9 Videos Relevant to Commercial Biotech

These videos were selected on the basis of being informative about the present state of commercial biotech.

1. Early Stage Venture Financing panel discussion from BIO in 2013, moderated by Luke Timmerman

2. Ben Goldacre's TED talk 'What doctors don't know about the drugs they prescribe

3. Burrill on Innovating in the New Austerity

4. Burrill on Personalised Medicine

5.Andrew Hessel at TEDxVilnius on 'Genetics for Fun and Profit

6. Gregory Stock talking at TED about 'To Upgrade Is Human'

7. Brad Doff talking at TEDxThunderBay on Sustaining Cities with Everyday Biotechnology:

8. Ellen Jorgensen talks at TED on Biohacking

9. Cathal Garvey talking at TEDxDublin about Bringing Biotechnology Into the Home

You may also be interested to see the following related articles What Do You Need to Know About Commercial Biotech and How is Biotech Patenting Different?

 

9 Points on Shanks v Unilever [2014] EWHC 1647 (Pat), a UK Patent Case on Employee Compensation

This is the latest case in the long running saga of Professor Shanks trying to obtain employee compensation from Unilever.  The points below represent what caught our eye as we read through it, and are not an attempt to summarise the case.

1. This is an appeal from a decision of the UK Intellectual Property Office (IPO) on employee compensation where the IPO had decided that Professor Shanks was not entitled to compensation because there had not been outstanding benefit to Unilever.  It was decided under the pre-January 2005 version of Section 40 of the Patents Act which awards compensation to an employee inventor where a ‘patent’ has been of outstanding benefit to the employer. [The new version of the Patents Act refers to benefit being derived from ‘the invention or the patent’.]

2. The decision notes that the case law sets a high hurdle for what an ‘outstanding benefit’ is.

3. The decision discusses in depth what the role of an appeal court should be.  A lot of weight is given to the decision of a Hearing Officer of the IPO, and ‘multi-factorial assessments’ which are part of that decision should not be overturned unless there is an error of principle.

4. Unilever licenced the invention and therefore it was clear that the benefit to them was due to the patent.

5. Professor Shanks argued that when assessing outstanding benefit the fact that Unilever ordinarily has large profits should not amount to the conclusion that Unilever are too big to give employee compensation.  The decision agreed this should not be the case.

6.  Unilever derived a benefit of £24.5 million from the patent.  The IPO had decided that was not of outstanding benefit, and the present decision did not find fault with that.  Unilever’s size and their consequent ability to derive more benefit from a patent was clearly relevant, as were many other factors.

7.  The decision also considered what a ‘fair share’ would have been for Professor Shanks. The IPO had decided it should be 5%, saying that the higher rates which academic inventors receive are not relevant in this industrial context.  The present decision agreed.

8.  The decision also considers whether Professor Shanks would be entitled to higher compensation that his co-inventors and concludes that he would not.

9.  More generally, the decision is in line with UK case law in this area which makes it very difficult for employee inventors to obtain compensation for an outstanding benefit.

The decision can be found here.

You may also be interested in related articles 10 Points on Arbitration and Advice to Scientists Setting up a Company.

8 Patent Videos

YouTube does not yet have many videos about patents, and surprisingly there does not seem to be a TED talk on the role of patents in the economic system.  The following videos were identified in a brief review of patent videos available from YouTube. They may be useful as teaching tools or to show the sorts of resources that are available to inventors and companies. Simply click on the title to see the video.

1. Ellen 't Hoen's TED talk on a Patent Pool of medical patents

2. Intellectual Property: How to Review a Patent Application

3. Patent Basics – Understanding a Claim

4. Intellectual Property: Patents,Trademarks & Copyright

5. How to protect your ideas

6. Protect & Market Your Ideas & Inventions

7. An Introduction to the Patent System

8. How to Patent search

You may also be interested in seeing a rather surreal promotional film made by Holly IP. It is

a concept film which requires you to read the accompanying notes to make sense of it. 

It can be accessed here.

 

10 Points on Patents and Tech Transfer

1. Tech transfer has its own patent strategy.  Often there will be a single opportunity to file a patent application and publication by the inventors will happen soon after filing. Usually that means that the application will be drafted with broad claims, and there may be no subsequent filings. This is different from the situation with research companies where there are a series of applications filed as research progresses, some of which may be directed to minor developments.

2. For a tech transfer office whether or not to file a patent application is a complex and potentially costly decision.  Thought needs to be given to the likelihood of successfully obtaining useful patent protection and also to whether there are complications on the case that will lead to future difficulties and increased costs. Patent Attorney advice should be taken on the likelihood of obtaining a patent with reasonably broad claims. All possible problems with the patent application should be considered, but a good rule of thumb is that strong inventive step arguments should be available for use in examination.

3. The inventors will initially need to provide the tech transfer office with the following information:

-          the scientific finding and their view of what the contribution is in comparison to what is known in the relevant area

-          all the different ways in which the scientific finding could be used

-          what they believe the closest relevant published documents are, including their own publications and, if applicable, their own previous patent applications

-          details of everyone who contributed to the invention, which of these are believed to be inventors and why

-          any other information that is potentially relevant to use or ownership of the invention, such as contractual obligations concerning patent filings, use of confidential information or use of materials provided under agreements

-          a list of companies that may be interested in licensing or buying the technology.

4. Consideration needs to be given to the work the scientists are planning to do in the priority year, and whether that needs to be foreshadowed in any way in the patent application.  In particular thought should be given as to whether there need to be claims in the patent application that reflect the work that will be done.

5. It is important to consider whether there are likely to be future patent filings on downstream inventions from same scientists.  The patent application will be prior art for such future patent filings, and so if there are likely to be future filings the patent application needs to be written in a way that minimises its prior art impact on those filings.  Further the overall strategy will also be affected by whether the scientists are planning to publish their work in the near future.  The prior art effect of such a publication may make it difficult or impossible to obtain patent protection for any subsequent developments.

6. Ultimately the patent application is required to have claims that are arguably valid and which cover subject matter capable of commercial exploitation.  Ideally such claims will be broad and be capable of being enforced.  Certain claim types, such as screening claims, only cover activities that can be done privately (for example in a research lab) and so infringement can be difficult to detect.  Product claims tend to be easier to enforce.  When drafting the claims thought should be given to the main interests of commercial parties who may licence or buy the technology.

7. In a tech transfer situation, where there is less control over the scientists, grace periods may have to be used to nullify the prior art effect of any public disclosure they have made. Grace periods are available in many territories, including the US, normally the most important territory. However if grace periods are going to be utilised then care has to be taken to ensure that all conditions are met for use of the grace period.  For example in certain territories the PCT route is no longer available if the grace period is going to be used.  Use of grace periods will however increase costs.

8. The patent application should be filed as soon as possible to obtain the earliest priority date and to minimise the possibility of a public disclosure of the invention by the scientists.  Preferably the patent application should be filed before any discussions with potential collaborators and commercial parties occur, even though these discussions will be confidential.  Discussion of the invention with third party organisations before filing a patent application can lead to claims of inventorship from scientists from such organisations.

9. Patent protection is expensive and the costs escalate as the case progresses.  The end of the priority year (at 12 months) and the end of the international phase (at 30 months) are appropriate time points to consider whether or not the application should be abandoned.  Proceeding beyond the international phase can be expensive and normally that would only be done if a commercial party had taken an interest.

10.  Patent Attorneys can be expensive.  However the costs of working with Patent Attorneys can often be minimised by making sure that they are used efficiently.  Patent Attorneys will usually charge based on the amount of time they spend on a case and therefore a tech transfer office needs to control this by ensuring they are not given tasks that could be done by the tech transfer office or by the scientists.  Often it is best not to let the scientists contact the Patent Attorneys directly.  Instead all communications should go via the tech transfer office to ensure that the Patent Attorneys are only used for tasks none of the other parties can do.

The above points are based on a longer post which can be accessed here.

You may also wish to see related articles Patent Advice for Research Companies and Biotech Patents in Europe.

Our article on the ethics of tech transfer published on the IP Finance blog can be found here.

10 Points on Patent Applications Directed to SNPs (single nucleotide polymorphisms)

1. Some inventions concern the finding of SNPs being associated with a particular condition. A SNP represents a position in the DNA of an organism where there can be variation.  Within the population different people will have different variants. These variants can cause functional differences, and in some cases they can cause susceptibility to disease conditions.

2. SNPs can be the basis of diagnostic method or personalised medicine inventions.  The typing of the SNP can thus be used to diagnose susceptibility to a condition or to determine the responsiveness of a patient to a particular therapy. An example of patent claims of an SNP-based invention can found here.

3. The main claims will often be diagnostic claims directed to detecting the presence of the SNP in an individual in order to determine susceptibility to the condition.  However other independent claims may also be appropriate depending on the prior art situation and the specific manner in which the SNP acts.  See points 4 to 7 for the sorts of questions that should be asked when thinking about possible claims.

4. Are the SNP’s themselves novel? If so, should novel polynucleotides comprising them be claimed?  Should probes and primers capable of detecting the SNP’s be claimed?

5.  Do the SNP’s cause a change in the sequence of the protein that is expressed? If so, should the novel protein be claimed? Should an antibody specific to the new protein be claimed?

6.  Does the SNP link that gene or protein to the condition for the first time? If so should diagnosis by measuring the activity or level of the protein be claimed?  This could be done in the form of single claim that covers diagnosis either by detection of the SNP or by detection of the protein level or activity.

7.  Does the discovery suggest new therapies that could be claimed for treating the condition?  Does it suggest a new screening method for identifying drugs to treat the condition?

8.  If the invention has personalised therapy embodiments then these can generally be claimed in two ways:

- a claim directed to use of the diagnostic method to select a patient for a particular therapy, and then administering the therapy

- a claim covering giving therapy to a person with the  relevant SNPs.

Clearly the second claim is broader, but it raises more patentability issues, possibly even novelty if the therapy is already being given to a broad range of patients.

9. The types of claims which are possible will also depend on the data that is available.  Whether or not the data supports each claim should be carefully reviewed.  Some claims may require the generation of further data before they are fully supported and it may be more appropriate to pursue them via a later filing.

10.  Given the new Guidelines that have issued from the USPTO about implementing the Myriad and Mayo decisions thought should be given to claims which refer to specific reagents and typing methods (see our post here about the Guidelines).

You may also be interested in the related articles 10 Points about Gene and Protein Sequences in Patent Applications and Top 10 Observations on Antibodies.

7 Points on the UK Decision Actavis v Lilly [2104] EWHC 1511 (Pat) (15 May 2014)

This is a very long decision with many different points considered, including procedural ones.  The points below focus on the take-home messages rather than going through why the judge came to each conclusion.  The points also focus on the claims interpretation parts of the decision.

1.  This concerns a request by Actavis for a Declaration of Non-Infringement in respect of a patent (EP 0432677) covering use of pemetrexed disodium in a cancer treatment and a corresponding SPC.  There have already been previous decisions on the case confirming the UK Court could consider validity of the French, German, Italian and Spanish designations. The Declaration for Non-Infringement is in respect of Actavis using the diacid, ditromethamine and dipotassium versions of pemetrexed. So the main claim interpretation issue concerns whether the claims of the patent can be construed to cover use of chemical compounds which are similar but not the same as the specifically mentioned compound.

2.  The two sides had very different opinions on the skilled person or team. There was also the suggestion that the skilled team could be different for different claims or different grounds (sufficiency and infringement).

3.  Though the Protocol on the Interpretation of Article 69 EPC refers to equivalents the Judge did not view these as leading to a US-style doctrine of equivalents.

4.  Claim interpretation, to ask which variants fell in the scope of the claims, was carried out using the Improver questions and Kirin-Amgen (what the person skilled in the art would have understood the patentee to be using the language of the claim to mean).

5.  The judge uses prosecution amendments and even considers the problems of anticipating technology evolution as part of analysing the claims, which seem similar to a US style Festo analysis.

6. After considering many scientific and legal points as part of the Improver questions the judge decides on non-infringement based on the principles of fair protection for the patentee and reasonable certainty for the third parties, saying that there is nothing in the specification or in the common general knowledge that would make ‘pemetrexed disodium’ mean anything other than what is conventionally means.

7.  The judge used legal experts provided by the parties to carry out claim construction and infringement analysis for other designations and the decision describes the relevant tests that were used.

The decision can be found here.  The previous High Court decision on whether the UK Court could consider the French, German, Italian and Spanish designations can be found here, and the appeal can be found here.

You may also wish to see related posts 10 Observations on Patent Litigation and 10 Points on UK Court Patent Decisions from 2013.

10 Points on AIA Post Grant Proceedings

These are based on a talk given by Michele Bosch at Finnegan on 8 May 2014.  This was a long and comprehensive talk with many statistics given. The 10 points below reflect my own observations rather than being an attempt to summarise the talk.

1.  The new AIA post grant trials are:

- Inter Partes Review (IPR) available on all patents from 16 September 2012 and a Petition needs to be filed within one year of service of an infringement complaint,

-Post Grant Review (PGR) available from 16 March 2013 on all ‘first-inventor-to-file’ patents and a Petition needs to be filed within 9 months of grant, and

- Transitional Covered Business Method Patent Post-Grant Review (CBM) available from 16 September 2012 to 2020 on all ‘covered business method’ patents and a Petitioner must be sued or charged with infringement.

The number of petitions filed as of 2 April 2014 is over 1260 (1100 for IPR, 160 for CBM).

2. There is a strong interest in post-grant trials at the USPTO because the Patent Trail and Appeal Board (PTAB) is perceived as a ‘friendlier’ forum than the Courts to challenge patents, the costs are lower ($300-400k versus over $1 million in Court proceedings), there is the possibility of stay of litigation, it is speedy and has procedural advantages, settlements are possible at this stage and it may influence the final Court decision.  The USPTO construes claims more broadly and there is no presumption of validity.  In addition the decisions are taken by Administrative Patent Judges who have no problem in finding patents invalid.

3. The three post-grant trials are different from each other in many ways.  They have different thresholds before proceedings can be initiated (e.g. IPR has ‘reasonable likelihood of success’), the proceedings have different grounds on which the patent can be attacked and they have different estoppel effects.  Anonymity is not possible (unlike in reexamination).

4.  In the first 18 months of IPR and CBMS some or all claims were cancelled on all patents.  However 2 patents have now been upheld with all claims found to be patentable.  Only 15% of petitions are denied. About 10% of instituted proceedings end with settlement.  Most trials have been in the areas of electrical or computer inventions.

5.  There are some similarities to EPO opposition, but there are also real differences.  Clearly if the same patent is being attacked in the two territories, then it is possible to make use of documents from one proceedings in the other.

6.  There are strict page limits and format requirements for the documents filed during the proceedings.  There are additional strict criteria for amendment requests, and many amendment requests have failed for procedural reasons. In fact no amendment requests have been granted to date, apart from ones where there were only claim deletions.

7.  The PTAB is quick to use redundancy reasons for eliminating grounds and documents, and therefore thought should be given to explaining why there are distinctions between the grounds and documents.

8.  The PTAB has stayed ex parte and inter parte re-examination proceedings when trials are initiated.  The Courts will also tend to stay, but not always.

9.  Claim construction is very important and can often be decisive.  The PTAB is willing to use its own.

10.  There is a very limited discovery process.  Additional discovery beyond the routine is often denied.

You may also be interested in the related articles Top 10 Tips For Success In EPO Appeals on Biotech Cases and Tips for Opposition Success.

6 Points on the EPO’s Enlarged Board Decision G1/12 on Correcting the Name of the Appellant

This is not a ground-breaking case and a Minority Opinion in the decision questions whether it was even necessary.

1.  The case concerns whether it is possible to correct the error of filing an appeal in the wrong name.  The patent proprietor had changed and this had been registered at the EPO.  However the appeal was filed in the name of the previous proprietor.

2.  The decision first considers the admissibility of the referral to the Enlarged Board.  The Enlarged Board decided that although a referral presupposes the existence of an appeal to a Board of Appeal, the admissibility of that appeal can be the subject of a referral.  The Enlarged Board also decided that the referral met the test of relating to a point of law of fundamental importance since it related to remedying a deficiency under Rule 101(2) and Rule 139 EPC and this was potentially relevant to a large number of cases.  In addition the Enlarged Board decided the test for requirement of uniform application of the law was also fulfilled by the referral.

3. However a Minority Opinion is also given in the decision which said that the criteria for a referral to the Enlarged Board were not fulfilled because the relevant law has been clear since T97/98, and there is no conflict with other decisions, such as G2/04.

4. Relying on T97/98 the Enlarged Board decided that the deficiency could be remedied if it ‘does not reflect a later change of mind as to whom the appellant should be’ and if the correct appellant is sufficiently identifiable, for example with the help of other information from the file.

5.  The Enlarged Board also confirmed that in this situation a free evaluation of evidence is to be used to establish the true intention.

6.  The decision also confirms that R139 EPC can be used to correct in the present situation.  This is a general rule allowing correction of errors in any document filed at the EPO.

G1/12 can be found here. T97/98 can be found here.

You may also wish to see related articles Top 10 Points from EPO Case Law in 2013 and 10 Points on the Ethics and Morality of Patents in Europe.

10 Points on the New USPTO Myriad/Mayo Guidelines on Patent Eligible Matter

These are based on a talk given by Anthony Tridico at Finnegan on 8 May 2014.

1.  At the start of the talk Dr Tridico spoke of how in the new Guidelines the USPTO has gone further than expected in interpreting the Myriad and Mayo decisions and that an element of inventive step now seems to be part of determining eligibility.  The Guidelines apply to all claim types and to all molecules (not just DNA and proteins) and so will have far reaching consequences.

2.  The Guidelines introduce a 3 step test an important part of which is to ask whether there is something ‘significantly different’ from the judicial exceptions (abstract idea, laws of nature, natural principles, natural phenomena and natural products).

3.  For natural products the important cases are Myriad, Chakrabarty  and Funk Brothers.

4.  In order to determine what ‘significantly different’ means 12 factors are provided which need to be weighed up together.  Words such as ‘synthetic’, ‘isolated’, ‘recombinant’, ‘cDNA’, ‘composition’, ‘primer’, ‘purified’ and ‘vector’ do not influence this determination.  One of the factors is whether the claim recites elements which are well understood, conventional and routine.  The Guidelines give examples of how they apply to natural products, combinations of natural products, processes and diagnostic claims.

5.  As an example the Guidelines show that a naturally occurring fruit juice would not be eligible matter.  A new combination of the juice with a naturally occurring preservative would not be eligible matter, but the pasteurised juice would be. Clearly ‘pasteurisation’ is the man-made difference which is sufficient for patentability.

6.  A bacterium with a naturally occurring plasmid is not eligible matter and neither is a naturally occurring chemical.  However a modified version of the chemical would be patentable as this would be a structural difference, particularly if it gave a functional difference.  Giving a naturally occurring drug in a defined dosage regimen should also be patentable, but it might be difficult to get a claim to simply treating a condition with a naturally occurring drug.

7.  For combinations of natural products a mere ‘mixture’ or ‘aggregation’ is not enough.  So gunpowder would not be patentable, but an alloy, having a different crystalline arrangement, would be.  A bacterium with 2 stable energy generating plasmids that each provide separate hydrocarbon degradative pathways would be patentable because possession of the 2 plasmids represents a structural and functional difference.  A pair of primers would not represent eligible matter.

8.  A method of identifying a mutation in a gene would not be eligible matter on its own, but performing this using a specified PCR reaction would be.  Diagnosis using new specific antibody should be eligible matter.

9.  For a natural principle, exposing a patient to sunlight to change mood would not be eligible matter, but specifying placing the patient at a particular distance from a light source would be.

10.  It is clear that when drafting a patent application one should be mindful of mentioning non-routine modifications.  One should careful saying what is routine, conventional, well understood or well known, and in claims one should avoid words like ‘analyse’, ‘compare’ and ‘determine’.  Layers of claims should be provided, particularly until more guidance is available on what claims represent eligible matter.  One should be prepared to take cases to appeal on eligibility issues, but in the meantime there will be a lot of uncertainty on biotech and diagnostics cases.

The Guidelines may be found here. Finnegan’s analysis of the Guidelines may be found here.

You may also be interested in the related articles 10 Points on US Patent Law Developments Focusing on Biotech and Top 10 Observations on Antibodies.

 

10 Points on Open Innovation

These points are based on the recent report ‘The Open Innovation Model’ from the ICC.

1. Open Innovation can be broadly defined as a collaborative approach to innovation where there is knowledge exchange with external organisations.

2. A company should view open innovation as a strategically managed exchange of information, based on the realisation that the best ideas will often come from outside.  Also in practical terms few innovation companies are able to realise the potential of every new finding.  Open innovation provides the possibility of ‘outsourcing’ such things.

3. There are different forms of the open innovation model, for example, based on bilateral collaboration, networks and ecosystems.  Open innovation is therefore a very flexible way of operating.

4. Open innovation has come about in response to many factors: globalisation, increasing complexity of products making R&D complicated and risky, industry convergence in certain areas (e.g. the food and pharmaceutical sectors), advances in ICT reducing the ‘perceived’ distance between companies, the increased tradeability of IP rights and the growth in in private venture capital making it easier to create startups to commercialise inventions.

5.  Open innovation requires the proactive management of IP.  There need to be clear predictable IP arrangements between all parties, and so as a practical matter there need to be effective IP protection systems in the relevant territories.  One consequence of this is that small players with less, or no, IP may be at disadvantage

6.  In general open innovation collaboration allows rapid product development (and shorter time to market), more innovations in the long term, being able to exploit new market opportunities and flexibility in the face of changing market conditions.

7. Organisations participating in open innovation do require ‘absorptive capacity’ allowing them to identify and use valuable external information.

8. Open innovation will also require organisational changes to manage the process.  For example, a joint steering committee may need to be set up.

9. There are transaction costs in setting up and managing an open innovation strategy.  There is also an ‘appropriation risk’ of your knowledge being stolen and so decisions will need to be made about how much to reveal to a collaborator.

10. Goverments can help by open innovation by improving the IP system, educating innovators about management of IP and fostering the creation of innovation networks and clusters,

The report can be found here.

You may also wish to see related articles Top 10 Points on the Trans-Pacific Partnership and Top 10 Points from Banking on IP.

6 Points on Amending a Priority Patent Application Before International Filing

This post is about the situation where a priority patent application is already on file and the inventors have generated data in the priority year.  The application can of course be amended to incorporate the new data before International filing.

1.  The new data needs to be reviewed to determine whether it simply supports the original inventive concept or whether it relates to a new inventive concept which might deserve a new priority filing of its own.  So, for example, one might think about whether the new data allows something to be claimed which is not within the scope of the claims of the priority document.

2.  Does the new data suggest an important new subconcept?  If so then thought should be given to amending the description and perhaps also the claims to refer specifically to the new subconcept. Thought should be given to how best the subconcept could be used to support patentability of the main existing inventive concept.  Introducing new claims to the subconcept will assist in defining the contribution made by the subconcept.

3.  Any new material that is added, and in particular new claims, should be done in view of all relevant disclosures that have happened in the priority year, from the inventors and from third parties.  Bear in mind that in some territories grace periods can be used to nullify the prior art effects of disclosures from the inventors.

4.  Consider whether inventorship for the priority application is different from inventorship for the International application in view of the new data.

5.  Be very mindful of retaining priority as much as possible for the subject matter in the International application.  It is normally best to not delete any material, and simply add the new disclosure.  Where for example new data shows a range can be extended from ‘10 to 20’ to ‘10 to 25’, don’t simply replace on by the other.  Retain the old range and introduce the new one, though this seems inelegant.

6.  Be careful of how you make corrections to the priority specification.  With DNA and protein sequences it may be best to retain the incorrect sequences and add the corrected ones.  You may end up in the situation of needing to base a claim on the incorrect sequences and defining an appropriate percentage homology may allow you to cover all useful sequences.

You may also wish to see related articles Top 10 Tips on Getting Difficult Cases Through and Top 10 Points about Gene and Protein Sequences.