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.

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’.

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.

Pharma Patents in India

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

1. There is an anti-patents environment in India where patent protection is provided due to the compulsion of TRIPS rather than to advance innovation. During the Novartis case the Additional Solicitor General called India the ‘Pharmacy of the World’ to justify its stance towards patents.

2. At present new guidelines are being discussed for pharmaceutical inventions at the Indian Patent Office. There have been allegations they show anti-pharm patent bias.

3. The Novartis Gleevec case concerned Section 3(d) of the Indian Patents Act which requires a new form of a therapeutic substance to have enhanced efficacy. Novartis lost because they could not demonstrate the required efficacy. This section is meant to prohibit evergreening.

4. India has used compulsory licencing provisions for pharma patents. There are 3 types of compulsory licensing. Under the normal Section 84 type a licence will be given three years after grant if reasonable requirements of the public are not met, or the product was not available at a reasonably affordable prices or if the invention was not worked in India.

5. India has Bolar provisions which allow making, using and selling of the patented invention in a way which is reasonably related to development and submission of information.

6. Since 2009 Indian practice has changed as to granting of ex parte injunctions. Since then 15 ex-parte injunctions have been granted at a pre-launch stage.

You may also wish to see related articles Top 10 Things You Need to Know about Biosimilars and Top 10 Points on the Trans-Pacific Partnership.

Bits and Pieces: Divided Patent System, Expectation of Success, Due Diligence, Access to Medicines

Here are recent articles we wrote or found interesting, as well as blog sites you may find interesting.

1. Lemley’s continuing analysis of US litigation stats now looks at outcomes of litigation in different technology sectors. ‘Our Divided Patent System?’ finds that pharmaceutical patent owners do much better than software or biotech.

2. Our most recent article on IPKat is ‘Obviousness, common general knowledge and expectations of success: Leo gets a mauling’ which reports the UK decision Teva v Leo and asks questions about what this recent case says about the way UK Courts look at inventive step on pharmaceutical cases.

3. Our most recent article on the IPCopy blog is ‘‘Expectation of Success’ as Part of Inventive Step Analysis’ which discusses the need to look at expectation of success when looking at inventive step of biotech inventions and wonders whether the UK Courts are doing this as they should.

4. We think fieldfisher’s IP blog is interesting, see here.

5. IPWatchdog’s article ‘Effectively Sourcing and Diligencing an IP Investment’ provides interesting perspectives on IP in a commercial situation.

6. A report from a South African summit on access to medicines provides a developing world perspective on the issue (see here).

Reforming University Tech Transfer

This article is a roundup of recent articles we have read about how to change university tech transfer.

The vast majority of university tech transfer offices do not break even, but some are very profitable. ‘The roadblock to commercialisation’ (see here) discusses new business models that tech transfer offices could adopt. It’s not clear to us that the suggested models adequately protect university interests, but they clearly provide food for thought.

‘Maximising the ROI of intellectual property (see here) discusses how universities could make more money from tech transfer as well as disseminating knowledge and technology better. The article also provides links to interesting reports.

‘Challenges in university technology transfer and the promising role of entrepreneurship education’ (see here) proposes that universities need to focus on entrepreneurship education to know how to make best use of the knowledge they have to offer.

‘Five challenges facing all tech transfer programs’ (see here) briefly discusses the issues faced by university tech transfer offices.

You may also wish to see our other articles on tech transfer:

- 10 Points on Patents and Tech Transfer

- 10 Observations on the Success and Failings of University Tech Transfer

- Problems of Patenting and Commercialising University Research

Our article on the IP Finance blog about ‘Ethics versus Money in University Tech Transfer’ can be found here.

Not All Ideas and Not All Data are Patentable

There are a variety of reasons why a new idea or a new finding (i.e. new data) might not be patentable. That could be technical (e.g. points 1 to 3 below), legal (e.g. point 4), policy (e.g. points 5, 6 and 8) or due to the definition of a legal fiction (e.g. point 7).

1. Finding Out How a Known Invention Works

Often data that explains how something known in the art works will not lead to a patentable invention. For example if one discovers the mechanism of action of a known treatment it will only be patentable if suggests a new way of carrying out the treatment, for example in a new class of patients or by delivering in a particular way. One cannot draft a novel claim based on the new finding which covers carrying out the invention according to the prior art.

2. Finding of a New Technical Effect in a Known Method

In Europe it is possible to claim a use based on a new technical effect even if the new effect was inherently occurring in the prior art. This was confirmed in decision G2/88 of the Enlarged Board of the EPO which suggested that ‘intention’ can be a limiting feature. However subsequent case law seems to suggest the claim must be drafted in a way where the prior art method is not covered, i.e. that the intention to make use of only the new technical effect is not enough to give novelty. It must be borne in mind that ‘Use’ claims are not available in certain territories, such as the US and India.

3. Method of Treatment Claims in the US

In the US all inherent treatments that occur when a drug is given to a patient are seen as disclosed when a particular treatment is disclosed in the prior art. That is why the feature of giving the drug to a patient ‘in need thereof’ can be needed to give novelty for a treatment of a new condition with a known drug.

4. Nature, Natural Laws, Natural Principles

In many territories substances which are found in nature can be patented as long as they are claimed in a way where their occurrence in nature would not be covered. Usually the feature of being ‘isolated’ is sufficient to do this. However the US is presently much stricter on this. According to the USPTO guidelines (see here) which issued after the Mayo and Myriad Supreme Court decisions any substance found in nature is not patentable. In addition claims relating to natural laws and principles are also not patentable. Thus diagnosis based on measuring the level of specific substance in a patient is potentially not patentable. The full impact of the guidelines is unclear but on the face of it they represent a major change in what is patentable in the lifesciences.

5. Medical Uses

In certain territories the new medical uses of known substances are not patentable or subsequent medical uses might not be patentable. Thus there may be problems trying to patent certain medical inventions. However often the situation is unclear and the policy may change in the future. The Andean region, the GCC countries and India are places where the situation is unclear for medical use invention.

In addition Section 3(d) of the Indian patents act requires new forms of drugs to have enhanced efficacy before they are patentable, which is seen as a measure that prevents evergreening.

6. In Vivo Diagnosis

In vivo diagnosis inventions are not patentable in Europe, China and India. However it may be possible to obtain protection for substances or devices used in such inventions. In addition it may be possible to obtain protection for devices that conduct analysis of in vivo parameters but do not lead to an immediate diagnosis.

7. Medical Use Claims in Europe

In Europe medical use claims set up a legal fiction which allows medical inventions to be patented. However such claims only apply to substances, and therefore certain types of medical invention remain unpatentable, such as new uses of known medical devices. In addition it can be uncertain as to whether some multi-step medical inventions are patentable using this claim format, for example where the invention concerns a first step of selecting a patient and a second step of treatment.

8. Software and Business Methods

In general many territories have some prohibitions on software and business methods. In the US the situation for computer-implemented methods remains unclear after the Alice decision (see here). However it is clear that patentability requirements are now stricter for such inventions. New ‘apps’ often raise complex patentability issues, but on the whole many will be seen as unpatentable software or business methods in many territories.

You may also wish to see related articles 10 Biotech Claims You Can’t Have in Europe and Top 10 Uncertainties in Patents.

The UK Bolar Exemption

These points are from a talk by Phil Bilney at Fieldfisher’s Pharma Patent Seminar on 16 October 2014.

1. A Bolar Exemption allows applicants for generic marketing authorisations under the abridged procedure to be exempt from patent infringement when conducting the necessary bioequivalence and stability studies (see TaylorWessing’s information about this here)

2. There was uncertainty about the scope of the UK experimental use exemption (s.60(5)(b) Patent Acts 1977). Directive 2001/83/EC set up the Bolar Exemption. Article 10(6) of this says:

‘Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.’ [Paragraphs 1 to 4 are concerned with bioequivalents and biosimilars]

This was implemented ‘narrowly’ in the UK, and ‘broadly’ in Germany and France.

3. After a formal consultation new paragraphs 6D to 6G were inserted into s.60 of the UK Patents Act to exclude ‘anything done in or for the purposes of a medicinal product assessment’ for regulatory purposes from infringement. This derisks clinical trial studies required for any regulatory approval, including marketing authorisations and Health Technology Assessments required by the British NHS.

4. This brings the UK into line with the majority of EU member states, and makes the UK a more attractive place for clinical trials.

5. However not all uncertainty is removed. It is unclear to what extent the exemption covers research tools and also third party manufacture and supply of a drug to the party conducting the trial. In addition it is not clear how the exclusion will relate to the Unified Patent Court and how opting in and out of the Unitary Patent will affect matters.

The IPKat discusses this here.

You may also wish to see related articles 10 Points on Regulatory Data Exclusivity and 10 Points on SPC’s (Supplementary Protection Certificates).

US Biotech Claim Drafting

These points are from a CIPA seminar given by Linda Huber on 17 October 2014.

1. The following formats are relevant to biotech cases: methods of medical treatment, therapeutic compositions and diagnostic methods. Method of treatment claims usually refer treating a defined condition, i.e. ‘A method of treating disease X comprising administering compound Y’. However this is not always the case, for example: ‘A method of eliciting an immune response comprising administering immunogen ABC’. Swiss style medical use claims are not allowed.

2. Diagnostic claims are often in the format ‘A method of diagnosing disease X comprising analysing a sample for the presence of Y’. However there can be issues of matter eligibility for this claim as discussed below.

3. In the US ‘inherency’ can be a problematic issue for the novelty of method of treatment claims. A method of treatment claim is anticipated if the prior art inherently discloses the treatment due to a ‘natural result flowing from’ the disclosure. So for example if the prior art discloses drug X to treat high blood pressure in a patient, and if the drug also inhibits hair loss during the treatment, then it would be seen as ‘inherently’ disclosing this (though it does not explicitly do so), destroying the novelty of use of the drug to treat hair loss. One solution to this is to limit the claim to a class of patients that do not appear in the claim, and often this can be done by defining the patient to be ‘in need thereof’. Clearly another way would be to limit using a feature not disclosed in the prior art, such as routes of administration, etc.

4. Written description and enablement can be problematic if a method of treatment claims refers to ‘A method of preventing disease X…’. There is an assumption in US practice that no disease is 100% preventable.  One can argue against such objections if there is data to show that 100% prevention is achieved. However amending the claim to refer to ‘A method of reducing the likelihood of disease X…’ can often overcome the objection. Alternatively the term ‘prevention’ can be defined in the specification as not requiring 100% prevention. Written description and enablement objections are often raised against gene therapy claims, especially where the specification does not show actual treatment. Amendment of the claim to instead refer simply to expressing the protein may overcome such objections, i.e. A method of expressing protein Y in a subject in need of treatment for disease X, comprising administering to the subject an expression vector encoding gene Z.

5. Post -AIA ‘best mode’ is still mentioned in the relevant statute, 35 USC § 112(a), but it is no longer a ground for challenging the validity of a patent. However failure to provide the best mode could still render a patent unenforceable as a matter of equity and so best mode should still be disclosed. It was noted that the specification does not need to point out what which embodiment is the best mode.

6. Two recent Supreme Court cases, Mayo v Prometheus and Association for Molecular Pathology v Myriad Genetics, have had a huge impact on biotech patents. Mayo concerned a claim to a method for optimising therapeutic efficacy of a condition by assessing the in vivo level of a particular metabolite to determine the amount of drug to administer. The Supreme Court held the method to relate to a ‘law of nature’ and therefore to be ineligible matter. In addition the ‘application’ of a law of nature is also unpatentable if it merely relies on elements already known in the art. The ‘take home’ message from Mayo is that the invention must not too broadly pre-empt the use of the law, and should include an inventive concept which is significant and separate from the natural law.

Myriad decided that genomic DNA was not patentable since it was part of nature, and separating a gene from the surrounding genetic material (so it is ‘isolated’) does not make it an invention. However cDNA is patentable because it does not occur in nature and its sequence is created in the lab. Part of the logic of the decision is based on the fact that the ‘information’ in genomic DNA is unchanged by isolating it, and therefore it would seem that the logic would not apply to other molecules. However, as discussed below, new USPTO guidelines have applied the Myriad principle of ‘naturally occurring molecules being unpatentable’ to all molecules. It was noted that the Supreme Court’s decision Alice v CLS Bank had little impact on biotech cases.

7. The USPTO issued new guidelines in March of this year in view of Mayo and Myriad. They give examples of what is patent eligible and seem to have broadened the principles set out in Mayo and Myriad. They are also quite unclear as to what is patent eligible. The guidelines provide a 3 part test for patentability which determines whether the invention provides something ‘significantly different’ from a judicial exception (abstract ideas, laws of nature or natural principles, natural phenomena and natural products). The guidelines list ‘factors that weigh toward eligibility’, such as:

- the claim providing meaningful limits on scope so that others can use the judicial exception,

- the claim reciting a particular machine or transformation of an article which integrates the judicial exception into a particular application, or

- the claim recites one or more elements which are more than well-understood, conventional or routine.

8. From the examples given in the guidelines it is clear that the level of ‘generality’ of an invention is important in determining its eligibility. Simply identifying mutant gene sequences in an individual by comparing to wild-type or treating a condition by exposure to sunlight are ineligible. However diagnosis using a specific defined antibody and flow cytometry is given as an example of a patent eligible invention.

9. The guidelines are clearly going to be problematic for diagnostic claims which are normally based on measuring the level of a natural product or characteristic. One possible solution is to refer to specific reagents, such as a novel antibody, in the claim. Alternatively one could introduce a treatment step into the claim. However the recent Supreme Court decision Limelight v Akamai made it more difficult to find infringement where split infringement occurs, and so it could be difficult to enforce claims which had diagnostic and treatment steps as they are likely to be performed by different parties. One way to avoid having these two distinct steps in the claims is to refer to have a first step which refers to ‘obtaining the results of a diagnostic analysis’, rather than performing a diagnosis. Other solutions include having a ‘system’ claim referring to the components of the diagnostic assay, claiming the relevant protein-antibody complex which is formed during diagnosis or writing the claim as a ‘method of selecting a treatment for disease X…’. Narrowing the scope of the claim should be helpful in overcoming eligibility issues.

10. For product claims, it will be important to find ways in which the product is structurally different from nature. Referring to ‘synthetic’ or ‘recombinant’ DNA may work or requiring that the natural sequence is linked to another ‘heterologous’ sequence may also succeed. For cells and organism the feature of being ‘transgenic’ may also be enough to distinguish them from nature.

11. It is not clear how the guidelines will impact method of treatment claims. Some Examiners are taking the view that administering a naturally occurring polypeptide is ineligible matter. Clearly it would be wise to have fallbacks in the specification that could be used to limit the claims, for example specific administration schedules and routes of administration.

 

You may also wish to see related articles 8 Points on the US Supreme Court Decision Limelight v Akamai and Building a Patent Portfolio.

 

Bits and Pieces on Inventive Step, Biotech Patenting, Big Data and Derisking Biotech

1. Here’s a slightly old, but interesting, article we discovered from the Singapore Academy of Law on ‘The Future of Inventive Step in Patent Law’.

2. Today our post ‘An Overview of Biotech Patenting’ was published on K2/Keltie’s blog IPCopy. Our intention was to set the scene for a series of articles which will explore the idiosyncrasies of biotech patenting and how it needs to fit into commercial considerations.

3. We came across this HBR article ‘Let Data Ask Questions, Not Just Answer Them’ which is about use of big data for hypothesis generation, rather than finding solutions. Clearly big data has a lot of evolution to do before it can be fully utilised.

4. We think ‘Target Practice’ on the Life Sci VC blog asks a lot of pertinent questions for people setting up biotech companies. It summarises the commercial considerations that need to go into research projects and suggests approaches that help to minimise risk.

Types of Equivalents in Biotech Patenting

Patent claims should cover the broadest expression of the ‘technical effect’ which is possible, and part of the art of a biotech patent attorney is to be able to draft claims having considered the equivalents of all the features present. Here are our favourite equivalents:

1. Homologues of Sequences

Whenever specific protein or nucleic acid sequences are mentioned thought should be given to homologous sequences that might be able to provide the same function. That function might not necessarily be the natural function of the sequence. For example for a vaccine invention the equivalent might have the same antibody or T cell epitopes. Homologues are normally defined by means of a minimal percentage homology to a specific sequence. In this case the specification should also give an example of an algorithm that can be used to calculate homology, though I have never come across an instance of an Examiner requiring the algorithm to be mentioned in the claims. In the example below the required function is to be able to tolerise an individual.

WO2010018378

1. A composition for use in preventing or treating allergy to ragweed by tolerisation comprising: (i) at least one original polypeptide selected from RGW03B, RGW03A or RGW03 (SEQ ID NO's. 9, 8 or 7) or a variant thereof;
(ii) at least one original polypeptide selected from RGWOl, RGWOlA or RGWOlB (SEQ ID NO's. 1, 2 or 3) or a variant thereof; iii) at least one original polypeptide selected from RGW04 or RGW04A (SEQ ID Nos: 10 or 11) or a variant thereof; and
(iv) optionally one or more original polypeptides independently selected from any of SEQ ID NO's. 4-6 and 12-31 or variants thereof; wherein said variants are:
(a) a polypeptide of length 9 to 20 amino acids that comprises a region consisting of: the equivalent original peptide sequence; or a homologous sequence which has at least 65% homology to the equivalent original peptide sequence, which sequence is capable of tolerising an individual to the equivalent original peptide sequence, or (b) a polypeptide of length 9 to 20 amino acids that comprises a region consisting of a sequence that represents either: a fragment of the equivalent original peptide sequence; or a homologue of a fragment of the equivalent original peptide sequence, which sequence is capable of tolerising an individual to the equivalent original peptide sequence and has a length of at least 9 amino acids, and wherein said homologue has at least 65% homology to any 9 contiguous amino acids in the equivalent original peptide sequence.

2. T cell Epitopes

Equivalents of T cell epitopes will be sequences that bind to the same T cell receptor. Examiners may not be too pleased to see sequences defined in terms of what they bind to. The example below shows the sorts of equivalents that could be considered.

WO0125793

1. A method of diagnosing coeliac disease, or susceptibility to coeliac disease, in an
individual comprising:
(a) contacting a sample from the host with an agent selected from
(i) the epitope comprising sequence which is: SEQ ID NO: 1 or 2, or an
equivalent sequence from a naturally occurring homologue of the gliadin
represented by SEQ ID NO : 3,
(ii) an epitope comprising sequence comprising: SEQ ID NO : 1, or an equivalent
sequence from a naturally occurring homologue of the gliadin represented by
SEQ ID NO : 3, which epitope is an isolated oligopeptide derived from a gliadin
protein,
(iii) an analogue of (i) or (ii) which is capable of being recognised by a T cell
receptor that recognises (i) or (ii), which in the case of a peptide analogue is not
more than 50 amino acids in length, or
(iv) a product comprising two or more agents as defined in (i), (ii) or (iii), and
(b) determining in vitro whether T cells in the sample recognise the agent;
recognition by the T cells indicating that the individual has, or is susceptible to,
coeliac disease.

3. Single Nucleotide Polymorphisms (SNP’s)

SNP’s are often ‘associated’ with other SNP’s, i.e. they tend to be found together in genomes. This is termed ‘linkage disequilibrium’. Diagnostic tests that detect the presence of a particular SNP could also be based on detecting SNP’s which are in linkage disequilibrium with it, and so it is worth thinking about whether to attempt to claim those other SNP’s. See the example below. [The Trilateral Report on SNP’s (see here) provides useful guidance on how Patent Offices assess their patentability]

WO2010116137

1. A method of testing a dog to determine the likelihood that the dog is protected from liver copper accumulation, comprising detecting in a sample the presence or absence in the genome of the dog of one or more polymorphisms selected from (a) SNP ATP7a_Reg3_F_6 (SEQ ID NO: 142) and (b) one or more polymorphisms in linkage disequilibrium with (a).

4. Crystal Factors and Crystal Structures

Where the feature is essentially a numerical value or a set of values then careful thought may be needed as to how to cover equivalents. X-ray diffraction data (structure factors) and structural coordinates obtained by crystallography are an example of this. As can be seen from the claims below equivalents can be defined in terms of being ‘obtainable’ by the relevant crystallographic method. [The Trilateral Report on claims relating to 3D structures (see here) provides guidance on how Patent Offices will examine such subject matter]

WO9910379 

1. Use of the structure factors obtainable by subjecting a crystal comprising at least an epitope binding fragment of the SM3 antibody, bound to a peptide recognised by the epitope binding site of SM3 to X-ray diffraction measurements to identify, screen, characterise, design or modify a chemical entity.

2. Use of the structural coordinates obtainable by subjecting a crystal comprising at least the epitope binding fragment of the SM3 antibody, bound to a peptide recognised by the epitope binding site of SM3 to X-ray diffraction measurements and deducing the structural coordinates from the diffraction measurements, to identify, screen, characterise, design or modify a chemical entity.

You may also wish to see related articles Top 10 Points about Gene and Protein Sequences and 10 Points on Patent Applications Directed to SNPs (single nucleotide polymorphisms).