Monthly Archives: October 2013

Top 10 Misconceptions About Patents

1.  The Claims as Filed will be the Claims as Granted

A surprising number of people are not aware of how much amendment of the claims often happens in examination.  They may therefore obtain a licence for a case soon after it is filed, and be surprised when its scope is limited before grant.

2. A Patent Attorney Drafted the Patent Specification

It is very possible that a patent attorney was not involved in drafting the specification in order to keep costs low.  Whilst this seems rare for UK originating cases, it is something that should be looked out for in US originating cases.  If a non-specialist drafted the case there will be a possibility that the invention has not been defined properly in the claims and sufficient fallbacks have not been introduced for amending the claims during examination.

3. Before Filing Someone Has Determined that the Claims Cover Patentable Subject Matter

No assumptions should be made about this.  Sometimes no one involved in the drafting process has searched in any way for relevant prior art.  Instead the patent application may simply have been drafted based on how the inventor(s) described the invention.  Further certain types of subject matter, e.g. software and business methods, are not patentable in every territory, and this aspect of the invention may not have been reviewed properly.

4. The Invention is a Fixed Concept

People assume that the invention is a given concept, and if that concept has been disclosed in the prior art then a patent cannot be obtained. However often inventions are better thoughts of as a set of broad to narrow concepts, and if the broader concepts have been publically disclosed, it may be possible to get a patent for narrower concepts.

5.  Filing a Patent Application Before Others Prevents Others Getting a Patent for the Invention

As discussed in (4) above, an invention can sometimes be like a series of concepts.  Therefore if you get a patent to a broad concept, it is still possible for other parties to get a narrower patent within your concept.  So if you have a broad patent covering ‘Use of X to perform Y’, it may be possible for someone to subsequently obtain a patent covering ‘Use of X to perform Y, where the temperature is 0 to 10⁰C’.  If the invention is only commercially valuable within that temperature range the narrower patent will cause problems for you.

6. No Patent Protection is Possible Once the Invention is Publically Disclosed

Many territories have grace periods for public disclosures which originate from inventors. That includes important territories such as Japan and the US, though not unfortunately the UK and the European Patent Office.  A grace period is often 6 months or a year from the disclosure and essentially means that the inventor’s disclosure does not form part of the prior art when assessing patentability. However different territories have different rules for how to take advantage of the grace period and attorney advice will need to be taken if reliance on a grace period is required.

7. Obtaining a Patent Gives Freedom to Operate

A patent is a negative right.  It does not give a party any right to practice the invention and override other patent rights.  Often a given product or activity can be covered by more than one patent, for example broad and narrow patents as discussed in (5) above.  Therefore a freedom to operate search will always be needed to identify all relevant third party patent rights.

8.  A Granted Patent Is Valid

Different Patent Offices have different standards for examining patents.  The USPTO and EPO are quite strict, whilst the UK IPO is generally more lenient.  Therefore there are different levels of ‘presumption’ about the validity of patents granted by different Patent Offices. Further Patent Offices are not always able to identify every relevant prior art document in their search, and therefore, for example, there is always the chance a patent is not valid because of the contents of a prior art document which has not yet been found.  Patents are often found to be invalid in opposition and court proceedings.

9. Others Will Respect Your Patent Rights

In general third parties are wary of infringing patent rights.  However if they believe the patent is not valid for any reason, then they may risk infringing it on the basis that during court proceedings they will be able to succeed in the having the patent revoked.

10. Patents are Worth a Lot of Money

Sometimes the assumption is made that once one has obtained a patent, it is valuable.  It is usually difficult to estimate the value of a patent application or patent.  The actual value will of course depend on the commercial worth of the subject matter they protect.  However, crucially, there may simply be no party wishing to purchase the patent case, and so no money can be made from it.  If the commercial goal is to sell or licence the patent case to third parties, it would be advisable to review how attractive the patent case would be to third parties before spending resources on it.

Advertisements

Top 10 Observations on Antibody Patenting

This is written from the perspective of a European Patent Attorney.

1. An antibody will normally be defined with reference to its specificity.  The specification should provide as much detail as possible for further limiting the specificity, for example to exclude cross-reacting antibodies that bind to related proteins.  One possible way of doing this is to provide basis for specifying that the antibody does not bind proteins with less than a given percentage homology to the protein the antibody has been raised to.

2. It is often difficult to get claims at the EPO which simply refer to the antibody being specific for a particular protein.  Therefore as much information as possible should be given for the region or epitope which the antibody binds.

3.  Examiners will often raise inventive step objections against claims to antibodies, and therefore it is desirable to give as many advantages of the antibody as possible, and preferably also unexpected properties.  Thought may be given to including date in the specification comparing the antibody properties to prior art antibodies.

4. This is an area where the EPO and USPTO are becoming stricter, particularly in how the antibody is defined.  Therefore including the sequence of the CDR’s will reduce the risk of objections against how the antibody is defined, though in theory this should not be needed.  Any form of structure-function analysis should also be provided.

5. Antibodies can be defined with reference to a hybridoma deposit.  However thought should be given as to how variants of the antibody made by the hybridoma can be defined.  There is a possibility the Examiner will require the claims to be restricted to the specific antibody made by the hybridoma.

6.  If the antibody is defined by having a particular activity, for example blocking binding to a particular receptor, then the specification should provide an assay that can be used to screen for the activity.  There is a risk the Examiner will consider it an undue burden to make antibodies with the required activity, and so the specification needs to be drafted with this in mind.

7. In general Examiners will want the claims restricted to specific antibodies and therefore thought should be given when drafting to the breadth of claims that are desirable.  If broad claims are important to obtain, then data supporting broad claims will be needed.

8.  In general where a novel protein is claimed an antibody specific for the protein can be claimed.

9.  Where an antibody is claimed then all functional fragments and derivatives should also be claimed.  The terms ‘monoclonal’ and ‘isolated’ should be included as features which could be used to limit the antibody claim.  Thought should be given to other standard features that could be used to define the antibody, such as its class, species (e.g. camel or shark) and whether it is humanised.

10.  For therapeutic antibodies thought may need to be given to claiming the composition that will be administered.  This could include a nucleic acid which expresses the antibody in vivo, rather than the antibody itself.  Clearly thought needs to be given to claiming such nuclei acids per se.

Top 10 Observations on the European Patent Office’s Problem Solution Test

As is well known, the European Patent Office (EPO) uses the problem solution test to evaluate inventive step.  The test has 3 steps:

– determining the closest prior art

– establishing the objective technical problem to be solved

– considering whether the claimed invention, starting from the closest prior art and the objective technical problem would have been obvious to the skilled person.

The test has more subtleties than one would imagine.  Here are our observations:

1. What is the Correct Technical Problem?

Choosing the correct technical problem is sometimes crucial to convincing an Examiner that the claims have inventive step. Ensure that that all of the technical advantages are represented in the problem as best as possible.  For example where the invention is a new gene the problem could be stated:

a) providing a novel gene

b) providing a gene that encodes a protein with X activity

c) providing a gene encoding a protein with X activity, the modulation of which can be used to treat condition Z

Clearly it will be easier to show that the prior art does not suggest (c) versus showing it does not suggest (a).  In general narrowly defined problems are advantageous in examination.

2. What is the Correct Closest Prior Art?

Ensure that the correct closest prior art is chosen, because that will define the problem.  Hindsight based on the invention can lead to an incorrect choice of closest prior art, and if that happens it should be pointed out to the Examiner.  In particular it should be borne in mind that the search is performed using knowledge of the invention.  Again if it is felt that the cited documents would not have been identified by the skilled person without hindsight then this should be used in inventive step arguments.

3. Is Recognition of the Problem Part of the Contribution?

Do not assume that the objective technical problem would have been recognised by the skilled person when looking at the closest prior art.  For example if the invention concerns minimising the side effects of a drug, unless the side effects are recognised the prior art, then identifying the side effects themselves is part of the contribution made by the invention, and that must be appreciated when inventive step is evaluated.

4.  Should the Application Refer to the Problem Which is Solved?

When drafting an application is not always clear as to whether one should define the problem being solved.  This is seen by some as a sort of admission which could disadvantage them if the prior art situation changed.  We believe a lot of caution is needed when drafting, and it is better to define ‘contributions’ made by the invention which reflect the different advantages.  Broad and narrow contributions can be defined which will assist with defining a problem during examination, but these should be written bearing in mind that the problem often changes as new prior art is identified in the search.

5.  Should the Claims Refer to the Technical Effect When it is Not a Limiting Feature?

This is a more subtle point than it would first appear.  The technical effect allows the problem to be solved, and so it must be fully appreciated when evaluating inventive step.  The following claims can have the same scope:

a) Compound X with formula Y

b) An inhibitor of crystallisation X, with formula Y

However the contribution is much more apparent from the way (b) is written.  Given that success in examination can often be determined by how much the Examiner appreciates the technical effect, including the technical effect within the claims can be advantageous.

6. The Application Needs to Show That the Problem has been Solved

When drafting, thought should be given to which problems have been shown to be solved by the available data, and whether there is a risk that an Examiner will consider the problem not to have solved.  This can happen in the situation where a compound is alleged to have therapeutic activity based on in vitro data.  Alternative problems should be considered, and basis should be provided for limiting to those problems.  In the case of a vaccine an Examiner may object that ‘protection’ against the condition has not been demonstrated, but may accept a claim which refers to ‘stimulating an immune response’ without requiring protection to be achieved.  The application should provide the flexibility to see the technical effect in different ways, allowing the problem and the invention to be defined in different ways.

7.  The Plausibility Test

The EPO may use the plausibility test when there is doubt about whether the technical problem has been solved.  It evaluates whether it is ‘plausible’ that the problem has been solved based on the content of the application, and so the Examiner may exclude additional data or documents from the analysis.  That means that when one is drafting in a situation where there may not be enough data one must take care to explain within the application how the data shows the problem has been solved.

8. Don’t Undersell the Problem which has been Solved

When drafting the application, one must not be too critical of the contribution that has been made.  A reasonable level of extrapolation can be done based on the technical effect which has been achieved.  If a compound has been found to reduce viral growth, then it is reasonable to claim the compound for use in treating conditions caused by the virus, and perhaps also conditions caused by related viruses.  One must not allow an over-critical approach to impact the drafting in a way that makes the invention look less impressive.

9. Choice of the Technical Problem in Opposition

Bear in mind when attacking a patent in opposition it is generally advantageous to define the problem more broadly.  A problem could be defined in the following two ways:

a) providing a new gene

b) providing a new gene which is the basis of pancreatic cancer

Problem (a) looks less impressive, and this more broadly defined problem could allow more prior art documents to become relevant to inventive step, and make it easier to show that the invention can be derived from the prior art.  When looking to define the problem the data in the patent under attack should be looked at in a very critical way.

10. Different Problems May be Solved for Different Claims

Bear in mind that the problem solved by the first claim may dominate the evaluation of inventive step.  Therefore thought should be given as to how the claims should be ordered to best present the invention.

Top 10 Points on Patent Applications That Refer to Nucleic Acid (Gene) Sequences or Protein Sequences

The points mentioned below apply both to where the nucleic acid or protein is claimed per se and also to situations where the invention somehow relates to use of sequences.

1.  Consider whether homologues of the sequences should be mentioned.  If so, then percentage homology ranges need to be provided and the description needs to refer to a specific algorithm that can be used to calculate the percentage homology.

2. Consider whether fragments of the sequences need to be mentioned.  If so, ranges of fragment lengths should be disclosed, and if fragments of homologues can be used then this should be made clear.

3. If homologues and/or fragments are relevant then basis should also be provided for limiting to functional sequences.  Functions apart from the natural function may also be relevant in the context of the invention.

4.  Thought should be given to claiming expression vectors that contain the sequence or express the sequence.

5.  Basis for limiting to ‘isolated’ forms of the sequence should be provided.

6.  Thought should be given to important mutants (homologues). Patent Offices are becoming increasingly strict in regards to homologues and, if possible, the application should contain details of areas that can or cannot be modified to give functional mutants.

7.  Normally it will be possible to claim antibodies that bind to novel proteins.  Thought should be given to antibodies that may cross-react to related proteins and how such antibodies could be excluded from the claims.  Antibody derivatives should also be claimed as well as use of the protein to make a specific antibody.

8. Thought should be given to claiming sequences with modified bases or amino acids.  Whether or not PNAs (peptide nucleic acids) should be claimed should also be considered.

9. Thought should be given to whether organisms containing the gene (e.g. transgenic animals or plants) should be claimed as well as organisms in which the gene has been knocked out.

10. Given the decision of the US Supreme Court in Association for Molecular Pathology v Myriad  ensure there is basis for limiting to non-natural nucleic acids, such as cDNA molecules and mutants.

Top 10 Uncertainties in Patents

This is written from the perspective of a UK-based patent attorney practising in the biotech/pharma sector.  The patenting process has many uncertainties, which makes it difficult to predict the claims which will be granted and how much the process will cost.  Here are our top 10 uncertainties:

1. Case Law and What is Patentable

Case law does evolve, and that can mean huge changes in what is patentable.  In past years transgenic plants and computer programs have become patentable.  Presently software, diagnostic methods and stem cell case law is continuing to evolve.

2. Inventive Step

How an Examiner views inventive step will often determine the scope of claims which will be granted.  However it is frequently very difficult to predict the inventive step objection which will be raised and how easy it will be to persuade the Examiner to change his/her mind.  Increasingly though Examiners are becoming stricter on inventive step in biotech.

3. Documents Identified in the Search

There is always the possibility of a surprise document being found in the search which makes patentability a lot more difficult than expected.

4. Search Problems

It can be difficult to predict whether there will be problems with the search at the European Patent Office (EPO), either in terms of lack of unity or lack of clarity.  Incomplete searches will impact tremendously on the scope of claims that will be granted.

5. Which Terms Will be Deemed Unclear in a Claim

One never knows which terms will be deemed unclear in claims.  This varies tremendously from territory to territory, with Canada being one of the strictest places on clarity.

6. Whether an Amendment Will Add Matter

Sometimes it is difficult to predict whether an amendment will be deemed to add matter.  That is particularly true if the amendment concerns combining two independent features or concerns deletion of a feature.  Strictness on added matter varies tremendously from territory to territory, with the EPO being one of the strictest.

7. Whether Functional Features Will Be Accepted in the Claims

The EPO can be very strict on whether functional features can be allowed in claims, particularly when they are used to define compounds or disease conditions.

8. Costs

There is uncertainty in the cost of a patent application through to grant because it is difficult to predict how complex examination will be.  Lengthy responses with substantial amendments may be needed, and several examination reports may issue.  In addition paying additional search fees and filing divisionals is expensive if required.  If appeal or opposition proceedings occur that will also increase costs.

9. Oral Proceedings at the EPO

Many surprising things happen at Oral Proceedings. Certain documents or arguments may suddenly become more relevant.  How the different parties will perform and whether justice will be done seems to vary markedly.

10. How Much A Patent Case is Worth

How to evaluate the worth of a patent case remains a very uncertain art.  However what it is clear is that investors at getting much better at evaluating biotech patent cases.

Top 10 Things You Need to Know About Data in Patent Applications

This is written from the perspective of a European patent attorney practicing in the pharma and biotech fields.

1. For pharma and biotech cases data is often needed to show that the invention works, i.e. that the technical effect can be achieved by the means which are described.  A mere description of how to carry out the invention is often not enough, and a lack of data can lead to objections of lack of sufficiency, support and even lack of inventive step (problem not being solved).  The European Patent Office may use the test of whether it is ‘plausible’ the problem has been solved from the specification.

2. Ensure that further data generated in the priority year is incorporated into the application at Convention filing.  When writing the priority application one must review whether the claims and description need to anticipate what the further data may show, for example more patient groups that could be supported by the new data.

3. When evaluating data be mindful of identifying all technical effects, no matter how minor and making a reference to them in the description.  Fallbacks should be provided which will make it possible to limit the claims to any one technical effect if required.

4. Ensure that the claims and description have fallbacks which represent generalised features derived from the data.  In particular consideration should be given as to whether ranges encompassing specific point values in the data need to be introduced into the claims and description.  This obviously makes it easier to amend the claims to limit them to preferred features.  However it is also a way of the Examiner appreciating the full impact of the data on the invention and on what is claimed.

5. Don’t prejudge the problem which is solved.  That may change when prior art is identified in the search.  The patent application needs to therefore be measured in the way the data is described, and preferably should not view the data as showing a single finding.  The relevant part of the description should say: ‘The data shows that X activity of Y. It shows how Y could be used to treat Z.  It shows preferred patient groups for treatment. It shows [the different aspects of the invention]’, i.e. reflecting all the different advantages made possible by the invention.

6. Specific advantages that should be considered beyond on the main technical effect include:

– does the data show some patient groups (e.g. with severe disease) might respond better?

– does the data indicate preferred doses, a preferred administration schedule or a preferred route of administration?

– does the data indicate other substances that could be coadministered to give further advantages?

7. The invention might not stop at the point of administration.  Data showing pharmacokinetic properties could be useful to show additional advantages.  That could affect how the problem is defined and so assist in arguing inventive step, i.e. the problem could become ‘a substance for treating cancer with X advantageous pharmacokinetic properties’.

8. Bear in mind that post-filing data can be filed during examination or in opposition to further support the data in the specification.  When the application is drafted that post-filing data should be anticipated if it is not available for inclusion in the patent specification.  It is difficult to predict how effective filing post-filing data will be in overcoming objections, but often it is helpful.

9. Post-filing data used to support arguments in examination or opposition can include third party, for example data published in journal articles.

10. Be wary of including data from other parties in the patent specification if it might affect inventorship.  Even a minor contribution can lead to a person being deemed an inventor and therefore careful thought may need to be given to which data is included in the specification if it comes from different sources.

Top 10 Patent and Commercial Biotech Blogs

Here’s our list of favourite blogs, and why they are so good.  When choosing and ranking we’ve placed particular emphasis on whether they provide interesting articles on a very regular basis.

1.       IPKat. This is THE blog for UK and European IP developments. Fast-moving, insightful, cheeky and thought-provoking.  Unparalleled for diversity and quality in the IP blog world. Multi-authored.

2.       Life Sci VC. Bringing order and stats to the chaotic world of biotech investing.  Every aspect of commercial biotech is tackled in insightful and evidence-based ways.

3.       PatentlyO. Doggedly analysing US patent law developments in a very informative way.

4.       IPWatchdog.  Strong opinions on US patent and innovation issues. Multi-authored.

5.       Xconomy. Fast-moving diverse articles on innovation and investing. Multi-authored.

6.       The Big Red Biotech.  It’s strength is capturing all commercial biotech developments, analysed with a concise informed wisdom.

7.       FierceBiotech. Comprehensive news from the world of commercial biotech. Multi-authored.

8.      In the Pipeline. Interesting, thoughtful, everyday thoughts on diverse pharma topics, from bench research to pharma scandals.

9.       K’s Law.  Focused on European Patent Office case law developments, but well written and professional.

10.    IP finance.  Diverse set of articles around commercial IP issues. Multi-authored.