Genentech Inc and Central Sydney Area Health Service v Celtrix Pharmaceuticals Incorporated
[1993] APO 39
•19 May 1993
official notice
decision of a delegate of the commissioner of patents
Application : No. 629820 in the name of GENENTECH INC and CENTRAL SYDNEY AREA HEALTH SERVICE
Title: Production of Insulin-like Growth Factor Binding Protein
Action: Opposition by CELTRIX PHARMACEUTICALS INC, and a request for dismissal of the opposition
Decision: Issued . Request for dismissal refused.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 629820 by GENENTECH INC and
CENTRAL SYDNEY AREA HEALTH SERVICE, opposition thereto
by CELTRIX PHARMACEUTICALS INCORPORATED, and a request
for dismissal of the opposition
background
Patent application 629820 by Genentech Inc and Central Sydney Area Health Service (Genentech) was advertised accepted on 15 October 1992. A notice of opposition under sec 59(1) of the Patents Act 1952 was served by Celtrix Pharmaceuticals Incorporated (Celtrix) on 19 January 1993. On 19 February 1993 Celtrix, in accordance with reg 5.4 of the Patents Regulations 1990, served a statement purporting to set out the grounds of opposition and the particulars relating to each ground. On 9 March 1993 Genentech invoked the provisions of reg 5.5 and requested the Commissioner to dismiss the opposition.
I heard the request for dismissal by telephone on 16 April 1993. Genentech was represented by Dr Peter A. Stearne, patent attorney with Davies Collison Cave, and Celtrix was represented by Dr William Pickering, patent attorney with F B Rice & Co.
THE STATEMENT OF GROUNDS AND PARTICULARS
So far as is material to the present request, the statement of grounds and particulars reads as follows:
"GROUNDS
B. The invention as claimed in Claims 1 to 29 is
not a patentable invention because the
invention so far as claimed in any one of
those claims, was published in Australia
before the priority date of those claims.C. The invention as claimed in Claims 1 to 29
was, before the priority date of those
claims, otherwise not novel in Australia.D. The invention as claimed in Claims 1 to 29
was obvious and did not involve an inventive
step, having regard to what is known or used
in Australia on or before the priority date
of those claims.
PARTICULARSB-C The invention as claimed by claims 1 to 29 is
not a patentable invention and was not (sic)
prior published in Australia before the
priority date of those claims or was
otherwise not novel in Australia because the
invention is disclosed in the following
documents:1. Australian Patent application No 17020/88
(627423) entitled "Human somatomedin carrier
protein sub units and process for producing
them" in the name of Biogrowth Incorporated.2. Spencer et al. (1984) "Isolation of the human
plasma carrier protein for somatomedin",
Abstracts, 7th International Congress of
Endocrinology, p. 1278.3. Baxter et al. (1985) "Purification and
radioimmunoassay of insulin-like growth
factor binding protein from human plasma",
Program and Abstracts, The Endocrine Society,
67th Annual Meeting, p. 201.4. Grant et al. (1986) "Separation of the
insulin-like growth factor binding proteins
in human serum and characterization of the
acid stable component of the 150K species",
Program and Abstracts, The Endocrine Society,
68th Annual Meeting, p. 83.5. Gelato et al. (1986) "Heterogeneity of
insulin-like growth factor (IGF) binding
protein species derived from the M=150K IGF
-binding protein complex", Program and
Abstracts, The Endocrine Society, 68th Annual
Meeting, p. 83.6. Martin, J.L. and Baxter, R.C. (1986)
"Insulin-like growth factor-binding protein
from human plasma, purification and
characterization", J. Biol. Chem.
261:8754-8760.7. Baxter et al. (1986) "Growth hormone
-dependent insulin-like growth factor (IGF)
binding protein from human plasma differs
from other human IGF binding proteins",
Biochem. Biophys. Res. Comm.
139:1256-1261.8. Hintz, R.L. (1984) Clinics in Endo. and
Metabol. 13:31-42.9. Povoa et al. (1984) Eur. J. Biochem.
144:199-204.10. Baxter et al. (1987) J. Clin. Endo. Metabol.
65:423-431.11. Martin, J.L. and Baxter, R.C. (1985) J. Clin.
Endo. Metabol. 61:799-801.12. Baxter, R.C. and Martin, J.L. (1986) J. Clin.
Invest. 78:1504-1542.13. Morris et al. (1982) "Structure of
somatomedin- binding protein: alkaline
pH-induced dissociation of an acid-stable,
60,000 molecular weight complex into smaller
components", Endocrinology 111(3):801-805.14. Kuffer et al. (1984) "Partial purification of
a specific inhibitor of the insulin-like
growth factors by reverse-phase high
-performance liquid chromatography",
J. Chromatography 336:87-92.15. Knauer et al. (1981) "Purification and
characterization of multiplication
-stimulating activity (MSA) carrier protein",
Cellular Biochem. 15:177-191.16. Enberg, G. (1986) "Purification of a high
molecular weight somatomedin binding protein
from human plasma", Biochem. Biophys. Res.
Comm. 135(1):178-182.17. Povoa et al. (1985) "The somatomedin-binding
protein isolated from a human hepatoma cell
line is identical to the human amniotic fluid
somatomedin-binding protein", Biochem.
Biophys. Res. Comm. 128(3):1071-1078.18. Drop et al. (1984) "Immunoassay of a
somatomedin-binding protein from human
amniotic fluid: levels in fetal, neonatal,
and adult sera", J. Clin. Endocrinol.
Metabol. 59(5):908-915.19. Wood, W.I. et al. (1988) "Cloning and
expression of the growth hormone-dependent
insulin-like growth factor binding protein",
Molecular Endocrinol. 2:1176-1185.20. Baxter, R.C. et al. (1987) "Binding proteins
for insulin-like growth factors in adult rat
serum. Comparison with other human and rat
binding proteins", Biochem. Biophys. Res.
Comm. 147:408-415.21. Leung, D.W. et al. (1987) "Growth hormone
receptor and serum binding protein:
purification, cloning and expression",
Nature 330:537-543.22. Oshima, A. et al. (1988) "The human cation-
independent mannose 6-phosphate receptor.
Cloning and sequence of the full-length cDNA
and expression of functional receptor in COS
cells", J. Biol. Chem. 263:2553-2562.23. Brinkman, A. et al. (1988) "Isolation and
characterization of a cDNA encoding the low
molecular weight insulin-like growth factor
binding protein (IBP-1)", The EMBO Journal,
7:2417-2423.24. Lee, Y.-L. et al. (1988) "Insulin-like growth
factor (IGF) binding protein complementary
deoxyribonucleic acid from human HEP G2
hepatoma cells: predicted protein sequence
suggests an IGF binding domain different from
those of the IGF-I and IGF-II receptors",
Molecular Endocrinology, 2:404-411.25. Brewer, M.T. et al. (1988) "Cloning,
characterization, and expression of a human
insulin-like growth factor binding protein",
Bio. Chem. Res. Comm. 152:1289-1297.26. Grundmann, U. et al. (1988) "Cloning of cDNA
encoding human placental protein 12 (PP12):
binding protein for IGFI and somatomedin",
Nucl. Acids Res. 16:8711.27. Martin, J.L. et al. (1986) "Insulin-like
growth factor-binding protein from human
plasma. Purification and characterization",
J. Biol. Chem. 261:8754-8760.28. Baxter, R.C. (1988) "The insulin-like growth
factors and their binding proteins", Comp.
Biochem. Physiol. 91B:229-235.D The invention as claimed in claims 1 to 29
was obvious and did not involve an inventive
step in the view (sic) of the common general
knowledge in Australia at the priority date
to which Application 629820 is entitled. The
common general knowledge included the
disclosures in the following:1. Maniatis et al. (1982) Molecular Cloning: A
Laboratory Manual (New York: Cold Spring
Harbor Laboratories).2. Tissure Culture (1973) (Academic Press, Kruse
and Patterson, eds.).
3. Boliver et al. (1977) Gene 2:95-113.4. Urlaub and Chasin (1980) Proc. Natl. Acad.
Sci. USA 77:4216 [CHO cells].5. Gething et al. (1981) Nature 293:620-625.
6. Mantei et al. (1981) Nature 281:40-46.
7. Veira and Messing (1987) Methods Enzymol.
153:3-11.8. Messing et al. (1981) Nucl. Acids Res.
9:309-321.9. Maxam et al. (1980) Methods Enzymol. 65:499.
10. Henzel et al. (1987) Chromatography
404:41-52.11. Lawn et al. (1981) Nucl. Acids Res. 9:6103
-6114.12. Goeddel et al. (1980) Nucl. Acids Res.
8:4057."
Before proceeding further, it is worth noting that the statement sets forth ground B in terms of sec 59 of the Patents Act 1990 in which the test for validity is based on the concept of a "patentable invention". As sec 234(3) of the Patents Act 1990 applies to the present application the opposition cannot, strictly speaking, rely on this ground. However, upon applying a purposive construction to the statement (Borden Inc v Elkem A/S (1992) AIPC 90-893), I believe there is a clear inference in respect of ground B that Celtrix intends to rely on sec 59(1)(e) of the Patents Act 1952.
REQUEST FOR DISMISSAL
The request for dismissal is based upon the following deficiencies alleged by Genentech to exist in the statement of particulars:
"1. The particulars of ground B & C are defective in
that a number of cited references were published
after the priority date of the claims, this
being 22 March 1988.2. Particulars in respect of ground D are defective in
that their generality is insufficient to properly
inform the Applicant of the case to be met. The
particulars do not set forth the material facts of
this ground of opposition. There is no reference
to the particular field of common general knowledge
on which reliance is made. Common general
knowledge is said to "include" the disclosures in
12 references. The term "include" is uncertain and
may embrace other disclosures not listed in the
Statement of Particulars. Moreover, there is no
reference to what information in the various
references is relevant to this case."
DECISION
Relevant Law
Dismissal of an opposition is covered by the provisions of reg 5.5 of the Patents Regulations 1990 which read as follows:
"Dismissal of opposition
5.5 (1) An applicant may:
(a) within 1 month of being served with a copy of
a statement by an opponent under subregulation
5.4(1) ("filing of statement"); or(b) if the complete specification in relation to
an opposed application is re-examined under
subsection 97(1) of the Act ("re-examination of
complete specifications") - within 1 month from
the day when the re-examination is completed
under regulation 9.5 ("completion of
re-examination);
request the Commissioner in the approved form to
dismiss the opposition.(2) As soon as practicable after a request is
made, the Commissioner must inform the opponent
of the request having been made.(3) The Commissioner may dismiss the opposition
whether or not the applicant has requested
dismissal of the opposition."
The general principle in considering a request for dismissal is that an opposition should only be dismissed if it is "so obviously untenable that it cannot possibly succeed" (General Steel Industries Inc v Commissioner for Railways (NSW) and Others (1964) 112 CLR 125 at page 129). Furthermore, the decision in L'Air Liquide v The Commonwealth Industrial Gases Ltd (1992) AIPC 90-872 provides authority for a dismissal in part of an opposition as requested in the present situation by Genentech.
Findings
As regards the first reason for requesting dismissal, Dr Stearne argued that a number of the particularised documents were published after the priority date of the claims of application 629820 and, consequently, did not support the opposition under grounds B and C (i.e. prior publication and novelty).
Dr Pickering responded by pointing out that the statement of particulars must set out the material facts on which each ground of opposition is based, but not the evidence by which those facts are proved (Mobay Corporation v Dow Chemical Company (1992) AIPC 90-895). He then submitted that there was no evidence of record to establish the publication dates of the particularised documents in question and, more importantly, that the argument advanced by Dr Stearne was concerned with questions of fact which raise substantive issues of the opposition rather than being confined to matters of material fact.
In the L'Air Liquide decision (supra) the Assistant Commissioner stated that in his opinion a dismissal of corresponding grounds might be appropriate if the publication date of the citation is later than the latest priority date that could be accorded the opposed specification. However there is no evidence to suggest that this is the case in the present situation. Consequently, in my view any attempt on my part to form an opinion as to the likely success of Celtrix's case in relation to prior publication and novelty on the basis of the arguments before me would amount to conducting a de facto hearing of the substantive opposition. This is clearly not appropriate to an action for dismissal.
Notwithstanding this, it is particularly relevant to note that the first reason for dismissal is in effect predicated upon the assertion that grounds B and C of the opposition should be dismissed because they are not supported by some of the particulars. In Norwood Industries Pty Ltd v Macbird Floraprint Pty Ltd (1992) AIPC 90-912, the delegate of the Commissioner at page 38,602 held that:
".... despite the presence of a number of ineffective particulars, dismissal of an opposition with respect to a particularised ground can only occur where none of the particulars support that ground. Furthermore, the Commissioner may not dismiss a ground of opposition only in relation to certain inadequate particulars."
Nothing in the arguments before me suggests that Celtrix has failed to provide any particulars that support grounds B and C of the opposition. I therefore find that the first reason for dismissal is unfounded.
As regards the second reason for requesting dismissal, Dr Stearne drew my attention to the decision of the Assistant Commissioner in Diamond Scientific Co v CSL Limited (1992) AIPC 90-927 where at page 38,690 he held:
"Furthermore, as I have said above, the applicant has the right to know, at the time the statement of grounds and particulars is filed, the complete case that it has to answer in the opposition."
Dr Stearne submitted that the present statement of particulars failed on two counts to give Genentech fair notice of the case to be met in relation to ground D (i.e. obviousness).
Firstly, he argued that the open-ended nature of the phrase "The common general knowledge included the disclosures in the following:" (emphasis added) as used in the statement leaves reasonable doubt as to the documents Celtrix would ultimately rely upon to establish common general knowledge. In Dr Stearne's view, this phrase opened the way for Celtrix to introduce particulars not specifically identified in the originally filed statement. And secondly, Dr Stearne argued that the statement of particulars merely refers to a long list of documents without giving an indication of what Celtrix considers to be common general knowledge, or how each document is to be relied upon. This was again contrary to the views expressed in the Diamond Scientific v CSL decision (supra).
In my opinion I am unable to infer from the way in which the statement of particulars is expressed in relation to ground D that Celtrix intends to rely upon a group of documents larger than those listed by the statement to support its case. It seems to me from the dictionary meaning of "included" that this expression may be alternatively construed to mean that the common general knowledge upon which Celtrix will rely is encompassed by the listed documents alone. Nevertheless, it is well to remember in regard to the former interpretation that any subsequent attempt by Celtrix to amend the statement of particulars so as to add particulars not specifically referred to in the original statement would be subject to some fetters (Diamond Scientific v CSL (supra)).
Dr Pickering responded to Dr Stearne's second concern by pointing out that Celtrix had given a clear signal that it intends to oppose the grant of a patent on application 629820 on the basis that it is obvious which, in the present circumstances, must be determined by having regard solely to matters of common general knowledge (Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Limited 144 CLR 253). Such matters had been adequately particularised. Dr Pickering further pointed out that as the documents listed in the statement of particulars were cross-referenced in the complete specification of application 629820, the material disclosed by these documents should be well known to Genentech. He then claimed that, taking the above into consideration, the material facts provided are sufficient to inform Genentech of the case to be met in respect of ground D.
As previously stated, the particulars relating to ground D (obviousness) indicate that the ground is based on the common general knowledge as established by a number of expressly listed technical documents. Thus it seems to me that this level of particularisation sufficiently identifies the facts relied upon by Celtrix to support the ground of obviousness. In reaching this conclusion I have not had regard to whether the facts are likely to establish a successful case since such an analysis would, of course, pre-empt the substantive opposition. It is also well to remember here that the statement of particulars should not, as Dr Stearne appears to be suggesting, refer to the evidence or to the line of argument that will be pursued in evidence (L'Air Liquide v The Commonwealth Industrial Gases and Borden v Elkem (supra)). I therefore find that the second reason for dismissal is unfounded.
CONCLUSION
I find that the statement of particulars adequately supports the opposition under grounds B, C and D and, consequently, I refuse to dismiss the opposition in so far as it relates to these grounds. In accordance with the general principle that costs follow the event, I award costs against Genentech.
Pursuant to reg 5.8(1)(a)(iii), the time for filing evidence in support of the opposition is 3 months from the date of this decision.
O.L.Haggar
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Davies Collison Cave,
Melbourne
Patent attorneys for the opponent : F B Rice & Co,
Sydney
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