Celgene Corporation

[2012] APO 71

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Celgene Corporation [2012] APO 71

Patent Application:                   2011101702

Title:A drug dispensing system

Patent Applicant:  Celgene Corporation

Delegate:  Dr S.D.Barker

Decision Date:  25 June 2012

Hearing Date:  Response to examiner objection received on 23 May 2012

Catchwords:  PATENTS – innovation patent – examiner objections – lack of novelty and innovative step for the same reason as for the parent patent – claims to a system and method of communicating are not a manner of manufacture – patent revoked

Representation:  Patentee:  Freehills Patent & Trade Mark Attorneys

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2011100687

Title:A drug dispensing system

Patent Applicant:  Celgene Corporation

Date of Decision:  25 June 2012

DECISION

Claims 1, 2, 3 and 4 lack novelty in the light of the citation.  Claims 1 to 5 lack innovative step in the light of the citation.  Claims 1 to 5 are not directed to a manner of manufacture. 

I revoke the patent.

REASONS FOR DECISION

1. Innovation patent 2011101702 (the patent) was filed by Celgene Corporation on 23 December 2011. The patent was sealed on 13 January 2012. The patent is a divisional application from innovation patent 2011100687 (the parent patent), which is a divisional application from innovation patent 2010101328 (the grandparent patent), which is itself a divisional application from innovation patent 2010100294 (the great-grandparent patent). Both the grandparent and great-grandparent patents ceased under section 143A due to failure to gain certification within the time prescribed by regulation 9A.4. The parent was the subject of a written decision ([2012] APO 12 dated 17 January 2012, hereafter referred to as my earlier decision) finding that grounds of revocation had been made out, and allowing the patentee an opportunity to amend. That decision has been appealed, and the matter is pending before the Federal Court.

2. The Commissioner issued an examination report on the patent on 16 April 2012.  The patentee provided amendments, and asked that a formal decision be issued if the examiner was not persuaded to certify the patent.  The patentee formally waived its right to be heard, and asked that an appealable decision be issued.

   The patent

3. The patent is titled “A drug dispensing system”.  The specification states that some pharmaceuticals with useful activity are known to have adverse side effects in some members of the population.  Thalidomide is known to cause birth defects, but also has useful activity in the treatment of erythema nodosum leprosum (ENL).  The essence of the patent is a system for carrying out certain checks prior to dispensing the drug.  The invention as described is discussed at length in my earlier decision.  The system as claimed is understood by considering claim 1 of the patent as proposed to be amended:

   A system for dispensing a drug to a patient in need of the drug, so as to minimise or prevent the occurrence of an adverse side effect known or suspected of being caused by the drug, the system comprising:

   means for receiving, from a remote pharmacy via a client application, an approval request for a prescription for the drug presented by the patient including:

   a unique patient identification number corresponding to the patient, the patient having been prescribed the drug by a prescriber;

   pharmacy registration data from the remote pharmacy;  and

   data representing factors which influence risk of occurrence of a known or suspected adverse side effect if the patient receives the drug;

   a computer readable storage medium storing thereon a database including:

   patient registration data, said patient registration data including the unique patient identification number assigned to the patient by a risk management system;

   prescriber registration data;

   pharmacy registration data;  and

   a prescription approval code for association with the prescription to be dispensed upon verifying from the database that the:

   patient, prescriber and remote pharmacy are registered in the medium;  and

   risk of occurrence of a known or suspected adverse side effect in the patient is acceptable;  and

   means for communicating the prescription approval code associated with the prescription to the client application of the remote pharmacy.

4. The key features of the system that is described and claimed in the patent are
   
   

   • means for receiving a request for a prescription,
   • a computer readable storage medium, and
   • a means to communicate information back to the pharmacy.

5. There is also an independent claim 4 directed to a method of communicating approval:

   A method for communicating the approval of a risk management centre for a drug for dispensing the drug to a patient in need of it, so as to minimise or prevent the occurrence of an adverse side effect known or suspected of being caused by the drug, the method comprising the steps of:

   ·receiving registration data from a prescriber;

   ·receiving registration data from the patient;

   ·receiving registration data from a remote pharmacy;

   ·assigning a unique patient identification number to the patient;

   ·writing the received registration data and unique patient identification number to a database stored in a computer readable storage medium;

   ·upon presentation by the patient of a drug prescription to the remote pharmacy, receiving from the pharmacy via a client application a request including:

   the unique patient identification number corresponding to the patient presenting the drug prescription;
   pharmacy registration data of the remote pharmacy; and
   data representing factors which influence the risk that a known or suspected adverse side effect will occur if the patient receives the drug; and

   ·associating a prescription approval code with the prescription to be dispensed upon verifying from the database that:

   the patient, prescriber and remote pharmacy are registered in the medium; and
   the risk of an adverse side effect occurring in the patient is acceptable; and

   ·communicating the prescription approval code associated with the prescription to the client application of the remote pharmacy.

6. It is clear that this process is essentially what would result from using the system of claim 1.

   The objections

7. There are three objections raised in relation to the innovation patent.  First it is objected that the invention is not a manner of manufacture (as required by section 18(1A)).  Second, it is objected that the invention is anticipated by US 2007/0219825 (the citation) – specifically claims 1 to 4 lack novelty and claims 1 – 5 lack innovative step.  A third objection to lack of clarity has been overcome by amendment, so is no longer relevant.

   The parent patent

8. The claims of the parent patent are directed to a “method of treating a patient with thalidomide”, whereby certain checking steps are undertaken before the drug is dispensed.  In my earlier decision I found that claims 1, 3, 4 and 5 were not novel, and claims 1 to 5 were not innovative.  In addition, I found that the claims were not directed to a manner of manufacture.

   Differences between the present patent and the parent patent

9. Claims 1 to 3 of the present patent are directed to a system rather than a method.  Claims 4 and 5 of the present patent are directed to method of communicating approval.  The system and method of the present patent relate to dispensing any drug having known or suspected side effects, whereas the method of the parent patent was restricted to thalidomide.  However, apart from the nature of the drug and matters of form, the system that is claimed in the patent is the system that is used in the method of the parent patent.  The features of the system as claimed are broadly

   ·    means for receiving a request from a remote pharmacy

   ·    a computer readable storage medium

   ·    means for communicating a prescription approval code to the remote pharmacy

10. Claim 2 adds the feature that the risk factors relate to pregnancy.  Claim 3 adds the feature that the drug is thalidomide or lenalidomide.  Claim 4 is an independent claim, directed to a “method for communicating the approval of a risk management centre”.  The method is essentially the method of the parent patent (absent the limitation to thalidomide).  Claim 5 is appended to claim 4, and adds the feature that the prescription approval code is from a list stored on the computer readable storage medium.

11. I consider that all of the features of the claims of the patent appear in the claims of the parent patent.  The following table shows where the features are found in the claims of the parent.

Present Patent	Parent Patent
Claim 1	Claim 1
A system comprising	A method comprising [a method implicitly operates by means of a “system”]
.  means for receiving a request from a pharmacy, including a patient identification number, pharmacy registration data, and data representing risk factors	.  “[the pharmacy] consulting a computer readable storage medium”
.  computer readable storage medium storing thereon a database including registration data and a prescription approval code	.  “in which is recorded …”
.  means for communicating to the pharmacy	.  “communicating the prescription approval code to the pharmacy”
Claim 2
.  risk factors relating to pregnancy	Claim 3:  “it is also verified the patient is not pregnant”
Claim 3
.  the drug is thalidomide or lenalidomide	Claim 1:  “A method of treating a patient with thalidomide” Claim 5:  also relates to lenalidomide
Claim 4	Claim 1
A method of communicating approval	A method of treating a patient comprising certain steps
.  receiving registration data from prescriber	.  “the patient, a prescriber and the pharmacy are registered”
.  receiving registration data from patient	.  “the patient, a prescriber and the pharmacy are registered”
.  receiving registration data from pharmacy	.  “the patient, a prescriber and the pharmacy are registered”
.  assigning a unique patient identification number to the patient	.  “each patient having a unique patient identification number”
.  writing the data to a database stored in a computer readable storage medium	.  “consulting a computer readable storage medium in which the patient, a prescriber and the pharmacy are registered”
.  upon presentation of a prescription, the pharmacy sends a request with certain data	.  “upon presentation by the patient of the prescription to the pharmacy, consulting a computer readable storage medium … in which is recorded an assessment of whether the risk of an adverse side effect occurring in the patient is acceptable”
.  associating a prescription approval code with the prescription upon verifying certain matters	.  “associating a prescription approval code with the presentation by the patient of the prescription for thalidomide upon verifying” certain matters
.  communicating the prescription approval code to the pharmacy	.  “communicating the prescription approval code to the pharmacy
Claim 5	Claim 2
.  the prescription approval code is stored on a computer readable medium	.  “wherein the prescription approval code is generated from a list stored in the computer readable storage medium

1. The features of the claims of the present patent correspond to features of the claims of the parent application (except that claim 1 is directed to a different aspect of the invention, i.e. a system). 

   Novelty and Innovative Step

2. I discussed the law on novelty and innovative step in my earlier decision, and found that the citation discloses a method that is the same as that of the parent patent.  The citation discloses a system, involving a database (computer readable storage medium), and communication by telephone, fax or web-based means.  To the extent that the same method is used, the systems involved are also the same.  It follows that claims 1, 2, 3 and 4 lack novelty for equivalent reasons to those given in my earlier decision.  Claim 5 is different, as it corresponds to claim 2 of the parent patent.  Claim 2 was found to be novel, so the same conclusion applies to claim 5 of the present patent.  However, claim 2 was found to lack innovative step.  For reasons equivalent to those in the earlier decision I consider that claims 1 to 5 lack innovative step.

   Manner of manufacture

3. I discussed the law on manner of manufacture in my earlier decision, and found that a method of dispensing thalidomide was not a manner of manufacture.  In the present patent the claims are directed to a system and to a method of communicating an approval.  However, as discussed in the earlier decision at [63], it is necessary to find the essence of the invention, a task that involves considering the improvement, the contribution to the art, or the real nature of the patentee’s invention.  My conclusion at [64] of the earlier decision remains relevant.  I will repeat it, with some small modifications that reflect the different claim drafting of the present patent:

   In the present case the essence of the claimed invention is the checking of risk during the dispensing of a drug (either thalidomide or another drug known or suspected of causing harm).  However, no new risk factors are considered.  All that is involved is double checking whether the original decision of the prescriber was correctly made, and confirming (or rejecting) that there is an acceptable risk associated with thalidomide (or other drug) treatment.  This is analogous to a process of treating a patient characterised by the patient double checking the instructions on the bottle of tablets before taking a tablet.  While this is clearly a sensible thing to do, the essence of the invention clearly does not lie in the useful arts, or the field of economic endeavour.  The claims of the present patent are similarly directed to a sensible thing to do, but the essence of the invention does not lie in the field of economic endeavour.

4. The system in claim 1 can be a computer system.  While a computer system is a tangible article, in the present case that computer is characterised solely by the processing that it carries out.  As a consequence, the essence of the claimed system is the processing of information about registration of persons and the risk to a patient, and the generation of a prescription approval code.  The purpose of the processing is the minimisation of the risk of harm to patients.  While this is clearly a sensible thing to do, the way in which it is achieved by the system does not lie in the useful arts, or the field of economic endeavour.  This conclusion is similar to that in Invention Pathways Pty Ltd [2010] APO 10 at [40]:

   “Computers and the internet are now as ubiquitous as paper and the postal service as a means of collecting, displaying and disseminating information and their use as elements in a business scheme without something more, some substantial physical effect produced in the operation of the method, does not in my view and within the terms of NRDC result in an ‘artificial state of affairs’ any more than were those action to be taken on paper”

5. Similarly, in Jumbo Interactive Ltd & New South Wales Lotteries Corp v Elot, Inc. [2011] APO 82 the delegate found that a system for operating on-line lottery games was not a manner of manufacture.

6. The method of communicating approval defined by claim 4 is almost identical to the process covered by claim 1 of the parent patent.  In essence it differs from the parent in that it does not include the step of dispensing the drug.  My discussion in the earlier decision is equally applicable to the present patent, and my conclusion that the claims of the parent are not directed to a manner of manufacture applies equally to the method claims of the present patent.

7. I conclude that the invention defined by claims 1 to 5 is not a manner of manufacture.

   Conclusion

8. Claims 1, 2, 3 and 4 lack novelty in the light of the citation.  Claims 1 to 5 lack innovative step in the light of the citation.  Claims 1 to 5 are not directed to a manner of manufacture.  The patentee requested “a decision of an intention to revoke this patent”.  I do not believe that I can make such a decision.

9. According to section 101F(1), a patent “must” be revoked if a ground of revocation has been made out and has not been removed.  This is subject to section 101F(3):

   The Commissioner must not revoke a patent under this section unless the Commissioner:

   (a)       has given the patentee a reasonable opportunity to be heard;  and

   (b)has, if appropriate, given the patentee a reasonable opportunity to amend the relevant specification for the purposes of removing a ground for the revocation of the patent and the patentee has failed to do so.

10. The patentee has had a reasonable opportunity to be heard, and has had a reasonable opportunity to amend the specification.  In this situation, it seems to me that I must revoke the patent.  A different outcome resulted in the earlier decision because I considered that the patentee had not had a reasonable opportunity to amend, but that is not the case in the present patent.

11. Despite the request of the patentee, I must revoke the patent.  This decision can be appealed to the Federal Court under section 101F(4).

    Dr S.D.Barker
    Delegate of the Commissioner