Category Archives: Biotech

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.

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.

 

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’.

Injunctions in UK Pharma Cases

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

1. There are 4 types of injunction: pre-action (very rare in the UK), interim, final and cross-border.

2. The Enforcement Directive 2004/48/EC made interim and final injunctions available across Europe. They are discretionary and subject to national law, and are not harmonised.

3. Cross-border injunctions are only available if validity is not challenged (GAT v Luk [2006]). Though Solvay v Honeywell [2012] decided interim injunctions were available even if validity was challenged. See Bird & Bird’s comments on GAT v Honeywell here and comments on Solvay v Honeywell from CMS here.

4. In the UK an injunction is a discretionary remedy where no other form of remedy is adequate. It is contempt of court to not comply and the applicant has a duty of full and frank disclosure.

5. The American Cyanamid guidelines view the granting of injunctions as a ‘serious question’ in issue. The adequacy of damages, balance of convenience and special factors (e.g. the undertakings) must be considered.

6. Interim injunctions are more common in pharma cases and final injunctions are standard. When granting an injunction the Court may look at whether the alleged infringer acted to ‘clear the way’ of infringed patents (SmithKline Beecahm v Apotex [2002]). However in Cepahlon & Ors v Orchid & Anor [2010] failure to clear the way did not lead to an injunction being granted. Merck v Teva [2012] and Novartis v Hospira [2013] though seem to show a hardening of approach towards infringers. See Bird & Bird’s comments on Cepahlon & Ors v Orchid & Anor [2010] here.

7. In other EU countries:

In Germany different courts have different approaches. The Dusseldorf court is seen as a friendly court for interim injunctions in pharma cases. The focus is more on the merits of the case rather than economic arguments. It may grant ex-parte interim injunctions. The bifurcated system often results in injunctions before the outcome of the validity action.

In France an injunction will be granted based on the likelihood of patent infringement.

In Austria injunctions are common and this is considered a pro-patentee system.

8. The Unified Patent Court raises new issues. A pan-European injunction will be possible and forum shopping will probably happen when asking for injunctions.

You may also wish to see related articles 10 Points on What Patent Judgments Achieve and 10 Points on Open Innovation.

 

Biotech Roundup: Time Frame of Investments, Gap in Funding Proof of Concept, Personalised Medicine and Reverse Payments

Here are various items of biotech news that recently caught our eye. We’ve provided a summary of each trying to show how the news item relates to the bigger picture.

1. Time Frame of Biotech Investments

Advent Capital is setting up a fund to invest in early and midstage European biotechs (see here). The proviso is that they wish to see returns in 6 years. That illustrates the drawbacks of investing in biotech companies developing drugs. It usually takes 10 to 15 years to develop a drug, and that keeps a lot of investors away who want to see returns in around 5 years.

2. The Gap in Funding Proof Of Concept Work

UK non-profit organisations Cancer Research and Leukaemia & Lymphoma Research are funding proof of concept work in treating blood cancers (see here). This illustrates how infrastructure needs to be provided to do ‘basic’ research which won’t see any immediate returns. It remains for government to enter into these funding gaps to make sure research and innovation systems operate effectively.

3. Personalised Medicine

Personalised medicine is a difficult technology to develop as it is proving challenging to identify the appropriate markers. However it clearly has a lot of scope for improving patient care. ‘Incentives, Intellectual Property, and Black-Box Personalised Medicine’ (see here) examines changes needed to the innovation landscape to better develop this technology.

The US Supreme Court Akamai decision makes it harder to find induced infringement for multi-step method claims (see here) as it requires primary infringement by a single party. However for personal medicine the diagnostic part and the treatment parts of the invention could well be performed by different parties. This adds to the difficulties in obtaining patent protection beyond those caused by the Mayo and Myriad decisions.

4. What exits are happening in US biotech?

An article from the Life Sci VC blog (see here) discusses the proportion of IPO versus M&A exits that are happening in US biotech. The ratio is 40% IPO to 60% M&A. It’s therefore important to biotech to keep both options open.

5. Reverse Payments (Pay for Delay)

A recent PatentlyO article (see here) explained the economics of pay for delay settlements where it can be in a patentee’s interests to pay a generics company to stay out of the market, but this risks being anticompetitive.

A slightly old article on the European position can be found here.