[Ip-health] A US court judgment that is relevant to Novartis case

[Jeff Williams]

Joana and all,

  So after reading this closely several times, the only reasonable
conclusion that can be arrived at here is that the USPTO has
demonstrated it cannot effectively recognize, and therefore
evaluate patent applications dealing with many chemical compounds
or "Types" or derivatives thereof.

  If this is a correct evaluation in brief of the United States Court
of Appeals decision below, than it seems that some US drug
companies have been "Gaming" the USPTO, or their legal
staff's do not have a good working knowledge of US patent
law and regulation.  If the former, than possibly RICO actions
would be a good legal route to go against those US drug
companies seeking to thwart generic drug producers via
this form of intimidation of filing felonious patent charges
by these larger and more financially able large US and
international drug companies.

  From my own and many of our members perspective, Pfizer
seemingly acted with malice and forethought in order to force
Apotex either out of business or to intentionally thwart a
generic version of Pfizer's Norvasc from entrance into
the marketplace, and most likely Pfizer was concerned about
Norvasc being able to be price competitive with Apotex
generic version.  As such, we believe that the US Chamber of
Commerce should ask Pfizer, one of the US Chamber of
Commerce's larger financial contributers, to publish in/with
every major media outlet, an appology to the public
forthwith.

Joana Ramos wrote:

> http://www.hindu.com/thehindu/holnus/006200703251901.htm
>
> A US court judgment that is relevant to Novartis case
>
> The Hindu Online
> Business
>
> D Murali
>
> Chennai, March 25: A recent decision of a US court may be relevant for a
> case currently on in Chennai court, says Ms Srividhya Ragavan, Associate
> Professor of Law, University of Oklahoma Law Center, in a mail sent to
> Business Line. "On March 22, the United States Court of Appeals for the
> Federal Circuit, which is the highest court in the US for patent
> appeals, issued a judgment on the same lines as the Indian statute and
> the Chennai Patent office," she explains. Novartis, which has been
> criticised by health activists for challenging Indian patent law in
> Chennai court, is said to be seeking the support of the European
> Parliament's members.
>
> Here's more from Ms Ragavan about the case.
>
> First, the Novartis case, in India.
>
> As many of us are already aware, the Chennai Patent office's refusal to
> award patent protection on Gleevac has been challenged by the drug maker
> in the High Court. The Chennai Patent office rejected an application on
> Gleevac on the grounds that the material sought to be patented by
> Novartis was obvious and hence, unpatentable. An invention has to be
> useful, novel and nonobvious in order to become eligible for patent
> protection. In order to determine whether something is nonobvious, the
> material (sought to be patented) is compared with the existing materials
> in the same field of science. If the application material embodies
> adequate levels of skill when compared with the existing state of
> knowledge, then it can be deemed nonobvious.
>
> What does the Indian law on the subject say?
>
> As far as chemical inventions are concerned, Section 3 (d) of the Indian
> Patent Act deems a mere discovery of a new form of a known substance as
> being obvious and hence, not patentable unless it also results in an
> enhanced efficacy. (What amounts to enhanced efficacy is left to the
> purview of the examiner through patent office guidelines). The statute
> outlines that forms of known compounds like "salts, esters, ethers,
> polymorphs, metabolites, pure form, particle size, isomers, mixtures of
> isomers, complexes, combinations and other derivatives" would be treated
> as the same substance or just as obvious variations. The Indian Patent
> Act deems that if Chemical A is already known, other forms of Chemical A
> like salts, isomers, esters etc., are just considered as different forms
> of Chemical A and not as a new invention.
>
> How is that relevant to the Novartis case?
>
> The Novartis application seems to relate to an isomer of an existing
> compound. That is, the active ingredient in Gleevac was known. Novartis
> felt that it was the first to invent the isomer of that compound. The
> Chennai patent office felt that it is just another form of an already
> known and existing compound and hence, did not qualify as an invention.
> When the atoms of a known compound are arranged differently, we call
> them isomers. Thus, an isomer of Chemical A will have the same chemical
> formula although the atoms are arranged differently. (Different
> structure but same formula). Novartis argues that isomers should be
> considered nonobvious over the existing compound.
>
> Now, the US case. What was it about?
>
> Pfizer, a huge pharmaceutical giant filed a suit against Apotex, a
> generic drug maker for infringing its patent on Norvasc. Norvasc is used
> to treat hypertension and some forms of angina. The active ingredient in
> the drug Norvasc is amlodipine but the ingredient is tinkered with and
> made into acid addition salt form. Thus, Norvasc is a besylate form of
> amlodipine (amlodipine besylate). Besylates are anacid addition salt
> forms of the original chemical. That is, if we assume that Chemical A is
> the original compound, Besylate of Chemical A is the salt form of
> Chemical A. In this case, amlodipine besylates is an acid addition salt
> form of amlodipine. Pfizer acquired a patent bearing number 4,879,303
> over amlodipine besylate in 1989.
>
> What was the contention of Apotex?
>
> When Pfizer sued for infringement, Apotex alleged that Pfizer's patent
> is invalid because the invention was obvious from Pfizer's own previous
> patent on amlodipine. Apotex pointed out that Pfizer was the patent
> owner over amlodipine (US Patent No. 4,572,909) which was issued in
> 1986. Amlodipine besylates, Apotex argued, are just the salt form of
> amlodipine and hence, are just obvious improvements.
>
> What was the decision?
>
> The Federal Circuit agreed with Apotex and held that amlodipine
> besylates was prima facie obvious over amlodipine. It is notable that
> there was no significant or enhanced utility in the besylate form. The
> Federal Circuit ruling merely reiterates an established principle that
> salts of known compounds are deemed to be obvious unless there is an
> unexpected utility or improvement or efficacy.
>
> On the verdict's relevance to India
>
> The principle reiterated by the Federal Circuit is what is already
> present in the Indian statute. Section 3(d) also states the same
> principle - salts, isomers, esters are not inventions but mere different
> forms of the same substance. In rare instances, they may be considered
> as inventions if they have an enhanced utility. The burden to prove and
> convince an examiner that there is an enhanced utility was clearly on
> Novartis. And, Novartis failed. Having failed its burden, Novartis lacks
> sufficient grounds to argue that the Indian statute should be amended.
> If at all, the US Federal Circuit judgment indirectly supports and
> affirms the Chennai patent office decision.
>
> --
> Joana Ramos, MSW
> Cancer Resources & Advocacy
> 7303 23rd Ave. NE
> Seattle, WA  98115
> 206-229-2420
> http://ramoslink.info/
>
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> Ip-health@lists.essential.org
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Regards,

--
Jeffrey A. Williams
Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!)
"Obedience of the law is the greatest freedom" -
   Abraham Lincoln

"Credit should go with the performance of duty and not with what is
very often the accident of glory" - Theodore Roosevelt

"If the probability be called P; the injury, L; and the burden, B;
liability depends upon whether B is less than L multiplied by
P: i.e., whether B is less than PL."
United States v. Carroll Towing  (159 F.2d 169 [2d Cir. 1947]
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