Association of Corporate Counsel (ACC)

Welcome back Mr Badertscher







EPO clarifies patentability of diagnostic methods

View original document | Send to colleague | Print | Suggest a topic (new)
Marks & Clerk
European Union
February 17 2010

The Enlarged Board of Appeal (EBA) at the European Patent Office (EPO) issued a decision on 15 February 2010 in case G1/07. This case concerned the patentability of diagnostic methods which (in certain embodiments) involve an invasive intervention with the human or animal body.    

In this case, the claims are directed to MRI imaging methods in which polarized 129Xe gas is “delivered to a predetermined region of the patient’s body”. In particular, the claims encompass embodiments where the gas is delivered to the patient by inhalation, and also by way of direct injection into the heart.

Some EPO case law concludes that any invasive intervention with the human or animal body undertaken as part of a method of curative treatment or of diagnosis constitutes a "surgical method" and is therefore excluded from patentability under Article 53(c) EPC. However, the case law is not uniform on this issue and the Enlarged Board of Appeal were asked to clarify whether it is:

(a) the nature, or

(b) the purpose

of the "surgical step" which is relevant in determining whether or not it should be considered a method of treatment by surgery.

This is important since depending on how it is interpreted, the term "treatment by surgery" could encompass activities which are not remotely surgical e.g. a routine injection of a therapeutic or prophylactic agent, the taking of a drop of blood for a diagnostic test, the swallowing of a pill or inhaling of a preparation.

The full decision in the case can be found here on the EPO website.

The detailed reasoning provided by the Enlarged Board of Appeal provides valuable guidance on some broad issues. By way of summary, it was found that:

A. The exclusions from patentability which are found in the EPC are not required to be construed restrictively or narrowly. Instead, the Enlarged Board states that "...the general rule ... that a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose must apply to the exclusion clauses contained in the EPC in the same manner as to any other provision,..."

The Enlarged Board stated that it was important that a provision (in this case an exclusion to patentability) "... is interpreted in such a manner that it takes its effect fully and achieves the purpose for which it was designed."

B. A method claim is excluded from patentability "... if it comprises or encompasses at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy."

C. The three alternative exclusions from patentability in Art 53(c) EPC 2000 (methods of treatment of the human or animal body by surgery, methods of treatment of the human or animal body by therapy, and diagnostic methods practised on the human or animal body) are distinct and independent exclusions, i.e. in order to be patentable a claimed method must neither be a therapeutic nor a surgical nor a diagnostic one.

Therefore, despite what is implied by the ordinary meaning of the word "surgery", the term "treatment by surgery" is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose.

D. Thus, an invasive step (in this case an injection into the heart) representing a substantial physical intervention on the body which requires professional medical expertise to be carried out, and which entails a health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method of treatment of the human or animal body by surgery.

E. A claim which encompasses an embodiment which is excluded from patentability under Art 53(c) EPC cannot be left to encompass that embodiment. To resolve this, it may be possible to:

(i) omit the feature which is excluded from patentability, or

(ii) disclaim the excluded embodiments (subject to the strict conditions for disclaimers defined in decisions G1/03 and G2/03).

However, the resulting claim must also comply with the remaining requirements of the EPC, in particular Article 84/Rule 43 EPC (claims/form and content of claims) together with Articles 56, 83 and 123(2) EPC (inventive step, disclosure of the invention, and added subject matter respectively).

As a general note, it is strongly recommended that when drafting a method claim including a feature which might be excluded from patentability under Art 53(c) EPC (i.e. a feature which could be interpreted as a method for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body) then in the application as originally filed that feature should either be:

(i) omitted from the claim, or

(ii) referenced as a feature distinct from the claimed method e.g. an agent/object that has been "pre-delivered" or "pre-implanted".

Inclusion of the feature in the claim may be essential for ensuring that it complies with the requirements of Articles 84/56/83 EPC, but it should be done so that protection is not sought for that feature itself.  

James Robertson

James Robertson

Popular related articles

  1. European General Court issues landmark judgment in AstraZeneca (Latham & Watkins LLP)

    On 1 July 2010, the General Court issued its long-awaited ruling in the AstraZeneca case.

  2. New European rules place tough restrictions on bonuses (Herbert Smith LLP)

    The European Parliament recently approved tough new rules which will limit the way in which remuneration packages for staff within credit institutions and investment firms are structured.

  3. Translation of the specification of a European patent is no longer required (Hogan Lovells)

    On 1 May 2010, the London Agreement on the Application of Article 65 EPC affecting the requirement to provide translations of European patents (the "London Agreement"), came into force in France.

  4. European Commission issues first report on patent settlements (Hogan Lovells)

    On 5 July 2010, the European Commission (the "Commission") published its first report on its monitoring of patent settlements in the pharmaceutical sector (the "Report").

  5. EU-US financial data transfer agreement due to enter into force in August (A&L Goodbody)

    On Thursday 8 July, 2010 the European Parliament approved the revised draft Agreement between the EU and the US on the transfer of financial data, known as the SWIFT Agreement.

  6. Committee of European Banking Supervisors releases results of the 2010 EU stress tests (Alston & Bird LLP)

    Yesterday, the Committee of European Banking Supervisors (CEBS) released the results of the 2010 EU-wide stress test, conducted in coordination with 20 national supervisory authorities.

  7. Pharmaceutical package anti-counterfeiting directive (Fasken Martineau DuMoulin LLP)

    Counterfeiting of medicinal products is an increasing problem, particularly in the developing world.

  8. European court upholds Commission case against AstraZeneca relating to Losec, but reduces fine (Hogan Lovells)

    On 1 July 2010, the General Court of the European Union (the "General Court") handed down its eagerly awaited judgment in relation to AstraZeneca's appeal against a 2005 decision of the European Commission (the "Commission") finding that AstraZeneca had abused its dominant position by blocking or delaying generic versions of its drug Losec.

  9. Advocate General refuses to extend privilege to in-house lawyers under EU competition law (Herbert Smith LLP)

    The Advocate General's opinion in the Akzo privilege case was published on 29 April 2010.

  10. Alternative Investment Fund Managers Directive (AIFMD) (Herbert Smith LLP)

    The draft AIFMD is in the final stages of becoming finalised.

  1. Summary of health care reform impacts on long term care providers (Vorys Sater Seymour and Pease LLP)

    The Patient Protection and Affordable Care Act of 2010 ("PPACA"), signed into law on March 23, 2010, contains many provisions affecting health care providers.

  2. Seventh Circuit appellate court warns health care employers against acceding to racial preferences of patients (Ballard Spahr LLP)

    A health care provider that relies on state laws relating to patient preferences to justify making race-based assignments may be creating a hostile work environment and subjecting itself to liability.

  3. Biotech’s new backbone (Fasken Martineau DuMoulin LLP)

    The funding difficulties for the biotechnology are well known, but financiers have come up with new and innovative ways to respond to these funding challenges - namely the Standby Equity Distribution Agreement ("SEDA").

  4. Uk Office of Fair Trading investigates product switching strategies (Hogan Lovells)

    Lifecycle management involving product development and regulatory and/or patent protection for successor drugs is an important aspect of the business plan of most research-based pharmaceutical manufacturers.

  5. Interim final rules released on preexisting condition exclusions, lifetime and annual limits, rescissions, patient protections, and preventive care (Morgan Lewis & Bockius LLP)

    The federal agencies responsible for Healthcare Reform regulations have recently issued significant guidance, including several model notices, applicable to some of the provisions under the Patient Protection and Accordable Care Act (PPACA) as amended by the Health Care and Education Reconciliation Act of 2010 (the Reconciliation Act; together, the Healthcare Reform Law).

  6. COBRA health continuation coverage subsidy extension (Whiteford Taylor & Preston LLP)

    On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act of 2009, referred to in the press as the Economic Stimulus Act.

  7. European General Court issues landmark judgment in AstraZeneca (Latham & Watkins LLP)

    On 1 July 2010, the General Court issued its long-awaited ruling in the AstraZeneca case.

  8. Bribery Act and the pharmaceutical industry (Fasken Martineau DuMoulin LLP)

    Tougher laws are set out in the Bribery Act enacted in April 2010 which will have the effect of imposing extra regulation on the pharmaceutical industry.

  9. Health care reform: elimination of retiree drug subsidy deduction (McDermott Will & Emery)

    Employers that provide retiree prescription drug coverage should analyze the increased future tax liability and the current accounting charges necessary to retain retiree prescription drug coverage, and evaluate the practical and legal risks of eliminating this benefit.

  10. CMS proposes to treat drug vial “overfills” as suspect free goods (Proskauer Rose LLP)

    CMS's annual summer tome, the proposed Physician Fee Schedule published this year on July 13, 2010, contains a significant new proposal that if adopted would affect the physicians, hospitals outpatient departments and others that bill for drugs and biologics under Medicare Part B.

  1. How conducting exit interviews can help protect your trade secrets (EpsteinBeckerGreen)

    HR professionals will tell you that an exit interview is a valuable tool for learning what a company is and is not doing well; what they may not tell you is that exit interviews are also an important tool for managing the risks of the electronic workplace.

  2. Protecting your ownership of employee-created intellectual property (Masuda Funai Eifert & Mitchell Ltd)

    Most employers assume that any intellectual property ("IP") created by an employee in connection with the employee's job duties will automatically become the exclusive property of the employer.

  3. Have you got your apps covered? (Freehills)

    Apps are the new black.

  4. Changing trends in the enforcement of open source software (Bereskin & Parr LLP)

    Open source software has not historically generated much litigation.

  5. Professor learns his lesson (Shepherd & Wedderburn LLP)

    Professor Weetman was employed by Newcastle University in 2007 on a short-term basis and claims that whilst there he redesigned a BSc module in biomedical sciences.

  6. Fictional characters in new media (Lathrop & Gage LLP)

    Spiderman, James Bond, Wonder Woman, Batman – these iconic heroes remain among the best-known fictional characters of our time, and, as characters, are afforded copyright protection, independent of the works in which they appear.

  7. Use of another's trademark in domain name may be permissible as a nominative fair use (Winston & Strawn LLP)

    Toyota sued Farzad and Lisa Tabari for trademark infringement for using the word LEXUS in domain names that advertised their auto brokerage services (buy-a-lexus.com and buyorleaselexus.com).

  8. Threats provisions: context is crucial (Reynolds Porter Chamberlain LLP)

    Anyone looking to assert their intellectual property rights in the UK should be aware of the threats provisions, which apply to a number of IP rights.

  9. Minimizing the risk that a new hire will lead to trade secret litigation: some simple preventive steps (EpsteinBeckerGreen)

    When hiring new employees, you can minimize the risk of inadvertently becoming embroiled in trade secret litigation by taking a few simple steps.

  10. Trade mark co-existence agreements find support in the High Court (Herbert Smith LLP)

    Solving a dispute over who can use a trade mark for what part of the market with a trade mark co-existence agreement is always a risky move.

  1. Quirky questions (Dorsey & Whitney LLP)

    A female employee of our company filed a Charge with the EEOC that she has been discriminated against because one of our executives is involved in a relationship with a subordinate female employee.

  2. Protecting your ownership of employee-created intellectual property (Masuda Funai Eifert & Mitchell Ltd)

    Most employers assume that any intellectual property ("IP") created by an employee in connection with the employee's job duties will automatically become the exclusive property of the employer.

  3. California court grants summary judgment to CISCO systems on computer fraud and abuse claim, holding that Brekka does not apply to ex-employees (Dorsey & Whitney LLP)

    Last week a federal district court in California granted Cisco Systems, Inc. summary judgment on its Computer Fraud and Abuse Act (“CFAA”) claim against an ex-employee who “on multiple occasions and without authorization, . . . used a Cisco employee’s password to gain access to Cisco’s computer systems and download Cisco’s proprietary and copyrighted software.”

  4. Changing trends in the enforcement of open source software (Bereskin & Parr LLP)

    Open source software has not historically generated much litigation.

  5. Supreme Court to hear several cases affecting labor & employment (Winston & Strawn LLP)

    The Supreme Court has accepted seven labor and employment-related cases to be heard in the Court's next term, which begins in October 2010.

  6. Recent cases remind M&A participants of when disclosure of merger negotiations is required (Morrison & Foerster)

    Two recent decisions by United States federal courts serve as useful reminders to companies and their advisors of the rules regarding disclosure of merger negotiations.

  7. Fictional characters in new media (Lathrop & Gage LLP)

    Spiderman, James Bond, Wonder Woman, Batman – these iconic heroes remain among the best-known fictional characters of our time, and, as characters, are afforded copyright protection, independent of the works in which they appear.

  8. Part 36: a distinct and highly structured regime (Reynolds Porter Chamberlain LLP)

    In recently emphasizing the distinct and self-contained nature of the Part 36 regime, the Court of Appeal has made clear that even the most basic principles of contract law cannot be assumed to apply.

  9. Depressed dispatcher unfit for duty, lacked disability or FMLA claim (Fenwick & West LLP)

    In Wisbey v Lincoln, a city employer lawfully (a) required a depressed emergency services dispatcher to submit to a fitness-for-duty exam and (b) fired her when she failed the exam.

  10. Damages for pure economic loss in a commercial context (Norton Rose)

    In November 2009, the Federal Court of Australia (in Hine v New South Wales Land and Housing Corporation [2009] FCA 1242) considered whether or not a legal remedy was available for perceived injustices arising from a direction given by the Department of Housing (DOH) to its contractors, in circumstances where losses claimed were pure economic losses arising from dealings in a wholly commercial context.

  1. Simplified UK Customs Regulations on counterfeit goods ease brand owners’ burden (Marks & Clerk)

    As we reported in June 2009, changes to the way that HM Revenue and Customs administered the regime for dealing with counterfeit goods placed a heavy burden on brand owners to commence court proceedings against owners of counterfeit goods.

  2. New trade mark law in Montenegro (Marks & Clerk)

    Following the separation of the union state of Serbia-Montenegro and the independence of Montenegro from Serbia in 2006, a new trade mark law is expected to be introduced in Montenegro shortly.

  3. Plumpy’nut® patent sparks controversy (Marks & Clerk)

    Plumpy'nut is a Ready-to-Use Therapeutic Food (RUTF) for treating severe malnutrition.

  4. Supreme Court Bilski ruling means business as usual for business method patents (Marks & Clerk)

    The US Supreme Court has today handed down its long-awaited opinion on the much-followed Bilski v Kappos case.

  5. Court of Appeal judgment in “Cipriani” trade mark case (Marks & Clerk)

    The Court of Appeal recently gave its judgment in the case Hotel Cipriani SRL & others v Cipriani (Grosvenor Street) Ltd & others ([2010] ECWA Civ 110.

  6. Court of Appeal criticises ECJ ruling in L’Oréal v Bellure (Marks & Clerk)

    The Court of Appeal recently handed down its final judgment in L'Oréal v Bellure, following the ECJ ruling on 18 June 2009.

  7. Pharma industry enters critical phase as patent cliff looms large, hastening consolidation (Marks & Clerk)

    More than 8 in 10 (82 per cent) of those working in the drugs industry believe big pharma will be unable to innovate sufficiently from within to replace blockbuster drugs going off-patent.

  8. Split decisions in UK and Germany on claim construction (Marks & Clerk)

    Parallel European Patent litigations between Occlutech and AGA Medical Corporation in the UK and Germany illustrate that the two countries can look at claim construction differently, despite the European Patent Convention (EPC) encouraging a uniform approach.

  9. OHIM proposals announced (Marks & Clerk)

    The Community Trade Mark Office (OHIM) has recently proposed certain changes to the current Community Trade Mark system.

  10. The Third Amendment to the Chinese Patent Law (Marks & Clerk)

    The "Third Amendment to the Patent Law" in China was passed on 27 December 2008 and entered into force on 1 October 2009.

Most popular articles on Lexology

View original document | Send to colleague | Print

If you are interested in submitting an article to Lexology, please contact Andrew Teague at ateague@lexology.com.

© Copyright 2006-2010 Globe Business Publishing Ltd