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15th August 2013 @ 01:24

An Open Source Drug Discovery for Malaria meeting was held at The University of Sydney on February 24th 2012.

The sixth talk of the day focused on 'Open Data', speakers include Mat Todd (University of Sydney), Andrew Trealoar (Australian National Data Service), Neil Saunders (CSIRO) and Nico Adams (CSIRO). The meeting can be found on YouTube here:

http://www.youtube.com/watch?v=URoDLUvEUL0

Transcript:

15th August 2013 @ 01:22

An Open Source Drug Discovery for Malaria meeting was held at The University of Sydney on February 24th 2012.

Hazel Moir, an economist gave the fifth talk of the day, which can be found on YouTube here:

http://www.youtube.com/watch?v=3eP8OTFYjKA

Transcript by Gabriella Young, Edited by Alice Williamson

Transcript:

This text is a transcript of the talk which is published on YouTube and entitled: OSDD Malaria Meeting Session 2 Part 2 - Hazel Moir 

Hazel Moir is an economist and will discuss the issue of Intellectual Property, from a slightly different perspective compared to previous speakers who dealt with data and policy.

1) How to get on with malaria treatment research in an imperfect world.
(00:30) Hazel re-iterates what other speakers have said, namely we live in a very imperfect world and posed the question of how do you get on with malaria research in this environment? She believes you can do successful pharmaceutical development without patents and cites a paper (Baldrin and Levine). See link to the paper by Michele Baldrin and David Levine p. 259-260

2) (1:00 )This link lists the 46 top pharmaceuticals in the world and shows how many of them were developed without patents and how some of the ones developed with patents, were actually developed serendipitously, without the incentive of the patent.
 
3) (1:23) Hazel emphasised that Open source will work the best for the very initial stage of pharmaceutical development. 

4) (1:38) It is not just patents that are of consideration, but also copyright. This is because, in Australia there doesn’t have to be creative data to be covered by copyright. That is, data is covered by copyright. 

5) (1:45) Hazel suggests that you may find sharing data in the early stage of OSDD look at the copyleft provisions of the Open Source Movement (see Wikipedia for meaning of copyleft, to ensure that people don’t take advantage of this, but are able to participate if they are able to share.

6) (2:18) Intellectual Property as a term is bandied about as a term, but it is imprecise and even meaningless. Patents, Copyrights and Trademarks are very different in nature, so it is suggested the term patent, be used in preference to this.

7) (02:55) There is almost no inventiveness required to obtain a patent. [You can patent something as simple as teaching children about finance by having a word for their pocket money (– this is an example of a current Australian patent)]
Also if you are going to need money to sue over a patent idea being used unlawfully.
(3:07) There are many of patents that may collect in any area where you are working, but are not worth being sued over (they are not “killer” patents). Most research organisations, regardless of the lack of a clear research exemption, work without a patent because they know their scientists don’t start talking to lawyers until they know they have product. For example, Searle’s scientists don’t talk to their patent lawyers until they have products. 
(4:00) The EU investigated pharmaceuticals and found there could be thousands of patents on a single molecule! (which underscores the lack of creativity and thus ease required to obtain a patent) When you are getting success, that is a time to talk to your university’s patent lawyer about how to patent, because you can take out a patent and then you can open licence it and because you own the patent you can then make it consistent with the goals of open source discovery, but still satisfy the need of venture capitalists. 

8)(4:39) It is often claimed that venture capitalists won’t fund you until you if you don’t have patents.
The academic research is unclear on this – some say that venture capitalists won’t fund you unless you have a patent, but there is also evidence that some venture capitalists just look at the discovery irrespective of whether a patent exists.

9) (5:13) Copyright is important – how you share the data in the first instance and then as research progresses, use the university experts. The patent lens is very useful, but the problem is that most patents are written in such a way that they are extremely difficult to access and are written in deliberately secretive terms by patent lawyers, is because there is a deliberate omission of words of important words so that other people cannot find out what they are doing.
[E.g., when Australia won the America’s Cup was patented in the Netherlands, lots of speculation about the design of the keel but no-one found the keel drawing until the after race had been won.]

10) (6:39) Take an active interest in your uni’s so-called “IP policy” that each clause specifies exactly which should specify what kind of monopoly being referred to– i.e., is it a patent monopoly, is a copyright monopoly, or do they want to have the unwritten ideas in your own mind included, because all of these are included in universities’ policies.

11) Consider saving some of your time to boycott of Elsevier – the Dutch publishing company have funded two U.S. Congresspersons to sponsor the Research Works Act, which was tabled just before Christmas 2011). The intent of this Act is to make it illegal for taxpayer funding bodies such as the National Institute of Health (NIH) in the U.S., to require those that receive their grants to make their data free to the public. This protest can be done in many ways – there is a Weblink, refuse to referee articles or submit to their journals, etc.
[link on this has been sent to Paul Willis].

12) (8:05) There are challenges in this research environment, but as this area relates to Malaria, we should consider asking Bill Gates (- whose wealth is in part due to his father being an I.P. lawyer and thus educating this son about the importance of patents and copyright) to ask for whether we can appeal under the Orphan Drug Act for Neglected Diseases (An orphan drug is a pharmaceutical that has been developed especially to treat a rare medical condition, the condition itself is called an orphan disease). 
(see here for further information)

13) (8:39)The essence of this Act is that it bypasses the whole patents and copyright process. It allows the drug approval body in your country to provide for the final product, a guaranteed period of exclusivity in the drug market whereby you cannot have your drug challenged, (which is unlike a patent, because the patent gives you a licence (right) to sue. The Act gives you a licence to sell and prevents anyone competing with you for that specific approved product in the marketplace.
This would provide an incentive for people to fund the clinical trials (end of the drug development process) – some public money is going into areas like Malarial Funding. 

14) (9:19) As Richard (previous speaker) said, a patent is a licence to sue. The Orphan Drug Act gives you a right to sell and it prevents anybody else competing with you for that specific drug approved product in the marketplace. Helen suggests that if this Act could be globally applied in the marketplace in markets (to cover the countries which in which malaria are prevalent). If we could get this system in place in these countries, this would provide an incentive for funding of expensive Phase 3 Clinical Trial that eat a very large amount of money (see Mary O’Kane's talk) Thus, some public money is going in.

Some public money is going in, but in areas like malarial research, where there is a tendency for people to think it should be publicly funded.

When a proprietary company does clinical trials, there is an incentive for the company to suppress erroneous data and to protect public health. This mass regulatory state is thus in the public interest to protect public health and to make sure the drug or therapy is safe and effective and this is the argument this research should be publicly funded and not privately funded.

15) Question for Hazel:-

Q. What qualifies as being patent protected? For example, compilation of Data – does there have to be a minimum condition of originality “sweat of the brow” doctrine, compared to compilation of data and metadata to it.

(12:20) Answer by ? : There is variation from country to country, but the High Court said you can’t have patent protection for something you generate yourself. However, depending on the way you present that data, you may be able to get some form of copyright protection, but certainly not for data in its raw state.

16) (13:35) There are (unfortunately) other ways to protect data, e.g., in the pharmaceutical industry regulator framework there are data exclusivity provisions, which apply which apply regardless of ? copyright and regardless of ? and which protects the data for five years in Australia and up to ten years in Europe (five years in U.S. but it varies). There is a significant push to extend out the period of data exclusivity period, but it depends on the data and what the data is being used for.

In Europe – more stringent?

Hazel’s understanding is there is no creativity requirement in relation to the “how much sweat” issue, but that the latter would be more important in the initial stages.

17) Matt relayed two questions often asked by people in relation to Open Source Drug Discovery:-

Q1) Why would we need to take out a patent? 
Q2) If you release all of your data, what is to stop a company taking the data and patenting it and restricting your access to this?

A1): The patents are an extremely nasty form of monopoly business model. It gives you the right to stop other people from using exactly the same invention you have come up with, irrespective of whether you have invented independently or not. This is not compulsory and you don’t have to use the patent in this way. It is possible to have a patent, publish it on the web and tell everyone is welcome to use it or more quietly announce that say this available on a common licence and ask for a token contribution to look at it.

A2): Chat to I.P Australia. Draw this work to the attention of I.P. Australia actively – the core of examiners.

They will charge of $1,300 to oppose someone else’s patent, which is much more expensive than applying for the patent in the first place. Approach the Commissioner of Patents in Australia, and inform them of the website, in writing and also go to see them personally. Also have a look at other key countries if the same access is available and the same approach can be taken with access. 

In theory, something in the public arena cannot be patented, technically.

(19.12) end.
15th August 2013 @ 01:18

An Open Source Drug Discovery for Malaria meeting was held at The University of Sydney on February 24th 2012.

Richard Jefferson from Cambia and the Institution of Open Innovation gave the fourth talk of the day, which can be found on YouTube here:

http://www.youtube.com/watch?v=UNNp3t1c1Js

Transcript:

http://www.thesynapticleap.org/node/406

15th August 2013 @ 01:16

An Open Source Drug Discovery for Malaria meeting was held at The University of Sydney on February 24th 2012.

Luigi Palombi from ANU gave the third talk of the day, which can be found on YouTube here:

http://www.youtube.com/watch?v=5IFfLHjh5P4

Transcript:

15th August 2013 @ 01:13

An Open Source Drug Discovery for Malaria meeting was held at The University of Sydney on February 24th 2012.

Mary Moran from Policy Cures gave the second talk of the day, which can be found on YouTube here:

http://www.youtube.com/watch?v=6C_oVmpg11M

Transcript: