5 IPKat Articles by Holly IP

We have now written 5 articles for the IPKat blog. We are very appreciative of the opportunity to write for this prestigious blog. These are the articles:

Taking It Personally: Patents, Medicines and Genetic Markers

This was about whether the European Patent Office was about to change its policy on the way it looks at the feature of patient groups when assessing the novelty of medical use claims. That would clearly have a lot of implications for claims covering personalised medicine inventions.

Is Innovation Always the Best Choice? A Review of the Global Innovation Index 2013

This article discussed what contributes to innovation and how it is measured, together with thoughts on how innovation policies fit into the wider issues of how a country should decide on where to use its resources.

Balancing IP and Human Rights: The Case of Medicines

This article explores the debate around the issue of access to medicines in the developing world, and whether this is a human rights issue.

The Heart of the Matter: One Patent, Two Views

This article reviewed the UK Court decision AGA Medical v Occlutech and contrasted the findings of the UK judge with what happened at opposition at the European Patent Office.

Publication of Patent Applications: Not So Unsexy After All

This is about proposals from the UK IPO to change the way it publishes application. The article considers all the possible consequences of this seemingly mundane issue.

We have also had the following articles published on blogs related to IPKat:

Are We Too Afraid to Rethink the Patent System (on the PatLit blog)

This article explores whether the patent system is still fit for purpose in the age of open innovation ecosystems.

Ethics Versus Money in University Tech Transfer (on the IP Finance blog)

This article considers whether hard-pressed university tech transfer offices should turn to Patent Assertion Entities to monetise their patents.


The Post-Alice Post-Myriad Post-Mayo World

A series of US Supreme Court decisions have changed the patenting landscape in the US in the areas of computer-implemented, biotech, pharma and chemical inventions.

Mayo Collaborative Services v Prometheus Labs, Inc. (see here) held that a claim to optimising a drug dosage based on measuring metabolites in the blood was not patentable because it related to a ‘law of nature’.

Association For Molecular Pathology et al v Myriad Genetics, Inc. et al (see here) held that DNA molecules found in nature could not be patented.

Alice Corporation Pty. Ltd v CLS Bank International et al (see here) held that ‘abstract ideas’ implemented on a generic computer without providing an ‘improvement’ were not patentable.

This post looks briefly discusses the aftermath of the decisions and how commentators have continued to react to them.

1. Mayo was criticised by the biotech industry for undermining patents relating to diagnostics and possibly causing investors to stay away from the field of personalised medicines. It has led to a tremendous amount of uncertainty as to which diagnostic methods are patentable, but arguably it did not have a large impact outside that specific area.

2. The USPTO Guidelines issued after the Myriad decision (see here) were highly controversial. The USPTO interpreted the decision very broadly so that all products found in nature were unpatentable (not just DNA). In addition many methods involving natural products were unpatentable based on complex and unclear tests devised by the USPTO. Clearly many biotech, pharma and chemical cases will be affected by Myriad.

3. Practitioners were ‘horrified’ by the Myriad Guidelines (see here and here). There continues to be a lot of uncertainty as to when subject matter is sufficiently different from nature to be patentable.

4. However, the Alice decision has probably had the greatest impact to date, directly affecting both prosecution of cases and litigation. At this stage it is not clear how many software patents would be rendered invalid by Alice. Some commentators believe it is very limited decision (see here). Others believe that a majority of the software patents which are being litigated now would be invalid under Alice (see here).

5. A recent Patently-O article lists decisions in which Alice has had an impact (see here). There continues to be a lot of uncertainty as to which computer-implemented methods are patentable.

You may also wish to see our related posts 10 Points on the New USPTO Myriad/Mayo Guidelines on Patent Eligible Matter and Top 10 Points on Patent Developments and Case Law in the US in 2013.


Observations on Working with Patent Attorneys

1. The amounts patent firms charge varies tremendously. Generally this will be reflected in the quality of work that they do. When choosing a patent firm it is important to make sure that you choose a firm that is consistent with your budget.

2. You should consider choosing a high quality firm if patents are important to the value of the company and if the technology is complicated.

3. In general high quality patent attorneys will be better at drafting patent applications, responding to objections during examination and defending patents against attacks by third parties. When drafting patent applications they are more likely to foresee potential problems and devise possible solutions. They will be proactive in understanding the technology and providing a range of options at each stage. They are better at dealing with ‘difficult’ cases and coming up with appropriate strategies.

4. Bear in mind that the patent attorneys may not be able to advise on the best overall strategy given the commercial goals of the company. Their mindset may be focused on individual inventions and so they may not be in a position to have global view of what is happening. For example they may not take into account that later inventions could be more important, and therefore fewer resources should be used in pursuing patent protection for earlier inventions.

5. Patent attorneys will normally charge based on time and therefore it is important to be efficient in the way that one instructs them. Creative ideas should happen at the start of the project, but then a strict line should be followed as to what will and what won’t be included in the patent application. Constantly changing the scope of the claims during the drafting process will add to the costs.

6. Always be alert to the claim scope that is needed for each case and whether it is going to be realistically possible as examination proceeds. Regularly review cases which are in ‘difficult’ examination to make sure they are worth continuing to pursue. The patent attorneys will not be able to make these decisions for you.

You may also be interested in the related articles Top 10 Reasons for Filing a Patent Application and Advice to Scientists Setting Up a Company.


The Human Factor In Innovation

We’ve picked out the following points from The Global Innovation Index 2014 as being of interest to us.

1. The theme of this year’s Global Innovation Index Report concerns how to nurture the essential human factor in human innovation. That means an appreciation that creative and critical thinking, an appetite for risks and thinking entrepreneurially are important for the innovation process.

2. Educated people make good innovators, and deep technical skills are required for disruptive innovation.

3. Whilst ‘brain drain’, i.e. emigration of skilled people, is detrimental to a country, diaspora networks can be of benefit. Migrants can act as a bridge to investors and institutions with technical skills.

4. The BRICS countries have their strengths, but as yet they are not showing the ‘holistic’ improvements needed in their infrastructure which will lead to them being top innovators.

5. The US is ranked 6th in the world in according to innovation efficiency ratio, being hindered by weaknesses in tertiary education and low levels of student exchange with the rest of the world.

6. Many countries are in the process of ‘catching up’ which needs to occur through imitation and technology acquisition rather than their own R&D. However technology transfer is not simple, requiring a complex set of skills and organisational structures before it is successful. The presence of a large poorly educated population is the primary reason for poor innovative performance.

7. More recent view of innovation recognises the contribution of a wide range of disciplines, and not just science education. Good arts teaching is also important. In particular teaching methods in the visual arts are close to those that nurture skills useful for innovation.

8. The recent expansion in the Indian educational system has been impressive. However now the issue is one of ensuring the quality levels of tertiary education. In addition the humanities and social sciences have been neglected.

The report can be found here.

Our IPKat post on last year’s report can be found here.

You may also wish to see related articles 10 Observations on the Success and Failings of University Tech Transfer and Top 10 Points on the Trans-Pacific Partnership.


What’s Wrong With an Academic or Rigid Approach to the Patent System?

This post is written by a practitioner who is very appreciative of the role of academics in contributing to the patent system. The purpose is to highlight though how practitioners need to approach the patent system because it is very different from a typical ‘academic’ understanding of it.

1. Patents are a very grey area. There are often good counterarguments to any position which is taken on validity or infringement issues. That means there is a tremendous level of unpredictability and risk involved when making decisions around them. Often the most likely outcome can be defined, but so often the most likely outcome does not happen, and that must be appreciated. So whilst an optimal strategy can be deduced it must be realised there is lot that cannot be catered for.

2. The patent system is changing all the time, sometimes dramatically. The Mayo, Myriad and Alice US Supreme Court cases have transformed the landscape of chemical, biotech and software patent practice in the US in ways that are still not clear. That means the practitioner needs to know the absolutes are changing and be able to plan for that as much as possible. As an example many practitioners were caught by surprise when software became patentable under European practice and their patent applications did not have basis for introducing claims to it.

3. The ‘academic’ approach looks for clear principles with which to understand something. Patent laws and decisions seemingly provide such clear principles. However what might not be appreciated is that the practical interpretation of laws and decisions can change, particularly where concepts such as novelty and inventive step are involved. In addition it can become clear that certain decisions were not correct, and will not be followed.

4. Analysing patentability is complicated, and so different people will have different approaches, coming to different conclusions. Different Examiners, Opposition Divisions and Boards of Appeal are capable of deciding the same things differently. That is part and parcel of legal systems where it is observed that many findings are reversed on appeal and so often decisions on points are not unanimous where there is more than one person who contributes to it.

5. Oral proceedings at the EPO will sometimes determine the outcome of difficult examination proceedings, and usually determine the outcome of opposition proceedings. However many factors will unduly influence that outcome, in particular how the individual attorneys performed on the day: if they are caught by surprise, misunderstand a point or misread what the Division or Board is thinking they may lose the case. That decision would reflect what happened on the day, rather than what should have happened based on case law. Parties taking part in oral proceedings should recognise this can happen, and when one is reading decisions of the Boards of Appeal to determine case law one must understand how such ‘human’ factors might have impacted the conclusion.

6. As well as dramatic changes happening in case law and practice (as mentioned in point 2 above) there are always small changes happening in patent practice. Usually practice seems to get more strict (such as claiming homologues of nucleic acids), but it can also become more lenient (such as the EPO becoming more lenient on added matter recently).

7. It is often difficult to give advice to clients, particularly on the chances of success or the scope of claims that might be gained in examination. Examiners can raise objections that were not predicted, and whether or not basis is available for the required amendments is then a matter of luck rather than justice. Whilst clients prefer more certain answers, that certainty will often not reflect the reality of the situation.

You may also wish to see related posts 10 Observations on the Complexity of Patents and Top 10 Problematic Things for a Patent Attorney to Advise On.


Mazzucato’s ‘Innovation as Growth Policy’

These points are taken from a recent article by Mazzucato and Perez titled ‘Innovation as Growth Policy: the challenge for Europe’.

1. The world is in a crucial time of transition as to how to direct the economy after the financial crisis of 2008. We have a polarisation of incomes, high unemployment, low growth and a fearful financial sector which is steering away from the real economy.

2. Presently private and public investment go into speculative and short-term investment. The spread of information and communications technologies (ICT) in the 1990’s and 2000’s turned into casino capitalism. That financialisation has hindered progress.

3. Banks and venture capitalists have become risk-averse wanting returns in 3 years. However major innovations take 15-20 years to develop. That means they are not investing in the ‘big waves’ of the future. Long term funding must therefore come from public institutions.

4. A deeper understanding is needed of the process of innovation so that policies can be implemented to promote it as a driver of economic growth. Innovation is not just about easy money being available. It also needs a direction for the deployment of resources, i.e. a mission-led approach to innovation is needed. ‘Green growth’ can serve as a powerful global direction for deploying the potential of the information revolution.

5. Green growth is relevant to energy sources and uses, designing products, promotion of collaborative economies and promotion of health and education.

6. The markets cannot find the green direction on their own because there is no ready-made route that will make the multiple possible directions and disparate innovations profitable. Governments must take on the required high risk R&D.

7. Present efforts to generate growth which is both smart and inclusive are not working. A major innovation effort is needed to change this and a dialogue in which innovation and employment are not seen as trade-offs.

8. Conclusions:

- public investments are needed in a mission orientated approach

- direct and indirect incentives need to be provided to promote innovation

- EU banks can be used to cure the investment crisis

- ‘green’ can be used as the key challenge and direction

- long term committed finance is required

- definancialisation of the economy is required

- regulation is needed to shift profitability to key green areas

- taxation must reward long-term investment.

You can see the report here.

You may also wish to see related articles 10 Points on Muzzacato’s Rethinking the Role of the State and What is Wrong with Pharma R & D?

10 Points on US Patent Litigation

These points are based on the article ‘Understanding the Realities of Modern Patent Litigation’ by Allison, Lemley and Schwartz.

1. The article is based on 949 merits decisions based on infringement suits decided in 2009 to 2013 from every case filed in 2008 and 2009. The decisions come from 462 different cases involving 777 different patents. Of the 949 merits decisions 636 were definitive wins for one side or the other. The remainder were interim wins, usually denial of a summary judgment motion.

2. The most common source of merits rulings were summary judgments of invalidity (430) and non-infringement (473). In contrast patentees were less likely to seek or obtain a summary judgment in their favour. Patentees brought and received rulings on 125 summary judgments on validity and 128 summary judgements on infringement.

3. Of the 949 merits decisions 290 patents went to trial. 273 merits decisions reached a Federal Circuit decision on appeal and another 126 were appealed but settled before decision. 82 of the merits decisions are pending before the Federal Circuit.

4. Less than 10% of the patent lawsuits filed in 2008 and 2009 resulted in a merits decision, i.e. more than 90% of lawsuits were settled before summary judgment or trial.

5. In a study in 1998 it was found that validity challenges were overwhelmingly based on obviousness. In the present study it was found that whilst obviousness was still important, there were fewer summary judgements based on it than anticipation. There are also a growing number of decisions based on patentable subject matter and the largest category of validity decisions was indefiniteness which barely registered in the 1998 study. This is due to indefiniteness being applied on software means-plus-function cases and also the rise of claim construction.

6. Only 31% of invalidity challenges succeeded at summary judgment, overall in 42.4% of cases. However patentees won only 26% of the definitive merits rulings as they do badly on infringement. Accused infringers win 57% of judgements on infringement.

7. Patentees do badly because of ‘fractioning’ of patent law. They have to win every issue of validity and also infringement to win overall. A patentee’s burden for summary judgement for infringement is higher than the accused infringer because they need to show lack of disputed issues for ‘all’ elements of the invention whilst the accused infringers need to show it for ‘any’ element of the invention. Also the patentee must survive at summary judgment and trial, whilst a win at either is sufficient for the accused infringer.

8. Patentees fared better on validity issues in multi-patent decisions.

9. Foreign patents were more likely to prevail in merits decisions, suggesting that foreign plaintiffs were only asserting their best patents.

10. Patent characteristics, such as number of prior art references, seem to have no correlation with overall win rates, validity or infringement outcomes.

The article can be downloaded here.

You may also be interested in related articles 10 Observations on Patent Litigation and Top 8 Disadvantages of a Specialist Patent Court.