Tyco v. Mutual Pharmaceutical: Obviousness of a Pharmaceutical Formulation

By Jason Rantanen

Tyco Healthcare Group LP v. Mutual Pharmaceutical Company, Inc. (Fed. Cir. 2011) Download 10-1513
Panel: Newman, Bryson (author), Gajarsa

Pharmaceutical formulation patents often make for challenging obviousness determinations, as the difficulty of reducing a new formulation to practice is balanced against the prior art, which typically includes the relevant pharmaceutical compound itself.  The formulation in this case, however, raised few such concerns for the Federal Circuit.

A pharmaceutical formulation is a particular form, such as a tablet or suspension, into which a chemical compound (often referred to as an Active Pharmaceutical Ingredient, or API) is placed in order to be easily administered to patients.  Pharmaceutical formulations may vary in a number of ways, such as in their effect (for example, an extended release formulation may prolong the release period of the API) or their dosage (5, 10, or 15 mg of the API, for example).

Patent No. 9,211,954 provides an example of the latter.  It claims a formulation of the API temazepam, a drug used for the treatment of insomnia. The patent claims priority to September 1986.

The obviousness issue in this case revolved around whether the formulation claimed by the '954 patent, which incorporates a 6-8 mg dosage unit of temazapam, was obvious in light of Tyco's prior 15 and 30 mg formulations of temazepam in light of a 1983 edition of the British National Forumulary reference.  Formulations of temazepam have been marketed since the 1970's, including Tyco's own RESTORIL. It was undisputed that the only difference between the earlier formulations of RESTORIL and the claimed formulation was the dosage (Tyco's earlier formulations contained 15 and 30 mg doses).  The district court granted summary judgment of obviousness based on Tyco's earlier RESTORIL product, together with the BNF dosing guidelines for temazepam.

On appeal, the Federal Circuit affirmed the obviousness ruling.  The most interesting aspect of the opinion is the section addressing Tyco's argument that the BNF reference – which recommended a 5-15 mg dosage for elderly patients – did not teach the 6-8 mg range of the '954 patent because it did not include or cite any evidence demonstrating that this range would be effective in the treatment of insomnia.  The CAFC rejected this argument:

The ’954 claims do not discuss the intended use of the capsules in a particular treatment regimen. The manufacture of a 7.5 mg temazepam capsule with the disclosed claim limitations would infringe both claims of the ’954 patent, irrespective of the efficacy of the product. Dr. Orr’s statements did not contest the fact that the BNF refers to dosages of temazepam between 5 and 15 mg. His statements are directed to the utility of temazepam as a treatment for insomnia.

Tyco argues that all the properties of a composition of matter relevant to patentability must be considered in evaluating whether that composition would have been obvious in light of the prior art, and that the unclaimed property of effectiveness in treating insomnia renders the claims at issue nonobvious. That argument is unavailing. “The discovery of a new property or use of a previously known composition, even when that property and use are unobvious from the prior art, can not impart patentability to the known composition.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (noting that “a new use of a known composition . . . may be patentable as a process”). The recommendation in the BNF of a range of temazepam dosages that include the dosages claimed in the ’954 patent renders obvious the claims to those dosages even in the absence of documentation in the BNF of the effectiveness of such dosages.

Slip Op. at 7-8.  The CAFC also rejected Tyco's arguments of teaching away, unexpected results, and commercial success.

17 thoughts on “Tyco v. Mutual Pharmaceutical: Obviousness of a Pharmaceutical Formulation

  1. 17

    The usual remark is that only bad patents get litigated. The good ones never go to trial. Does that rule apply to “use” claims, I wonder. Does this explain the paucity of jurisprudence in Europe?

    Malcolm could it be that these European “use” claims have a power that is beyond your imagination?

  2. 16

    So, with the burden of proving infringement being borne by the owner of the claim (and only the preponderance standing between such a claim and its extinction as invalid) Malcolm, I take it you are not surprised that there is no more caselaw in Europe than there is on business method patents.

    Still, as Paul Cole points out, pharma likes these claims to new, useful (by any criterion), valuable (to their owners) and non-obvious subject matters. Patients like these inventions too. They cure (or at least alleviate) their sickness and bring relief from burdensome symptoms. They make the world a better place.

    Sorry readers, but frankly I find the explanation of their lack of patentability in the USA, that “Not everything useful is patentable. That’s just the way it is” a bit lame.

    All the same Malcolm, I did enjoy your “water” retort.

  3. 15

    Howeever the enforcement of claims of this kind has not so far as I am aware been worked out

    It’s pretty easy to see why enforcement of a claim for a new medical use of aspirin would be difficult. Might as well claim a new medical use of water.

  4. 14

    In Europe we could claim aspirin for the treatment of asthma.

    The new indication is novel and unobvious so the EPO would grant a claim of that kind.

    What is the relative value of being able to treat a new disease with an old drug? Doctors would say that this is a more valuable invention than treating it with a new drug because the disease is being treated and the body is not being subject to the insult of an new drug with unknown and potentially harmful side effects.

    Howeever the enforcement of claims of this kind has not so far as I am aware been worked out and I have never seen any court order following such claims being held valid and infringed. Nor am I aware of any such order in Germany (but possibly a German colleague could comment here).

    There is no doubt, however, that our colleagues in pharma value claims of this kind.

  5. 12

    You might also be able to patent some formulation of an asthma medicine with aspirin. Yes, there would be obviousness issues.

  6. 11

    Suppose it is found that aspirin is effective against, say, asthma and that this discovery is new, useful, not obvious and a great relief for some sufferers. Does it deserve patent protection? If so, how can one claim it?

    It would have to be claimed as a method of treating a patient with asthma, including a step of identifying the patient as an asthmatic. If the dosage or treatment regimen was not different from aspirin dosages administered to identified asthma sufferers in the past (they get headaches, too) then you’d be shxt out of luck.

    Obviously people would be grateful for the discovery. “But not every discovery results in a valuable patent for the discovery. That is why our world is a living hxll.”*

    *patent txxbxgger freedom cry

  7. 10

    Ned, a nit-picking point, but I was not saying that the EPO claim begins: A package….. It begins: Use….. Not sure how the owner of such a claim would go about asserting the claim after it issues, and who she would sue. But I imagine the EPO has no idea either.

    Suppose it is found that aspirin is effective against, say, asthma and that this discovery is new, useful, not obvious and a great relief for some sufferers. Does it deserve patent protection? If so, how can one claim it?

  8. 8

    Max, have these claims been litigated in Europe?

    Question for Americans:

    Assume a drug is old, and its use in certain dosages is old for a number of uses, but a new use is discovered.

    Assume a European style use claim, where the claim, per Max, is to a packaged drug (old) of a dosage (old); where a label instructs for the new use (new).

    Is such a claim statutory in the US where a new use for an old compound is defined as a process?

    Is the statutory problem solved by claim construction that would construe such a claim as a claim for a process?

  9. 7

    Where’s Mooney to express shock that Judge Newman found a patent invalid?

    I’m right here. I’m sure she did her best to figure out a way to reverse the district court, but I don’t see how she could have reached any other conclusion than this one without throwing earlier, well-reasoned case law out the window. Sometimes that happens.

    Not this time.

    Maybe Noonan will turn up later to tell us how the decision is likely to destroy the pharmaceutical industry.

  10. 6

    Agreed Paul. But nevertheless Tyco chose to persevere in the USA till the end. Accordingly, I was wishfully imagining Tyco making corresponding efforts at the EPO, thereby generating an interesting EPO file wrapper.

    But I would not dream of criticising Tyco for having at the outset made the judgement, that there was no point in trying for a patent in Europe (or even that any EPO file wrapper would have a detrimental effect on their position in the USA).

  11. 5

    @ Ned

    It is dangerous to extract a bright line rule from a complex fact pattern.

    In this case:

    (a) Temazepam was a known hypnotic drug.
    (b) The new formulation with 7.5 mg was similar to that in Tyco’s existing 15 mg and 30 mg capsules.
    (c) It had been recommended at dosages of 5-15 mg for elderly patients in the British National Formulary (BNF range).
    (d) A doctor in the FDA had commented that existing doses might be too high.
    (e) Studies with 5 mg capsules had been published and such capsules had been on sale outside the US for more than a decade.

    Critical facts are that the whole of the BNF range was recommended for use with elderly pateients, there was no prejudice against using any part of the range and the claimed dose when viewed against the teaching of the art did not in truth provide any unexpected new effect. Against this very strong fact pattern it is not surprising that the verdict was unanimous. But a materially different fact pattern could give a different outcome.

    @MAX: I strongly doubt that this fact pattern would have supported a Swiss-form use claim or nowadays a purpose-restricted product claim. There was no new indication, and the new dosage did not produce any significant new medical effects.

  12. 4

    A European “use” claim is not a claim to the medicament, per se. Making the pills is not enough to infringe a use claim. What comes after (packets of 7.5mg pills, with user instructions for insomniacs) and infringes did not come before so doesn’t touch novelty.

    Does anybody know, does Tyco have patent family in Europe, with a not invalid, not old, not obvious use claim?

  13. 3

    Tyco’s arguments against the BNF reference appear to me to be born out of desperation. Not only does this reference encompass the claimed dosage range (6-8 mg), but it even describes the intended use (for insomnia) for the drug (temazepam). That even Newman agreed that claimed invention was obvious on summary judgment does not surprise me.

  14. 1

    As we have been discussing Paul Cole, a claim to an old compound reciting a new use is not patentable except as a process in the US. The point is made by this case: the manufacture of the old compound would be an infringement and that, under the law, is or at least should be an impossibility.

    This case is also on point concerning another pet peave of mine: the discovery of a new property inherent in an old compound does allow one to repatent the old compound. The use of the compound for the new use can be claimed as a process.

    So, even if the new use is claimed in a compound claim, the claim is anticipated and one never gets to the issue of obviousness.

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