Monthly Archives: May 2012

Top 10 Biotech Patent Claims That Can Be Difficult To Get At The European Patent Office (EPO)

This list is very much based on my personal experience.  The purpose is to provide examples of the sorts of problems that can occur on biotech cases.  This allows development of pre-empting strategies, such as making sure the application contains the appropriate fallback positions.

1. Claiming Gene and Protein Sequences Which Are Homologues Of Prior Art Sequences

Examiners are increasingly strict in allowing claims to sequences which are homologues of prior art sequences, probably due to the perception that is technically easy to obtain such sequences. Thought should be given as to why the skilled person might have thought the claimed sequence did not exist, what technical difficulties were overcome during cloning and what advantages the new sequence gives.

2. Claims That Cover Homologues Of New Gene And Protein Sequences

It has generally been the case that Examiners would allow applicants to claim sequences which had homology of 65-70% to a new gene/protein sequence as long as a functional limitation was also recited, such as ‘retaining kinase activity’.  However increasingly Examiners are likely to ask for further structural descriptions of the functional sequences.  Thought should therefore be given to fallbacks which specify which sequence positions need to be the same as the cloned sequence to retain activity.  In addition experimental work describing the properties of homologues should be included in the application if it is available.

3.Claims To Antibodies

Examiners seem to be getting stricter on all aspects of antibody patenting, both in terms of defining the antibody and showing that it has inventive step. If possible the specific epitope sequence bound by the antibody should be given and fallbacks should be introduced which define what the antibody does not bind.  In addition it would be very helpful to have data showing surprising properties of the antibody, such as high levels of affinity or specificity.  If the prior art is close then bear in mind that the onus is on the applicant to show novelty and appropriate fallbacks will need to be present to define the antibody so that it is clearly novel.

4. Claims Referring To Conditions That Are Defined Functionally

Sometimes the invention is relevant to more than one disease condition in which case a functional definition is appropriate for defining the condition in the claims (e.g. a condition in which TNF-α levels are elevated).  In this situation Examiners can be very strict on making sure that the specific conditions which are covered can be identified by the skilled person.  In my experience limitation to specific defined conditions is often required and it is rare for Examiners to allow claims that only define a condition functionally.

5. Claims To Mutant Proteins With Specific Activities

If the invention concerns finding a mutant enzyme with a new or improved activity, then it can be difficult to claim all mutants that would have that activity.  One must consider how to define equivalent mutations at the same or other positions, as well as how best to cover homologous proteins with the same mutation.  Clearly having data showing activity in a range of mutants would be helpful.

6. Claims To Diagnosis By Detecting All Relevant Polymorphisms In A Gene

Where the invention concerns the finding that polymorphisms in a specific gene can be used to diagnose susceptibility to a disease condition then it can be difficult to claim all possible polymorphisms that could form the basis of the diagnostic test.  Claims to detection of specific listed polymorphisms for which data is available should be possible, but claims to polymorphisms which are in linkage disequilibrium to them might not possible, though such linked polymorphisms could be identified by routine means.

7. Claims To Use Of A Crystal Structure To Design A Molecule

Where the invention concerns the deducing of a crystal structure then it should be possible to obtain claims covering use of the specific structure to design molecules bind or modulate the molecule that has been crystallised.  However it can be difficult to obtain claims covering use of any crystal structure of the same molecule that can be obtained in the same way (i.e. Use of a crystal structure obtainable by [crystallisation, X-ray diffraction and computation steps] to design a modulator of protein X).  Clearly claims which are limited to use of a specific set of coordinates would be very narrow.

8. Claims To A Composition Defined Functionally

Where the invention relates to a large number of compositions which cannot easily be defined by specifying the amounts of each component then a functional definition can be appropriate (e.g. A composition comprising component A and component B in synergistic amounts).  Whether or not an Examiner will accept a functional definition will be decided on a case-by-case basis, and therefore the assumption should not be made that a functional definition will not be accepted.

9. Claims To A Product Which Solves More Than One Problem

Under European practice the problem solution approach is used to assess inventive step. Normally all of the claims will be analysed with reference to the same problem being solved.  However given that products, such as molecules, will have more than one property they can be solutions to different problems, some of which are obvious and some which are not.  As a simplistic example, if the invention concerns the discovery that adding a (novel) protein with a specific sequence to a composition causes stabilisation of the composition, and this property of the protein is not obvious, it might still not be possible to obtain a claim to the protein per se if it has homology to known proteins.  Finding homologues to known proteins can be deemed to be obvious by Examiners (solving the problem of providing another protein with similar properties, say), and so claims to them can be difficult to obtain even where they turn out to have surprising properties which provide an inventive solution to a problem.

10. Claims To All Functionally Equivalent Epitope Sequences

Where the invention concerns identification of a T cell epitope sequence then it should normally be possible to cover homologues of the epitope.  However it can be difficult to define a functional limitation for the homologues which is acceptable to the Examiner.  A reference to a complex test, such as ‘capable of binding the same T cell receptor’ might not be acceptable.  Thus thought needs to be given to providing several different functional limitations.

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Top 10 Biotech Patent Claims You Cannot Have In Europe

1. Claim To A Method Of Treatment Using A Substance: Method of treating condition X by administering substance Y.

Method of treatment claims are not allowed in Europe.  Instead medical use claims of the format ‘Substance Y for use in a method of treating condition X’ need to be used.  Whilst medical use claims can be limited in ways that will provide protection for most inventions, there are a small number of inventions where the medical use claim is a problematic format. One example of this is inventions that concern a multi-step therapeutic method where there is an initial step to determine whether or how to administer therapy.  The claim below represents such an invention.

An anti-X drug for use in a method of treating X, wherein said method comprises determining Y phenotype in a patient, and based on the phenotype possessed by the patient administering the appropriate anti-X drug.

Whether or not Examiners will accept such claims will probably be decided on a case-by-case basis.

2. Claim To A Method Of Treatment Using A Device: Method of treating condition X by delivering [physical action Y] using device Z.

As mentioned above method of treatment claims are not allowed in Europe.  This also has implications for trying to protect new ways of using known medical devices.  For example if the invention concerns use of a device to deliver 10 volts to the patient, and delivery of 5 volts with the same device is known in the prior art, then one might pursue protection using the following medical use claim:

Device Z for use in a method of treating Y, wherein in said method 10 volts is delivered by device Z.

Although the situation is not entirely clear, such a claim is probably not allowable in Europe since it seems that the medical use claim format is only applicable to substances.

3. Claim To A Mechanism Of Action Of A Drug: Substance X for use in treating Y by the mechanism of acting on Z (where X is known for treating Y)

In the case where the mechanism of action is found for a known treatment this cannot form the basis of a claim which would cover carrying out the known treatment, i.e. carrying out treatment with the new knowledge of how it works is not patentable over prior art describing the treatment. Clearly there may be situations where knowledge of the mechanism leads to new forms of treatment which are carried out in a different manner, for example on a new patient group.  Those could be protected by using the appropriate medical use claims.

4. Claim To A Transgenic Animal or Plant [where the technical feasibility is confined to a particular variety]

In practice this will affect a very small number of inventions that concern transgenic organisms.

5. Reach-Through Claims/Claims That Define Substances in Functional Terms:

Example 1: [Functionally defined] substances A, B, C… obtainable by [screening method].

Example 2: A substance with the following properties: [functionally defined properties].

Claims which are directed to products only defined by means of screening methods that could be used to identify or obtain them, or by functionally properties of the substances, without any structural definition will almost certainly not be allowed. However some claims that refer to, but are not directed to, functionally defined substances will be allowed.  For example a method claim that referred to use of a ‘reducing agent’ could be allowed, particularly where easily available reducing agents could be used.

6. Claim To A Human Embryo

Whether cells derived from a human embryo, such as human embryo stem cells, are patentable is a more difficult question.  At the moment the European Patent Office seems to be taking a fairly lenient view.

7. Claim To A Method Of Diagnosis Practised On The Human Or Animal Body: Method of diagnosing X comprising measuring parameter Y in the human or animal body, and thereby diagnosing whether the human or animal has X.

For many conditions diagnosis will of course be performed using a sample from the body and there are no problems in claiming that method.  Where diagnosis is performed on the human or animal body using a reagent then it should be possible to obtain protection using a claim of the format: [Reagent] for use in a method of diagnosing X, wherein said method comprises….However where a reagent is not used, for example where diagnosis is by X-rays, then obtaining protection will be more problematic.  The relevant case law is complicated, but whether or not it will be possible to obtain a method claim might depend on whether the method results in an actual diagnosis (versus being an intermediate step) or whether a medical practitioner is required to carry out the method.

8. Claim To A Surgical Method

The term ‘surgical’ is interpreted broadly by EPO Examiners to include any invasive procedure. Thus taking a sample or administering by needle or particle can be interpreted as being covered.  Often objections can be overcome by excluding the relevant step from the claim.

9. Possibly: Medical Use Claim Limited To A Patient Group Which Overlaps With/Encompassed By A Known Patient Group.

Example: Aspirin for use in a method of treating headache in a patient, wherein said patient has red hair.

A medical use claim can be limited by patient group.  At the moment EPO case law is unclear about the extent to which the new patient group can overlap with known patient groups for treatment of that condition with the drug.  In the case of aspirin it will inevitably have been used to treat people with red hair, even though the Examiner may not be able to prove it using the documents from the search, and therefore it should not be possible to obtain the Example claim above.  Clearly there will be many situations where it will not be clear-cut, and one can expect Examiners to judge on a case-by-case basis.

10. Claim To A Nucleic Acid Without Disclosing The Industrial Application In the Patent Application

One of the intentions behind this was to stop patents being obtained to EST sequences when no further work had been done to find the function of the gene from which the EST came.  The EPO is not applying this rule to protein sequences (although the ‘usual’ requirement of industrial applicability will still apply of course).  At the EPO ‘disclosing the industrial application’ can be satisfied by disclosing any application.  Thus the function of the gene does not need to be known for example as long as an appropriate use is provided.  However national patentability requirements of the EPC member states can be stricter and so it is advisable to disclose the function of the gene where possible.

Top 10 Problematic Things for a Patent Attorney to Advise On

The following list is very much based on my personal experience of practising as a European biotech patent attorney, with tech transfer offices and research companies as clients, and a lot of healthcare cases. The aim is to produce an informative list of things we might find it difficult to advise on, where clients might assume that we should be able to.  Apologies for entries which state the obvious.

  1. Inventive Step (Obviousness). Inventive step is perhaps the most well-known unknown.  When deciding to file patent attorneys can propose reasonable-sounding arguments in support of inventive step, but how applicable they remain after the Patent Office search and the specific objections that are raised is an open question.
  2. The Value of a Patent Case.  ‘How much is my patent application worth?’ is often close to unanswerable. It depends on how you decide to measure it, and there are complex and different ways to do that. It’s a little like deciding on the value of a stock, but without a central stock market where buyers and sellers will determine the price.
  3. Which Claims Will be Granted Where? Patent Offices are similar but different.  Some are strict (EPO, US, Japan), and others are lenient (Australia, Canada).  Some are tough on data to support therapy, and others are not. This should not be the case, but it is.
  4. Who Are The Inventors? Unpublished contributions which were of some assistance to forming the inventive concept, at least for some embodiments, can be difficult to assess. It must be remembered that inventorship is an absolute concept, and should not depend on how nice you want to be.
  5. Do We Have Freedom To Operate?  Given the number of pending unexamined applications out there, the fact that claim scope can be broadened post-filing and before grant, and that you do not yet know what dosages, carriers and patient groups you wish you treat, perhaps.
  6. Will The Amendment Be Allowed (Added Matter)? I find added matter to be surprisingly difficult to predict sometimes at the EPO.  It can depend on the mindset/personality of the Examiner.  Some will allow little ‘leeway/extrapolation’ from the language of the application, but as compensation will be the same with prior art based objections (so inventive step will be easier).
  7. Which Auxiliary Request Will Be Allowed? I find this one difficult to predict too. Sometimes one assumes that the reasoning which knocks out requests 2 and 3, will also cause request 4 to fall.  However, don’t assume that, and so be careful in the requests that you withdraw.
  8. Which Claim Construction Will Be Used? Entire cases can hinge on the ascribed meaning of a word.  To complicate matters the UK has ‘purposive construction’ and Article 2 of the Protocol on the Interpretation of Article 69 EPC refers to equivalents of elements in the claims.
  9. How Much Data Is Needed To Support A Medical Use Claim?  For the EPO clinical data should not be needed, but for the US it seems close to necessary sometimes. How much data is needed for variant compounds or similar conditions to those exemplified can be difficult to judge as Patent Offices seem to be becoming stricter on this.
  10. Cost? Things always seem to cost more than expected.  In biotech there are more complications than we cater for as Examiners become stricter and more creative, and the European patent that cost a fortune to validate in so many designated states is unexpectedly opposed.

Top 10 Facts About UK Biotech That May Be Useful For A Patent Attorney

  1. The UK remains a centre of excellence for research.  It produces 5% of the world’s scientific research, but has less than 1% of the world population. However it is perceived as being poor at commercialising research.
  2. Investors are more risk averse and are less likely to invest in companies whose future depends on the success of a single drug.  Companies are finding ways to de-risk.
  3. A lot of UK biotech companies have gone under in the last few years.  However certain opinions say that is not necessarily a bad thing.
  4. Biotech financing increased in 2011 in the UK compared to the previous two years, but lack of financing is still seen as a big obstacle in the sector.
  5. Big Pharma seems to be leaving the UK. However GSK has publically welcomed the tax benefits of the Patent Box scheme and seems committed to the UK.  Whilst Astra-Zeneca is down-sizing in the UK, it is still here.
  6. UK academics are now much more commercially aware, and are often keen to have their own startups.
  7. The current biotech buying spree in the US could potentially come to the UK at some point (in a more modest form).
  8. There is disappointment that the UK has not been able to create more large biotech companies, ideally those able to easily carry out their own clinical trials.
  9. The UK does have experienced management in the biotech sector.  However UK corporate culture remains too risk-averse.
  10. The next UK biotech IPO remains a long way away.

You may also wish to see related articles Biotech Due Diligence Advice and What is Wrong with Pharma R &D?

Top 10 Non-Patent Contributions Made by Patents

This is written from the perspective of a UK-based European Patent attorney.  Apologies for my ignorance of contributions in other territories.

  1. Ethics in Biotech. Patents for biotech inventions have stimulated debate on the ethics of biotechnology. Issues such as the suffering of animal models and the embryo origins of stem cells have had to be confronted.  The European Patent Office has handled this well and in a business-like way, but the European Parliament has had a more turbulent time.
  2. Purposive Construction of Laws. The UK House of Lords decision in Catnic introduced the concept of purposive construction of patent claims.  This helped to make it acceptable to interpret UK legislation with a view to the original purpose behind it.
  3. The EPO as a Model for European Cooperation.  The European Patent Convention and European Patent Office were early models for how European countries could work together to create trans-national legislation and institutions.
  4. The Theory of the Commons.  As intellectual property, patents represent something taken from the ‘commons’, and so the regulation of this monopoly right stimulates debate as to which monopolies are fair (see http://en.wikipedia.org/wiki/Tragedy_of_the_anticommons).
  5. The Personality of the Patent Attorney.  Our profession is (generally) conservative, clean-living, attentive to the details, cautious and responsible.
  6. Translation Software.  Patents provide an incentive to reduce the costs for translating technical/scientific documents by developing software capable of doing this.
  7. How do we have ideas? The concept of inventorship has raised questions of how ideas and creativity are generated and how many individuals are involved.  Is the concept of a ‘sole inventor’ a myth?
  8. What is art? Patents and other forms of IP constantly raise questions about what can be protected and what cannot.  There is, we believe, some level of philosophical enrichment of society when the issues of whether recipes, software or the laws of nature are inventions or artistic works are debated.
  9. Economic Theory. Economics has been enriched by the analysis of how patents do and don’t contribute to the well-being and progress of society.
  10. ‘The Poor Man’s Tale of a Patent’.  Charles Dickens’ story on the frustrations of using the patent system.

Top 10 Blogs For News Relevant To Biotech And Patents

Holly IP has two Twitter accounts, @HollyIPltd and @BusinessSnippet.  Tweets are sent out on most working days on topical issues relating to patents and biotech.  Ideas for those tweets often come from the blogs/sites listed below, which we have found to offer good quality objective up-to-date analysis and commentary.

  1. IPKat
  2. Big Red Biotech Blog
  3. Fierce Biotech
  4. Life Sci VC
  5. Xconomy
  6. Patently-O
  7. techdirt
  8. Pharmalot
  9. IP Watchdog
  10. The Burrill Report

Top 10 Topical Issues For a UK Based Biotech Patent Attorney

Issues that relate to long-term and short-term trends, immediate news and things to worry about for the future.

  1. Patent Box Starts 1 April 2013.  What do UK clients need to know?  How should they adapt their claims and filing strategies?
  2. Big Pharma Reorganisation. Big pharma is having to rethink itself given expiry of valuable patents and increasing cost of R & D which is not yielding enough new drugs.
  3. Biologics Are Going To Be Bigger Than Pharmaceuticals.  Abbott’s Humira is now the top-selling drug.
  4. Venture Capital Funding is Decreasing.  Early stage biotech companies will find it more difficult to get VC funding as investors start to get impatient with the sector.
  5. Uncertainty Over Diagnosis Claims in the US.  The US Supreme Court decision Mayo vs Prometheus is very unhelpful for obtaining protection in the US for diagnostic inventions.
  6. Virtual Business.  Biotech companies are increasingly using a virtual model where R & D is outsourced.
  7. The EPO recently decided that emails do not represent a public disclosure (T2/09) and that websites which are not accessible by a search engine using keywords related to their content are also not publically disclosed (T1553/06).
  8. The UK Courts are making an increased effort to follow EPO decisions and interpretations (inventive step in Conor vs Angiotech and industrial applicability in HGS vs Eli Lilly).
  9. The Flexibility of the Medical Use Claim.  The EPO decided in G2/08 that medical use claims could be limited in a diverse number of ways, so that, for example, administration schedules could be protected.
  10. US applicants may start to cut back on their European filings.