Monthly Archives: April 2010

Actavis and Novartis

ACTAVIS’ “EXPECTATION OF SUCCESS” AFFIRMED

ACTAVIS UK vs NOVARTIS AG

The High Court, Court of Appeal has recently upheld a decision on Appeal from the High Court, Patents Court, that the Novartis’s European Patent (UK) 0948320, a sustained release formulation of Fluvastatin (a Cholesterol lowering drug), is invalid on the ground of obviousness.

Earlier in the Patents Court

Actavis claimed for the revocation of Novartis patent on grounds of obviousness and insufficiency in the Patents Court. There was also a counterclaim by Novartis for infringement of its patent. Novartis conceded that the claims as granted could not be granted and applied for their amendment.   The claim and counterclaim before Justice Warren is reported at Actavis UK Ltd v Novartis AG [2009] EWHC 41 (Ch) (16 January 2009) . The teaching of the patent was compared to the pleaded prior art and common general knowledge and the judge found that the patent was obvious. The claim on insufficiency however failed.  The Actavis’ preparation would have infringed the defendant’s patent had it been valid but in view of the finding of obviousness the counterclaim failed.

Advances In A Case And Analysis

 

Solubility: high and very high

Fluvastatin was a well-known statin available in an immediate release formulation in 1996 (priority date of the patent is October 1996). A dosage regime of a 40 mg capsule to be taken twice a day was well known by that date plus there was extensive knowledge of sustained release formulations generally. The patent suggests that there is a need for a sustained release formulation of Fluvastatin and in creating such a formulation, there is a problem of its high water solubility and that any of the conventional methods would not work.

Judge Lloyd says “the problem presented in the Patent was illusory”.

Patent is seeking to deal with a problem of high water solubility of Fluvastatin. However, there would be problem only at very high and very low solubility. The solubility of the drug is high and not very high and therefore Fluvastatin is not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained release form.

Common General Knowledge and an Expectation of success

Although there was lurking in the Patents Court about some arguments about other claims namely 2, 3, 10 too, however, the only claim which really matters is claim 1, which is permitted to be amended by Justice Warren.

Claim 1 is as follows:

“A sustained release pharmaceutical composition comprising a water soluble salt of Fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combination’s thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.”

Actavis advanced a case that a sustained release form of Fluvastatin would be expected not only to be a more convenient formulation for patient compliance (the common perception in October 1996 was that a reduction from 2 doses daily to a single dose would result in improved patient compliance) but would be likely to have significant medical advantages, namely improved therapeutic effect and fewer side effects and hence there was a strong motive to create a sustained release form and a strong expectation that all three types of benefits would be obtained, the two medical and the convenience. The Judge rejected the “medical advantage” but accepted the “more convenient” advantage point.

The fact that an immediate release formulation was already available which could be taken at a dose of up to 40 mg once a day and up to 80 mg per day in two doses, was a part of the common general knowledge of the skilled team. As a result, the skilled team would have an expectation of being able to develop an 80 mg sustained release formulation with some clinical efficacy. It would however be uncertain about clinical efficacy, and there would be no strong expectation that it would be achieved. It would be unable to predict with anything approaching certainty that any reduction in the risk of side-effects would be achieved. The team might get better efficacy or fewer side effects, but it would certainly get better compliance.

The problem and solution gave the same answer and the Judge affirmed the invalidity of the Novartis Patent on the ground of obviousness. The problem was to produce a sustained release of fluvastain. And the solution was provided by any of the standard methods for such formulations, which was obvious. The problem is not to look for better medical effect as discussed above and thus the decision of the Patents Court was rightly upheld.

There was some dispute between the parties about the effect in the case of the decision of the in Conor Medsystems Incorporated v Angiotec Pharmaceuticals Incorporated.

In Conor, The patent claim in question was a taxol coated stent for treating restenosis and prior art claimed a use of stent coated with one of the drugs of the class of drugs to which taxol belonged to. The House of Courts held the patent to be not obvious as it was not obvious for taxon to show the same therapeutic effect.

However, this should always be kept in mind that the obviousness is a question of fact and is a multifactorial question. “The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.” Generics v Lundbeck[2007] RPC 32.

In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation and for that there was a technical motivation. [Pozzoli v BDMO [2007] FSR 37)].  The “Problem and Solution approach” gave the same answer. The problem was to produce a sustained release form of Fluvastatin, which would be solved by any of the standard methods for such formulations. The problem was not to look for better medical effects and the Judge affirmed the invalidity of the Novartis Patent on basis on the ground of obviousness. Since this was one of the first cases after Conor, it is to be seen further whether the Conor would make any change in interpreting the issue of obviousness or not.

Case No: A3/2009/0675

About the Author: Ms. Meenakshi Khurana, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: meenakshi@iiprd.com.

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Nokia & Ipcom

Introduction:

It all started when the licensing deal between Nokia and Ipcom broke in Germany. From then, it was a legal war between these two giants. While Ipcom along with its bunch of patents trying to target each and every mobile model of its rivalry, Nokia trying to revocate Ipcom’s each patent one by one. For now, Ipcom sued Nokia for they infringed its UK patents “540 808” (“808”) and “1 186 189” (“189”).

Validity of “808” Patent:

In “808” patent the principal claim relates to a synchronization method for mobile radio telephones in a cellular network comprising number of fixed stations and mobile telephones based on a GSM method, the synchronization includes an initial synchronization, a normal operation synchronization and lock-on synchronization. Testing obviousness using the principles (structured approach) in the court was not a dispute point for either of the parties. However, Nokia pointed out the claim 1 was divided into three compartments as initial, normal and lock-on synchronization, and hence in such a case it is legitimate to look into parts separately and to determine they were inventive individually. The judge agreed and Nokia presented a publication “GSM recommendations” for the obviousness attack. Nokia also relied on “Baier” patent publication and “D’ Avella”, an IEEE journal publication. The patent is anticipated by the prior art “GSM” except the data pre processing portion that happens in the normal synchronization. Also, based on the judge construction of claim and specification, “Baier” teaching of Pre-processing is very much obvious to one skilled in the art as “Baier” patent is related to a GSM scheme. Inspite of Ipcom’s argument on the technical point, Judge was of the opinion and concluded that the prior art “D’Avella” also discloses about preprocessing and hence finally concluded that the patent “808” is obvious in light of common general knowledge or in light of “Baier”, “D’Avella” and Common general knowledge taken together.

Infringement by Nokia 6300:

The judge noted that the Nokia 6300 which operates in EDGE mode, can use either GMSK or 8PSK modulation depending on the channel conditions. When 6300 uses GMSK, it follows a GSM method. The judge concluded that if the patent is valid, then the 6300 would infringe the Claims 1, 9 and 11.

Validity of “189” Patent:

In “189” patent the principal claim relates to a method for allocating access rights to atleast one subscriber station in the telecommunications network. The method further includes a check process whenever the subscriber station receives a receipt or an acknowledgment of an access authorization data. The method carries out the check process to determine whether the access authorization data that has threshold value (s) being compared to a Pseudorandom number (R).

It will be interesting to note that the judge refused to accept Nokia’s claim construction particularly in the check process. Nokia construction on check process as to whether the access threshold information is being transmitted and as such this is of no interest to the mobile station. According to judge claim construction, the check process is a check whether the mobile station is to use part of the access information to perform the access threshold function. Nokia relies on “GSM recommendation” prior art which includes a GPRS and it is an add-on to GSM. It was a piece of cake to destroy the novelty of Claim 1. The key feature “check process” to do an access threshold test is clearly disclosed in the prior art. Also, Judge issued the same opinion when Nokia pleaded to discuss the second prior art “Ericsson”. Finally, the judge concluded that there is no need to go into obviousness section over common general knowledge as it is not going to add significant value (most of them are covered in GPRS “GSM recommendation” part).

Infringement by Nokia N96:

The functioning of Nokia N96 is based on UMTS standard. Refusing to take the Nokia’s stand on infringement, Judge declares that the N96 performs both types of check as required by claim1. Therefore if “189”patent is valid, Nokia N96 would have infringed.

Although, Nokia won the battle, still the Legal War is on…as there are more cases to come…No doubt Ipcom, – $ 18 bn (approx) in the present battle, will evaluate the patent portfolio it has (including the acquired  patents!) and strongly comeback against Nokia next time…

Case Nos: HC 08C02525 and HC 08C03143

Author – Veera Raghavan Rajendran, Senior Patent Consultant

The author can be reached:  Raghavan@iiprd.com.

Eli Lilly Vs Sun Pharma and others

Lilly’s Patent relates to method of treating Attention-Deficit/ Hyperactivity disorder (ADHD) with administration of effective amount of Tomoxetine. Lilly markets atomoxetine capsule under the brand name STRATTERA®. The US Patent 5,658,590 was assigned to Lilly On August 19, 1997 with a principal claim that recites a particular method of treating ADHD. Submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of atomoxetine by Sun Pharma and others before the expiry of the said patent led to Lilly’s action against the infringement of their patent.

Although the claims do not include any indication about the dose and the complete composition of the medicine, it specifically discloses the treatment of ADHD by physicians. The independent claim states that  “A method of treating Attention-Deficit/ Hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of Tomoxetine”.

Plaintiff argues that each of the Defendants’ act of filing an ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A) .Plaintiff further argues that the commercialization of generic atomoxetine before the expiration of the ‘590 Patent would constitute further infringement under 35 U.S.C. §§ 271(a), (b), and/or (c).

Defendants assert that Lilly’s patent is for the treatment of patients by physicians and none of the Defendants are doctors, they never treat patients, and they do not prescribe medicines. Rather, they sell drugs to wholesalers or pharmacists, who in turn sell the drugs to patients possessing prescriptions from physicians. Defendants contend that Lilly cannot establish infringement under 35 U.S.C. § 271(e)(2) for the same reasons that Defendants argue infringement does not exist under 35 U.S.C. § 271(a) .

In a similar case Warner-Lambert Co. v. Apotex Corp the Federal Circuit concluded that there was no direct infringement because “there is no evidence in the record that Apotex has directly practiced or will ever practice any of the methods claimed. In reaching this conclusion, based on facts that are identical to the facts at issue in this case, the Federal Circuit explained that the activities of pharmaceutical manufacturers are fundamentally different than prescribing physicians and, therefore, pharmaceutical companies cannot directly infringe such method of treatment claims and defendants’ motion for partial summary judgment as to no direct infringement was granted. Lily lost the battle based on the evidence ground and for the same reasons, also lost the reconsideration request for the decision.

In the present case, the patent specifically teaches about treatment of patients by Physicians, which implies that a particular dose will be prescribed to the patient depending on the age of the patient and severity of the case. Hence, the method involves prescription of atomoxetine in a particular dosage to a patient as per the case. Although, the drug manufacturers neither prescribe nor administer the drug to the patients in any form, but availability of atomoxetine in the market by different manufacturers in different dosages will directly read upon the claimed method as the dosage prescription by the physician is a part and sole of the method involved in the patent. This will further have an impact on the method of treatment.

The above analysis leads to many questions like: Who will be responsible for influencing the treatment method of ADHD, physicians or the drug suppliers? As the drug manufacturers have managed to out themselves by saying they don’t treat patients and only manufacture drugs! It won’t be shocking if the manufacturers come out with a statement that they never forced patients to buy their drug as they just manufacture drugs and don’t treat patients.

Civil Action No. 07-cv-3770 (DMC).

Author:  Mr. Devpriya Kumar, Patent Consultant

The author can be reached devpriya@iiprd.com