19 Jul 2019

T 0285/14 - Patenting a drug interaction warning

Key points

  • Claim 1 is directed to "Pirfenidone for use in treating a patient in need of pirfenidone therapy, characterized in that the treating comprises avoiding, contraindicating or discontinuing concomitant use of fluvoxamine."
  • " The patent in suit relates to pirfenidone therapy. Pirfenidone, which has anti-fibrotic properties, had previously been approved in Japan for the treatment of idiopathic pulmonary fibrosis" 
  • " According to the patent in suit, the invention is based on the discovery of an adverse drug-drug interaction between pirfenidone and fluvoxamine, which results in reduced clearance of pirfenidone and, as a consequence, increased exposure of patients to pirfenidone. The patent therefore seeks to avoid such potentially adverse interaction when administering pirfenidone therapy, and to that end proposes that the concomitant use of fluvoxamine should be avoided, contraindicated or discontinued"
  • The patent is revoked as obvious because starting from D5 describing pirfenidone, the skilled person would check if CYP enzymes were involved in the metabolism of pirfenidone, found that this is the case, and would then proceed with interaction studies involving fluvoxamine, which was the only compound listed in D37 as a strong inhibitor of the CYP enzyme at issue.
  • The claim suggests that the first medical use of pirfenidone is not patented, but I find it difficult to see what the non-infringing medical use is of pirfenidone. Even avoiding concomitant use of fluvoxamine is patented. So the non-infringing use is co-treatment with pirfenidone and fluvoxamine and letting the patients suffer? I'm not sure what to make of this kind of second medical use claims for evergreening. 
EPO T 0285/14 - link

Reasons for the Decision
1. Analysis of claim 1
1.1 Non-therapeutic indication
The purpose specified for pirfenidone in claim 1 - "for use in treating a patient in need of pirfenidone therapy and in need of fluvoxamine therapy" - is a therapeutic application within the meaning of Article 53(c) EPC. In this, the board takes the view that "treating a patient in need of pirfenidone therapy" explicitly does not cover the non-therapeutic application of pirfenidone, contrary to the opponent's first approach to the interpretation of claim 1.
1.2 Patients to be treated
According to paragraph [0024] of the patent in suit, a patient in need of pirfenidone therapy is a patient who would benefit from the administration of pirfenidone, i.e. one who is suffering from any disease or condition for which pirfenidone may be useful.

16 Jul 2019

Summertime Reading : Andean Court

R. Helfer, K. Alter and M. Florencia Guerzovich, " Islands of Effective International Adjudication: Constructing an Intellectual Property Rule of Law in the Andean Community", American Journal of International Law 103 p.1-46 (2009)

https://scholarship.law.duke.edu/faculty_scholarship/2072/


Abstract
The Andean Community - a forty-year-old regional integration pact of small developing countries in South America - is widely viewed as a failure. In this Article, we show that the Andean Community has in fact achieved remarkable success within one part of its legal system. The Andean Tribunal of Justice (ATJ) is the world's third most active international court, with over 1400 rulings issued to date. Over 90% of those rulings concern intellectual property (IP).
The ATJ has helped to establish IP as a rule of law island in the Andean Community where national judges, administrative officials, and private parties actively participate in regional litigation and conform their behavior to Andean IP rules.  In the vast seas surrounding this island, by contrast, Andean rules remain riddled with exceptions, under-enforced, and often circumvented by domestic actors.
" Few scholars and practitioners are aware that the Andean Tribunal of Justice is one of the most active international courts in a world increasingly populated by international courts and tribunals. This fact alone is striking. The ATJ interprets the laws and regulations of the Andean Community—a marginally successful regional integration pact created by five small developing nations on the mountainous western edge of South America. More unusual still are the cases on the ATJ’s docket, which is dominated by disputes relating to trademarks, patents, and other IP rights. Within the Andean Community, intellectual property is principally regulated at the regional rather than the national level." 
" We were surprised by the large number of IP-related cases that national courts refer to the Andean Tribunal. Even more striking, however, was our finding that the ATJ has contributed to building an effective rule of law for intellectual property in a region of relatively weak national legal systems. We measured effectiveness along three different dimensions. First, the Andean legal system and Andean litigation have created economically valuable and enforceable private property rights. Second, ATJ rulings have dramatically improved the decision-making procedures of domestic IP administrative agencies, bolstering their autonomy, increasing their fidelity to the rule of law, and balancing property rights against the public interest. Third, the ATJ has provided a mechanism for private parties, Andean officials, and domestic IP agencies to counter individual member states that seek to circumvent the region’s distinctive approach to IP protection." 

 

12 Jul 2019

T 0851/18 - Paper debit orders

Key points

  • In March 2018, a paper debit order for the appeal fee is submitted, when only XML debit orders were allowed. The appellant submits (auxiliary, but I discuss it first) that the payment is valid. 
  • " In ... Entscheidung vom 4. Juli 2018 (T 590/18) hat die Kammer bereits festgestellt, dass der Präsident des Euro-päischen Patentamtes grundsätzlich berechtigt war, die Modalitäten der Zahlung per Abbuchungsauftrag wie geschehen zu verändern. " 
  • " Aus diesen Grundsätzen - an denen die Kammer festhält - folgt auch, dass das Amt nicht verpflichtet ist, einen zum Beispiel per Telefax rechtzeitig eingereichten sowie inhaltlich klar und eindeutigen erteilten Abbuchungs-auftrag stets als wirksame Zahlung der Beschwerdegebühr akzeptieren." The Board distinguishes from T 152/82 because at the time of that decision, the debit order did not need to specify the exact amount, such that the debit order at issue actually complied with the version of the ADA then in force.
  • " Insbesondere führt die Verpflichtung, den Abbuchungs-auftrag mittels eines elektronisch verarbeitbaren Formats (XML) zu übermitteln, nicht zu einer unverhält-nismäßigen Erschwerung des Zugangs zu den Beschwerde-kammern als gerichtlicher Instanz der Europäischen Patentorganisation und verstößt deshalb - entgegen der Auffassung der Beschwerdeführerin (Patentinhaberin) - auch nicht gegen Art. 113(1) und 125(1) EPÜ sowie gegen Art. 6(1) der EMRK ([European Convention on Human Rights]."
  • r.2.2.2 " Ein Verstoß gegen Art. 6(1) EMRK ist bereits deshalb nicht gegeben, weil die Zahlung per Abbuchungsauftrag - wie oben dargelegt - lediglich eine vom Amt nach Art. 5(2) der Gebührenordnung freiwillig eröffnete weitere Möglichkeit zur Gebührenzahlung darstellt." (in addition to bank transfer). 
  • As a comment, in my view this reasoning is too easy. Even though debit orders are an alternative means of payment, this does not mean that it can be a trap for appellants. If we assume that Article 6 ECHR requires that an appeal fee can be paid in a reliable way (I did not check the ECtHR case law on this point), this regulates all payment methods in my view. To take an extreme hypothetic situation: presume that payment in cash at the EPO in Munich would be possible, can the EPO levy a surcharge for debit orders in a capricious way, e.g. for appeals against refusals of patent application relating to plants? I don't think so. The fact that payment with a bank transfer is possible, does not mean that the ADA are exempted from basic legal principles such as the ECHR (in fact, the present Board assess the reasonableness of the ADA in r. 2.2.5, so I don't suggest that the present Board would have allowed the above extreme hypothetical situation even though r.2.2.2 suggest so). 
  • The Board then notes that point 5.5 ADA provides for the extension of periods if one of the allowed ways of filing debit orders is not available. The Board concludes that (r.2.2.5) " Die Kammer sieht in diesen Regelungen ein ausgewogenes System, dass insbesondere auch die Interessen potentieller Beschwerdeführer in angemessener Weise berücksichtigt." 
  • The EPO had issued a warning about the invalid payment, as courtesy service mentioned in point 5.1.3 ADA. The EPO, however, sent the warning by post such the appeal period had already expired by the receipt of it. The Board notes that it is a courtesy service in any way, such that parties have no right to it. I note that the invalid debit order was filed 22.03.2018 together with the paper Notice of appeal. The appeal period expired 05.04.2018 and the EPO despatched the paper warning only on 04.04.2019. 
  • The request for re-establishment is refused because a professional representative had signed the debit order. The appellant had provided evidence of isolated mistakes of assistants, but had not indicated reasons why the representative was unable to meet his obligation of  "Sorgfalts- und Prüfungspflicht" . 
  • The Board allows the request that certain documents are only included in the public file in anonymized form. 



EPO T 0851/18 -  link

Sachverhalt und Anträge

II. Die Beschwerde der Beschwerdeführerin (Patentinhaberin) vom 15. März 2018 ist am 22. März 2018 beim Europäischen Patentamt eingegangen. Am selben Tag ist - zum Zwecke der Zahlung der Beschwerdegebühr - ein Abbuchungsauftrag unter Verwendung des Formblattes EPA-Form 1010 einge-gangen.




Entscheidungsgründe
1. Die in Artikel 122 (1) EPÜ genannten Voraussetzungen für eine Wiedereinsetzung in den vorigen Stand sind nicht erfüllt. Der darauf gerichtete Antrag war deshalb zurückzuweisen.

1.1 Die Beschwerdeführerin (Patentinhaberin) hat im Einzelnen dargelegt und durch Vorlage eidesstattlicher Versich-erungen ihrer Mitarbeiter untermauert, dass und warum eine ihrer Mitarbeiterinnen ein nicht mehr gültiges For-mular für die Erteilung des Abbuchungsauftrags verwendet hat. Allerdings ergibt sich aus den Erklärungen und dem Inhalt der Akte im Übrigen auch, dass die Beschwerde und der Abbuchungsauftrag letztlich von einem bei der Beschwerdeführerin (Patentinhaberin) angestellten Euro-päischen Vertreter unterzeichnet wurden.

9 Jul 2019

J 0005/18 - Re-establishment

Key points

  • This case concerns a request for re-establishment for failure to file a response to an Art.94(3) Communication with further processing. The US patent attorney had emailed on 25.02.2014 to the European patent attorney (prior to the Notice of loss of rights setting the time limit for requesting further processing) that "Our client has decided not to file a response to the First Examination Report dated August 26, 2013, ... However we are interested in further processing. I cannot recall whether you must take action at the deadline for response or only after the EPO sets a further deadline."
  • The US patent attorney leaves the firm, a new US patent attorney takes over the case and an assistant  (trainee patent attorney?) in the US firm indicates that no further action is necessary and the time limit is removed.
  • The Board finds a lack of due care: " When the US representative, Ms V., consulted the document management system and believed that the letter dated 25 February 2014 was an instruction for the EP representative to request further processing she did not act with all due care required by the circumstances. The letter dated 25 February 2014 did not give the slightest indication that the EP representative had already been instructed to request further processing. Quite the contrary, this document clearly demonstrated that no action had been taken at that stage. As stated above, the necessary legal assessment did not even require any specific knowledge of the EPC, but simply the common legal skills that can be expected of any representative." 
  • The Legal Board recalls that " the exception from the high standard of due care is only available for assistants who are merely carrying out routine duties; it is not available for representatives who are entitled to act on behalf of the applicant". Moreover, "A historical interpretation of the law as made by the Enlarged Board of Appeal in R 18/13 shows that the reports on Article 122 EPC, only state that "the Conference did not want to rule out that an employee could be excused", while the possibility of apologising for any fault on the part of the applicant or the representative was not discussed. This means that an excuse for the representative's fault was out of the question."


EPO J 0005/18 - link


Summary of Facts and Submissions
I. The appeal of the applicant (appellant) lies against the decision of the examining division posted on 11 December 2017 wherein the request for re-establishment of rights was rejected and the application deemed withdrawn. The background of the appealed decision is as follows:
II. With a communication posted on 26 August 2013, the examining division set a time limit of four months for a reply to its communication pursuant to Article 94(3) EPC and later granted a two-month extension following a request by the applicant. The applicant did not reply within the extended time limit, so on 1 April 2014, a notice of loss of rights pursuant to Rule 112(1) EPC was dispatched which informed the applicant that further processing or a decision on the matter could be requested within two months after notification.

8 Jul 2019

T 1979/13 - Not addressing all grounds in appeal

Key points

  • In this opposition appeal, the OD had found claim 1 of the Main Request to lack basis in the application as filed. The patentee addresses only Article 123(3) and Rule 80  in the Statement of grounds filed on 30.11.2013.
  • Therefore, the Statement of grounds does not comply with Rule 99(2).
  • "  Weder in der Beschwerdeschrift noch in der Beschwerdebegründung findet sich ein einziges Wort, das auf den Einwand der Einspruchsabteilung unter Artikel 123 (2) EPÜ eingeht. Die von der Beschwerdeführerin angeführten Textstellen der Beschwerdebegründung auf Seite 1 unten sowie Seite 2 beziehen sich ausschließlich auf die Punkte II.2 sowie II.3 der angefochtenen Entscheidung." (Point II.2 was about Rule 80, point II.3 about Article 123(2).
  • " Es ist für die Kammer daher nicht nachvollziehbar, warum eine wie auch immer geartete Argumentation zu Punkten der angefochtenen Entscheidung, durch welche die Beschwerdeführerin nicht beschwert ist, einen Grund dafür darstellen sollte, warum die angefochtene Entscheidung aufzuheben ist." 
  • This decision is perhaps not very surprising. Note however that the Board needed almost six years to decide the case. 



EPO T 1979/13 - link



Entscheidungsgründe
1. Unzulässigkeit der Beschwerde (Regel 101 (1) EPÜ)
1.1 Die Beschwerde wurde fristgerecht eingereicht. Jedoch ist die Kammer zu der Auffassung gelangt, dass die Beschwerde im Sinne der Regel 99 (2) EPÜ nicht ausreichend begründet ist.
Das Patent war von der Einspruchsabteilung widerrufen worden, da der unabhängige Anspruch 1 des einzigen der angefochtenen Entscheidung zugrundeliegenden Antrags, der dem gültigen Hauptantrag entspricht, gegen Artikel 123 (2) EPÜ verstößt.

5 Jul 2019

T 0231/14 - Form refusal, appeal inadmissible

Key points

  • In this examination appeal, the application was refused with Form 2061 (decision according to the state of the file). There is no substantial procedural violation. The appeal is inadmissible because the applicant did not rebut all grounds for refusal.
  • In the last Communication of the Examiner (correctly referenced in Form 2061), the claim was rejected as obvious over: D1 with D7, D2 with D7, and D3 with D7.
  • The Statement of grounds addresses novelty over D1, novelty over D7, and inventive step in view of D1 with D7. However, the Statement neither addressed D2 with D7, nor D3 with D7.
  •  " Tatsächlich ist eine Behandlung der erfinderischen Tätigkeit des beanspruchten Gegenstands im Hinblick auf die Kombination der Dokumente D2 und D7 bzw. D3 und D7 weder einer schriftlichen Eingabe der Anmelderin im erstinstanzlichen Verfahren noch der Beschwerdebegründung zu entnehmen." 
  • The applicant argued that no reasoning was necessary, because the form refusal would involve a substantial procedural violation as being not properly reasoned. The Board does not agree.
  • "  Im vorliegenden Fall lässt sich jedoch nicht aus der Tatsache, dass die Entscheidung eine "Entscheidung nach Aktenlage" ist, folgern, dass ein Verstoß gegen das Begründungserfordernis von Regel 111 (2) EPÜ vorliegt, der die Beschwerdeführerin von ihrer Verpflichtung  entbinden könnte, die Beschwerde im Einklang mit den oben, unter Nr. 1.1 aufgeführten Grundsätzen in der Sache, d.h. im Hinblick auf die einzelnen Zurückweisungsgründe, zu begründen." 
  • The Board finds the inventive step objection based on D3 with D7 to be properly reasaoned. "Jedenfalls in Bezug auf den Einwand mangelnder erfinderischer Tätigkeit basierend auf D3 in Kombination mit D7 kann der Vorwurf "mosaikartig" erhobener Einwände nicht gelten, da dieser Einwand erst im letzten Bescheid vom 24. Juni 2013 (siehe Punkt 3) erhoben wurde. Zudem sind in diesem Bescheid die Begründungen betreffend die Kombinationen D1 mit D7 und D3 mit D7 in den separaten Abschnitten 2 bzw 3 wiedergegeben, jeweils unabhängig voneinander formuliert und deutlich voneinander unterschieden. " 
  • The appeal is rejected as inadmissible.


EPO T 0231/14 - link

Entscheidungsgründe
1. Gemäß Artikel 108 EPÜ, dritter Satz, EPÜ ist innerhalb von vier Monaten nach Zustellung der Entscheidung die Beschwerde nach Maßgabe der Ausführungsordnung zu begründen. In der Beschwerdebegründung hat der Beschwerdeführer darzulegen, aus welchen Gründen die angefochtene Entscheidung aufzuheben oder in welchem Umfang sie abzuändern ist und auf welche Tatsachen und Beweismittel er seine Beschwerde stützt (Regel 99(2) EPÜ). Wenn die Beschwerdebegründung diese Bedingung nicht erfüllt, ist die Beschwerde als unzulässig zu verwerfen (Regel 101(1) EPÜ).
1.1 Die in Artikel 108 EPÜ geforderte Begründung der Beschwerde ist so auszulegen, dass sie sowohl die rechtlichen Gründe, d.h. die Rechtsgrundlage, als auch die faktischen Gründe, d.h. die Tatsachen und Beweismittel, umfasst, die die Kammer braucht, um zu entscheiden, ob die angefochtene Entscheidung aufgehoben werden muss.

2 Jul 2019

T 0437/14 - After G1/16

Key points

  • This is the follow-up decision after the Enlarged Board confirmed in G 1/16 that undisclosed disclaimers are to be examined according to G2/03.
  •  "  In its earlier interlocutory decision, the board also already decided that the disclaimers establish novelty over accidental anticipations under Article 54(2) EPC, namely D5 and D7, and that they do not remove more than what is necessary to restore novelty over D5 and D7" 
  • " The board in the present composition further considers that there is no evidence that, while establishing novelty over those accidental anticipations, the disclaimers provide a technical contribution adding subject-matter extending beyond the content of the application as filed. In particular, no evidence was put forward by the opponents, and the board does not see any either, that the limitation of the genus of compounds covered by the formula in claim 1 which results from the excision of the seven specific compounds defined in the disclaimer, becomes relevant for establishing inventive step or sufficiency of disclosure. " 
  • The disclaimer is hence allowable. Next issue is priority.
  • " What remains to be decided is whether the insertion of the two disclaimers into claim 1 leads to the loss of the priority right. " 
  • " As set out in points 2.5 and 2.6 above, the two disclaimers present in claim 1 do not provide a technical contribution and fulfil the requirements of Article 123(2) EPC. Thus, they cannot "change the identity of the invention within the meaning of Article 87(1) EPC" and do not "affect the right to priority from the first application", as stated in G 1/03." 
  • An attack based on toxic divisional applications is also rejected because of partial priority.  "Claim 1 is, in fact, a generic "OR"-claim encompassing alternative subject-matter which is directly and unambiguously disclosed in the priority document and is thus entitled to a partial priority for that alternative subject-matter within the meaning of G 1/15" 


EPO T 0437/14 - ECLI:EP:BA:2019:T043714.20190312  link

Summary of Facts and Submissions
I. This decision concerns the appeals filed by opponents 1 and 3 and the patent proprietors against the interlocutory decision of the opposition division finding that European patent No. 1 933 395 as amended meets the requirements of the EPC.
[...]
Referral to the Enlarged Board of Appeal
XII. After reviewing a number of earlier decisions of the board of appeal, the board considered that the case law which had developed after G 2/10 was not uniform, as regards whether the "gold standard" was applicable to undisclosed disclaimers. It then decided to refer to the Enlarged Board of Appeal several questions of law aiming at clarifying whether the principles developed in G 2/10 were to be applied to undisclosed disclaimers and/or whether the criteria developed in G 1/03 continued to apply.
XIII. Since the allowability of the disclaimers and the relevance of the attacks based on D57 and D58 depended on the answer to the questions posed to the Enlarged Board of Appeal, the board did not give a ruling on these issues.
XIV. With its decision G1/16 dated 18 December 2017 (OJ EPO 2018, A70), the Enlarged Board of Appeal provided the answers to the questions referred to it.