“Today in Pharm. Resources, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2007), (Moore, J.), in her first important pharmaceutical opinion, the newest member of the court authored an affirmance of a summary judgment of invalidity under 35 USC § 112, ¶ 1, against a claim to “[a]n oral pharmaceutical composition in the form of a stable flocculated suspension in water comprising: (a) megesterol acetate; (b) at least two compounds selected from the group consisting polyethylene glycol, propylene glycol, glycerol, and sorbitol; and (c) a surfactant.”
Citing Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1380 (Fed. Cir. 2007), the court said that the patentee “sought extremely broad claims in a field of art that it acknowledged was highly unpredictable, therefore, [the patentee] has set a high burden that its patent disclosure must be to satisfy the requisite quid pro quo of patent enablement.”
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The judgment is a very lucid one–and more importantly, is very concise and to the point –rare for a US patent judgment. Perhaps our Madras HC judges (who wrote a good 40 pages in the Novartis patent case without much lucidity or analysis) could learn a lesson or two!!.
For those interested in this decision, please see here. Also, Patently O has posted the following summary of the case:
“Par’s megestrol acetate suspension is prescribed to people who lose their appetites — often during treatment for cancer or AIDS. Interestingly, the company created this popular drug while attempting to design around a megestrol patent owned by BMS.
After obtaining patent protection, Par sued Roxane for infringement. The district court, however, granted summary judgment of invalidity under 35 USC 112 ¶ 1 — finding that “Par is not entitled to the broad claims it asserts.”
Enablement analysis begins with the presumptions that an issued claim is enabled and that a challenge to enablement requires clear and convincing evidence. Unlike its close analog written description, enablement is reviewed by the CAFC on a de novo basis.
A claim is enabled when a PHOSITA can make and use the claim without undue experimentation. Broader claims, of course, require broader disclosure to ensure that their “full scope” is enabled. The unpredictable nature of an area of technology often serves patentees well as they argue non-obviousness. (It cannot be obvious if the results could not have been predicted). However, the enablement requirement demands more disclosure for unpredictable arts.
Broad Claims: Here, Par’s claim includes the following elements: “(a) megestrol acetate; … and (c) a surfactant.” The CAFC finds this claim very broad because it would “allow the choice of any surfactant in any concentration.” (emphasis in original). In its disclosure, Par described three working examples and only one new surfactant. As a matter of law, the CAFC found that “these three working examples do not provide an enabling disclosure commensurate with the entire scope of the claims.”
So how is this relevant for our pending Novartis patent case? Those that have looked at the facts carefully will notice that there is a an enablement issue here. Novartis’s invention consists of the following steps:
i) Synthesizing the Imatinib free base, a compound that was patented in the US, EU and several other countries. However, this could not be patented in India, owing to the fact that in 1993, India did not provide product patents for pharmaceutical substances.
ii) The conversion of the free base to a salt form — imatinib mesylate by adding methanesulfonic acid.
iii) The obtaining of the beta crystalline form of imatinib mesylate, a polymorphic form that is allegedly the most stable form of the salt. A patent application was filed for this and it is this application that is the subject matter of dispute in India
iv) The making of Glivec, a drug that is based upon the above beta crystalline form of imatinib mesylate.
Novartis claims that Glivec (beta crystalline form of imatinib mesylate) is more effective than the Imatinib free base, since it displays better bio-availability properties i.e. it is absorbed more easily into the blood.
Novartis claims all acceptable pharmaceutical salt forms in its main 1993 patent (step (i) above). This would ordinarily include Imatinib Mesylate as well. The question however is: does the 1993 patent “enable” the making of imatinib mesylate? (step (ii) above). I personally think it does–but am happy to be corrected. If it does not, then imatinib mesylate cannot form part of the claims. It also cannot taken to be a “known” substance. Section 3(d) requires that the new form demonstrate increased efficacy over the “known” substance. If Imatinib Mesylate is not a “known” substance, then the comparison under section 3(d) cannot be with Imatinib Mesylate. And to this extent, the case against Novartis on section 3(d) becomes a weak one.
However, as I said earlier, I personally think the patent enables the making of Imatinib Mesylate and the case on section 3(d) therefore still remains a strong one. Would be interested to hear what readers think.