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Declaratory Judgment Action
A declaratory judgment (DJ) action may typically be brought by a potential patent infringer to seek a judicial declaration that a patent is invalid, not infringed or unenforceable. Historically, a DJ may only be brought if there is a reasonable apprehension of a patent infringement suit. Under prior Federal Circuit precedent, a licensee would have to first breach a patent license before bringing a DJ action against the licensor. Without such a breach, the Federal Circuit had concluded that there was simply no actual case or controversy. On January 9, 2007, the Supreme Court issued its decision in MedImmune, Inc. v. Genentech, Inc., holding that a patent licensee (MedImmune in this case) can challenge the validity, enforceability or noninfringement of a licensor's (in this case Genentech) patent in a declaratory judgment action even if the licensee is still paying royalties (although under protest) and otherwise complying with the license agreement. Previously, a licensee who wished to challenge the validity of a licensed patent had to first cease paying royalties. In doing so, the licensee risked treble damages, attorney's fees or injunctions, should the patent subsequently be found valid and infringed. Thus, the licensee was required to choose between continuing to license a patent of questionable validity, or cease payments and sue, risking enhanced damages if the patent was subsequently found valid. In an 8-to-1 decision, the Supreme Court partly resolved this dilemma, ruling that a licensee could, in fact, sue to challenge the validity of the underlying patent while still paying royalties to the patent owner.
Make Medicine For You
Molecule of Diabetes
Forces against Diabetes
What is a medicinal product? It is always the result
of a subtle marriage between a compound (the active substance which treats
a patient) and an appropriate excipient (a neutral substance in which the
active substance is incorporated so that it can be absorbed by the body).
Thus the necessary tablet, capsule or syrup is obtained. But what would happen
if biodegradable materials were used instead of these neutral excipients?
This was already possible with some active substances, and can now be applied
to many others! The team led by Didier Bourissou in the Laboratory for Fundamental
and Applied Heterochemistry (CNRS/University Toulouse 3), has indeed managed
to develop a novel synthetic process for these materials which significantly
increases their diversity.
What are the principles underlying these "new generation" drugs? The biodegradable excipient containing the active substance can take the form of an implant – a 1 cm-long rod about one millimetre in diameter – which is inserted just under the skin. This procedure is performed by a doctor and only takes a few minutes. The specificity of these polyesters is that they can be hydrolyzed; in other words, broken down by water, which is unlucky for them, as our bodies are full of this substance. Thus the excipient gradually breaks down, over a week, a month or three months, depending on its type, releasing the active substance it contains. Hence the major advantage of the technique: biodegradable excipients enable the controlled administration of sustained-release drugs. This is of considerable benefit in the setting of chronic diseases, as it avoids frequent, repeated intakes of medicines. Another positive point is that this method reduces side effects; by circumventing the digestive tract, the active substance passes directly into the bloodstream. Thus it is also possible to reduce the quantity of drug administered, as there is no longer any need to allow for its partial destruction as it passes through the digestive tract.
In view of these advantages, why can the technique not be extended to a broader range of active substances? Because, until now, we only knew how to make these biodegradable polymers using two monomers (the basic components of polymers), lactide and glycolide. It is rather like making a bead necklace when only green and red beads are available. And in the same way that such a two-coloured necklace would not match all outfits, so the polyesters obtained cannot be combined with just any active substance. Without accounting for the fact that when using these little reactive lactide and glycolide monomers, industrial preparation of the polymers requires lengthy reaction times at high temperatures (e.g. several hours at 140°C-160°C).
This is where Didier Bourissou's team same up with the
idea of changing the recipe and ingredients in order to facilitate access
to these polyesters and increase their diversity. Many tests later, they achieved
their goal. In collaboration with Isochem, they have developed a new synthetic
process for these polymers. This involves new elementary building blocks,
the O-carboxy anhydrides, which are much more reactive (i.e. more beads for
our necklace), so that the polyesters can be prepared under much less harsh
laboratory conditions (e.g. a few minutes at 25°C). And above all, a
much wider variety of polymers is available, thus multiplying the chances
that an active substance will find its appropriate biodegradable excipient.
These promising results have given rise to the filing of two patents.
Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, womenfitness.net etc.
Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances.
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