Archive for February, 2010

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Claims to “New Uses of Old Compounds” – The Noose Tightens

Friday, February 19th, 2010

In Perricone v. Medicis, 432 F.3d 1368 (Fed. Cir. 2005), the court reversed the Board, and found that a claim to treating sunburn with certain vitamin esters was patentable in view of art disclosing the same compounds to benefit normal skin. The Board had found the claim invalid as inherently anticipated by the prior art use, but the court found no disclosure in the prior art of applying the compounds to sunburned skin.

In Ex parte Matsubara, Appeal 2009-006581 (Feb. 10, 2010), the Board affirmed the Examiner’s rejection of a claim to a method for improving bone metabolism by (a) selecting a human or animal having a tendency toward a decrease in bone density (e.g., afflicted with osteoporosis), and (b) therapeutically administering to said human or animal certain types of fermented soy milk or “FSM.”  The Examiner rejected the claim as inherently anticipated by a publication that disclosed studying the lipid metabolism in aged, ovariectomized rats after giving them FSM, in view of a publication that established that such rats were an art-recognized model of osteoporosis. Applicants argued that the prior art showed no effect of FSM on osteoporosis and no “selection step” of choosing the rats to evaluate, since the prior art was not concerned with studying osteoporosis.

After quoting sections of Perricone discussing inherency, that the Fed. Cir. panel found inapplicable to the decision that it reached, the Board affirmed the rejection, stating that “the claimed method ‘is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art’…regardless of whether the inherent result is recognized.”  Although I have argued that the use of an old compound for a “different purpose” than disclosed in the art should be sufficient to distinguish the prior art use if a “new use for an old compound” is being claimed, Perricone may deserve a closer reading.

It may well be that the Fed. Cir. reversed in Perricone because no manipulative step of applying the esters to sunburned skin was disclosed in the prior art, not simply because the claimed purpose was not in the prior art. The panel did begin by agreeing: “If [the prior art] discloses the very same methods, then the particular benefits must naturally flow from those methods even if not recognized as benefits at the time of [the art's] disclosure. Thus [the art] anticipates if its disclosure of ‘topical application’ satisfies the application step in Dr. Perricone’s various asserted claims.” The panel went on to find that the art did not disclose the application step of applying the esters to sunburned skin.

So, given that new uses of old compounds remain statutory subject matter and can be extremely valuable, how do we claim them? I think it is important that the prior art rats given FSM and the rats treated by Matsubara were both models for osteoporosis. At least some Examiners give weight to the value of “selection” or recognition that a specific subpopulation can be helped by administration of an “old drug.” For example, consider a claim to “a method of treating a human male afflicted with prostate cancer comprising administering an effective anti-cancer amount of Lipitor to said human male.” Hopefully, the prior art does contain a publication on the treatment of prostate cancer with a chemotherapeutic agent, e.g., docetaxel, that also incidentally discloses that some of the patients were given Lipitor to lower cholesterol. Then you are left hoping that the inventor’s dosing regimen is different than the standard dosing regiment used to lower cholesterol. The noose tightens.

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Views of the EPO Enlarged Appeal Board in Treatment by surgery/MEDI-PHYSICS G 0001/07

Thursday, February 18th, 2010

Under what circumstances is injection a prohibited surgical method? Views of the EPO Enlarged Appeal Board in Treatment by surgery/MEDI-PHYSICS G 0001/07 .  Opinion

From Paul Cole

The present proceedings resulted from a referral in decision T 0992/03 relating to EP-A-1066537. That specification was concerned with magnetic resonance methods for imaging the pulmonary and/or cardiac vasculature and evaluating blood flow using dissolved polarised 129Xe. Representative claims presented to the Appeal Board are set out below

1.  A method for MRI imaging the pulmonary and/or cardiac vasculature using dissolved-phase polarized 129Xe, comprising the steps of:

            positioning a patient in an MRI apparatus having a magnetic field associated therewith;

            delivering polarized 129Xe gas to a predetermined region of the patient’s body, the polarized gas having a dissolved imaging phase associated therewith;

            exciting a predetermined region of the patient’s body, having a portion of the dissolved phase polarized gas therein with at least one large flip angle RF excitation pulse; and

            acquiring at least one MR image associated with the dissolved phase polarized gas after said exciting step.

6.  A method according to any of Claims 1 to 5, wherein

          said delivering step includes having the patient inhale the polarized 129Xe gas into the lungs, the 129Xe having a gas phase resonance which is higher than the dissolved-phase resonance, and wherein at least a portion of the 129Xe gas enters into the pulmonary vasculature in a dissolved-phase, and wherein at least a portion of the dissolved-phase 129Xe then enters the blood stream with an associated perfusion rate.

22. Use of 129Xe for the preparation of a hyperpolarized imaging agent for use in methods of treatment or diagnosis involving performance of the method as described in any one of claims 1 to 21.

The Appeal Board held that the claimed subject matter did not fall within the diagnostic method exclusion because the claimed steps were confined to the examination phase and did not include steps considered constitutive for making a diagnosis. However the claimed method covered administration of polarised xenon into the heart by injection, and the method was intended to be used inter alia for providing real-time feedback during surgery. Existing case law of the Appeal Boards had held that introduction of a catheter into the pericardial pace was an excluded method of surgical treatment (T 0035/99; see also T 0182/90 as to methods of injection), but that applying radiation to the body for the purpose of cosmetic removal of hair was not excluded (T 0383/03). Issues arising in the appeal to the Enlarged Board included whether it was possible to exclude the administration step (“pre-delivered contrast agent”) or whether the claim would be allowable if the administration step were defined at a higher level of abstraction (“administering a contrast agent”).

In particular, the Appeal Board considered that clarification of the term “treatment by surgery” was required and referred to the Enlarged Board the following questions:

1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a “method for treatment of the human or animal body by surgery” pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health?

2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a “treatment of the human or animal body by surgery” pursuant to Article 52(4) EPC if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

The above questions were answered in an 80 page opinion of the Enlarged Board handed down on 15 February 2010.

The Enlarged Board reaffirmed the position in G 0001/04 that any therapeutic or surgical feature in a method claim causes that claim to fall under the prohibition, and “surgery” is not to be interpreted as limited to surgical methods pursuing a therapeutic purpose. It could not give an authoritative once and for all definition of “surgery” since the scope of what is regarded as surgery may change over time, and the relevant criterion should be handled on a case by case basis. However, in answer to the first question, a claimed imaging method in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires. professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to a.53(c) EPC.

In response to the second question, the claim cannot be left to encompass an embodiment which is excluded by a.53(c). Omission of the excluded step should be considered on a case by case basis, but e.g. claims to operation of devices without requiring a surgical step have been held allowable, see T 0245/87, T 0789/96 and T 0329/94, compare T 0082/93. Expressions such as “predelivered” and “preimplanted” have been employed to make clear that the feature pertaining to that step was not part of the claimed invention. However, the remaining requirements of the EPC and in particular a.123(2) and in opposition cases a.123(3) must still be fulfilled.

As regards the third question, a claimed imaging method does not fall within the prohibition merely because during a surgical intervention the data obtained by the use of the method immediately allows a surgeon to decide on the course of action to be taken during the surgical intervention.

It will be appreciated that the function of the Enlarged Board is not in itself to decide the outcome of the appeal, but merely to answer the legal questions put to it by the referring board. The case will now be returned to that board, who will have to decide in the light of the answers given and any amendments filed by the applicants what claims might eventually be allowed.

Comments

The present decision provides useful clarification of the relevant law, but probably does little more than to provide more authoritative support for the general approach already adopted by the EPO. It is believed that the number of applications where the outcome will be materially different as a result of the present decision is likely to be small. However, it will be interesting to see what claims are eventually allowed in this case.

The prohibition under the EPC is to surgical methods rather than surgical apparatus so that in a situation such as the present it may be desirable to present apparatus claims, in this case apparatus for MRI imaging including firstly apparatus for administration of 129Xe to the human body and secondly MRI apparatus configured to supply exciting pulses with a large flip angle and to produce a resultant MRI image. The argument could then be that there would be no motivation to bring together these pieces of apparatus but for the discovery of the new imaging method. For an example of this approach compare the granted claims in EP-B-0436717 (Maddox, Cobe Lab) with the granted claims of the equivalent US-A-5474772, for a more detailed explanation see Fundamentals of Patent Drafting, Paul Cole, CIPA, London, 2006 at pp. 218-222.

The use claim has not been considered by the Enlarged Board, but it would appear in principle to be allowable. The recitation of methods of treatment or diagnosis merely specifying performance of the previously defined method may be too general, however, and it would be expected that the EPO would require further definition characteristic of potential disease states e.g. for the purpose of providing clinically useful images of the left and right pulmonary veins and associated capillaries, the left atrium and left ventricle, the myocardium, the ascending aorta, the coronary arteries, the aortic arch, the descending aorta, the left and right subclavian arteries, and the left and right carotid arteries as recited in the description of the application.

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PTO Biotech/Chem/Pharma Customer Partnership Meeting Announced

Thursday, February 18th, 2010

The USPTO has announced that it will hold a meeting of the Biotechnology/Chemical/Pharmaceutical Customer Partnership on Tuesday, March 2nd, in the Madison Auditorium of the USPTO in Alexandria, VA (agenda attached). You can attend in person or via a link to join online. In the past, I have been less than enthusiastic about these events. From their start in the 90′s, they devolved from small meetings of representatives of IP law user groups with senior Examiners (I met John Doll at one of these meetings) to try to resolve differences in examination policy (e.g., what does per cent sequence identity mean?) to one-day conferences which were mostly consumed by the PTO telling us how great they were (or planned to be in the near future). But this agenda looks like it has some meat on the bones. Topics include reissue, PTA, accelerated examination and synthetic biology. Time to give it another try.

BCP 030210 _Agenda Updated

Accessing the event:

1.    Double click on the link below (or copy it into your internet browser)https://uspto.connectsolutions.com/r45099374/

2.    Select the “Enter as a Guest” option.

3.    External guests – please login using your email address

       USPTO Employees – please login using your last name, first name

4.    Click on the “Enter Room” button

5.    You will be admitted to the meeting

Assistance

If you need assistance with login, please contact Darcy Bates at (571) 272-2499 or Carrie Scott at  (571) 272-2992.

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ANOTHER “HAIL MARY” CLAIM BITES THE DUST

Wednesday, February 17th, 2010

In my post of April 22, 2009, I spent quite a lot of time discussing why “mechanism of action” claims may issue but, like the “Hail Mary” pass in football, remain vulnerable to invalidation as inherently anticipated by the prior art, taken with discoveries made long after the filing date of the claims. Much of this discussion was in the context of the reexamination of the NF-kB patent claims asserted by Ariad against Lilly. I posited that the PTO had effectively taken the position, with respect to such claims, that:

 (A) Method claims whose only recited steps are altering biological mechanisms of action are invalid as anticipated, under principles of inherency, by a prior use of a biologically active compound that meets two requirements:

1.  More than a year prior to the effective filing date of the claim at issue, an “old compound” was administered, so as to treat a condition or achieve a result encompassed by the condition or result recited by the claim at issue; and

2.  At any time, it is shown that the mechanism of action of the “old compound,” when used to treat the condition or achieve the result, is the mechanism of action recited in the claim.

 In the Ariad reexamination, at one point, the PTO Examiner cited the Old Testament of the Bible against the claims, in combination with a recent publication that demonstrated that reservatrol, a compound present in red wine, inhibited the NF-kB pathway. Thus, Bible stories in which red wine was consumed inherently anticipated claims to a method of inhibiting NF-kB activity in a cell by contacting the cell with an NF-kB inhibitor (some of the claims at issue in the patent asserted by Ariad were even broader than this).

This principle was applied by the Board on February 12, 2010, again in Lilly’s favor, to invalidate claim 24 of Pfizer’s Viagra patent (U.S. Pat. No. 6469012):

Claim 24. A method of treating erectile dysfunction in a male human, comprising orally administering … an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity. (Ex parte Pfizer, Appeal No. 2009-004106, Bd. App. Feb. 12, 2010).

Pfizer had sued Lilly for infringing claim 24 by selling Cialis, admittedly a PDEv inhibitor. Lilly requested reexamination and urged that claim 24 was invalid as inherently anticipated by a (I assume “ancient”- as it is described in Chinese Herbal Medicine Materia Medica)  treatment for impotence involving inter alia, drinking rice wine and imbibing an herb whose Latin name translates as “horny goat weed,” in combination with later evidence that demonstrated that the herb in fact contained icariin, a selective cGMP PDEv inhibitor, that would be effective to treat ED when administered in regimens disclosed in the Chinese literature. The Board found the evidence convincing, and affirmed the Examiner’s invalidation of the claim.

So the next time a professor-client or tech transfer person wants you to write this sort of claim, based on a newly discovered mechanism of action, remember that, like the Hail Mary pass,  you can put it up there, but it might not stay up for long.

You can read more about it at Law36o.

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