Thursday, 31 October 2013

Patent litigation statistics: a task for do-it-yourself enthusiasts?

The UK Intellectual Property Office has just released various bits of information sought by individuals under the Freedom of Information Act 2000 and which were supplied in May 2012.  One such request related to patent litigation. Like any other government department, the IPO is obliged to give honest and accurate answers, but doesn't have to spend much in terms of effort and resources in order to get those answers. Accordingly, responses to FOI requests often have a sort of do-it-yourself flavour.  Anyway, the IPO's entry on its website looks like this:
Subject: Patent litigation statistics

Date of response: 3 May 2012

Summary of request:

I would like to learn how to obtain UK patent litigation statistics, such as annual median
damages award. It would be excellent if the statistics shows which cases were lost profit
awards and which cases were reasonable royalties, and so on.


The costs awarded by the Hearing Officer are not recorded by us anywhere other than in the
decisions themselves, which can be viewed on our website under the heading 'Results of past
patent decisions' (see

If you use the keyword search function and search for costs you will find all the decisions
where we have awarded costs. We are not sure what you mean by the terms 'lost profit' or
'reasonable royalties'; perhaps you will be able to tell from looking at them.

We do not hold data on costs awarded at the courts. You could try the Patents Court in the
first instance (see

ERA unitary patent event to focus on the Rules

There's an ERA conference coming up soon which should be of considerable interest to readers of this weblog. On 25 and 26 November 2013: "Latest Developments on the EU Unitary Patent" takes place in Brussels, the political capital of Belgium and the eating capital of the European Union, so far as this blogger can see. Anyway, concerning this event:
"The public consultation on the Rules of procedure for the Unified Patent Court (UPC) was closed on 1 October 2013. The Drafting Committee will now evaluate the written contributions and prepare proposals on the Rules of procedure. This conference will offer an update on the legal developments regarding introduction of the Unitary Patent in the EU, and give practical recommendations on litigation strategies".
Participants are Paul van Beukering (Chairman of the Unified Patent Court (UPC) Preparatory Committee), Penny Gilbert (Powell Gilbert LLP),  Klaus Grabinski Drafting Committee on the Rules of Procedure for the UPC; Bundesgerichtshof judge); Willem Hoyng (Drafting Committee on the Rules of Procedure for the UPC), Johannes Karcher (Coordinator, Legal Framework Working Group of the UPC Preparatory Committee), Christof Keussen (Glawe Delfs Molle), Winfried Tilmann (Drafting Committee on the Rules of Procedure for the UPC), Bettina Wanner (Bayer Intellectual Property GmbH), Karen Vandekerckhove (DG Justice, European Commission) and Eskil Waage (International Legal Affairs, PCT European Patent Office).

For further information and registration details, just click here and all will be revealed.

Wednesday, 30 October 2013

Should the U.S. Federal Circuit Court retain its monopoly of patent litigation?

The Chicago-Kent Journal of Intellectual Property has just published "Keynote Address: Is It Time to Abolish the Federal Circuit’s Exclusive Jurisdiction in Patent Cases?" by the Hon. Diane P. Wood (Chief Judge of the U.S. Court of Appeals for the Seventh Circuit).  This 10-page address, which has been reported on the IPKat weblog with an introduction by Dan Bereskin QC, is available in full here.

Judge Wood's comments have already been treated to a serious riposte from Edward Reines, a partner in Weil, Gotshal & Manges), which you can find on the respected Patent Docs weblog here, together with some perceptive comments from readers.

Pierre's guidelines: a new, improved version

Back in September, this blog drew the attention of readers to Unified Patent Court - Draft Rules of Procedure is a 306-page handbook, which includes the Agreement in the three official languages of English, French and German. At that time it was announced that a German version of the Draft Rules was being prepared by the law firm Reimann Osterrieth Köhler Haft and that the UK's Powell Gilbert was also named in this venture, which appears to be masterminded by French avocat Pierre Véron.

Piere has now told us that improved version of the handbook comprising a trilingual version of the 19 February 2013 rules in English and French has been added to the website at it includes hypertext links to the legal documents referred to in the Agreement (e.g. Regulations on European Patent with Unitary Effect, Lugano Convention), internal hypertext links for cross references, as well as bookmarks for easier navigation. The direct link to this version is here (for ease of use, you can download this PDF file onto your computer and open it locally with Adobe Reader).

A fully trilingual version, including the draft Rules of Procedure in German, should now be available in November.

Monday, 28 October 2013

Tilmann to speak at UPC forum

C5's 6th Forum on Pharma & Biotech Patent Litigation is coming up on Tuesday, January 28 and Wednesday, January 29, 2014, in the convenient forum of the Radisson Blu Hotel, Amsterdam. According to organisers C5,
The Unified Patent Court has become a significant development for every IP and pharma expert in the world, regulatory bodies on both sides of the Atlantic are sanctioning pharma companies for anti-competitive behaviour, EU national courts are increasing their referrals to the ECJ for answers and clarifications on a wide spectrum of topics, new European alternative IP courts are being created and emerging markets keep altering their IP laws and procedures. These changes will force everyone within the biotech and pharma field to re-think and adjust their patent litigation strategies.
One of the speakers is Winfried Tilmann (right), who is of Counsel in Hogan Lovells' Dusseldorf office, a well-known figure in European patent litigation circles and the author of "The compromise on the uniform protection for EU patents" (see abstract here). Winfried is gearing up for a spot of positive thinking about the UPC, which has continued to receive a lukewarm reception in many quarters. He says:
"This conference, as regards the Unified Patent Court (UPC), comes at the right time for businesses preparing for the transitional period of the new Court, especially deciding on the question whether to use or not to use the opt-out-provision of the UPC Agreement in order to avoid a revocation action being started against their European patents before the UPC the effect of which would cover the entire territory of the contracting states".
If you're thinking of attending, programme and registration details can be found here.  There's a 15% discount off the conference price to IPKat readers (and their friends on PatLit ...) who quote the discount code 630KAT.

Patent Lawyer mag focuses on Finland, Brazil

The current (September-October) issue of The Patent Lawyer, published bimonthly by CTC Legal Media, has a focus on litigating patents in Finland, where on 1 September 2013 all civil intellectual property litigation has been centralised and will be heard by the Market Court.  The idea is to expedite proceedings: according to Petri Eskola, the reorganisation should result in cases getting to trial within a year, an improvement on the 14-to-20 month time-lag under the old system.

There's also a pretty upbeat appraisal of patent litigation in Brazil by Andre Oliveira. While most readers of this blog are unlikely to have had much experience of this, given the impending soccer world cup and Olympic Games which Brazil is hosting, it's quite likely that the country's attitude to ICT and business method patents will be the subject of judicial attention.

Are we too afraid to rethink the patent system?

PatLit is delighted to host this piece by London-based patent attorney and guest blogger Dr Suleman Ali (Holly IP).  Here Suleman takes the opportunity here to ask some big questions about our immediate legal environment:
Are we too afraid to rethink the patent system? 
How well is the patent system working -- and should it be changed?  For many companies, patent strategy is complex and expensive. In certain technical areas companies cannot be passive when it comes to patents.  They have to build up a patent portfolio for defensive purposes, i.e. to deter litigation by competitors.  In recent years we’ve seen the outbreak of patent wars as parties have been prepared to spend a huge amount of resource in litigating across the world.  Clearly patents represent a burden on companies, but there is little doubt that the benefits outweigh the losses. 
In their seminal study published in 1990 Merges and Nelson looked at the effect of claim scope on the development of technology in different sectors with the goal of examining whether claim scope could be ‘fine tuned’ to make the patent system more efficient.  They concluded that initial broad patent filings could inhibit development of technologies, particularly where there needed to be a cumulative series of innovations. However it is noteworthy that they were cautious in the way they presented possible changes, and really their work provided a deeper understanding of the impact of the patent system rather than putting forward alternatives. Some commentators, for example John Golden, have warned that sweeping changes would inevitably lead to unintended consequences, suggesting instead that making small incremental changes is the best way to change the patent system, if it is to be changed. 
When one considers how change could come about, one sees that perhaps the means for radical changes to the patent system simply do not exist.  Such changes would be subject to intense lobbying at the European Union (EU) and in the US -- which would probably sabotage the purpose of any attempted change. 
However, as we move to new types of research ecosystems, perhaps questions about rethinking the patent system are becoming more urgent.  There is an increasing acceptance that open innovation models have a place in hi-tech areas and open innovation communities already exist in the fields of software, 3D printing, synthetic biology and green technologies.  However Jason Schultz and Jennifer Urban have noted that open innovation communities often do not see a role for patents in their ecosystem.  Many people in such communities have anti-patent views and these communities will sometimes develop defensive strategies against the threat of patent litigation.  They may, for example, set up patent pools which create an environment within which all parties can contribute.  This has led to accusations of collusion and clearly there is always the risk of a patent pool being used offensively against companies outside the patent pool.  From the strategies that are emerging it seems that open innovation communities are more focused on countering the negative aspects of the patent system, rather than seeing patents as helpful economic tools. 
It is also known that many companies don’t benefit fully from their patents, with surveys showing that 30-40% of patents regarded as ‘important’ by companies might not be commercialised.  In view of this there have been suggestions that we need to provide more incentives for companies to commercialise their inventions.  One very radical proposal, from Ted Sichelman, is to introduce a new right that would protect investment in the commercialisation process.  This would be a positive right to sell a specific narrowly defined novel product.  Being a ‘positive’ right it would provide immunity from enforcement of a third party patent right if the patentee had not commercialised its invention within a specified time.  In return the patentee would be given a fixed royalty.  This commercialisation right essentially recognises that costs do not end at the invention stage, and is a way of protecting the further investment needed to develop and bring a product to market.  Clearly such a positive right would counter the need to build up a patent portfolio for defensive purposes, and would also avoid the need for expensive patent wars. 
Unfortunately present debates about the patent system seem to be between the very anti-patent and the very pro-patent, so proposals for change are unlikely to undergo complex objective analysis by all parties that participate in, or are affected by, the patent system.  Perhaps we need to start recognising that patents do not incentivise commercialisation in certain situations, and that some sort of new positive right may provide a solution.  More worryingly, perhaps, patents in their present form are slowly going to become redundant as more sectors move to open innovation models.  If that is the case we need to start to think about how to change things now so that the development of new research ecosystems is not hindered by patent rights which are becoming less and less fit for purpose.

Friday, 25 October 2013

Patents and right to health - Brazil and South Africa follow in India's footsteps

Just a few months ago, the judgment of the Supreme Court of India in the Novartis' Gleevec case fueled an international debate on the protection of innovation in the pharmaceutical sector and its compatibility with the right to health. The discussion frequently focused on Section 3(d) of India's Patents Act, which sets out a test of 'enhanced efficacy' (therapeutic efficacy, for pharmaceutical substances, according to the Supreme Court) for the patentability of new forms of known substances:
3. The following are not inventions within the meaning of this Act,—

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

The Supreme Court explained that the test constitutes 'a second tier of qualifying standards for chemical substances/pharmaceutical products', designed as a filter to prevent repetitive patenting and 'evergreening' practices. The ample historical re-construction, and the comments of the judges on the development of patent law in India, clarified that Section 3(d) sets the balance between the protection of IP and the safeguard of public health from a wide perspective, which includes access to medicines and development of a national generic industry. From this point of view, the provision represents India's attempt to comply with its international obligations arising from the TRIPS Agreement, in light of the Doha Declaration on TRIPS and public health and of its own national interests as a developing country.

Recent reform proposals, currently under discussion in Brazil and South Africa, show that other countries are likely to follow in the footsteps of India. The Projeto de Lei n° 5.402/2013 (a brief overview here) seeks to apply significant changes to Brazil's Industrial Property Law (Lei 9.279/1996), which comprise (i) the exclusion of term extensions to compensate for regulatory delays either in the granting of a patent or in the approval of a medicine (revoking Article 40), and the adoption of (ii) a provision (Article 10.XI) identical to India's Section 3(d), (iii) higher standards for inventive step (amending Article 13), (iv) a pre-grant opposition procedure (amending Article 31), (v) a provision (Article 195.3) rejecting data exclusivity. Further changes include the necessity of prior consent from the National Sanitary Agency (ANVISA) for granting patents on pharmaceutical substances or processes, and the establishment of governmental use licenses.

Main changes introduced by the Projeto de Lei n° 5.402/2013
Patent term
Revocation of Article 40 (‘The term shall not be less than 10 years for an invention patent and 7 years for a utility model patent, beginning on the date of granting […])
No extension of the patent term for regulatory approval of new drugs
Test of enhanced efficacy for new forms of known substances
Article 10.XI (new)
'The following are not considered to be inventions or utility models:
XI – new forms of known substances that do not result in the enhancement of the known efficacy of the substance.

For the purposes of this Article, salts, esters, ethers, polymorphs, metabolites, pure form, size of particles, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance shall be considered the same substance, unless they significantly differ in terms of properties regarding efficacy.'
Article 13 (amended)
'An invention is endowed with inventive step provided that, to a technician versed in the subject, it is not derived in an evident or obvious way from the state of the art, and that it represents a significant technical advancement in relation to the state of the art.'
Pre-grant opposition
Amendments to Article 31
The opposition may be filed after the publication of the application and before the end of the examination
Technical opinions may be asked to public administration, organisation, scholars and experts
Data exclusivity
New Article 195.3 authorises 'the use, by governmental entities, of test results or other undisclosed data, for market approval of products equivalent to the product for which they had been initially presented.'
Consent of the National Sanitary Agency for approval of pharmaceutical patent
New Article 229-C requires ANVISA’s consent in light of public health considerations
ANVISA may refuse its consent if the grant of a patent application is contrary to public health
Public, non-commercial governmental use
New Article 43-A allows the government to use the subject matter of a patent or patent application without the owner’s consent, for reasons of public interest

The explanation attached to the reform proposal takes the view that such changes are essential to allow Brazil to pursue policy objectives (increasing access to medicines, lowering health care expenses, promoting domestic innovation, stimulating the development of generic competition in the internal market, etc.) which differ from those of more economically developed countries. The idea, according to the policymakers that promoted the reform, is to follow the paths of India and Argentina, rather than that of the United States.

Brazil's proposal, which is supported by numerous international scholars, addresses some of the issues examined by the Center for Strategic Studies and Debates in a recent report ('Brazil's Patent Reform - Innovation Towards National Competitiveness'). The study highlighted that the current regime appears to favour foreign innovators, and that the grant of pharmaceutical patents determined a drop in foreign investments and technology transfer agreements, undermining the development of a domestic pharmaceutical industry. Further, the report underlined the benefits deriving from generic competition, as well as the interplay between a restriction of the patentability of pharmaceutical substances and the increased availability of essential medicines at lower costs.

Similar issues are also under consideration in South Africa, where the Department of Trade and Industry presented, in September, a 'Draft National Policy on Intellectual Property', which suggests modifications in many areas of IP law. Inter alia, the draft focuses on the reform of patent law, in light of public health policy considerations, contemplating the introduction of a new Search and Examination Office, pre and post grant opposition procedures, stricter patentability requirements, and other provisions aimed at fostering generic competition and facilitating access to medicines. 

Draft national policy on IP of South Africa – Recommendations
Technology – Public policy
Establish a new Search and Examination Office
Develop human-resource capacity for the handling of technology, including technology transfer
Adopt rules to regulate technology transfer agreements related to restricted/prohibited technologies
Do not support international patent reforms which undermine South Africa’s public policy
Address parallel importation and compulsory licensing in line with Doha Declaration
Promote schemes and regulations to encourage use of patents and help achieve developmental goals (poverty alleviation and health)
Do not enter into bilateral agreements that may impair the flexibility granted by TRIPS
Pre and post opposition of patents
Introduce a dual opposition procedure (pre/post grant)
Patents and public health
Incorporate the flexibilities contained in the TRIPS and Doha Declaration
Do not grant patents on medicines that may be expiring
Adopt a cost and benefit analysis (monetary/non-monetary) through processes and benchmarks in line with those used in India and Brazil
Amend the Patent Act to take into account public health
Data protection
Maintain commitment to protection of data under Art. 39 TRIPS but refrain from conceding clinical data exclusivity
Generic medicines
Use of the Bolar provision before expiry of the originator’s patent
Raise awareness that generics are not counterfeited medicines

In particular, the second chapter of the Draft Policy analyses the relationship between IP and public health, admittedly from the point of view of 'a developing country like South Africa'. The drafters identify three main mechanisms to ensure access to medicines at lower prices and to facilitate generic competition: compulsory licensing, parallel importation, and limitations to the patentability of pharmaceutical substances. Accordingly, they essentially propose (i) to introduce compulsory licensing provisions, (ii) to facilitate parallel importation from other jurisdictions, (iii) to adopt provisions aimed at increasing generic competition (e.g. Bolar provision and a fast procedure for generic approval), (iv) to implement strict requirements for patent protection, which should exclude diagnostic, therapeutic and surgical methods, including new uses of known products, from patentability, and (v) to ensure that the protection of intellectual property does not conflict with public health policies.

In an open letter addressed to the Department of Trade and Industry, several organisations and academics welcomed the proposals contained in the Draft Policy, suggesting an even more radical approach. The signatories supported the introduction of a search and examination system, especially in relation to the pharmaceutical sector, the implementation of pre and post grant oppositions, and the use of compulsory licensing and parallel importation. They also highlighted the importance of improving transparency during the application procedure (including disclosure of the INN - International Nonproprietary Name - of the pharmaceutical subject matter) and of avoiding the conferral of data exclusivity.  On patentable subject matter and patentability criteria, the letter endorsed the adoption of stricter rules aimed at preventing 'patent evergreening' and the patentability of DNA and cDNA sequences:
[We] recommend that additional criteria also be put in place in South Africa, to exclude from patentability or to clarify lack of inventive step with respect to new forms of known medicines or their components (salts, polymorphs, esters and other derivatives), new dosages and formulations, and new combinations of known medicines or components. These exclusions from patentability or clarifications of inventive step are all compliant with Article 27.1 of TRIPS, and countries such as India, Argentina and the Philippines have already put such criteria in place. Strict subject matter exclusions and patentability criteria prevents originator pharmaceutical companies from obtaining multiple patents on the same drug—a practice known as “patent evergreening,” which keeps medicine prices high by preventing the entrance of generic competitors. [...] Both DNA and cDNA sequences should also be explicitly excluded from patentability, as they are products of nature—cDNA sequences in particular are relevant to developing therapeutic products. Adopting this exclusion is essential if South Africa is to develop a rich biotechnology/biosimilars sector. In addition the DNPIP must reject the introduction of utility model patents in South Africa in regard to pharmaceutical products [...].
The reform proposals examined above showcase a fundamental issue which prevents a global harmonisation of patent law. Disparities in the economic and social development of many countries inevitably prompt reactions inspired by the protection and promotion of national interests and priorities. The debate on Brazil's and South Africa's reforms offers a significant occasion to reflect on these elements and their interplay, a necessary step towards an internationally harmonised system of patent protection.