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.

Biotech Roundup: EC Report on Pharma, Dendreon Bankruptcy, Cost of Drug Development and Tackling Failure in Pharma R&D

1. We wrote on the IPCopy blog on the complex issue of how much data is required for a biotech patent, and briefly examined how the UK Courts have dealt with the issue in recent years. See ‘When is a Biotech Invention Completed? How Much Data is Needed?’

2. The Fifth European Commission Report on Pharma Patent Settlements is available here. Willkie Farr & Gallagher’s interesting analysis on how the Report must be seen in the context of the Servier and Lundbeck cases can be found here. A response by EFPIA can be found here.

3. The Dendreon bankruptcy led to interesting analysis by Xconomy (see here), New York Times (see here) and FierceBiotech (see here).

4. The cost of developing a drug ($2.6bn) was being discussed again after new figures were release by Tufts (see here). Life Sci VC essentially agreed with the Tufts analysis and figure (see here). Forbes have a more sceptical piece on this here.

5. Xconomy wrote on ‘Lowering the Cost of Failure in Biopharmaceuticals’ which listed the mistakes that big pharma is making in managing projects.

Biotech and the New USPTO Interim Guidance on Patent Subject Matter Eligibility

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

The new Guidelines are slowly being analysed by US attorneys and subsequent posts will provide links to the best analyses. See below for posts with useful initial comments.

From the viewpoint of a European biotech patent attorney the Guidelines are important in determining what is patentable and what we need to show to support eligibility. Now it seems ‘isolated’ natural products are patentable provided the ‘markedly different’ test can be met. The markedly different test requires a new characteristic in terms of structure or function. That means new biological, pharmacological, chemical or physical properties, a new phenotype or new structure or form. Importantly, if that test is passed there is no need to proceed to the ‘significantly more’ test. Clearly this provides a lot of guidance as to the sort of data that may be needed to support patentability.

The ‘significantly more’ test requires improvements to a technology or field, applying the judicial exceptions (i.e. the law of nature, natural product, etc) by means of machine, affecting a transformation; or adding a specific limitation other than a well-known one, or a meaningful limitation linking to a particular technology or environment. Clearly this provides an idea of the sorts of limitations that claims will need to have to give eligibility.

However, our biggest concern at the moment is Mayo type of invention (Example 5 in the main Guidelines document).  The invention concerns a relationship between the concentration in the blood of a substance and the likelihood the drug will be ineffective or cause harmful side-effects. The Guidelines say that ‘the relationship is a natural consequence of the ways in which thiopurine compounds are metabolized in the body, even though human action is needed to trigger a manifestation of the relationship’. This leads to ineligibility. It is unclear to us what types of relationships could be the basis of eligible inventions, and what further limitations would have rendered the Mayo invention eligible. In particular this is of concern for diagnostic and personalised medicine inventions.

See IPWatchdog here for interesting initial comments on the ‘Alice’ aspects of the Guidelines.

See Managing IP’s comments here.

See PatentDocs here.

See Lexocology here.

Update: See PharmaPatents here.

What’s Trending in Patents? Commil v Cisco, Hospira v Genentech, Amending in IPR, Alice and Claim Breadth, DDR Holdings

1. Commil v Cisco was granted cert by the US Supreme Court which will now decide on whether a defendant’s belief that a patent is invalid as a defence to inducing infringement. The ‘Written Description’ blog comments on this here.

2. IEEE Spectrum’s yearly roundup of the strongest US patent portfolios can be found here. Johnson & Johnson continues to dominate the biotech and pharma fields. IEEE Spectrum’s very sophisticated ranking system is discussed here. An unrelated article on Patent Rating Systems by AcclaimIP can be found here.

3. See our post on the UK decision Hospira v Genentech on the PatLit blog here. This has an interesting discussion of ‘product by process’ claims which is further discussed on IPKat here.

4. Amending claims during IPR proceedings before the PTAB is proving to be difficult. PatentDocs discusses it here. Jones Day discusses it here.

5. From Electronic Frontier Foundation news about a Defensive Patent Licence (see here). Our own thoughts on rethinking the patent system here.

6. Is the Alice test becoming a way of judging claim breadth? PatentDocs looking at Ultramercial v Hulu believe so (see here). See also Pearl Cohen here, and EquityNet here.

7. DDR Holdings v Hotels is the decision that upheld a computer-implemented invention patent. Patently O here and here, PatLit here, IPWatchdog here. According to Judge Chen this was patentable because the claims “do not merely recite the performance of some business practice known from the pre-Internet world along with the requirement to perform it on the Internet. Instead, the claimed solution is necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks.”

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 Cannot Have in Europe and Tips for Success in EPO Appeals on Biotech Cases.