EPO Enlarged Board of Appeal Decisions 2010 RSC Law Group Seminar – 16 November 2010 Recent Chemistry Case Law – Patents Alex Rogers, Patent Attorney Haseltine Lake LLP

London – Bristol – Munich – The Hague – Guangzhou

2010 Enlarged BoA Decisions

• G 1/07 - Method for treatment by surgery • G 2/08 - Dosage regime • G 1/09 - Pending application • (G 4/08 - Langue de la procédure) • (G 3/08 - Patentability of programs for computers)

G 1/07 - Method for treatment by surgery The Claim • " 1. A method for MRI imaging the pulmonary and/or cardiac vasculature...comprising the steps of… … delivering polarized 129Xe to a predetermined region of the patient's body...” Key points • Claim covered, but did not mention, delivery via injection to the heart (this was suggested in description). • 129Xe not therapeutic

The Law • Excluded from patentability – “methods for treatment of the human or animal body by surgery or therapy” (then Article 52(4) EPC, now Article 53(c) EPC)

Main Question Posed “Is a claimed imaging method … which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body … to be excluded from patent protection as a method for treatment of the human or animal body by surgery … if such step does not per se aim at maintaining life and health?”

The Answer – Yes! • A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses… an invasive step…is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to Article 53 (c) EPC.

The Answer, cont… • Clarified what a surgical step is… • an invasive step representing • a substantial physical intervention on the body which requires professional medical expertise to be carried out and • which entails a substantial health risk even when carried out with the required professional care and expertise

Other findings •May be possible to exclude surgical embodiment by disclaimer – Be careful: must comply with EPC and relevant BoA case law, i.e. G 1/03 and G 2/03 (and …pending case - G 2/10)

•May be possible to omit step itself (e.g. claim subsequent step(s) after surgical one) - “requires an assessment of the individual case under consideration”

Application of G 1/07 • T 0266/07 – “Method for producing a magnetic resonance angiogram of selected vasculature in a subject, wherein a contrast agent has previously been introduced into the selected vasculature” – OK - not excluded - method ‘starts’ after introduction of contrast agent

• T 1068/07 (now pending as referral to EBoA as G2/10)…"Does a disclaimer infringe Article 123(2) EPC if its subject-matter was disclosed as an embodiment of the invention in the application as filed?"

G 2/08 - Dosage Regime The Claim • “1.The use of nicotinic acid or a compound metabolized to nicotinic acid… for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia…” • Known compound for known medical use • New aspect – the dosage regime • Is this overall use “new” in the EPO’s eyes?

The Law • Excluded from patentability – – "methods for treatment of the human or animal body . . . by therapy . . .”

• But, not… • “products, in particular substances or compositions, for use in any of these method”

The Law, cont… Article 54: (1) An invention shall be considered to be new if it does not form part of the state of the art. (2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art. • •

In other words, ‘substance X for use in treating disease Y’ is considered ‘new’ if X known, but use for treatment of Y is new. But if X for use in treating Y is known, but nature of treatment is different, is this ‘new’ ?

Question 1

• Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

Answer 1 – Yes! • Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.

Question 2 •If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?

Answer 2 – Yes!

• Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.

‘Swiss’ claims will no longer be allowed in EP applications Swiss claim = Use of a substance X for the manufacture of a medicament for the treatment of disease Y Form now allowed – A substance X for the treatment of disease Y Applies to EP applications having filing or (if claimed) priority date three months after publication of G1/07 in Official Journal of the EPO (Oct 2010) •Not retrospective

G 1/09 – Pending Application

• Or when can you file a divisional application? • If application refused, can appeal within two months… • Appeal has retrospective effect – refusal set aside, and application pending again

G 1/09 – Pending Application • But what if you do not Appeal? • What is status of application in two-month Appeal window? Dead or alive? • Answer – alive (or pending) – therefore an divisional can be filed • (as long as time limits under R36(1)(a),(b) have not expired)

Thank you Questions? E-mail: [email protected]

EPO Enlarged Board of Appeal Decisions 2010 RSC Law Group Seminar Recent Chemistry Case Law – Patents Alex Rogers, Patent Attorney Haseltine Lake LLP

London – Bristol – Munich – The Hague – Guangzhou