Celgene Corporation
[2013] APO 14
•29 January 2013
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Celgene Corporation [2013] APO 14
Patent:2012101491
Title:A method to monitor and authorise the distribution of a drug
Patentee: Celgene Corporation
Delegate: Dr S.D.Barker
Decision Date: 29 January 2013
Hearing Date: 15 November 2012, in Canberra
Catchwords: PATENTS – examiner's objections – method of authorising distribution of thalidomide – novelty, innovative step and manner of manufacture considered – claims are novel as approval is generated at a different point in time – claims lack innovative step as the differences do not make a substantial contribution to the working of the invention – claims are not directed to a manner of manufacture – the mere writing of information to a computer file is not an artificial state of affairs – patent revoked
Representation: Patentee: David Shavin QC, assisted by Lisa Taliadoris of Jones Day
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent:2012101491
Title:A method to monitor and authorise the distribution of a drug
Patentee: Celgene Corporation
Date of Decision: 29 January 2013
DECISION
Claims 1 – 5 lack innovative step.
Claims 1 – 5 are not directed to a manner of manufacture.
I revoke innovation patent 2012101491.
REASONS FOR DECISION
Innovation patent 2012101491 was filed by Celgene Corporation on 28 September 2012. The patent claims to be a divisional under the terms of section 79C. The parent is identified as 2011100687 (which was the subject of written decision [2012] APO 12 – hereafter referred to a as my first decision), which is a divisional of 2010101328 (ceased), which is a divisional of 2010100294 (ceased). There is also a related sibling patent 2011101702 (revoked following written decision [2012] APO 71 – hereafter referred to as my second decision).
The patentee appealed my first and second decisions (Federal Court matters VID 102/2012 and VID 501/2012). These matters progressed up to the point where the patentee's evidence was due. The patentee filed the present divisional innovation patent and discontinued the appeals.
The present innovation patent was sealed on 18 October 2012. Given the history of these patents, the Commissioner decided to immediately examine the present patent (pursuant to section 101A). The examination report issued on 22 October 2012, raising two objections: the application is not a manner of manufacture within the meaning of section 18(1A)(a), and the invention defined in all claims is not novel and lacks an innovative step. These grounds of objection have been raised many times in relation to the various parent and sibling patents, so a hearing was set immediately. The hearing was conducted in Canberra on 15 November 2012. The patentee was represented by David Shavin QC, assisted by Lisa Taliadoris of Jones Day.
1 The patent
The patent is titled “A method to monitor and authorise the distribution of a drug”. The specification states that some drugs 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 summarised in the Abstract filed with the specification on 28 September 2012:
"The present invention relates to an improved method to monitor and authorise the distribution of a drug such as lenalidomide or thalidomide comprising creating a database using a unique patient identification number and authorising dispensing of the drug(s) by generating a prescription approval code and providing the prescription approval code to a pharmacy."
The description is essentially the same as that of any of the previous patents. At the hearing Mr Shavin provided a helpful explanation of the way that the patentee saw the invention. This explanation was different in some respects from the explanation provided at the previous hearings. I will briefly explain Mr Shavin's submissions before discussing the way that the invention is described in the specification.
1.1 The patentee's view of the invention
Thalidomide is a useful drug that has known dangerous side effects. Consequently there is a need to be as confident as possible that thalidomide will not be given to a patient who is contraindicated, or that a patient taking thalidomide will not engage in activities that may place others at risk of exposure to thalidomide. There is a process (or perhaps several processes) of risk minimisation in place that rely on the pharmacist collecting information from patients at the point of dispensing. However, it is considered that this may not be carried out properly in some cases, and it would be better for the prescriber to collect this information from patients. Further, in order to allow for a fully considered risk assessment to be carried out in a timely manner, the information should be quickly entered into a central database where all records relating to the patient, and particularly relating to the present prescription, are available to be considered as soon as the patient presents to a pharmacy. As will become apparent, there are several features of this process that are not in substance disclosed in the specification.
1.2 The invention as described
According to the specification, the way in which distribution of lenalidomide or thalidomide is monitored and authorised is through the use of a database that stores information about prescribers, pharmacists and patients. When a patient presents at a pharmacist with a prescription, the pharmacist must make a request for authorisation to dispense, which is processed as follows (page 5):
"querying the computer readable storage medium to verify that the prescriber and the pharmacy are registered;
querying the computer readable storage medium to verify that the patient is a registered patient with a unique patient identification number;
in the event that both the pharmacy and the prescriber are registered and that the patient is registered and the patient's unique patient identification number is verified, querying the computer readable storage medium using the registered patient's unique patient identification number to access the registered patient's data to verify by reference to the unique identification number assigned to the patient data that the risk of a side effect occurring upon administration of lenalidomide or thalidomide to the patient is acceptable;"
Once these queries have been completed, a prescription approval code is generated and communicated to the dispenser (page 5):
"in the event that the risk is acceptable, authorising the pharmacy to dispense the prescription by generating a prescription approval code assigned to the prescription"
The specification is clear that the registration of the patient may be carried out by either the pharmacist or the prescriber. At page 13 the specification states:
"The registration of the patient may be carried out by a registered pharmacy, for example at the time of the patient's initial visit to the pharmacy. It has been found, however, that it may be more efficient, and better compliance with the methods of the present invention may be provided, if registration of the patient is carried out by a registered prescriber of the drug at the time the initial prescription is generated."
10. The key features of the method that is described in the patent are
- creating a database (of prescriber, pharmacist and patient data in a computer readable storage medium);
- verifying that there is an acceptable risk; and
- providing a prescription approval code.
1.3 Creating a database
11. The process that is described is based on the prescriber, pharmacist and patient being registered in a database. If any party is not registered, then the thalidomide cannot be dispensed. For instance, at page 22 the specification says:
"If the prescriber is not registered in the computer readable storage medium, the prescriber will be ineligible to prescribe the drug. Similarly, if the pharmacy is not registered in the computer readable storage medium, the pharmacy will be ineligible to dispense the drug."
12. This information is stored in a computer readable storage medium.
1.4 Acceptable risk
13. The way in which the risk assessment is carried out is not explained in simple terms. The consistory statement says at page 5 that
"upon receiving a communication from a pharmacy including a request for authorisation to dispense a prescription … in the event that both the pharmacy and the prescriber are registered and that the patient is registered and the patient's unique patient identification number is verified, querying the computer readable storage medium using the registered patient's unique patient identification number to verify by reference to the unique patient identification number assigned to the patient data that the risk of a side effect occurring upon administration of lenalidomide or thalidomide to the patient is acceptable"
14. It is easy to understand that the process confirms that the prescriber, pharmacy and patient are registered. But how does the process verify that the risk of an adverse side effect is acceptable?
15. The specification is silent on whether the risk assessment is done by a person (at the Risk Management Centre, abbreviated to RMC), or whether it is done by the computer system without the need for human intervention. At the hearing I suggested that the example seemed to indicate that it was done by person. Mr Shavin submitted that the example is not as clear as that, and it could be done by a computer. On reflection I see Mr Shavin's point. The specification is curiously silent on how the risk assessment is done. For instance, at page 27 the specification says :
"The registered pharmacy has received, from the RMC, details of the type of information it needs to collect from the patient for forwarding to the RMC, in order for a prescription approval code to be generated. Details that need to be provided include the pharmacy, the patient's UPIN and prescriber details, the dose prescribed, whether counselling was offered to the patient and the date and result of the pregnancy test (if applicable).
The information is then forwarded to the RMC, where it is verified. The verification process includes checking that the patient has been registered and that he/she does not fall into any risk groups for which thalidomide is contraindicated. Once the script is verified by the RMC a prescription approval code is assigned to the prescription by the RMC. The prescription approval code is then provided to the pharmacist, who may then dispense thalidomide to the patient."
16. However, it is not reasonable to conclude that the invention involves an automated risk assessment merely because the specification is vaguely drafted. Risk assessment per se is not new. It is well known that prescribers use their knowledge of their patients and the risks associated with drugs when deciding whether to prescribe (this is the traditional approach to prescribing). The specification does not describe an automated risk assessment step, and does not suggest any algorithm that a computer could use for carrying out a risk assessment. Rather, the description emphasises collecting all relevant data to be used in the risk assessment, and is silent on how the assessment is done. I do not see any reasonable basis to believe that the specification is suggesting that the invention relates to an automated means of risk assessment as against the traditional approach. A fair reading of the description is that the risk assessment is carried out by a human, and not by a computer.
17. Indeed, if it were seriously suggested that the invention includes an automated risk assessment, it would be necessary to consider whether there was a full description of such a method, and particularly whether there was a best method of performance of such a method. I have not considered these matters because I do not believe that the invention as described is an automated risk assessment.
18. The detail that is provided to the RMC is risk related. The specification states at many points that registration of patients is based on completion of a questionnaire on risk issues. For instance, at page 14 the specification states:
"The type of information that is gathered from the patient will depend on the preconditions that need to be fulfilled before a prescription approval code is issued."
19. The risk factors that would be considered are matters that are already known in the art. At page 15 the specification says:
"As will be evident to those skilled in the art, the risk parameters to be considered and the risk groups defined by those parameters will be based upon factors which influence the risk that a known or suspected adverse side effect will occur if a patient receives the drug, and will vary depending upon the drug in question. Where the drug is a teratogenic drug, for example, such risk parameters may include elements which would impact the risk of a foetus and/or female of child bearing potential being exposed to the drug, such as the age, sex and reproductive status of the patient. For example, a first risk group may comprise female patients of child bearing potential; a second risk group may comprise female patients of non-child bearing potential; a third risk group may comprise sexually active male patients; and a fourth risk group may comprise sexually inactive male patients. Preferably, the risk group is female patients of child bearing potential."
20. Based on the risk group assigned to a person, they may be precluded from approval for dispensing the drug (page 16). However, the specification indicates a preference for providing the patient with information regarding the risks associated with the drug. At page 17 the specification states:
"Preferably the patient is provided full disclosure of all the known and suspected risks associated with taking the drug. For example, in the case of teratogenic drugs, the prescriber preferably counsels the patient on the dangers of exposing a foetus, either one which may be carried by the patient or one carried by a recipient of the bodily fluids of the patient, to the teratogenic drug. Such counsel may be provided verbally, as well as in written form. In preferred embodiments, the prescriber and/or pharmacist provides the patient with literature materials on the drug for which a prescription is contemplated, such as product information, educational brochures, continuing education monographs, and the like. Thus, in the case of methods involving teratogenic drugs, the prescriber and/or pharmacist preferably provides patients with literature information, for example, in the form of the aforesaid product information, educational brochures, continuing education monographs, and the like, warning the patient of the effects of the drug on foetuses. In the case of other drugs which are known or suspected of causing an adverse side effect, the patient is counselled as to the dangers of taking the drugs, and if steps which may be taken to avoid those risks. For example, if the concomitant use of the drug and another drug, for example alcohol, is to be avoided, the prescriber and/or pharmacist advises the patient of the risks of drinking alcohol while taking the drug."
21. The result of the information provided to patients is that they are able to provide informed consent.
1.5 The prescription approval code
22. Approval to dispense thalidomide or lenalidomide is communicated by a prescription approval code. The nature of the prescription approval code is not stated in the specification. Consequently I have attempted to draw inferences from the role that it plays. The code is "assigned to the prescription" (page 5). This suggests that a record is kept of the prescription and the code that has been issued, but does not indicate what form the code might take. The prescription cannot be filled unless a prescription approval code is provided, giving the prescription approval code a gatekeeper role. From this I conclude that anything that could reasonably be seen as indicating approval can be seen as an approval code.
23. The specification contains a single example, which does not shed any light on the approval code. The example is based on the assumption that the prescriber, pharmacist and patient are all registered in the system. The relevant part of the example says (at page 27 – 28):
"Once the script is verified by the RMC [the RMC is a Risk Management Center, which is defined on page 12 as “a centralised collection of information that manages the risk of adverse side effects known or suspected of being caused by the drug”] a prescription approval code is assigned to the prescription by the RMC. The prescription approval code is then provided to the pharmacist, who may then dispense thalidomide to the patient.
If a prescription approval code is not provided to the pharmacist, the pharmacist will notify the patient and/or prescriber."
24. I conclude that the prescription approval code is anything that could reasonably be seen as indicating approval.
1.6 What is the outcome of the method?
25. The method described in the patent is a variation on the existing method of dispensing lenalidomide or thalidomide. However, it is not immediately clear what is achieved (in terms of a different outcome) by following the method of the patent. The following is a sample of statements that appear in the specification that are relevant to this issue:
"the Australian Therapeutic Goods Administration (TGA) has approved an application by Celgene Pty Limited to market thalidomide for the treatment of erythema nodosum leprosum (ENL) and multiple myeloma in specified circumstances … due to the severe teratogenic risk of thalidomide, methods are needed to control the distribution of this drug so as to preclude administration to foetuses" (page 3)
"an improved survey is needed which would be representative of all users of a particular drug, such as thalidomide and lenalidomide" (page 4)
"the present invention is directed to a method to monitor and authorise the distribution of lenalidomide or thalidomide" (page 4)
"the present invention also relates to a method of reducing the risk of an adverse side effect known or suspected to be caused by a drug occurring in females of childbearing potential receiving the drug directly or indirectly" (page 5)
"the present invention also provides a system for dispensing one or more drugs to a patient in need of the drug(s) so as to minimise the risk of an adverse side effect known or suspected of being caused by the drug(s)" (page 8)
"the methods described herein provide advantageous and effective means for monitoring, controlling and authorizing the distribution to patients of drugs known or suspected of causing adverse side effects" (page 9)
"used to avoid exposure of foetuses to teratogenic drugs" (page 9)
"reducing or minimizing the possibility that a contraindicated individual will be exposed to the potentially hazardous drugs" (page 10)
"the methods of the present invention preferably involve requiring the patient to fill out an informed consent form" (page 19)
"by filling out and signing an informed consent form, the patient acknowledges that he/she understands the risks associated with the drug" (page 19)
"the registration into one or more computer readable storage media of the prescriber, pharmacy and patient, according to the methods described herein, provide a means to monitor and authorize distribution of contraindicated drugs, including teratogenic drugs" (page 25)
26. The method appears to be directed towards several outcomes - reducing the incidence of a contraindicated patient taking lenalidomide or thalidomide, reducing the incidence of a patient being unaware of the risks associated with lenalidomide or thalidomide, and developing records of lenalidomide or thalidomide use.
27. The risk associated with lenalidomide or thalidomide being taken by a contraindicated patient is significant, due to the birth defects known to be associated or suspected with these drugs. However, such an outcome is only possible if prescribers have been wrongly prescribing them. I can find no statement in the specification that suggests this is believed to be the case. I note that I raised this point in my first decision, and no extra information has been inserted into the description of the present patent. It seems likely that such information does not exist. Rather, the risk that is being referred to in the specification seems to be the "you can never be too safe" kind of risk. Consequently, as the specification provides no reason to believe that contraindicated patients are currently being prescribed thalidomide, the method of the invention will not lead to any additional patients being denied lenalidomide or thalidomide. The difference between the method of the invention and the existing process is that there will be greater confidence that contraindicated patients will not receive the drug.
28. Turning to patient information, it is apparent that as a result of the method patients may have a fuller understanding of the risks associated with lenalidomide and thalidomide (and better able to give informed consent). For instance, the specification states at page 18 that male patients "are preferably counselled to use condoms every time they engage in sexual relations, since many teratogenic drugs may be found in semen". However, the specification provides no reason to believe that patients are not being properly informed of the risks associated with lenalidomide and thalidomide. In this case, the method of the invention will not lead to any patients receiving information that they would not otherwise possess. The difference between the method of the invention and the existing process is only that there will be greater confidence that patients have the necessary information. Similarly to what is said above, this point was raised in my first decision and the patentee has not inserted any further information into the description of the present patent.
29. The method is also said to achieve a monitoring of the distribution of the drug. The method that is described has several steps where data is stored in a computer readable storage medium, and where the computer readable storage medium is queried. For instance:
"recording in a computer readable storage medium an assessment of whether the risk of an adverse side effect occurring in the patient is acceptable" (page 7)
"recordal in the computer readable storage medium of an assessment that the risk of an adverse side effect occurring in the patient is acceptable" (page 8)
30. I have carefully studied the single example of the invention, and it does not mention monitoring. The specification refers to the possibility of follow-up actions (for instance, an additional patient survey is mentioned on page 22), but I am not sure that this is the monitoring that the claim envisages as it is unconnected to any of the features of the claim. I think that the most likely construction is that monitoring refers to keeping records, which could be achieved by keeping manual records outsider the computer system, but it is more likely that monitoring is simply storing patient, prescriber, pharmacy, risk and approval code data in the computer readable storage medium.
2 The claims
31. The specification contains five claims. The claims differ only slightly from those in the earlier patents.
2.1 Claim 1
32. Claim 1 as filed is as follows:
A method to monitor and authorise the distribution of lenalidomide or thalidomide comprising:
creating at least one database by:
storing in a computer readable storage medium registered prescriber data by receiving for registration prescriber data including at least one of the prescriber's name, the prescriber's address and affiliation with one or more health care institutions, and registering the prescriber;
storing in a computer readable storage medium registered pharmacy data by receiving for registration pharmacy data including at least one of the pharmacy name, address and affiliation and registering the pharmacy;
storing in a computer readable storage medium patient data by:
receiving for registration patient data including at least one of name, sex, address, date of birth;
receiving patient data that is probative of assessing the risk that a known or suspected adverse side effect will occur if the drug is taken by the patient;
assigning a unique patient identification number to the patient data in the computer readable storage medium, and registering the patient;
upon receiving a communication from a pharmacy including a request for authorisation to dispense a prescription issued by a prescriber to a patient, said request including prescription details and patient data sufficient to identify the patient:
querying the computer readable storage medium to verify that the prescriber and the pharmacy are registered;
querying the computer readable storage medium to verify that the patient is a registered patient with a unique patient identification number;
in the event that both the pharmacy and the prescriber are registered and that the patient is registered and the patient's unique patient identification number is verified, querying the computer readable storage medium using the registered patient's unique patient identification number to access the registered patient's data to verify by reference to the unique patient identification number assigned to the patient data that the risk of a side effect occurring upon administration of lenalidomide or thalidomide to the patient is acceptable;
in the event that the risk is acceptable, authorising the pharmacy to dispense the prescription by generating a prescription approval code assigned to the prescription; and
providing the assigned prescription approval code in respect of the prescription to the pharmacy to authorise the distribution of lenalidomide or thalidomide.
33. There are several key questions to be addressed in order to construe this claim.
2.2 How does the method "verify … that the risk of a side effect … is acceptable"?
34. The claim says that there is a "querying" of the computer readable storage medium to "verify by reference to the unique patient identification number" that "the risk of a side effect occurring upon administration of lenalidomide or thalidomide to the patient is acceptable". It seems that the unique patient identification number (UPIN) is the key to the verification. However, I do not believe that the verification is solely by confirming that there is a UPIN. The more sensible construction seems to be that the UPIN is used as means to access the data stored in the system, and thereby make a risk assessment.
35. The claim does not otherwise define how the risk assessment is carried out. For instance, it is not apparent whether the assessment is carried out by a computer in an automated fashion or by a human operator. This ambiguity can be resolved by reference to the body of the specification (see Interlego A.G. v Toltoys Proprietary Limited [1973] HCA 1, 130 CLR 461 at 479), where it is apparent that the invention is directed to a manual assessment rather than an automated assessment. This is the construction that I will apply to the claim.
2.3 What is the output of the method of claim 1?
36. Claim 1 is a method, and methods are characterised by the steps of the method. Claim 1 says it is a "method to monitor and authorise the distribution" of one of two drugs. The steps proceed up to the point where a dispenser is authorised to dispense the drug, but do not include the step of dispensing. While it is logical that the drug will then be dispensed and used by the patient, these are not steps of the claimed method.
37. The monitoring aspect of the method is not defined in the claim. There is an ambiguity on the face of the claim as to whether the monitoring is part of the computer system, or sits outside of the computer system. This ambiguity can be resolved by reference to the body of the specification (see Interlego v Toltoys at 479). The monitoring system as claimed should be construed as monitoring by recording information on the patient, prescriber, pharmacy, risks and approval in the computer readable storage medium.
2.4 What is the role of the prescription approval code?
38. The final part of the claim says
"in the event that the risk is acceptable, authorising the pharmacy to dispense the prescription by generating a prescription approval code assigned to the prescription; and
providing the assigned prescription approval code in respect of the prescription to the pharmacy to authorise the distribution of lenalidomide or thalidomide"
39. The only role for the prescription approval code is to “authorise the distribution of lenalidomide or thalidomide”.
2.5 Who inputs patient data to the system?
40. Mr Shavin submitted that one of the benefits of the process is that risk data is collected by the prescriber and entered by the prescriber, and that benefits resulted from this arrangement (compared to collection and entry by a pharmacist). The claim contains no requirement for the data to be entered by a prescriber. The claim merely says "receiving patient data that is probative of assessing the risk that a known or suspected adverse side effect will occur if the drug is taken by the patient". The plain language of the claim is that this data can be entered by any person.
2.6 Claim 2
41. Claim 2 is appended to claim 1:
2. A method according to claim 1, wherein the patient data sufficient to identify the patient is the patient's unique patient identification number.
The added feature is the use of a unique patient identification number (UPIN).
2.7 Claim 3
42. Claim 3 is appended to either claim 1 or claim 2:
3. A method as claimed in claim 1 or 2 wherein a registered prescriber submits the patient data, obtains the unique patient identification number assigned to the patient and includes the unique patient identification number on a prescription issued by the registered prescriber.
43. The added features are that the prescriber obtains the UPIN and includes it on the prescription.
2.8 Claim 4
44. Claim 4 is appended to any of claims 1, 2 or 3:
4. A method as claimed in any of claims 1, 2 or 3 which further includes providing the patient's unique patient identification number to a registered prescriber to enable the registered prescriber to record the unique patient identification number on a prescription of lenalidomide or thalidomide.
45. The added feature is that the prescriber is provided with the UPIN.
2.9 Claim 5
46. Claim 5 is appended to any of claims 1, 2, 3 or 4:
5. A method as claimed in any of claims 1 to 4 wherein the steps of storing in a computer readable storage medium registered patient data further includes using the received patient registration data and a predefined set of risk parameters to assign a patient to one of a plurality of risk groups to assess whether the risk of a side effect is acceptable.
47. The added features of this claim are that patient data is compared to a set of risk parameters to assess whether there is an acceptable risk to the patient.
3 The objections
48. There are two 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 – specifically claims 1 – 5 lack novelty and innovative step. I will deal with the anticipation issues first.
4 Novelty
49. Section 7 of the Act states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
50. It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19, 137 CLR 228 at 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement"
51. This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
52. The examiner has raised a novelty objection against claims 1 – 5 based on US patent application 2007/0219825 by Derek J. Maetzold and Terrance C. Coyne (the citation). The citation states on its face that it was published on 20 September 2007. Since the present patent was filed under section 79C, the claims are entitled to the priority date that would have applied to those claims had they been included in the specification of the parent (regulation 3.12(2D)), provided they are fairly based on the matter disclosed in the parent (regulation 3.12(1)(d)(i)) and examination of the application was requested within 2 months of the date of grant (regulation 3.12(1)(d)(ii)). In the present case, I accept that those criteria have been met. Prima facie the claims are entitled to the priority date of the original parent application: 31 March 2010. Consequently the citation is prior art for the purposes of section 7.
53. The citation states at paragraph [0003] that it relates to
"methods for delivering a drug to a patient. More particularly, the methods restrict access to the drug to only those patients for which the risk that they will experience an adverse side effect is acceptable"
54. The way in which the citation achieves this end is explained in paragraph [0009] as
"a method for restricting delivery of a drug that provides a combination of some or all of the following elements: (i) a method for registering prescribers, patients, and pharmacies with a program to enable restricted distribution of the drug; (ii) a method for providing education and counselling to prescribers, patients, pharmacies, laboratories, and clinics who may need to interact with the patient during their drug treatment program, specifically related to the drug and the drug delivery method; (iii) a method for collecting and providing up-to-date patient-specific health information beyond what is collected in an office examination to enable a physician or others responsible for overseeing the drug treatment program to better manage the drug treatment program and minimize undesired side effects; (iv) a method for providing a secondary review of the patient’s health to help identify any risk factors in a patient to help prevent occurrence of adverse side effects; and (v) a drug service center to manage and ensure compliance with the above elements."
55. It is step (i) of this method that is of particular significance in the present case. At paragraph [0011] the citation says:
"the generation of the prescription approval comprises providing a database, in which at least one prescriber, at least one pharmacy and the patient are registered; creating a patient profile in the database … enabling the at least one registered prescriber to access to the patient profile in the database … and upon a determination by the registered prescriber that the risk is acceptable, generating a prescription approval"
and then at paragraph [0012]
"wherein after the prescription approval has been generated, the at least one registered pharmacy is permitted to dispense the drug to the patient as ordered by the prescription"
56. The drugs envisaged include thalidomide (which is specifically named in paragraph [0024] of the citation). The citation makes it clear that the method of the citation can be used for any drug "known or suspected of causing an adverse side effect" (page 2), although it does not specifically refer to lenalidomide. The present patent admits that "a concern exists that lenalidomide may cause birth defects if it is taken during pregnancy". I think it is clear that lenalidomide is a drug "known or suspected of causing an adverse side effect", and that the citation provides a clear and unmistakeable disclosure that the process applies to lenalidomide.
57. The system disclosed in the citation involves a database (which is a computer readable storage medium), and communication by telephone, fax or web-based means. The database stores information about registered prescribers, pharmacies and patients. Patient profiles are created in the database. Baseline information about risk is stored in the database, and where the risk is acceptable a prescription approval is generated.
58. It is clear that there are substantial similarities between the method described in the citation and that in the innovation patent. The examiner's report identified where the features of claim 1 can be located in the citation. I will repeat the relevant part of the report:
a method to monitor and authorise the distribution of lenalidomide or thalidomide (paragraphs [0003], [0024] & [0036]) comprising:
creating at least one database by:
storing in a computer readable storage medium registered prescriber data by receiving for registration prescriber data including at least one of the prescriber's name, the prescriber's address and affiliation with one or more health care institutions, and registering the prescriber (paragraph [0027]);
storing in a computer readable storage medium registered pharmacy data by receiving for registration pharmacy data including at least one of the pharmacy name, address and affiliation and registering the pharmacy (paragraph [0028]);
storing in a computer readable storage medium patient data by:
receiving for registration patient data including at least one of name, sex, address, date of birth (paragraph [0030]);
receiving patient data that is probative of assessing the risk that a known or suspected adverse side effect will occur if the drug is taken by the patient (paragraphs [0011] & [0046]);
assigning a unique patient identification number to the patient data in the computer readable storage medium, (paragraph [0073]) and registering the patient;
upon receiving a communication from a pharmacy including a request for authorisation to dispense a prescription issued by a prescriber to a patient, said request including prescription details and patient data sufficient to identify the patient (paragraphs [0065]-[0066]):
querying the computer readable storage medium to verify that the prescriber and the pharmacy are registered (paragraphs [0009] & [0091]);
querying the computer readable storage medium to verify that the patient is a registered patient with a unique patient identification number (paragraphs [0009] & [0091]);
in the event that both the pharmacy and the prescriber are registered and that the patient is registered and the patient's unique patient identification number is verified, querying the computer readable storage medium using the registered patient's unique patient identification number to access the registered patient’s data to verify by reference to the unique patient identification number assigned to the patient data that the risk of a side effect occurring upon administration of lenalidomide or thalidomide to the patient is acceptable (paragraphs [0011] & [0046]);
in the event that the risk is acceptable, authorising the pharmacy to dispense the prescription by generating a prescription approval code assigned to the prescription (paragraph [0011], "upon a determination by the registered prescriber that the risk is acceptable, generating a prescription approval"); and
providing the assigned prescription approval code (implicit feature of D1) in respect of the prescription to the pharmacy to authorise the distribution of lenalidomide or thalidomide (paragraphs [0091]-[0092]).
59. The patentee’s submissions at the hearing were that several features are missing from the citation. These features are:
1. The prescription approval is not a code
2. The approval is not generated in response to a prescription
3. The communication from the pharmacy is not a request for authorisation
4. The approval is not generated in response to a request from the pharmacy
5. The UPIN is not used to interrogate the database
6. The UPIN is not included on the prescription
7. Patients are not assigned to predefined risk groups
60. The feature that I believe is not disclosed in the citation is the point at which the approval is generated (which is features 2 and 4 above). The examiner noted that the approval code is mentioned at [0011]:
"upon a determination by the registered prescriber that the risk is acceptable, generating a prescription approval"
This means that the approval is generated after a determination by the prescriber. The question is whether this is immediately after the determination by the prescriber (and prior to the involvement of the pharmacy), or any time after the determination by the prescriber (including after the presentation of a prescription at the pharmacy). I think that the more reasonable reading of the citation is that the approval is generated immediately after the determination by the prescriber, and before the presentation of the prescription at the pharmacy. It follows that the citation does not disclose the feature of generating the approval once a communication is received from the pharmacy.
61. I will briefly consider the other matters, as it is necessary to form a view for the purposes of determining innovative step.
The prescription approval code
62. The specification of the innovation patent does not contain a definition of the term "prescription approval code", or an example of such a code. Mr Shavin asserted that a code should be understood to be "a system of words, letters, figures, or symbols used to represent others, especially for the purposes of secrecy". However, this is only one definition of a code, and I do not think that the purpose of the code in the present patent is to maintain secrecy. The Macquarie Dictionary defines "code" as
"3. a system of symbols for use in communication by telegraph, heliograph, etc., as morse code. 4. a symbol (made up of signs, numbers, letters, sounds, etc.) in such a system. 5. a set of words, pictures or other readily recognised symbols used for conveying messages briefly, as road signs. 6. a system of arbitrarily chosen symbols, words etc. used for secrecy. 7. a system of symbols for conveying information or instructions to an electronic computer."
63. In essence, a code is a representation of a piece of information. I have difficulty seeing why a word (such as YES) is not properly viewed as a code. As noted in my first decision, writing uses symbols (i.e. the letters of the alphabet) to create words that represent information, and a YES or NO response can be regarded as a "prescription approval code". Additionally, a signal sent to the computer at the pharmacy is not a YES, but an electronic signal that is decoded by the pharmacy computer as the word YES. The electronic signal is clearly a code according to Mr Shavin's definition. Second, YES is itself a shorthand (or code) for something like "you are authorised to dispense thalidomide to the person named in the prescription". In either case a "code" is sent to the pharmacy.
64. Mr Shavin also submitted that in the citation the approval could be the prescription itself. Paragraph [0077] contains the statement:
"Once the patient's baseline lab test results have been confirmed, the prescription is sent to a specialty pharmacy, instructing the speciality pharmacy to dispense sitaxsentan sodium to the patient."
65. I agree that the form of the prescription approval in the citation is broad, and can encompass many things (as can the "prescription approval code" in the present claims).
The nature of the communication from the pharmacy
66. Mr Shavin pointed out that at [0047] the citation says:
"Prior to dispensing the drug, the pharmacy preferably confirms, for example, via a standard on-line transmission that the patient has been registered and is eligible to receive the drug"
67. This suggests, at least in one embodiment of the invention, that there may be only a limited communication. However, the specification also states at [0010]:
"The method of the embodiments comprises permitting a prescription to be filled by a pharmacy only after a pharmacy has received an approval for release for the prescription."
68. I think it is clear that the citation is disclosing methods where the pharmacy seeks an approval to dispense, not merely confirmation of registration.
Use of the UPIN
69. The claim says that the UPIN is used as part of the verification process. The claim does not specify how the UPIN is used. The citation clearly says that verification is based on patient data, and also that a unique identification number is assigned to the patient (see [0073]). The role of the identification number is not explained in the citation. Similarly, the claim does not define the role of the UPIN in verification. In both cases the number is associated with patient data, and thus is part of the package of information that is considered. The patentee cannot say that the number is used in a different way when the claim does not define how the number is used.
Assignment to predefined risk groups
70. This feature is only found in claim 5, so is not relevant to the novelty of claim 1.
Other matters
71. Several other matters were raised at the hearing that I will also address. The patentee’s written submissions indicated that the citation allows the drug to be dispensed without the presentation of a prescription. The submissions state:
"In contrast, Maetzold et al. contemplates that the pharmacy may dispense the drug on receipt of instructions from the prescriber or a drug service centre rather than on presentation of the prescription by the patient in the pharmacy."
72. It is true that there are some passages in the citation that refer to embodiments where "this registration card or form may also serve as a request for a prescription for the drug" (para [0030]). However, it is quite clear that the citation is not restricted to this embodiment, and that it is directed generally to "permitting a prescription order to be filled by a pharmacy only after the pharmacy has received an approval" (see para [0010]). It is clear that the citation discloses a patient presenting a prescription to the pharmacy.
73. The patentee also submitted that the citation does not require an approval to be issued each time the drug is dispensed (i.e. it may not be required for a refill). The patentee’s written submission says:
"Some embodiments of Maetzold et al. appear to require that a prescription approval is obtained each time before the drug is dispensed. Other embodiments treat that as optional."
74. The patentee acknowledges that there is a disclosure of requiring an approval each time a prescription is filled. The fact that some embodiments may treat this as optional does not remove the disclosure of those embodiments where it is obtained. This feature is clearly disclosed.
75. I conclude that it has not been shown that claim 1 (and consequently the appended claims 2 – 5) are lacking in novelty.
5 Innovative step
76. Section 7 of the Act states that an invention is taken to involve an innovative step unless the invention would only vary from the prior art information in ways that make no substantial contribution to the working of the invention. The Federal Court has considered innovative step in Dura-Post (Aust) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81, 81 IPR 480. At [73] – [74], 496 – 497 Kenny and Stone JJ state:
"Section 7(4) requires a comparison to be made between the invention as claimed in each claim with the information s 7(5) describes. That is, s 7(5) identifies the kinds of information to which the invention as claimed in each claim is to be compared. This information is particular kinds of prior disclosures. Section 7(6) requires that each such prior disclosure be considered separately. That is, the invention as claimed in each claim must be compared separately with each relevant prior disclosure.
In making this comparison, s 7(4) requires that each comparison be made from the perspective of a person skilled in the art, whose task is to identify and assess the variations between the invention as claimed in each claim and the prior disclosure and determine whether or not these variations make a substantial contribution to the working of the invention as claimed in each claim. Dura-Post accepted, as do we, that the primary judge was correct in holding that “substantial” contribution in the context of s 7(4) meant 'real' or 'of substance'. The place of common general knowledge in this provision is straightforward enough. Section 7(4) contemplates that, in performing this task, a person skilled in the art has certain background knowledge that that person uses in identifying and assessing these variations."
77. The objection of lack of innovative step based on US 2007/0219825 (the same citation discussed above in relation to novelty) is directed to claims 1 – 5. The first step in determining whether there is an innovative step is to identify the variations between the invention as claimed and the citation. In my consideration above I concluded that claim 1 differs from the citation in that the approval code is generated upon a communication from the pharmacy (features 2 and 4) rather than at an earlier point in time. The variation between the invention as claimed and the citation is the point in time at which the approval code is generated. The next step is to determine whether the variation makes a substantial contribution to the working of the invention as claimed. A change in the point in time at which the approval is generated does not lead to a different outcome. That is, the patients who would receive thalidomide following the process of the citation would also receive thalidomide following the process of the innovation patent, and vice versa. Further, it is not apparent that the process of the innovation patient achieves the outcome in a cheaper, more efficient or otherwise beneficial way. I cannot see any contribution that the variation over the citation makes to the invention other than to confer novelty. I conclude that this variation does not make a substantial contribution to the working of the invention, and thus claim 1 lacks an innovative step.
78. Turning now to the appended claims, claim 2 adds the feature of the UPIN being used to identify the patient. The citation discloses a unique identification number that is assigned to the patient, but does not disclose its role. However, it is difficult to see any role for a unique identification number than to identify the patient. I am satisfied that the citation discloses this feature, so it follows that claim 2 also lacks innovative step.
79. Turning to claim 3, the feature of including the UPIN on the prescription is not disclosed in the citation. While this is a minor variation, I can see that it would make it easier for the pharmacist. However, it does not change the way that the invention works, and in this case I am not satisfied that the convenience for the pharmacist should be regarded as a substantial contribution to the way that the invention works. I am satisfied that claim 3 also lacks an innovative step.
80. Claim 4 includes the feature of providing the prescriber with the UPIN. This feature is not mentioned in the citation. Again, this variation may make the operation of the process more convenient, but it does not seem to make a substantial contribution to the way the invention works. I am satisfied that claim 4 also lacks an innovative step.
81. Finally, claim 5 includes the feature that patient data is compared to a set of risk parameters to assess whether there is an acceptable risk to the patient. The citation refers to this feature in relation to a known prior art document: "patients are assigned to risk groups based upon the risk that taking the drug will lead to the side effect" (at [0007], referring to document US 6,315,720). The citation lays out flow charts in Figures 1 to 5 describing the process of registering a patient and dispensing a drug. I note that there are questions such as "Is patient a FCBP" (female of child bearing potential), "Is the patient on Cyclosporine A", "Is the patient on Vitamin K Antagonists (Warfarin)", "Is the patient pregnant". It seems clear that the citation discloses a method where the risk assessment is based (at least in part) on a consideration of risk parameters. As this feature is clearly disclosed in the citation, claim 5 lacks an innovative step.
82. The invention defined by claims 1 – 5 lacks an innovative step in the light of the citation.
6 Manner of manufacture
83. The examiner reported that claims 1 – 5 represent nothing more than a scheme, and consequently are not directed to patentable subject matter.
84. Subsection 18(1A)(a) provides that an invention is a patentable invention if, so far as claimed in any claim, it is “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies”. The concept of manner of manufacture has developed over time, and is not readily reduced to a simple formula. The leading consideration of manner of manufacture is the decision of the High Court in National Research Development Corporation v Commissioner of Patents [1959] HCA 67, 102 CLR 252. The Court made the observation (at [14], 269) that it is necessary to look at the concept of what is patentable:
"The inquiry which the definition demands is an inquiry into the scope of the permissible subject matter of letters patent and grants of privilege protected by the section. It is an inquiry not into the meaning of a word so much as into the breadth of the concept which the law has developed by its consideration of the text and purpose of the Statute of Monopolies. … The right question is: 'Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?' "
85. The existing case law provides examples of various subject matter that does, and does not, constitute a manner of manufacture. In National Research Development Corporation (hereafter referred to simply as NRDC) a method for eradicating weeds was held to be patentable subject matter. The Court laid down the well known requirement that a process must produce “an artificially created state of affairs” in order to be held patentable (at [25], 277). This formulation has been applied by the Federal Court in a number of cases. Of note is Grant v Commissioner of Patents [2006] FCAFC 120, 234 ALR 230 where the court at [30], 237 referred to "any artificial state of affairs, in the sense of a concrete, tangible, physical, or observable effect". Further, the effect produced must be "material" (NRDC at [22], 275) or a "useful effect" (International Business Machines Corporation v Commissioner of Patents [1991] FCA 625, 105 ALR 388 at [14], 394). Insignificant physical effects will not be sufficient. For example, the Grant decision is a case where the claimed process produced a movement in the ownership of assets (which can be seen as an effect), but was not a manner of manufacture.
86. Further, the artificial state of affairs must lie in the field of economic activity. Examples of fields of economic activity are the cultivation of the soil for the production of its fruits (NRDC), retail trading (Welcome Real‑Time SA v Catuity Inc [2001] FCA 445, 51 IPR 327) and the repair and rehabilitation of members of the work force (Joos v Commissioner of Patents [1972] HCA 38, 126 CLR 611).
87. Mr Shavin argued that the present case is analogous to Catuity, in that a computer is used as an integral and essential element of a system to record and generate information. The written submissions provided by the patentee state at [36]:
"The physical effect resulting from the method of the Patent is analogous to the writing of new information to the Behaviour file the subject of the patent in Catuity and the generation of a curve on computer graphic displays the subject of the patent in International Business Machines Corporation v Commissioner of Patents (1991) 33 FCR 218."
88. The computer is said to be central, not merely incidental (written submissions at [40]):
"It is the computer that generates the prescription approval code, following assessment of information particular to a certain patient stored therein, authorising the dispensation of thalidomide or lenalidomide."
89. While I accept that the method is carried out using a computer, I do not agree that the computer is central. The computer stores information, and communicates information. However, the computer does not make the risk assessment. In the present case the use of a computer is not determinative, and it is more important to look at what is produced by the process according to the test laid down in NRDC.
90. The claimed method of monitoring and authorising the dispensing of lenalidomide or thalidomide leads to an outcome where (i) a record has been created, and (ii) the pharmacist has approval (or a lack of approval) to dispense the drug. It is not an outcome of the claimed process that the patient has received the drug. The critical question is whether either of these outcomes, or the sum of them, can be seen as an artificial state of affairs.
91. Turning first to the keeping of records, I have construed the claim as directed to keeping records in a computer readable storage medium. The outcome of such a process would be a change in the memory state of the computer.
92. In Re Virginia-Carolina Chemical Corporation’s Application [1958] RPC 35 at 36 the Tribunal recognised the principle that "the intellectual or visual content of a paper or card related to the fine and not the applied arts, and was accordingly outside the statutory definition of invention". This logic was said to be equally applicable to articles such as cinematographic films and gramophone records (at 36). Information stored in a computer readable storage medium is directly analogous to information stored on any other medium.
93. On the other hand, the patentee relies on comments in Catuity. At [128] there is a statement that writing information to a computer file is a physically observable effect:
"In any event, to the extent that 'physically observable effect' is required (and I do not accept that this is necessarily so) it is to be found in the writing of new information to the Behaviour file and the printing of the coupon."
94. I note that this was not a simple case of writing information to a file. In order to write the information to the card, the patentee had to overcome the problem of limited memory space on the card by altering the format of the information. Additionally, a 'physically observable effect' is not the same as an artificial state of affairs. His Honour found an artificial state of affairs in the totality of the arrangement, not merely the writing of data to a file. At [127] this is made clear:
"an artificial state of affairs in that cards can be issued making available to consumers many different loyalty programs of different traders as well as different programs offered by the same trader. All this can be done instantaneously at each retail outlet. So what is involved here is not just an abstract idea or method of calculation. Moreover this result is beneficial in a field of economic endeavour - namely retail trading - because it enables many traders (including small traders) to use loyalty programs and thereby compete more effectively for business. Such competition is in turn beneficial to consumers, both in the general sense that competition is good and in the sense that they can obtain benefits in the form of discounts and free goods and services."
95. I conclude that Catuity does not stand for the proposition that the mere writing of information to a computer file is in itself an artificial state of affairs. According to traditional principles laid down in Virginia-Carolina, absent a mechanical purpose or substantial effect achieved by the writing or information, the mere storage of information (albeit in a computer rather than on paper) cannot be regarded as an artificial state of affairs.
96. The process also produces an approval (or denial of approval) to dispense the drug. An approval is a permission for an action to occur. I cannot see how a permission can be regarded as an artificial state of affairs.
97. Looking at the sum of the record keeping and approval, I do not see that there is anything further created. This is very different to the state of affairs in Catuity. I conclude that the claims of the present innovation patent are directed to a process that is not a manner of manufacture. Further, I do not consider that the description includes any other subject matter that would constitute a manner of manufacture.
7 Conclusion
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.
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.
100. The patentee has had a reasonable opportunity to be heard, and has been heard. The present innovation patent represents the fifth attempt by the patentee to obtain certification for this invention. On two previous occasions I issued written decisions with reasons, and those decisions were appealed to the Federal Court. In my first decision I allowed the patentee an opportunity to amend, and no amendments were filed. Two different divisionals were filed, with slightly different claims (the present patent being the latest divisional). Both of those divisionals have failed to gain certification. There has been ample opportunity for the patentee to draft claims for the present patent to take into account the objections consistently raised. It is not apparent to me that there is any amendment that could be made to save the patent.
101. I must revoke the patent. This decision can be appealed to the Federal Court under section 101F(4).
8 Final observation
102. If the claims were regarded as encompassing both manual and automated risk assessment there would be a lack of fair basis (as the description does not provide a disclosure of an automated risk assessment), and a lack of full description.
Dr S.D.Barker
Delegate of the Commissioner of Patents
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