Generics (UK) Ltd. (Mylan) filed an action to try to invalidate a Supplementary Protection Certificate (“SPC”) for a drug for the treatment of Alzheimer’s disease called rivastigmine.  An SPC extends the life of a granted “basic patent” in certain circumstances beyond the date on which the patent would otherwise come to the end of its statutory term. Novartis markets rivastigmine under the trade name Exelon.

Rivastigmine is the name for the (-)-enantiomer of N-ethyl-3-[(1- dimethylamino)ethyl]-N-methylphenyl–carbamate. Earlier, scientists at the Hebrew University of Jerusalem, made and tested the unresolved racemic compound (RA7).  A racemate is an equimolar mixture of a pair of enantiomers.  RA7 was one of a number of compounds proposed for the treatment of AD, but the publications made no mention of resolving it into its individual enantiomers.

The sole question in this action is whether a relevantly skilled pharmaceutical development team would find it obvious in the light of the RA7 publications to resolve the racemic mixture of RA7 into its individual enantiomers.

Stereo-isomers or enantiomers have identical physical and chemical properties in every respect, except two. They differ in their optical properties (the direction in which they rotate the plane of polarised light) and they react at different rates with other chiral compounds. Since living systems contain chiral proteins and constitute a chiral environment, the chirality of compounds administered to humans is important in therapy.

Whether to resolve?

The Court dealt witht he question of whether or not one skilled in the art would have resolved the enantiomers from the racemic mixture.

Firstly, it was common ground that the skilled team would consider the question of resolution in relation to its lead compound or compounds taken forward for development. It could scarcely have been otherwise given the fact that, of the chiral medicinal compounds introduced in 1984 and 1985 (excluding semi-synthetic compounds where nature had produced an enantiomerically pure starting point) about 50% were racemates.

Secondly, it was common ground that the actual resolution of RA7 did not involve any problematic chemistry. RA7 is easily resolved into rivastigmine using a standard stereochemical resolving agent. Novartis did not seek to make anything out of the practical chemistry involved. They contended that the skilled team would be aware that resolution could, in some cases, represent a difficult task, and that this would make the skilled team reluctant even to attempt a simple resolution. Although I accept that questions may arise as to the extent of resources which a skilled team might be prepared to devote to difficult resolution, I am not persuaded that in 1987 the skilled team would be hesitant about seeing whether a chiral compound could be easily resolved.

Novartis argued that the skilled team would see no advantage in the present case in an improvement in potency.  However, the Court thought differently:

I am unable to accept that the skilled team would fail to see practical benefits in resolution. Firstly, there is the question of the metabolism of the compound. Whilst the very process of blocking the active site on the AChE results in a breakdown of the drug molecule, this is not the only metabolic process to which the drug might be subjected. Those drug molecules which do not interact with the target enzyme could be broken down by other enzymes, for example pseudo-cholinesterase, in a stereospecific way. Dr Newton was clear that metabolism was an area where there might (not would) be a stereochemical effect between enantiomers. Secondly, the skilled team would be aware that the process of penetration of the blood brain barrier could be stereo-selective. Thirdly, delivering a drug as a resolved enantiomer avoids the possibility of unknown, stereo-specific side effects emerging downstream.

Ultimately, the Court decided that the enantiomer was obvious in light of the racemic mixture:

I think the correct analysis is that a pharmaceutical composition for treatment of AD comprising rivastigmine was conceptually obvious in the light of Weinstock and would immediately occur to the skilled team. The team would consider that resolving RA7 would be a worthwhile step to take for good technical reasons. The team would find that the chemistry involved is trivial. Applying the principles outlined above I have no doubt that the inventive concept is obvious in the light of Weinstock.

I believe that conclusion to be consistent with the “problem and solution approach” employed by the Boards of Appeal. The objective technical effect demonstrated by the patent in comparison with the Weinstock prior art is simply that which one would expect from resolution of a chiral compound. The skilled person would know how to solve the problem of achieving those effects by an application of the common general knowledge about chiral compounds.

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The agreement is meant to fight against the infringement of intellectual property rights (IPR), in particular the proliferation of counterfeiting and piracy on a global scale, providing a mechanism for the parties to work together in a more collaborative manner to achieve the common goal of effective IPR enforcement.

It includes provisions on civil, criminal, border and digital environment enforcement measures, robust cooperation mechanisms among the ACTA parties to assist in their enforcement efforts, and the establishment of best practices for effective IPR enforcement.

With respect to the legal framework, the ACTA establishes a strengthened standard that builds on the minimum standards of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is said that this marks a considerable improvement in international trade norms for effectively combating the current global proliferation of commercial-scale counterfeiting and piracy.

Representatives of eight governments – Australia, Canada, Japan, South Korea, Morocco, New Zealand, Singapore and the US – signed the agreement. Representatives of the European Union, Mexico and Switzerland attended the ceremony and confirmed their continuing strong support for for the agreement but said they’d sign some other day.

Formal ACTA negotiations started in June 2008, with the final round of negotiations being held in Japan in October 2010. Following translation and technical work, the ACTA was opened for signature on May 1, 2011.

The U.S. Chamber of Commerce’s Global Intellectual Property Center (GIPC) applauded the conclusion of the Anti-Counterfeiting Trade Agreement in a press release:

“The signing of the ACTA is a big victory for the American business community, workers, and IP-intensive sectors across our economy,” said Mark Elliot, executive vice president of the GIPC. “This accord raises the bar on enforcement by improving cooperation among partners, harmonizing how we confront IP theft, addressing IP theft online, and setting a positive example for nations that aspire to have strong IP enforcement regimes. We urge the negotiating countries to move quickly to complete the relevant domestic processes in signing and implementing the agreement to help protect IP jobs and spur economic growth.”

Not everyone thinks the agreement is great, though.  Gigi B. Sohn, president and co-founder of Public Knowledge noted:

“Although the final version of the Agreement was an improvement from earlier versions, we continue to believe that the process by which it was reached was extremely flawed.  ACTA should have been considered a treaty, and subject to public Senate debate and ratification or, in the alternative, debated in an open and transparent international forum such as the World Intellectual Property Organization (WIPO).  Instead, public interest groups and the tech industry had to expend enormous resources to force the process open to permit public views to be presented and considered.”

But, ACTA no longer exports the worst parts of the Digital Millennium Copyright Act — the 1998 law that makes it a crime to unlock a DVD to back it up. Although it has a loosely worded ban on tools used to unlock “digital rights management” technologies, a footnote makes it clear that it is not required for  manufacturers and software developers to ship products with DRM restrictions.

Second, ACTA no longer demands that countries hold Internet providers responsible for copyright infringement committed by their subscribers.

Some aspects of ACTA, however, remain controversial since the agreement does not mention “fair use” anywhere.

Critics say the biggest problem is that the eight signatory  countries don’t include the main offenders in copyright disputes. Most agree that until you get China to sign this document, this probably won’t change much.

You can read the finalized text of ACTA here.

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1. Reducing the Cost of European Patents: The London Agreement
2. London Calling: What the London Agreement Means to You
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Description of the invention

Under the proposed legislation, there will be a requirement that the description must enable the claimed invention to be produced across the full scope of each claim and not merely in relation to one among other embodiments. The enablement requirement will have a similar effect to the corresponding provisions of UK legislation, the European Patent Convention and the Patent Cooperation Treaty.  This requirement will also apply to provisional applications; however there will remain no requirement to describe the best mode in a provisional specification.

Introducing new matter

Under the proposed legislation, whether amendments are allowable will no longer be dependent on claim scope but rather whether the amendment changes the description contained in the specification as filed.  Applicants will not be allowed to add new matter that would go beyond the disclosure contained in the specification at its filing date, except to correct a clerical error or obvious mistake.

Fair Basis

The proposed legislation will replace ‘fair basis’ with the European concept of ‘support’, namely: there must be a basis in the description for each claim; and the scope of the claim must not be broader than is justified by the extent of the description, drawings and contribution to the art.

Usefulness

The proposed legislation will introduce the additional requirement that the invention has a specific, substantial and creditable use. The use will need to be set out in the specification.

Omnibus claims

Under the proposed legislation, omnibus claims will be allowed only where strictly necessary. For example, where a chemical composition can only be described with reference to a spectroscopic profile.

Expanded prior art base

The proposed legislation expands obviousness prior art base by removing the requirement that allows only documents or acts that the skilled person could be reasonably expected to have ascertained, understood and regarded as relevant.  While a skilled person will be deemed to be aware of all publicly available prior art information, such information may still be excluded from obviousness considerations if it can be shown that the skilled person could not have appreciated its relevance.

Expanded common general knowledge

The proposed legislation expands the common general knowledge to include knowledge of the skilled worker as it existed anywhere in the world at the priority date.

Practical implications

With the proposed changes to the prior art base and common general knowledge, it seems reasonable to expect that Australian applicants will find obviousness more challenging. In many cases, however, the Australian Patent Office’s practice of relying on the prosecution of corresponding US/European patent applications may result in there being limited real change in this regard.

Infringement exemption for experimental use

An exemption to Australian patent infringement is proposed where the predominant purpose of the relevant act is to gain new knowledge, or to test a principle or supposition regarding a patented invention. Further, the exemption is to apply irrespective of whether the person undertaking the relevant act had in mind to later commercialize, for example, an improvement arising from the act, or whether that person was aware of the patent at the time the relevant act was undertaken.

According to the proposal, a person may undertake an act that would otherwise be an infringement of a patent claim ‘if the act is done for experimental purposes relating to the subject matter of the invention’.

‘Experimental purposes’ is non-exhaustively defined as including:

• determining the properties of an invention
• determining the scope of a claim relating to the invention
• improving or modifying the invention
• determining the validity of the patent, or of a claim relating to the invention, and
• determining whether the patent for the invention would be, or has been infringed by the doing of an act.

Further, the amendment proposes that the experimental activities be ‘related to’ the subject matter of the invention. The intention here is to achieve two outcomes:

1. that the exemption is to apply to experiments that include the claimed invention, so that the person undertaking the relevant work is not required to conduct patent searches before starting an experiment, and
2. that the exemption is to apply to experimentation on a patented invention, i.e. it does not cover experimentation using a patented invention. Importantly, it does not follow that infringement of a research tool patent is to be exempted merely because of the proposed amendment.

Acts that remain outside the proposed infringement exemption include those where the purpose is commercialization. These include ‘market research’ – testing the likely commercial demand for a product, and manufacture for the purpose of sale or use for commercial purposes.

Today’s post is by Australian patent attorney with Freehills Patent & Trade Mark Attorneys.

Related posts:

1. Patent Office Receives Hate Mail Over Proposed Patent Changes
2. Australian Federal Court: Amend Patent Claims Before Filing Suit
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In hindsight, we had a heavy backlog of pending examination cases, need for transparency in the system, controversies over pharmaceuticals and software patents and a longer list to deliberate upon.

On the other side of the coin, we could use a periscope to notice some of the positive changes that have happened over the last couple of years. A significant one would be the drive to digitalize the patent documents to a respectable extent, because of which patent practitioners worldwide can easily access Indian patent data on a click, instead of waiting for weeks together. Another feather in the cap was the appointment of the IPO as an International Search Authority, for which of course the IPO will have to use all their muscles.

It was also noteworthy to have the IPO initiate the drive to increase the pool of their patent examiners, which will be a significant step in filling the gaps of the years gone behind. The man leading the ship for most of these positive crusades, Mr. Khurian, in a sudden turn of events resigned as the Controller General of Patents, Designs & Trademark, only to keep us all guessing on his decision’s implications.

In light and support of the above comments, closer2patents, an India based patent services firm would like to share, an analysis conducted on the Annual Report (’09-‘10) of the IPO. The analysis aims to summarize the key points and statistics highlighted in the Annual Report, and make a few comparisons with other countries on those lines. The analysis can be accessed at the closer2patents blog.

Comments and questions are always welcome.

Today’s post is by guest barista Abhishek Pandurangi, Founder at closer2patents, B.Tech (Chem), LL.B, Patent Agent-India

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1. Indian Biogenerics on an Upswing
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“Article 229-C – The grant of patents for pharmaceutical products and processes depend on prior consent from the National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária – ANVISA).”

This modification caused several disputes, in the last 10 years, between ANVISA and the Brazilian PTO (INPI), which considered this change as an intervention in its sphere of competence.

Taking into account the absence of definite regulations and, as long as its prior consent was still necessary, ANVISA conducted full patent reexaminations, including the verification of the legal requirements of novelty and inventiveness.

On January 24, 2011, however, the Federal Counsel-General of Brazil (Advocacia-Geral da União – AGU) published a final legal opinion on the matter, which limits the power of ANVISA on the analysis of patent applications in the pharmaceutical sector, putting an end to the conflict with the Brazilian PTO. The Federal Counsel-General is the highest body of assistance of the Executive Power and represents the Federal Government, both judicially and off courts.

According to that final legal opinion, the responsibilities of ANVISA will be limited to the analysis of safety (e.g. the existence of possible health risks) and efficacy of drugs. The fulfillment of legal requirements for patentability will be exclusively verified by the Brazilian PTO. The final opinion of the Federal Counsel-General is not subject to appeal.

The real impact of this final legal opinion is still not clear. In the short term we may hope for a certain reduction of bureaucracy, which could accelerate the patent granting process in the pharmaceutical area.

via Pedro Bhering at Bhering Advogados in Rio de Janeiro – Brazil.

Related posts:

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