Category Archives: Patent

Even More on the New Eligibility Guidance, Myriad and Promega v Life Tech

The new Guidance is available here. A PDF version is available here. The associated ‘Nature-Based Products’ examples are available here.

A further article from IPWatchdog discussing the new guidance can be found here. It discusses in detail how the new guidance differs from the previous one and how this should mean that more computer-implemented inventions will be found to be eligible. Whilst the IPWatchdog blog has had the most negative reaction to the Alice decision of all the blogs we read, it is also the one that has had the most informative comments on the implications of the changes in law in this area.

In another post IPWatchdog discusses the ‘significantly more’ part of the Alice test and how this can be shown (see here).

Personalised Medicine Bulletin discusses the life sciences aspects of new guidance with a focus on the new Myriad decision (see here). It notes the ‘markedly different’ analysis which can be used to support eligibility of products related to natural products.

Pepper Hamilton discuss the Myriad decision here, and comment on what it means for biotech and diagnostics patents in general.

PatentlyO discusses Promega v Life Tech here. This is about enablement of a claim where the term ‘comprising’ brings in other embodiments which are not shown to be enabled, i.e. combinations of loci that might not co-amplify. This seems a much stricter way of looking at enablement than in Europe.

Our previous posts on the new guidance can be found here and here.


More on the New Eligibility Guidance and In re BRCA1- and BRCA2-Based Heredity Cancer Test Patent Litigation (Fed. Cir. 2014)

The New Interim Guidance on Subject Matter Eligibility

The new Guidance is available here. A PDF version is available here. The associated ‘Nature-Based Products’ examples are available here.

PatentDocs have now posted their analysis of the impact of the new guidance on business and software inventions here. Mintz Levin’s post about the guidance can be found here. Our previous post can be found here.

In re BRCA1- and BRCA2-Based Heredity Cancer Test Patent Litigation (Fed. Cir. 2014)

The Federal Circuit held Myriad’s claims to screening for BRCA1 and BRCA2 mutations (by probing or sequencing) to PCR primers as ineligible. The screening method was found to relate to an abstract idea. The primers were found to not be distinguishable from the DNA claims found invalid by the Supreme Court.

PatentDocs’ post on this is here. PatentlyO’s detailed review can be found here.

Roundup of Tech and Developing World Issues

  1. ‘Pharmaceutical Patent Enforcement: A Developmental Perspective’ is an article about the complex issue of how India should deal with pharma patents, taking into accounts its obligations under TRIPS. You may also wish to see our related posts ‘6 Academic Articles on Changing TRIPS and the Global IP System’ and ‘10 Points on the Max Planck Institute’s Declaration on Patent Protection’.
  2. ‘Building Competitive Green Industries’ is a report by infoDev into business opportunities for developing countries in sectors relating to climate change related and clean technology. The report takes the optimistic view that climate change represents an opportunity for developing nations to benefit from development of green and clean technologies. Whether or not one agrees with this it is for developing countries to prepare for climate change as best as they can, and this report presents options they can take.
  3. ‘Making Sense of the CETA’ is a critical analysis the Canadian-European trade agreement. It raises critical questions about how much power a trade agreement should have to interfere with issues of public importance. The reason why we have included it in this post is to highlight the issues that the developing world needs to consider when entering into trade agreements.
  4. A WIPO seminar on the ‘Evolution of Technology Diffusion’ provides insights into the difficulties of transferring innovation around the globe. See a paper here on the same topic.
  5. See here for a McKinsey report on how Southeast Asia can benefit from disruptive technologies.
  6. See here for Mariana Mazzucato arguing for government intervention in markets.
  7. See here for the World Economic Forum’s choice of the top 10 tech innovations of 2014.

Late Requests in Appeal, Stem Cells and Medical Use Claim from epi Information December 2014

This post provides interesting snippets we saw in the latest edition of the epi’s journal ‘epi Information’ concerning three areas of evolving case law: late requests in appeal, stem cells and the differences between EPC 2000 medical use claims and Swiss Style claims.

From the ‘EPO Boards of Appeal and Key Decisions’ conference of 8-9 October 2014

‘Late Requests’, based on a presentation by Mr Hugo Meinders (Chairman of Board of Appeal 3.2.07)

This was about implementation of Articles 12(2), 12(4), 13(1) and 13(3) of the Rules of Procedures of the Boards of Appeal

  • According to Art. 12(2) the parties should file their complete case at the first exchange. The Board has the power not to admit in the appeal proceedings requests which could have been presented or were not admitted in the first instance proceedings.
  • According to Art. 13(1) any amendment to a party’s case after it has filed its grounds of appeal or reply may be admitted and considered at the Board’s discretion. The discretion shall be exercised in view of inter alia:

~ the complexity of the new subject-matter submitted,

~ the current state of the proceedings and

~ the need for procedural economy.

  • According to Art. 13(3), anything filed after issue of the summons is not admitted if it cannot be dealt with by the Board or the party without adjournment of the proceedings. Although the way late filed requests are handled may vary from one Board of Appeal to another, the political will to increase the productivity of the Boards of Appeal may have far reaching consequences for the users of the system. Thus, although not mentioned by Mr Meinders, the Boards of Appeal seem to show a desire to act more as a pure second instance reviewing the correctness of the first instance decision.

From a Report of a Meeting of the Committee on Biotechnological Inventions

Stem Cells

The latest opinion from the CJEU in C364/13 suggests that “parthenotes” are not embryos and therefore are not excluded from patentability. In addition T2221/10 appears to follow the EPO’s current practice, namely that cases filed before publication date of the single blastoma extraction process (SBP) are not patentable.

Medical use claims

T1780/12 concerned the difference in scope between Swiss style and EPC 2000 claims.

There is some concern by doctors, for example in Switzerland, that they may infringe the EPC 2000 format medical use claims. There is also concern regarding infringement for off label marketing. We think that there are differences in scope, because Swiss style claims require the manufacture of a medicament: at a very basic level are two different types of claims have different wording. There is a suggestion that EPC 2000 medical use claims might cover the use of an intermediate in a pharmaceutical formulation which then is metabolized to an active ingredient in the body. That probably would not be covered by a Swiss style claim.

You may also wish to see related articles 10 Biotech Claims You CannotHave in Europe and Tips for Success in EPO Appeals on Biotech Cases.

What’s Trending in Patents? Illegality for cross-undertakings, Teva v Leo, Wearables, Generics Litigation, China and Innovation Statistics

1. The recent UK Supreme Court decision Servier v Apotex concerned whether patent infringement in another territory is an ‘illegality’ which would be relevant to payment of cross-undertakings. The decision can be found here. IPKat’s post can be found here. Wragge & Co’s post can be found here.

2. We’ve written for IPKat on Teva v Leo (see the decision here, see the post here). However we were interested in the observations of Wragge & Co (see here) which ask whether Birss departed from the Pozzoli test for inventive step, whether he had freedom to do so, and how this may have affected the result.

3. This is not strictly a patent topic, but we hear so much about ‘Wearables’ being an important sector for innovation, we thought we’d mention TechCrunch’s article critically assessing the technology (see here).

4. We liked the present edition of Patent Lawyer (see here), particularly the articles on US patent litigation, software patents and making amendments at the EPO. See our post on the Post-Alice Post-Myriad Post-Mayo World here.

5. A recent Pharmalot article (see here) discusses the fact that more generics are filing for litigation.

6. China continues to be topical. Xconomy wrote about its growth plans (see here). Iam wrote about Chinese R&D spending (see here). A post from Freshfields gives some insights into China’s policies on company acquisition (see here). See our post on China and the Patent system here.

7. PWC’s Strategy& have interesting stats on innovation on their website (see here). See our post 10 Points on Ernst & Young’s Biotechnology Industry Report 2014 ‘Unlocking Value’, here.


Reasons to go to Mediation in a Pharma Patent Dispute

Michael Fysh spoke at fieldfisher’s Pharma Seminar on 16 October 2014. The following points are based on the handout he gave at the event.

Advantages of Mediation in General and in Pharma Cases

  1. Cost savings in a field where litigation is normally very expensive.
  2. Avoiding uncertainty, anxiety and commercial ‘downtime’.
  3. There are no appeals to worry about.
  4. There is no ‘judge risk’. Litigation inevitably has uncertainties.
  5. It is possible to settle international disputes involving the same parties and IP.
  6. Resolution of collateral disputes is possible.
  7. A wider range of possible solutions is available, and a skilful mediator will be able to provide solutions beyond the power of a Court to provide.
  8. Mediation is faster than litigation.
  9. Mediation allows confidentiality of sensitive commercial information.
  10. Mediation allows for a ‘win-win’ situation, for example by the setting up of a new commercial relationship.
  11. There is no costly enquiry into damages.
  12. Psychological/cultural benefits. For example there is no ‘loss of face’ as the parties themselves choose what to accept.
  13. What happens in mediation is ‘without prejudice’ and is not binding if mediation fails. The parties can go on to litigate confident that the mediation discussions remain confidential.
  14. Even unsuccessful mediation can lead to a better mutual understanding of the parties’ positions.

Disadvantages of Mediation in Patent Cases

  1. It needs the agreement of the other party to set up mediation. That requires time and so mediation is not suitable where emergency action is needed, such as an interlocutory injunction.
  2. It is impractical where a party wishes to create a legal precedent, for example the construction of a patent claim or contractual clause, or the Court’s view on a legislative development.
  3. It is unattractive to parties seeking summary judgment.
  4. It is not of interest where publicity is actively sought by a party.
  5. It is irrelevant where revocation of IP is sought where a Court will need to be involved.

You may also wish to see related posts Top 10 Points on Arbitration in UK Patent Disputes and Top 8 Points On the Disadvantages of Having a Specialist Patent Court.

EU Pharma Patent Settlements

These points are from a talk given by John Cassels at fieldfisher’s Pharma Patents Seminar on 16 October 2014.

  1. Anticompetitive behaviour can arise either due to agreements between parties or from unilateral behaviour, and patent settlements are agreements that may be anticompetitive. Anticompetitive behaviour can be approached either through looking at the ‘object’ of the agreement or through the ‘effect’. The EU normally analyses the ‘object’ as this is easier to prove.
  2. Pay for delay (or ‘reverse settlement’) agreements are where a patent holder pays a competitor to not enter the market and not to challenge the validity of the patent. See TaylorWessing comments on pay for delay here.
  3. EU case law is still evolving in this area and decided cases so far focus on individual bad behaviour of the parties, rather than developing principles to guide which pay for delay settlements are anticompetitive. However in the recent Servier case it was relevant that the ‘product’ patent had expired and Servier was relying on a ‘process’ patent. Servier was also found guilty of abusing its dominant position over a particular ‘molecule’. See Law360’s report here.
  4. In the Lundbeck decision the internal documents of the parties were very damaging, referring to a ‘club’ being formed and ‘piles’ of cash being made.
  5. The EU fining guidelines can be found here. The fines increase for repeat offending and refusal to cooperate.

You may also wish to see related articles Evergreening in the Pharma Sector and Mazzucato’s ‘Innovation as Growth Policy’.