary patents: preparing for the new system – an HSF video podcast for Practical Law

Concerned about the new patent system planned for European patents starting in 2023? Andrew Wells and Rachel Montagnon have filmed a video podcast for Practical Law on what businesses can do to prepare for the advent of the UPC and unitary patent (published on 28 November 2023).  The discussion covers:

  • An overview of the UPC and unitary patent system
  • The advantages of the UPC and the potential risks
  • Opting out of the UPC
  • Considerations for patent co-owners and licensees

Watch the video here (available to Practical Law subscribers along with a transcript).

Andrew Wells
Andrew Wells
Partner - London
+44 20 7466 2929
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant - London
+44 20 7466 2217

The UPC Rules of Procedure are now in force

The UPC Committee has issued a consolidated version of the UPC Rules of Procedure following the approval of final changes to the 18th draft in July. These Rules are now in force as of 1 September 2022. For details of the final changes made to the Rules before their implementation, see our blog post here.

Consolidated versions of the Rules are also available in French and German, the other official languages of the UPC.

For detailed background and comment on the UPC and the Rules of Procedure see our UPC and unitary patent hub.

Key Contacts

Sebastian Moore
Sebastian Moore
Partner, London/ Milan
+44 207 466 2801

Andrew Wells
Andrew Wells
Partner, IP
+44 20 7466 2929
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant - London
+44 20 7466 2217
Laura Orlando
Laura Orlando
Partner, Milan
+39 02 3602 1386

Ina vom Feld
Ina vom Feld
Partner, Dusseldorf
+49 211 975 59091

Frederic Chevallier
Frederic Chevallier
Partner, France
+33 1 5357 1360

 

 

UPC – The location of 13 local and one regional division courts announced and numbers of legally qualified judges at each

The UPC Administrative Committee has issued confirmation of the location of the various local and regional divisions of the Unified Patent Court (UPC) (see below).  Whilst all other participating states will have one local court (or participate in the Nordic-Baltic regional division announced), Germany will have three local division courts – Dusseldorf, Hamburg and Mannheim.

Under the UPC Agreement, where there has been on average more than 50 patent cases a year under current national patent litigation proceedings in the states where these UPC Courts of First Instance are to be set up, there will be judicial panels of three legally qualified judges, two of whom would be local nationals of that state (or of those states in the case of the regional division), plus one technically qualified judge.  The announcement from the Administrative Committee has therefore also confirmed the numbers of local legally qualified judges that each court will have (see below). For more on the structure of the UPC courts and the judiciary see the Court Structure section of our UPC Hub.

The Administrative Committee’s decision lists the following locations for local divisions of the Court of First Instance of the UPC – and the numbers of legally qualified judges to be on the panel at each:

a. Vienna, Austria – 1 Legally Qualified Judge
b. Brussels, Belgium – 1 Legally Qualified Judge
c. Copenhagen, Denmark – 1 Legally Qualified Judge
d. Helsinki, Finland – 1 Legally Qualified Judge
e. Paris, France – 2 Legally Qualified Judges
f. Düsseldorf, Germany – 2 Legally Qualified Judges
g. Hamburg, Germany – 2 Legally Qualified Judges
h. Mannheim, Germany – 2 Legally Qualified Judges
i. Munich, Germany – 2 Legally Qualified Judges
j. Milan, Italy – 2 Legally Qualified Judges
k. Lisbon, Portugal – 1 Legally Qualified Judge
l. Ljubljana, Slovenia – 1 Legally Qualified Judge
m. The Hague, The Netherlands – 2 Legally Qualified Judges

In addition, one regional division of the Court of First Instance of the Unified Patent Court will be established: the Nordic-Baltic regional division, mainly located in Stockholm, with two legally qualified judges. This regional division is expected to cover cases from Sweden, Estonia, Latvia and Lithuania.

The Courts of First Instance announced cover all the states that are have currently fully ratified the UPC Agreement.   Ireland, Greece, Cyprus, Czech Republic, Hungary, Romania and Slovakia which are yet to do so, but are expected to participate in the longer term, cannot have their court locations confirmed until they do fully ratify of course.  The seats of the central division are currently fixed as Paris and Munich, with the location of the third seat which was to have been London still undecided, although Milan looks to be a front runner.

Our fully integrated, market leading European patent litigation team is ready to advise on all aspects of the practical and strategic issues which you should be considering in preparation for the UPC – please contact us for further information.

Find more about how the UPC will work, and other recent developments on the system on our UPC Hub www.hsf.com/upc.

Author

Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, IP
+44 20 7466 2217

UPC Rules of Procedure – final version approved

The UPC Rules of Procedure (the Rules) have been approved. Amendments to the previous (18th) draft (from 2017) have been released by the UPC Administrative Committee, in tracked changes form, with a full consolidated version promised to be “published in English, French and German during the course of the summer, before the Rules’ entry into force on 1 September 2022” according to the UPC website  The Rules have also been approved by the European Commission. One of the most significant changes is to opt-out procedures.

The main changes/additions involve:

  • Opt-out and unauthorised opt-out/withdrawal (Rules 5 and 5A)
  • Access to pleadings (and decisions and orders) and redaction of these for GDPR and confidentiality reasons (Rule 262)
  • Redaction of information as between parties – including confidentiality clubs (Rule 262A)
  • Remote hearings/video conferencing for whole hearings/individuals (Rule 112)
  • Signing of lodged documents and electronic submissions generally (Rule 4)
  • Various amendments to allow notification of the defendant in ex parte applications
  • Cooperation with other EU courts and third state courts re taking of evidence
  • Service
  • Judicial impartiality
  • Decisions by default
  • The non-suspensory effect of certain categories of appeal

Most of these changes have been made to bring the procedure up to date, allowing for the more on-line nature of court interactions post-pandemic, or where the opportunity to consider  the rules in a more practical context has arisen and gaps have become apparent.  We deal with each of the above in more detail below.

Opt-out applications must be for ALL EP designations not just the UPC participating ones (Rule 5)

  • Previously Rule 5.1(b) provided than an “application to opt out shall be made in respect of all of the Contracting Member States for which the European patent has been granted or which have been designated in the application”. The amended wording in the final Rules removes the reference to Contracting Member States. This also applies to Rule 5.7 re withdrawal of opt-out.
  • This change means that all EP designation owners must agree opt-out (or withdrawal of opt-out), not just those owning designations for states participating in the UPC. With the sunrise period for registered opt-outs likely to start as soon as Germany deposits its ratification of the UPC Agreement ie around 3 months before the new court commences, and the UPC committee suggesting that early 2023 is a likely start date for the new court, agreement of all designation owners should be sought as soon as possible in order to meet these deadlines.
  • Interestingly, the explanatory notes to these changes state that the Contracting Member State wording needed to be removed because: “This wording is inconsistent with the indivisibility of the application to opt out. It implies that the UPC solely has jurisdiction over UPCA Contracting Member States, which is not the case”.  This comment reflects to so-called “long arm jurisdiction” that the UPC may assert over non UPC participating Eu states and even non-EU states.  This is a complex and controversial area on which we will be blogging at a later date.

Opt-out – correcting unauthorised applications for opt-out (new Rule 5A)

  • This new rule determines how the Court has to deal with an unauthorised application to opt out or an unauthorised withdrawal of an opt-out.
  • The proprietor or applicant (of the patent/application) or holder (of the SPC) may lodge an application to remove the entry of an unauthorised application to opt out or withdrawal of the opt-out from the Registry setting out the reasons.
  • The Registrar will ensure that the status of the patent or application or supplementary protection certificate indicated in the register as opted out or opt-out withdrawn shall be marked as subject to an application for removal, and will decide the application for removal “as soon as practicable“. The decision of the Registrar may be reviewed by an application for review to the President of the Court of Appeal.

 Other amends re opt-out

  • Rule 5.3(c): The amendment clarifies which number i.e. the EP publication number but not the numbers for local designations is to be cited in the application to opt out.
  • Rule 5.4: The first sentence of paragraph 4 specifies that the requirement of representation – otherwise mandatory for proceedings before UPC under Rule 8 – does not apply to the applications to opt-out and for withdrawal of opt-out made pursuant to rule 5. Right holders can make the declaration themselves or they may choose anyone to do it for them.

 Access to UPC pleadings, orders etc and confidentiality (Rule 262)

  • Decisions and orders Rule 262.1(a)

These will now be available publicly on the register (with redaction of personal data (as defined under the GDPR) and confidential information as defined in Rule 262.2. The Court will decide of its own motion what should be redacted, taking into account requests for confidentiality.

  • Pleadings and evidence – Rule 262.1(b)

These will be made available to the public on reasoned request to the Registrar (decision made by the judge-rapporteur after consultation with the parties). What such a reasoned request should look like or what factors will be taken into account is not specified in the Rules. The existence of the pleadings (but not contents) will be listed on court files. If pleadings or evidence are to be made public (following an accepted reasoned request) there will be a 14 day period during which parties can request redactions and provide redacted documents to be used for this purpose.

Further (and this is not new) material for which there has been redaction request shall not be made fully available to any applicant unless there is a successful access request – which request shall contain:

(a) details of the information alleged to be confidential, so far as possible;

(b) the grounds upon which the applicant believes the reasons for confidentiality should not be accepted; and

(c) the purpose for which the information is needed.

The Court will invite written comments from the parties prior to making any order and will allow the application unless legitimate reasons given by the party concerned for the confidentiality of the information “outweigh the interest of the applicant to access such information”.

Confidential information in pleadings and evidence – restrictions between parties including “confidentiality clubs” (new Rule 262A) 

  • A party can apply to the Court for certain information in pleadings, or the collection and use of evidence in proceedings, to be restricted or prohibited or that access be restricted to specific persons.  The application needs to include the grounds on which the applicant believes the information or evidence should be restricted (in accordance with Article 58 of the UPC Agreement which provides that, in order to protect the trade secrets, personal data or other confidential information of a party to the proceedings or of a third party, or to prevent an abuse of evidence, the Court may order that the collection and use of evidence in proceedings before it be restricted or prohibited or that access to such evidence be restricted to specific persons).  The Court will consider in particular whether the grounds relied on by the applicant for the order “significantly outweigh” the interest of the other party in having full access to the information.
  • The application needs to be lodged at the same time as lodging of the material and both redacted and unredacted versions must be provided. The Court can ask for written comment from other parties re this request.
  • If application is for “confidentiality club” restricted access those in the “club” must be no greater than necessary in order to ensure compliance with the right of parties to an effective remedies and a fair trial and will include at least one natural person from each party and the respective lawyers or other representatives of those parties.

Video-conferencing of oral hearings allowed

  • Additions in Rule 112.3 create the legal basis for the Court to conduct the whole oral hearing or parts thereof by videoconference if all parties agree or the Court considers it appropriate to do so in exceptional cases (likely to be travel restrictions or disproportionality eg: long journey for short and simple oral proceedings).
  • Of its own volition, the Court can order any of the parties, representatives, accompanying persons, witnesses and experts to participate in the oral hearing by videoconference – includes simple attendance as well as being heard/giving evidence.
  • In all cases, the oral hearing must be transmitted simultaneously in picture and sound to the court room – ie s that the public can watch it from the court room even if the proceedings are all on-line.
  • Rule 104 – amends re aims of interim conference: Rule 104(h) is amended so that it reads: “It shall be also an aim of the interim conference to discuss with the parties if the oral hearing or a separate hearing of witnesses and experts shall be held wholly or partly by video conference” in order to ensure these video-conferencing issues are highlighted and confirmed at any early stage.

Lodging of documents: written pleadings must be signed before lodging and lodged electronically only (Rule 4)

  • Written pleadings and other documents must be signed and lodged at the Registry or relevant sub-registry in electronic form and parties need to use of the official forms available online. The receipt of documents shall be confirmed by the automatic issue of an electronic receipt, which shall indicate the date and local time of receipt.
  • Where it is not possible to lodge a document electronically for the reason that the electronic case management system of the Court has ceased to function, a party may lodge a document in hard-copy form at the Registry or a sub-registry- but an electronic copy of the document shall be lodged as soon as practicable thereafter.

Various amendments to allow notification of the defendant in ex parte applications (including Saisie)

  • Amends have been made to allow for the Court to have discretion to notify the defendant on the making of ex parte applications for preliminary measures (Rule 209), and for preserving evidence (Rule 194 – Saisie). The Court must warn the applicant of its intention to notify the defendant and give the applicant the option to withdraw its application instead.
  • In relation to the Saisie, there are also amends to allow the standing judge appointed to decide immediately on an application to preserve evidence and the procedure to be followed on the application (see Rule 194.4)

Judicial cooperation in the taking of evidence

  • The rules on seeking cooperation from other courts in the taking of evidence have been updated to fit with the new EU regime that has come in since the last draft.
  • Rule 173 states that judicial cooperation in the taking of evidence will be governed by:
    • recast Regulation (EU) 2020/1783 on taking evidence for courts of EU member states; and
    • for third countries, by the Hague Evidence Convention or other international agreements as they apply;  or where no such convention applies, then national law on the procedures to be followed for the judicial cooperation in the taking of evidence will be used.

Other changes – service, objection to judges, decisions by default, suspensive effect of appeals

  • Service of documents – Changes have been made to align the Rules with new EU law rules on service.
  • Provisions to allow objection to assigned judges Rule 346 – This includes situations where there are perceived conflicts of interest or questions over judicial impartiality, although this must happen at an early stage of the proceedings. The assigned panel can continue the proceedings or stay them pending a decision on this.
  • Decision by default – The approach to these has been clarified following discussions with the European Commission: not every failure to take a step within the time limit foreseen in the Rules or set by the Court results in a decision by default. the explanatory notes say that since such default judgments have far reaching consequences on the right of the defence of the defaulting party, “it is clarified that pursuant to this provision such decisions by default can only be given with due consideration to the overall procedural conduct of the defendant in that specific case. Unless there is evidence that the failure was only a mere oversight and happened accidentally a decision by default can be given”.
  • Rule 223: No suspensive effect of certain appeals – This applies to appeals
    • against procedural decisions requiring leave of the Court of First Instance under Rule 220.2;
    • for any “discretionary review” of such decision by the Court of Appeal; nor
    • for costs appeals under Rule 221.3.

Authors

Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, IP
+44 20 7466 2217
Andrew Wells
Andrew Wells
Partner, IP
+44 20 7466 2929

UPC: Review licensing deals to avoid heartbreak, counsel warn

Laura Orlando’s comments on reaching agreement on who has the right to seek or request opt-out or opt-in in relation to European patents and the up-coming UPC jurisdiction over them have been quoted by Managing Intellectual Property in an article of 16 June 2022: UPC special focus: Review licensing deals to avoid heartbreak, counsel warn.  

Milan-based Orlando, co-lead of the HSF IP practice worldwide and of EMEA Life Sciences for the firm, suggests getting agreements recorded to avoid problems further down the line. She is quoted saying that “it’s paramount that licences and co-ownership agreements are reviewed now to include regulation on the UPC” and further commented that like other aspect of the licensor-licensee relationship, it will go much more smoothly if the parties already communicate regularly.

Laura advises that it is best practice to update older licences to reflect the unitary patent and UPC coming into force: it is not just rights over opt-out that need consideration but any review should include clauses relating to finer points such as the control over litigation forum.

Read the full article at Managing Intellectual Property here (subscription only)

Laura Orlando
Laura Orlando
Partner, Milan
+39 02 3602 1386

 

IP in the energy transition: An obstacle or a facilitator?

The Director of the US Patent and Trade Mark Office, Kathi Vidal, has described how important the US system of patent protection is to the development of a clean-energy future in an address to the ARPA-E Energy Innovation Summit (see the full address here). Ms Vidal wants the patent system to “power the new technologies aimed at the reduction of greenhouse gas emissions“. With this in mind, the USPTO has introduced a Climate Change Mitigation Pilot Program to provide a fast-track review of patent applications that cover a product or process that mitigates climate change.

This address is in contrast to recent comments made by the UN Secretary-General that “removing obstacles to knowledge sharing and technological transfer – including intellectual property constraints – is crucial for a rapid and fair renewable energy transition” and that “renewable energy technologies…must be treated as essential and freely-available global public goods” (see our report on this here).  So, is IP an obstacle to the transition or an essential facilitator?

Ms Vidal noted that IP can be “the primary vehicle used by our universities, our government labs, our big companies, and our startups, and our individuals to turn new inventions and technologies into commercial products and entirely new industries“. IP can be crucial for companies carrying out the R&D necessary to develop new technologies that are essential to facilitate the energy transition. IP, for example in the form of a patent, is an asset that can be leveraged to recoup investment, and to access capital for the R&D and subsequent commercialisation of new technologies. Many companies seem to be taking this approach – for example, Ms Vidal noted in her address that the US Patent Tech Centre that focuses on green technologies received 40,000 patent applications last year. Having said that, the exercise of IP rights in green technologies is likely to require more nuance than rights in other areas. Industry players will need to consider carefully how best to ensure both return on investment and dissemination of their technologies, including to combat climate change in countries which could not otherwise afford it.

IP is a strategic issue in the development of green technologies that should be on the radar of all those involved in the on-going push for low-carbon technologies. And an all or nothing approach is unlikely to be the answer.  If IP is not proactively considered as part of innovation strategy in this space, not only may investors and developers lose out but, ultimately, society as a whole will, if potentially beneficial technologies cannot advance or, once advanced, be disseminated.  Accelerating, encouraging and enabling innovation is critical for an effective, long-term global response to climate change and promoting economic growth and sustainable development.

For thoughts on what the energy sector can learn from pharma in this respect, see our article here.

 

Rebekah Gay
Rebekah Gay
Partner - Sydney
+61 2 9225 5242
Emma Iles
Emma Iles
Partner - Melbourne
+61 3 9288 1625
Andrew Wells
Andrew Wells
Partner - London
+44 20 7466 2929
Natasha Daniell
Natasha Daniell
Associate - London
+44 20 7466 2697

UN Secretary-General calls for removal of intellectual property constraints on sharing of renewable energy technology

At the launch of the World Meteorological Organisation’s State of the Global Climate 2021 Report, UN Secretary-General António Guterres has said that renewable energy technologies, such as battery storage, should be treated as essential and freely-available global public goods. Mr Guterres noted that “removing obstacles to knowledge sharing and technological transfer – including intellectual property constraints – is crucial for a rapid and fair renewable energy transition“.  A link to Mr Guterres’ full address can be found here.  Mr Guterres’ comments raise important questions as to how governments incentivise innovation and the development of the new technologies needed to bring about the energy transition if, as seems widely accepted, that responsibility is expected to fall in large part on the private sector (elsewhere Mr Guterres notes the need to reform domestic policy frameworks to “catalyze private sector investments” in renewable energy technologies).

In this context, we think much can be learnt from the pharmaceutical industry in how to use IP rights to both incentivise innovation whilst also facilitating the sharing of technology. The COVID-19 pandemic is an excellent example of this – pharmaceutical companies have been able to sell their vaccines profitably in developed countries, but have also licenced their rights to manufacturers in developing countries to ensure widespread access.  Nevertheless, there have been moves to implement an IP waiver in relation to the treatment and prevention of COVID-19, with the most recent draft proposal at the World Trade Organisation proposing temporary waivers in relation to vaccines.  We have previously written about the lessons the energy sector might be able to learn from the experience of the pharma sector – see our article here.

Mr Guterres’ address is another signal that energy companies should be considering their global IP strategies in the context of the energy transition now, to the extent they have not already done so.

Rebekah Gay
Rebekah Gay
Partner - Sydney
+61 2 9225 5242
Emma Iles
Emma Iles
Partner - Melbourne
+61 3 9288 1625
Andrew Wells
Andrew Wells
Partner - London
+44 20 7466 2929
Natasha Daniell
Natasha Daniell
Associate - London
+44 20 7466 2697

China’s first decision in a case initiated under its patent linkage system

China has recently seen the first decision in a case initiated under its patent linkage system. Under this system, when a generic drug company files an application for marketing authorisation, it can make one of four declarations, including that there is a registered patent relating to the product but it will be declared invalid or non-infringed. If such a declaration is provided, the patent owner is notified of the application for marketing approval, and must commence proceedings within 45 days with the Beijing IP Court or before CNIPA. There is then a 9-month moratorium on marketing authorisation approval.

In this case, the plaintiff, Chugai Pharmaceutical Co., Ltd (Chugai), is the patentee of Chinese Patent No. 200580009877.6 (US family member No. 10/588,609) protecting the ED-71 preparation, and also the marketing authorization holder of the relevant patented drug, Eldecalcitol Soft Capsules.  The defendant, Wenzhou Haihe Pharmaceutical Co., Ltd (Haihe), is a generic drug maker that had applied for marketing authorization, which triggered the filing of a declaratory patent infringement lawsuit before the Beijing IP court by Chugai. Chugai also defended the patent in invalidity proceedings initiated by two other parties (not Haihe).  The case was recently concluded, with the patent being declared invalid although Chugai had tried to rescue it by incorporating a specific antioxidant (d1-α-tocopherol) from claim 2 to further limit the broad technical term “antioxidant” of claim 1, while the generic drug was found non-infringing against the amended claim 1 by the court.

More details were freshly provided recently by Haihe’s law firm which held a public webinar to introduce this case, showing that Chugai lost the infringement case mainly because of its voluntary amendment to claim 1.  In particular, Haihe had relied on both the doctrines of estoppel and contribution in its non-infringement defence.  From this very limited information, we believe it is highly likely that the generic drug of Haihe contains an antioxidant that is different from the d1-α-tocopherol added into the amended claim 1 meaning the Haihe generic drug is caught by granted claim 1 but not amended claim 1.  In this regard, when the different antioxidant in the Haihe generic drug is further noted in the Specification of the patent, the court may become more inclined to apply the doctrine of contribution instead of estoppel, as there leaves even less room for the plaintiff to argue.

The case demonstrates that a patentee shall normally not voluntarily amend their claims during invalidity proceedings, unless absolutely necessary. Here, it is unlikely that adding d1-α-tocopherol to further limit the term “antioxidant” in claim 1 can overcome an inventive step challenge, unless d1-α-tocopherol is largely different from other peer antioxidants and/or brings significant/unexpected technical effect (this is not easy to prove).  And, even if claim 1 did survive through such amendment, it would largely restrict the application of the doctrine of equivalence (“DOE”) in the infringement case, as doctrines of estoppel and contribution will become available to the defendant.  On the contrary, if no voluntary amendment was made and claim 1 was declared invalid by CNIPA, as long as the infringement case is ongoing, Chugai can still assert claim 1 which only requires the broad concept of “antioxidant” and can thus cover the Haihe drug, as no estoppel can be raised here from voluntary amendment.

One possible strategy for a patentee to recover from such tough situation may be to win a judicial review of the unfavourable invalidation decision and then settle with the petitioner to peacefully end the invalidity proceeding, so as to enable the amendment to be withdrawn.  There are already several precedent cases where the patentees took this strategy and were successful in being able to revert to the granted claims without amendments.  However, there are also contrary cases in which the court held that the patentee’s statements and amendments made during the invalidity proceeding should be deemed as effective regardless of whether an effective invalidation decision is finally made.  To move forward in this way, the patentee is usually suggested to seek the support of influential legal experts.

In our experience, both tech expert opinions and legal expert opinions can have a significant impact in supporting such complex cases.  In relation to key legal issues, including whether amendments already made can be withdrawn based on settlement of invalidity proceeding, it may be a good option for the patentee to invite influential legal experts and scholars to issue a legal expert opinion (may have similar effect with amicus brief under common law system) based on the specific case facts and from a more neutral perspective. In many scenarios, such legal expert opinions can have a significant influence on the court’s legal findings and are warranted in high stakes / high value cases.  Technical experts are also very useful when complex technical issues arise, such as in relation to assessing equivalence of technical features from a technical view.

Another suggestion to patentees is to avoid engaging two law firms to handle the invalidity and infringement proceedings separately, whenever possible.  The goals are different in these two proceedings and may bring tensions between each other.   For example, in the invalidity proceeding, lawyers are naturally inclined to introduce more limitations/interpretations to the claim languages to make the patent survive, but this may easily create estoppel which may become hazardous for the infringement proceeding.  In many scenarios, to say/do more before CNIPA means to face more dangers on the infringement side before court, thus a veteran IP lawyer should very carefully devise strategy to find out the balance between the two proceedings.  In recent years, it seems multinational patentees are becoming more and more willing to engage a single law firm to handle both invalidity and infringement proceedings to ensure all the positions are consistent.

It was reported that Chugai has filed appeals for both the invalidity and infringement proceedings.  According to relevant rules, if no effective judgment is issued within the 9-month moratorium, the marketing authorisation approval proceedings for the generic drug will continue.  Therefore, it will be interesting to see whether the appeals of Chugai can be concluded within this time frame and how the subsequent proceedings will run to fit in the law.  We will keep following up.

Contacts

Peng Lei
Peng Lei
Partner, Kewei
+86 21 2322 2113
Rebekah Gay
Rebekah Gay
Joint Global Head of IP, Sydney
+61 2 9225 5242
Shaun McVicar
Shaun McVicar
Partner
+61 3 9288 1587

Interest from Pharma businesses worldwide in Europe-wide enforcement via the UPC

Laura Orlando, co-head of our Global IP practice and of Life Sciences in EMEA, has been interviewed by Managing Intellectual Property in an article focusing on the UPC and trends in the approach to opt-out being taken by the pharma sector.

Whilst several others quoted emphasised that the uncertainties surrounding the new system and the added risk of central revocation could lead many to protectively opt-out their key patents, Laura commented that some pharma patentees are taking a broader view, employing more strategic considerations, including the use of unitary patents. She said she was seeing a willingness from some to opt patents in and enforce them Europe-wide.

Read the article in Managing Intellectual Property here (subscription required).

Contact 

Laura Orlando
Laura Orlando
Partner, Milan
+39 02 3602 1386