Could you patent the sun?

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12 April 1955 history was made when the National Foundation for Infantile Paralysis announced: “The vaccine works. It is safe, effective and potent”.

This announcement came as a welcome relief to millions of American parents after a nationwide trial using an experimental polio vaccine was conducted.  More than 1.8 million children were signed up by frantic parents to be part of the trial. Kids were injected with either the vaccine or a placebo. It was a double blind study, neither the child nor the caregiver knew who was receiving the vaccine or a placebo. A nationwide trial of an experimental vaccine using school children as virtual guinea pigs would be unthinkable today.

A polio-survivor said it shows how much people feared polio that mothers and fathers were willing to accept the word of researchers that the vaccine was safe.

One year after the trial started, the National Foundation announced that the Salk vaccine proved 80 to 90 percent effective in preventing polio. In 1961 the rate of polio had dropped by 96% in the United States.

In an interview Edward R. Murrow asked Salk who owned the patent to the polio vaccine. Salk replied “Well, the people, I would say. There is no patent. Could you patent the sun?” Over the last half-century, Salk’s rhetorical question has become the cry for those who rally against pharmaceutical patents.

Dr Salk might have believed that personal gain is secondary to helping mankind and meant every word. He did, however, not mention that the National Foundation for Infantile Paralysis looked into patenting the Salk vaccine and concluded that it could not be patented because the vaccine did not meet the novelty requirements and would not be considered a patentable invention by the standards of the day.

This raises the interesting question of the distinction between a discovery, which is not patentable, and an invention. Should a vaccine be considered a natural occurring substance i.e. a discovery, or a product of human innovation and engineering i.e. an invention?

A vaccine contains live or dead cells from a pathogen itself, or genetically modified versions of the virus or bacteria. When considering that the flu vaccine has to be made anew every year and involves months of work by highly trained scientists, it would be considered a stretch to say vaccines are naturally occurring.

The US Supreme Court in 1980 made a clear distinction between a discovery and an invention. Products of nature, like the sun, are not patentable; however isolating and purifying a product of nature may render it patentable if it fullfils all the other requirements for patentability. Despite the Supreme Court not specifically addressing the patentability of vaccines, thousands of patents relating to vaccines have been issued in the United States.

Even though the decision not to apply for a patent for the polio vaccine was a purely academic one, it might be said that morally it was the right one. The vaccine trial was made possible by volunteers. No money was received from federal grants or pharmaceutical companies. The trial was financed by donations made to the National Foundation for Infantile Paralysis. David Oshinsky wrote: “It’s the incredible organisation involved, with tens of thousands of mothers and families coming together to save their children. And it was all done privately.

It could therefore be said that Salk was correct in saying that the “patent” belongs to the people.

MRF
info@rademeyer.co.za

(App)ropriate  Protection

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VARIOUS WAYS TO PROTECT YOUR MOBILE PHONE APPLICATION

Mobile phone applications have become increasingly popular, and given the reliance that people place on their smart phones – for good reason. As a result, savvy entrepreneurs are increasingly looking towards ways of protecting their new smart phone applications in order to secure their place in the market.

A smart phone application is essentially application software which is developed to run off a handheld device. Traditionally, software has found protection by way of copyright. In South Africa, copyright protection arises automatically and protects the source code, the screen layout as well as any characters or animation forming part of the software. While this form of protection can be used to ensure that someone does not copy the exact same application in terms of how it looks, it does not prevent someone from independently producing a version of the application. Given these shortfalls, it is often desirable to protect the underlying principle involved in the operation of the application. In this respect, it is worthwhile considering patent protection.

The issue of patenting software and mobile applications is a contentious one in South Africa.  South African patent law is governed by the South African Patent Act and, in terms of the Act, a program for a computer, as such, is specifically excluded from patentability. However, foreign jurisdictions whose legislation is largely similar to ours in terms of patentability requirements can be looked to for guidelines in this regard. The current trend in the UK is to grant software patent applications, with the proviso that the program must produce a technical result which goes beyond the normal effect that a computer program has, when run on a computer. Similarly, in Europe, computer implemented inventions have been allowed. The European Patent Office has held that if a computer program has a technical character, then it is not excluded from patentability. Patents for software have been granted in many fields where the software provides some kind of a technical contribution including in medical devices, industrial processes, communication/media technology such as voice recognition, and video compression.

Guided by these principles, mobile applications are not necessarily excluded from patentability. In particular, the method involved in the implementation of the application and how it interacts with various hardware components is not excluded, provided the application produces some kind of a technical result. Otherwise put, the underlying method may be inventive, and the use of software to implement the method, will not preclude valid patent protection.

In South Africa, the Patent Office does not examine a patent application on the merits. So, provided your application complies with the necessary formalities, the patent will be granted. However, grant does not necessarily mean that the patent is valid. The validity will only be determined when a third party challenges the validity, which will ultimately be decided by the court. To date, the South African courts have not yet made a ruling on this issue. Therefore, whether a particular mobile phone application is patentable is largely determined on a case by case basis. It is however, always advisable to file a provisional patent application at least as a preliminary form of protection in order to ensure that you do not miss your chance to do so at a later stage.

Furthermore, filing a provisional patent in South Africa may be a cost effective solution to obtaining patent protection in foreign jurisdictions where patents directed towards software and mobile applications are allowed e.g. the US, UK and EU. Comparatively, filing a provisional patent in South Africa is cheaper than one filed in a foreign jurisdiction. It also provides you with a 12 month period in order to assess the market so that when the time comes to file in foreign jurisdictions you would have had time to do your research and can file only where it will be commercially viable.

There are several other forms of protection to consider either in conjunction with, or as an alternative to patents. Trade mark protection can be a valuable tool in terms of marketing your product. The name, logo or slogan of your brand associated with the mobile application can be protected. Contractual agreements are also of value in terms of software or mobile phone applications. In particular, confidentiality agreements and licence agreements should be considered.

There are various forms of protection available to someone who has developed software or a mobile phone application. It is advisable to consider all forms of protection and to choose the ones which make commercial sense for your particular product.

Hillary Brennan – Practitioner
hillary@mrf.co.za

Monty Rademeyer – Partner
monty@mrf.co.za

iPolicy

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AN OVERVIEW OF THE DRAFT NATIONAL IP POLICY

The Draft National Policy on Intellectual Property was released for public comment in September 2013. The policy aims to co-ordinate and streamline intellectual property legislation in South Africa. Some of the objectives of the policy include “to improve access to IP- based essential goods and services, particularly education, health and food” and to “introduce a public health perspective into the IP laws”. These objectives and the strong focus on health were largely as a result of years of campaigning by organisations like Medicines Sans Frontiers (MSF) and the Treatment Action Campaign (TAC) for cheaper medicines, the price of which these organisations believe are inflated by patents and protection offered thereunder.

While the policy covers a wide range of issues, it is unfortunately not always clear and somewhat ambiguous – an aspect which has received much criticism.

Not much is said about Registered Designs and Trade Marks in the policy apart from the suggestion that ambush marketing legislation, which was used during the 2010 Soccer World Cup, should be extended to cover all large sporting events.

Copyright was afforded a little more attention. The policy recommended against extending the terms of protection beyond 50 years, choosing not to follow many other developed countries. It also suggests that royalty administration and collection should be centralised in one state-run collecting society. Reference is also made to allowing reverse engineering of software, the objective of which is to allow for software to be adapted for local needs of creating “broad exemptions for education, research and library use” as well as fair rights use for internet users.

Patents received the most attention with a strong focus on the patent prosecution system in South Africa. The current system is a deposit based system in which patent applications are only examined as to their formalities. If the application complies with the formalities, the application can proceed to grant. A drawback of such is a system is that more “weak” patents are granted, which could prevent people from doing acts, which, without the existence of the patent, they should be entitled to do. Such patents can only be removed from the register through lengthy and costly revocation proceedings where the merits of the patent are then assessed and decided by the court.

The policy recommends that an examination system be implemented, where patent applications are examined as to their merits. An examination on the merits requires an investigation into whether the invention is novel and inventive. It is believed that this will reduce the amount on “weak” patents that are granted each year. The policy also recommends the adoption of a pre- and post-grant opposition procedure. This will allow all interested parties to challenge patents without having to engage in expensive litigation. The policy does, however, acknowledge that the adoption of an examination system would require a vast array of skilled persons and that South Africa may not have the capacity to implement such a system. The policy suggests the use of the resources and staff of universities and research institutions in the examination process.

The recommendation of an examination system was heralded by activist groups such as the TAC and MSF, who lobbied for the adoption and implementation of a patent examination system for all pharmaceutical patent applications as well as for the strengthening of patent requirements to prevent “evergreening”. Evergreening refers to making small changes to an existing drug which is about to reach the end of its term for patent protection, in order to gain a new patent. The policy addresses these concerns through the recommendation of an examination system. This, it is believed, will result in “stronger” patents being granted, as they have undergone examination and will lead to less patents being granted in the pharmaceutical industry which may prevent generic medicines from being produced.

While the policy is not always clear, it does set out some objectives which give an indication of where IP may be heading in the future. The policy reads much like a wish list and it will certainly be interesting to see how the laws will be adapted to fulfill these objectives.

Hillary Brennan – Practitioner
hillary@mrf.co.za

Pa(per)tent Pitfalls

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Pitfalls of paper anticipation in South African patent law 

When attempting to patent an invention in South Africa, two main requirements must be met, the invention must be both novel and inventive. These two requirements are universal, albeit defined differently in different jurisdictions.

When the validity of a patent is being tested, the above two requirements are formed into questions, i.e. 1. is the invention novel? And 2, provided the answer to 1 is a yes, then is that invention inventive?

The second question, inventiveness, is subjective, and is generally determined as to whether the invention is as a result of a logical step in the development or advancement within a particular industry. Stated another way: “could a person skilled in the art easily have taken that step?” If the invention is obvious to a person skilled in the art, the invention will not sustain a valid patent. Both questions must be answered in the affirmative to obtain a valid patent.

However, despite this, the Australia Federal Court of Appeal decided that a valid patent would be sustained in the absence of novelty when it dealt with this exact question in 2011 in Albany Molecular Research Inc v Alphapharm Pty Ltd (2011) FCA 120.

The case deals with chemical molecules and involves regioisomers, which are a type of isomer. Isomers are groups of chemical compounds that have exactly the same chemical formula, but different geometric structures.

Relevantly, it is often the case that a synthesis reaction intended to produce a particular compound which exists in the form of different isomers will necessarily result in a mixture of the different isomers, not all of which will be useful or desirable.

Therefore the question put to the court was as follows;

Albany Molecular Research Inc (‘AMR’) is the patentee of Australian patent no. 699799, which essentially claims fexofenadine compounds, and more particularly one specific pharmaceutically-effective regioisomer of those compounds.  Alphapharm Pty Ltd, (the respondents), manufacture and sell generic pharmaceutical products in which the active ingredient is fexofenadine hydrochloride.  It was not disputed that if the claims of AMR’s patent were valid, then the respondents’ products would infringe.

The AMR patent specification discloses, and claims, methods to prepare the desired fexofenadine regioisomer in a substantially pure form.

The claims to the methods were not in dispute, but the patent also includes claims directed to the resulting substantially pure compounds themselves (‘compound claims’).

The ultimate question in the case was whether a claim to a compound can be deemed valid when the compound is theorised in the prior art, but not known to exist, or have been produced, in an isolated form?

The court found that the claims, while not being novel, were indeed inventive, which resulted in the patent being deemed valid.

The reason for the apparent loop hole is the anticipation concept, stated differently the disclosure of a concept or the presence of an idea or the explanation of a theory.

The existence of the particular isomer had previously only been a theory. The laws of chemistry state that if a particular isomer has a central carbon atom connected to four different molecules, there will be a non-superposable mirror image, and hence each compound is therefore designated as either the L-isomer or the R-isomer. Whether any person had ever been able to isolate or recover or physically create a particular R or L isomer is irrelevant, the theory states that if one exists, so should the other.

What it all means, is that the novelty is anticipated by a theory, based on the relevant laws. The novelty is not destroyed by the actual physical presence of the isomer, it is destroyed by its theorised existence, the ‘paper anticipation’. A ‘paper anticipation’ of this nature will affect the drafting of specifications for patents of the molecular kind. More specifically, a ‘patent application’ of this nature should highlight the distinction that it is not the product to which a claim is made, but the method to obtain that product.

It is yet to be seen whether the decision of the full bench appeal in the Australian courts will be supported elsewhere. What may be said however is that a patent application dealing with chemistry, molecules, microbes, bio-molecules or the like, should identify where the novelty actually lies in the invention and what may or may not be claimed.

Monty Rademeyer – Partner
monty@rademeyer.co.za 

Patenting (Human) Genes

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The Monopoly on Genetic Human Genes

The US Supreme Court recently decided this very issue in the case of Association for Molecular Pathology, et al v Myriad Genetics, Inc.

Myriad Genetics (“Myriad”) carries out tests for BRCA genes, the genes responsible for diagnosing an elevated risk of breast and ovarian cancer. Patients can undergo genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Woman with the faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer. This form of testing recently made news headlines when Angelina Jolie revealed that she underwent a double mastectomy after one of the BRCA genes was identified in her body.

Myriad obtained patent protection for the two human genes known as BRCA1 and BRCA2 which correlate with this increased risk, along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes.

These patents granted Myriad the right to control access to the BRCA genes and prohibited others from researching or doing diagnostic testing of the genes.

In their patents, Myriad claimed protection for every naturally-occurring version of those genes, including mutations, on the basis that they had invented something by isolating the genes from the body. The Association of Molecular Pathology (“AMP”) representing a variety of genetic researchers, medical organizations and patients, all of whom had been accused of infringing on Myriad’s patents on the BRCA genes, contended that human genes were not patentable on the basis that they are a product of nature. Patent protection cannot be obtained for products of nature by virtue of Section 101 of the United States Code and AMP alleged that the mere fact that the genes were isolated from the body did not mean that it was patentable.

The Supreme Court agreed with AMP and held that the BRCA1 and BRCA2 genes were naturally occurring and were therefore not patentable. However, it was held that the synthetically created genetic material, or cDNA, was patentable.

The decision has had mixed reviews. While the decision comes as a relief to geneticists who can now make use of the BRCA genes, companies involved in biotechnology research might find it to be a financial blow by limiting commercial incentives to continue researching into DNA.

In the wake of this decision, companies and universities announced that they will provide the tests for the BRCA genes. Myriad last week sued two such companies, Ambry Genetics and Gene by Gene, claiming that the tests infringed other patents owed by Myriad which had not been invalidated by the court.

The outcome of this on-going litigation will help to shape the biotechnology research industry and the way in which companies approach the protection of the fruits of their research and development.

Hillary Brennan – Candidate Practitioner
hillary@mrf.co.za