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Eli Lilly & Co v Pfizer Overseas Pharmaceuticals

Eli Lilly & Co v Pfizer Overseas Pharmaceuticals

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FEDERAL COURT OF AUSTRALIA
Eli Lilly and Company v Pfizer Overseas Pharmaceuticals [2005] FCA 67
PATENTS – patent for treatment of impotence in man – application for revocation of claim 10 of patent – cross-claim for infringement of claim 10 of patent
PATENTS – construction – whether “cGMP PDE_V inhibitor” means an inhibitor selective for that PDE or an inhibitor affecting that PDE to any extent regardless of effect on other PDEs
PATENTS – novelty – whether the invention was novel when compared to prior art as it existed at priority date – application of reverse infringement test – whether Murray or Korenman teach the use of a cGMP PDE_V inhibitor to treat impotence – whether Korenman needed to disclose the PDE inhibitory activity of pentoxifylline for there to be an anticipation
PATENTS – obviousness – whether the invention compared to the prior art base as it existed before the priority date involved an inventive step – whether the notional team would include a medical practitioner experienced in sexual medicine – whether the team on reading Rajfer would be led as a matter of course to try oral cGMP PDE_V inhibitor to prevent impotence – whether fact that Rajfer’s experiments were in vitro rendered invention not obvious – whether Murray formed part of common general knowledge at time – whether the team on reading Murray would directly be led as a matter of course to try an oral cGMP PDE_V inhibitor to cure impotence – whether secondary indicia of commercial success and satisfaction of long-felt want established inventive step
PATENTS – fair basis – whether claim 10 is fairly based on the body of specification – claim 10 not confined to “compounds of the invention”
PATENTS – sufficiency – whether there is sufficient disclosure that will enable addressee to produce something within each claim without new inventions, additions or difficulty – whether there is sufficient disclosure if the skilled addressee could make a single embodiment within the method claimed – whether the best method is disclosed in complete specification – what is relevant date for assessing if the best method has been disclosed
PATENTS – whether best method disclosed – whether best method known to patentee must be identified as such – whether “complete specification” includes amendments
PATENTS – manner of manufacture – whether the invention is a manner of new manufacture – whether what is claimed in claim 10 is mere desideratum – whether known properties of compounds disclosed in Bell patents made them suitable for orally effective treatment for erectile dysfunction
PATENTS – false suggestion – whether there was false suggestion which materially contributed to the decision to grant the patent
PATENTS – infringement – whether Lilly has infringed claim 10 of patent by supplying and selling product Cialis, a cGMP PDE_V inhibitor – whether Cialis cures or prevents impotence within meaning of claim 10 – whether mere sale or importation can infringe a method claim
WORDS AND PHRASES – “complete specification”
Patents…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2005] FCA 67
Decision Date: 10 FEBRUARY 2005

CaseChat Overview and Summary

In the case of Eli Lilly & Co v Pfizer Overseas Pharmaceuticals, the dispute centered on the validity and infringement of a patent related to a pharmaceutical product used for the treatment of impotence. The patent in question was held by Pfizer Overseas Pharmaceuticals, while Eli Lilly & Co was alleged to have infringed the patent through its product, Cialis. The matter was adjudicated in a lower court, where the central legal issues involved the validity of claim 10 of the patent and whether Eli Lilly's conduct constituted an infringement of this claim.

The court examined the validity of claim 10, which pertained to the use of compounds with a specific physiological effect. The court concluded that claim 10 was invalid because it did not disclose an inventive step, given the common general knowledge in the field, particularly considering certain scientific publications that predated the relevant filing date. Additionally, the court found that claim 10 was not fairly based on the matter disclosed in the patent specification. Despite these findings, the court also determined that claim 10 was novel and not invalid for other reasons such as insufficiency, failure to disclose the best method, not being a manner of manufacture, or being obtained by a false suggestion. Furthermore, the court ruled that if claim 10 were valid, Eli Lilly's sales of Cialis would have constituted an infringement.

In summary, the court found that while claim 10 was invalid, Pfizer had succeeded on other issues, and if the claim were valid, Eli Lilly's actions would have constituted an infringement. The proceeding was adjourned to a later date, and counsel were directed to submit minutes of proposed orders.

Orders

Orders of the court

1. The proceeding is adjourned to a date to be fixed.

2. Counsel are directed to submit minutes of proposed orders.

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

HEEREY J

In Bristol-Myers at [82]-[96] Black CJ and Lehane J give detailed consideration to the construction of s 117. The case involved a use claim for a cancer treatment medication and the supply by a manufacturer of a product to medical practitioners with instructions consistent with the use claim. In that context, their Honours held there had been infringement by the supplier. Lilly did not seek to distinguish that decision and I therefore follow it.15.4 Conclusion on infringement issues I conclude that if claim 10 of the Patent were valid, Lilly’s conduct would have constituted an infringement of it.16.0 SUMMARY OF FINDINGS The Patent contains a number of claims which define the scope of an alleged invention for the treatment of impotence. Claim 8 claims the use of a compound, defined in terms of its chemical structure, which is the active ingredient of Viagra. This claim is not alleged to be invalid. Claim 10 claims the use of all compounds which have a certain physiological effect. It is this claim which Lilly says is invalid, and which Pfizer says is infringed by Lilly’s product Cialis. I find that claim 10 is invalid because it is obvious, that is to say it does not disclose an inventive step in the light of common general knowledge in this area, particularly having regard to two scientific publications which became part of that knowledge before the relevant date. I also find that claim 10 is not fairly based on matter disclosed in the specification in the Patent. On other issues Pfizer succeeds. Claim 10 is novel and is not invalid for insufficiency, failure to disclose the best method, not being a manner of manufacture and being obtained by a false suggestion. I further find that were claim 10 valid, Lilly’s sales of Cialis would have constituted an infringement.17.0 ORDERS The proceeding will be adjourned to a date to be fixed. Counsel are directed to submit minutes of proposed orders.

Ratio Decidendi

Legal Principle Established

Established by: HEEREY J

Pre-priority date publications by Beavo (1990), Nicholson (1991) (as well as Murray) identified zaprinast as a selective PDEV inhibitor. As already mentioned, a number of witnesses were aware at the time of this characteristic of zaprinast.9.3.4.6 Oral administration is not taught Oral administration was an obvious preferable route for drug administration, and particularly so in the case of impotence treatment. It hardly needs evidence to conclude that a man would prefer taking a tablet to injecting his penis.9.4 Q13 Can Rajfer be relied on to establish a lack of inventive step? That as at the date for determining sufficiency.11.4 Q23 Is there sufficient disclosure if the skilled addressee could make a single embodiment within the method claimed? The High Court said in Lockwood (at [60]) that all alternative means need not be disclosed; it is sufficient if the addressee can produce “something within each claim without new inventions or additions or prolonged study of matters presenting additional difficulties”. This necessarily means that one embodiment is sufficient. Whether or not this statement is, as Lilly contends, obiter, it is a considered statement by a unanimous bench of the High Court and, it hardly needs saying, should be followed by a judge at first instance. Nor do I see any logical ground for the distinction urged by Lilly between mechanical patents and chemical patents; certainly the Act provides no basis for such a distinction. In any case, there seems to be a practical dilemma inherent in Lilly’s argument. If one embodiment is not enough, are two, ten or twenty required, and who is to say how many are needed?11.5 Q24 Does the specification provide sufficient information to enable a skilled addressee to use a single embodiment of a cGMP PDEV inhibitor in applying the method claimed in claim 10? Pfizer’s witness Dr Robertson was in practice as a medicinal chemist in Australia at the relevant times. He has had substantial, and successful, experience in the making of medicinal compounds, including the reading and working of patent specifications. His experience included both new drug research and development and generic drug design and manufacture. He was subjected to lengthy and searching cross-examination. However, he seemed to me to deal adequately with matters put to him and I was left with a firm impression that he was a competent and practical expert in his field. As to the identification of the compound subjected to testing and for which results are claimed in the Patent, I accept the evidence of Dr Robertson that the skilled addressee reading the Patent as a whole, and noting the progressive narrowing of claims, would be likely to focus on claim 8. He deposed:“53. If I wanted to make a compound which was already known, and claimed in the Patent, then I would simply make one which was described in the Patent. I found the Patent to be very typical of those that I read and worked upon in 1993. Patents of this type generally describe particular chemical entities and claim a wide area around those entities and then the claims successively narrow down towards the entity which is usually of particular interest to the patentee. In the Patent, Claim 1 is broad, but the scope of the claims gets narrower until you reach claim 5 which describes 9 compounds. Claim 6 then describes a more specific compound, claim 7 claims another, the compound described in claim 7 is then claimed as a specific salt form in claim 8, the citrate salt. To my mind a patentee does not go to the bother of isolating a citrate salt for a compound and then determine that it is in fact a monocitrate salt and seek a specific claim to that salt unless that is the compound of significant interest and, when relevant, been tested and used in clinical trials. To me it is, and during the period [previously defined as May 1994 to January 1995] would have been, a reasonable inference to make that the Patent has been framed in order to make it clear that the compound in claim 7 (a salt form of which is in claim 8) is the same compound that data has been given for on pages 9 and 10 of the Patent. Because of this, if during the period, I was setting out to manufacture a generic pharmaceutical based on the Patent, I would manufacture the compound described in claim 8. However, even if a citrate salt had not been made and mentioned in the claims, then claim 6 and 7 describe two of the nine especially preferred compounds listed on page 6-7. If, in the absence of claim 8, I had to determine which of the compounds in claim 6 and claim 7 I most preferred, I would on balance favour the compound in claim 7. The compound in claim 6 has a morpholine structure and can’t be made into a salt very readily. Morpholine can also be metabolically vulnerable sometimes. Accordingly I would prefer the piperazine in claim 7. This is the freebase of the salt in claim 8, sildenafil monocitrate. As I have said earlier, I would infer that the tests and data referred to in the Patent relate to sildenafil, which is the third compound listed in the nine especially preferred compounds on page 6-7 of the Patent.”