(CIRCUIT BENCH AT DELHI)
ORDER (No. 25 of 2013)
Prabha Sridevan, Chairman:
The appellant applied for grant of patent to the invention titled âA Composition Comprising One to Three Bioactive Agents and a Vehicle Comprising a Modified and Unmodified Liquid Carrierâ.
2. According to the appellant at the time of invention, the state of the art did not know a pharmaceutical composition that provided sustained-release delivery of bioactive substance wherein the release performance is predictable and reproducible immediately after manufacture of the product and when the appellant surprisingly found that they had a composition which achieved just that and therefore they applied for patent application No.1466/DELNP/2005 on 12.4.2005. The appellant is aggrieved that by the impugned order, wherein the Assistant Controller of Patents and Designs found that the invention was obvious and did not deserve the grant.
3. The facts preceding the rejection are as follows:
The appellant made a request on 7.10.2005 for examination of the patent. The First Examination Report was dated 27/11/2006, the objection was that the claims 1-15 do not involve an inventive step in view of citation D1 (International Publication No.WO 02/22107 A), D2 (United States Patent Publication No.2002/068065), D3 (United States Patent No.6074657), D4 (United States Patent No.5736151), and D5 (International Publication No.WO 9420505 A) mentioned in the IPER. According to the objections, the claim fell within the scope of Section 3(e) of the Act, the claims were not clear, they did not sufficiently define the invention. The appellant responded to it by the letter dated 2, February, 2007. In this reply they stated that sustained release of the drug is the key feature of the invention and in D1 there was no specific teaching towards using a modified liquid carrier in a very low proportion and as regards D2 too the appellant gave the same reply. As regards D3 to D5, the appellant stated that there was no teaching of the composition of the present invention. They requested that all the objections be withdrawn and also for an opportunity to be officially heard before any adverse decision was taken.
4. On 23.11.2007, the respondent informed the appellant that the principal objections still remain and thereafter by a letter of the same day they fixed 27.11.2007 for hearing. The matter was heard on the that date and orders were pronounced on 21.07.2009. The appellant filed by way of evidence, the affidavit of Dr. Susan M. Machkovech, who is the Co-inventor of the impugned patent. She had also referred to the five prior arts D1 to D5 and stated that there was no specific teaching in D1 that using a modified liquid carrier in very low proportion to the unmodified liquid carrier that would result in sustained release performance.
5. According to the deponent, since ceftiofur crystalline free acid composition prepared in an unmodified liquid carrier, without incorporation of a modified liquid carrier did not provide adequate sustained release, the persons skilled in the art will not anticipate that by adding very low levels of modified liquid carrier, a sustained release composition could be prepared.
6. As regards D2, the deponent said âIn my opinion, the reference D2 does not teach or suggest the compositions having a ratio by volume of the modified liquid carrier to the un-modified liquid carrier as low as 0.00001:99.00000 of â2005 application, to provide predicable sustained release properties. According to her, there is simply no teaching in D3 of the composition of the present invention. This novel approach of using modified liquid carriers to prepare sustained release formulations with predictable in-vivo properties is not disclosed in reference D3. There is also no mention in D3 of formulations like those of the present invention comprising one of the more preferred carriers: a mixture of modified cottonseed oil with saturated coconut oil. As regards D4, the opinion of the inventor was that there is no mention in D4 that these ceftiofur hydrochloride compositions provide any type of sustained release properties and in fact, D4 does not disclose the preparation of any sustained release formulations whatsoever. As regards D5, there is no teaching, suggestion and/or motivation in D5 of the composition of the present invention claimed in â2005 application. According to her D1to D5 either alone or in combination do not disclose, teach, suggest or motivate present invention.
7. On the basis of this evidence, the appellant made his submissions before the Controller. The Controller considered the invention with reference to each of the 5 prior arts and held that it was obvious.
8. The learned counsel for the appellant submitted that the intention of the Act is to grant the patent and not to deny the patent. According to the learned counsel the respondent did not exercise his discretion to allow amendment. According to the learned counsel, in the invention the ratio between modified liquid carrier and un-modified liquid carrier is considerably lower than of the prior art. The learned counsel submitted that the problem that was sought to be addressed in the prior art was the immediate release of the drug, whereas, here what was resolved was sustained release, further the prior arts were economically unviable. Whereas the ratio used in the invention was quite contrary to the prior art which had no motivation for the low ratio.
9. The learned counsel submitted that the complete specifications contained terminology definition to make the invention better understood. The learned counsel submitted that D3 and D4 were not at all relevant to the invention. The learned counsel referred to the various decisions and submitted that even a slight alteration to the prior arts may mean great ingenuity. The learned counsel submitted that no expert evidence was filed by the Controller which is essential to decide the obviousness.
10. The learned counsel referred to the following decisions and also TERRELL ON THE LAW OF PATENTS at page 241, which dealing with obviousness had observed that the primary evidence is that of properly qualified expert witnesses and the court must find on fact whether what is state of the art on that date and whether having regard to the state of the art, the inventive step would be obvious.
11. The following decisions were referred to:
1.Intellectual Property Appellate Board Order No.79/2011 in OA/10/2010/PT/CH â Dr. Thomas Thomas N Vs. The Assistant Controller of Patents and Designs - where this Board had held that the sufficient time should be given to the applicant to respond to the First Examination Report.
2. 1985 R.P.C. â Windsurfing International Inc. Vs. Tabur marine (Great Britain) Ltd. â where it was held that Answering the question on obviousness required four steps to be taken:
i)identifying the inventive concept embodied in the patent;
ii)imputing to a normally skilled but unimaginative addressee what was common general knowledge in the art at the priority date;
iii)identifying the differences if any between the matter cited and the alleged invention; and
iv)deciding whether those differences, viewed without any knowledge of the alleged invention constituted steps which would have been obvious to the skilled man or whether they required any degree of invention.
3. 1972 R.P.C. â Technograph Printed Circuits Ltd. Vs. Mills and Rockley (Electronics) Ltd. â where it was held thatâonce an invention is known, it is possible to postulate the starting point from which the inventor would have arrived at his invention. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result.â
4. AIR 1930 â Privy Council â Canadian General Electric Co. Ltd. Vs. Fada Radio Ltd. â where it was held that âSlight alterations or improvements may produce important results, and may disclose great ingenuity. Sometimes it is a combination that is the invention; if the invention requires independent thought, ingenuity and skill, producing in a distinctive form a more efficient result converting a comparatively defective apparatus into a useful and efficient one, rejecting what is bad and useless in former attempts and retaining what is useful, and uniting them all into an apparatus which taken as a whole, is novel, there is subject matter of invention.â
5. AIR 1982 SC 1444 â Bishwanath Prasad Radhey Shyam Vs. Hindustan Metal Industries â where it was held that âAs Cotton L.J. put in Blackey v. Latham (1888) 6 Pat. Ca. 184, to be new in the patent sense, the novelty must show invention. In other words, in order to be patentable, the new subject matter must involve âinvention over what is old. Determination of this question, which in reality is a crucial test, has been one of the most difficult aspects of Patent Law, and has led to considerable conflict of judicial opinion.â
6. United States District Court for the Southern District of New York â Unigene Laboratories, Inc. and Upsher-Smith Laboratories, Inc. Vs. Apotex, Inc. and Apotex Corp. â where it was held that âObviousness under 35 U.S.C. $ 103(a) is a legal question based on underlying factual determinations. Eisai, 533, F.3d at 1356 (citing Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1478, 1479 (Fed. Cir. 1997). An obviousness analysis measures the difference between the claimed invention and the prior art to determine whether the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.â
âId. At 421 (describing that a person of ordinary creativity, [and is] not an automation); see also Bayer Schering Pharm. AG vs. Barr Labs., Inc., 575 F.3d 1341, 1350 (Fed. Cir. 2009) (Newmann, J., dissenting) (âThe statutory criterion is whether the invention would have been obvious to persons of ordinary skill at the time of the invention, not whether it is sufficiently simple to appear obvious to judges after the discovery is finally made.â
âA person of ordinary skill at the time of the invention interprets the prior art using common sense and appropriate perspective.â
7. 27 F.3d 551 United States Court of Appeals, Federal Circuit â In re Francis S. Gurley No.94-1025
Reference may be said to âteach awayâ from invention when person of ordinary skill, upon reading reference, would be discouraged from following path set out in reference, or would be led in direction divergent from path that was taken by patent applicant.
Reference will âteach awayâ from invention if it suggests that line of development flowing from references disclosure is unlikely to be productive of result sought by applicant.
It was held that âGurleys position appears to be that a reference that âteaches awayâ can not serve to create a prima facie case of obviousness. We agree that this is a useful general rule. However, such a rule cannot be adopted in the abstract, for it may not be applicable in all factual circumstances. Although a reference that teaches away is a significant factor to be considered in determining unobviousness, the nature of the teaching is highly relevant, and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.
12. The relevant extract of the complete specifications is as follows:
Pharmaceutical Compositions having a Modified Vehicle
Background of the Invention
1. Field of the Invention
The present invention relates to pharmaceutical compositions. More specifically, it relates to the use of pharmaceutically acceptable vehicles comprised of (i) a modified liquid carrier and (ii) an unmodified carrier, wherein the ratio by volume of the modified liquid carrier of the essentially un-oxidizable carrier is between 0.00001:99.99999 to less than 0.01:99.99, that provide the composition with predictable sustained-release properties.
2. Background of the Invention
In the pharmaceutical arts, drug delivery is an element as significant as drug activity. Many drugs or bioactive agents with apparent in vitro activity fail at the clinical level due to the inability to prepare, store, or deliver the bioactive agent to the site of action in effective concentrations over a sufficient period of time.
13. The complete specifications refers to D5 and after hearing referred to other prior arts, states that there still exists a need in the art for pharmaceutical compositions that provide sustained release delivery of a bioactive substance and wherein the release performance is predictable and reproducible immediately after manufacture of the product.
Brief Summary of the Invention
Surprisingly, we have found that a composition comprising:
a) one to three bioactive agents; and
b) a vehicle comprising:
(i) a modified liquid carrier, and
(ii) an un-modified liquid carrier
provides the desired release performance characteristics with a ratio by volume of modified carrier to un-oxidizable carrier as low as 0.00001:99.99999. Thus, the present invention provides a novel pharmaceutical composition that provides sustained-release of a bioactive component and wherein the release performance is predictable immediately after manufacture of the product. More specifically, the predictable performance is obtained by using a modified liquid carrier in very low proportion to the un-oxidizable carrier.
14. Thereafter the complete specification refers to three embodiment of the invention and describes the specific aspect of the method for producing the composition as follows:
A more specific aspect of the method comprises the steps of:
a)heating natural cottonseed oil or trilinolein in the presence of air to increase its oxidation products and yield a modified cottonseed oil;
b)combining said modified oil with saturated coconut oil or saturated coconut oil products to yield a carrier vehicle wherein the ratio by volume of the modified oil to saturated coconut oil is between 0.00001:99.99999 to less than 0.01:99.99;
c)adding crystalline ceftiofur free acid to said carrier vehicle; and optionally, thereafter;
d)heating said pharmaceutical composition;
e)cooling said composition;
f)filling one or more vials with said composition; and
g)exposing said one or more vials to gamma radiation
15. Fig. 1 diagram â a method that can be used to produce the inventive composition. Fig. 2 shows the correlation of in virto and in vivo release date. The common specification gives terminology definition for âbioactive substanceâ âSustained-delivery or Sustained-releaseâ. âUnsaturated oils suitable for modificationâ which mentions cottonseed oil as one of the liquid carriers. It defines the word âmodifiedâ and âmodificationâ and also âsubstantially peroxidized unsaturated oil vehicleâ. The invention is said to comprise of the composition as follows:
The Invention
The present invention comprises a composition comprising :
a)one to three bioactive agents;
b)a modified liquid carrier; and
c)an essentially un-oxidizable carrier;
wherein the ratio by volume of the modified liquid carrier to the essentially un-oxidizable carrier is between 0.00001:99.99999 to less than 0.01:99.99 (v/v), and wherein immediately after manufacture of the composition, said composition can be administered to a host to provide sustained release of one to three bioactive agents.
16. A preferred bioactive agent is crystalline ceftiofur free acid (CCFA). According to the specifications, the inventive compositions are useful for human and veterinary medicine and the composition of the present invention can be administered parenterally, topically, intravaginally, orally or rectally. According to the complete specifications an important aspect of the present invention is that by performing the modification of the carrier vehicle in vivo performance of the bioactive substance can be entirely controlled and predictable. The complete specification gives non limiting examples of the invention.
17. The claims are as follows:
1. A composition comprising:
(a) one to three bioactive agents of the kind such as herein described; and
(b) a vehicle comprising:
(i) a modified liquid carrier of the kind such as herein described; and
(ii) an un-modified liquid carrier of the kind such as herein described.
Wherein the ratio by volume of the modified liquid carrier to the un-modified liquid carrier is between 0.00001:99.99999 to less than 0.01:99.9, that provide the composition with predictable sustained-release properties and wherein immediately after manufacture of the composition, said composition can be administered to a host such that the one to three bioactive agents is released to the host on a sustained basis.
2. The composition as claimed in claim 1, wherein said one to three bioactive agents is selected from the group consisting of pharmaceuticals, immunogenic and immunomodulator compositions, vectors, viruses, spores, nutritional supplements and bacteria and mixtures thereof.
3. The composition as claimed in claim 2, wherein said bioactive agent comprises crystalline ceftiofur free acid.
4. The composition as claimed in claim 1, wherein said vehicle comprises a modified liquid carrier and an un-modified unsaturated oil suitable for modification.
5. The composition as claimed in claim 1, wherein said vehicle comprises a modified and an un-modified un-oxidizable oil.
6. The composition as claimed in claim 1, wherein said modified liquid carier comprises a modified vegetable oil wherein said vegetable oil is selected from the group consisting of corn oil, peanut oil, sesame oil, olive oil, palm oil, safflower oil, soybean oil, cottonseed oil, rapeseed oil, sunflower oil and mixtures thereof.
7. The composition as claimed in claim 4, wherein said modified liquid carrier comprises modified cottonseed oil.
8. The composition as claimed in claim 4, wherein said un-modified liquid carrier comprises coconut oil.
9. A composition as claimed in claim 4, comprising crystalline cetiofur free acid, modified cottonseed oil and saturated coconut oil.
10. A composition as claimed in claim 4, comprising optionally modified trilinolein.
11. The composition as claimed in claims 9 and 10, wherein the ratio by volume of modified cottonseed oil to saturated coconut oil is between 0.00001:99.99999 to less than 0.01:99.99.
12. The composition as claimed in claim 9, wherein the concentration of crystalline ceftiofur free acid in said composition ranges from 50 mg/ml to 250 mg/ml.
13. The composition as claimed in claim 9, wherein the concentration of crystalline ceftiofur free acid in said composition ranges from about 100 mg/ml to about 200 mg/ml.
14. A method for producing a pharmaceutical composition comprising the steps of modifying a liquid vehicle and combining said modified liquid vehicle with a bioactive substance.
15. A product prepared by a process comprising the steps of (i) modifying a liquid vehicle and (ii) combining said modified liquid vehicle with a bioactive substance.
18. D1- WO 02/22107 - World Intellectual Property Organization, PCT/US01/2603 -- D1 is an invention belonging to the appellant. The witness whose affidavit has been filed is the co-inventor of this invention also. The D1 specifications are almost identical to the impugned patent. The field of invention reads as follows: âThe present invention relates to pharmaceutical compositions. More specifically, it relates to the use of modified pharmaceutically acceptable liquid carriers that provide the composition with predictable sustained-release propertiesâ. Therefore it is apparent and it is admitted by the inventor that the invention lies in the very low proportion of modified liquid carrier to the unmodified liquid carrier. In the brief summary of the invention, it is claimed that D1 can be administered on a sustained release basis wherein the release performance is predictable. The difference lies only in the ratio and it is claimed in the complete specification that this use of modified liquid carrier provides the desired relief performance. The composition in D1 comprises of one or more bioactive agent and a modified liquid carrier. In the impugned invention, the composition comprises of 1-3 bioactive agent and a vehicle comprising a modified liquid carrier and un-modified liquid carrier. In D1 also immediately after manufacture of the composition, it can be administered to the host such that the bioactive agent is released to the host on a predictable sustained release composition. Therefore one of the advantages of D1 was predictable sustained release of the drug.
19. One of the preferred embodiments of D1 was a composition which comprises CCFA and the other component being a modified liquid carrier which includes non modified un-saturated oil, non modified saturated oil, non modified oxidizing vehicle or non modified non oil or a mixture of these. D1 also says that it is an advantage to identify a dosage form that provides sustained release capability and that this is obtained by the oil, a modified saturated oil, a modified non-oxidizing vehicle, a modified non-oil or any mixture thereof in combination with the bioactive agent. In addition to the modified component, the liquid carrier can also optionally include a non-modified unsaturated oil, a non-modified saturated oil, a non-modified non-oxidizing vehicle, a non-modified non-oil or any mixture thereof. It is noted here âthat other combinations which include as atleast one component a modified vehicle can be envisioned by one skilled in the artâ Then obviously the present invention must be obvious to POSITA. In all embodiments, a key feature is that a portion of the carrier vehicle has been modified either before, after or both before and after, it has been combined with the bioactive agent.
20. The preferred embodiment of D1 is where the delivery vehicle is a combination and it is modified unsaturated oil with a fully saturated oil or non-oxidizing vehicle. In even more preferred embodiments, the modified unsaturated oil is a substantially peroxidized unsaturated oil vehicle. For this embodiment, the ratio of modified unsaturated oil to saturated, non-oxidizing oil is from about from about 0.01:99.99 to about 90:10 (v/v), the total amount of each being 100 percent, with particular reference to the range from about 10:90 to about 25:75 (v/v), and most particularly from about 10:90 to about 20:80 (v/v).
21. In D1 as also in the Invention, the performance of the bioactive substance administered in vivo 30 days, 60 days, 90 days and so on is comparable to the performance just after manufacture.
22. In both the Invention in question and in D1, it is found that the sustained release formulation can be achieved by alternate routes and one of which is by adding the drug to non modified and unsaturated oil and directly subjecting it to terminal irradiation to modify the unsaturated oil and produce the vehicle with sustained release characteristics. We have already seen that in one of the specific aspect of the method of the present invention is to use a combination of heat and gamma irradiation after combining the modified oil with the non-modified oil to the CCFA. These were all matters of common general knowledge.
23. As regards oral and therapeutic administration and parenteral application, the D1 composition and the patent composition are almost identical.
24. The examples given in D1 shows that the modified vehicle and the unmodified vehicle are combined in ratio ranging from 10:90, 20:80, 1:99, 5:95, 40:60 and so on. And the resulting product, in every example, was a stable sustained release formulation of CCFA.
25. D2 â D2 is again an invention which belongs to the appellant herein and it is a composition of one or more bioactive agent and non aqueous liquid carrier. Here again, the problem addressed is drug delivery and the D2 invention can be administered on a sustained release or immediate release basis. One of the preferred embodiments chooses CCFA as one of the bioactive agents and a mixture of modified or non modified oxidizable oil with a non modified non oxidizable oil and so on in various combination. Therefore, one of the composition uses a vehicle comprising of a modified oil and one of unmodified oil. D2 specifically prefers cottonseed oil as in the invention. In certain embodiment of the invention, where a modified liquid carrier is utilized, in addition to the modified component, the liquid carrier can also optionally include a non-modified oxidizable oil, a non modified non-oxidizable oil, a non-modified non-oxidizing vehicle, a non-modified non-oil or any mixture thereof. Another preferred embodiment of the present invention, the ratio of modified oxidizable oil to non oxidizable oil is as follows: âThe ratio of modified oxidizable oil to non oxidizable oil is from about 0.01:99.99 to about 90:10 (v/v), the total amount of each being 100 percent, with particular reference to the range from about 10:90 to about 25:75 (v/v), and most particularly from about 10:90 to about 20:80 (v/v)â. Of course this invention relates to the specific water activity of the composition.
26. D3 â D3 is an invention which again belongs to the appellant as the assignee. It is an administration of an injunctible antibiotic in the ear of an animal. This uses CCFA as the bioactive agent.
27. D4 â D4 again belongs to the appellant as the assignee. The invention is an antibiotic oil suspension which provides for inclusion of small amount of water in oil suspension of active drugs.
28. D5 â This again is an invention which belongs to the appellant and it relates to a novel crystalline form of centiofur free acid and sustained-release pharmaceutical composition containing this crystalline form. Claim 13 of this invention is for a composition, where the non aqueous liquid is oil.
29. All these prior arts are kindred inventions. According to the inventor, the predictable performance is obtained by using a modified liquid carrier in a very low proportion to the unoxidizable carrier. In re Francis S. Gurley (cited above), the claim was for a printed circuit material which is epoxy based. The prior art was circuit boards similar to the invention but resin based and in the prior art it was specifically mentioned that the use of epoxy would make the boards inferior to circuit boards made from resins. It was contended by the inventor that the prior art therefore teaches away since it discourages the person skilled in the art from reaching towards epoxy. The Court held âGurleys position appears to be that a reference that âteaches away can not serve to create a prima facie case of obviousness. We agree that this is a useful general rule. However, such a rule cannot be adopted in the abstract, for it may not be applicable in all factual circumstances. Although a reference that teaches away is a significant factor to be considered in determining unobviousness, the nature of the teaching is highly relevant, and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same useâ. The court also said that even if the prior art teaching was discouraging, the claimed invention âasserted no discovery beyond what was known to the artâ. If that were so, then in this case where the prior art clearly does not discourage, and leads towards the various options in fact, we must also hold that the invention did not carry the state of the art beyond what was known on that date.
30. In Unigene Laboratories, Inc. and Upsher-Smith Laboratories, Inc. Vs. Apotex, Inc. and Apotex Corp. (cited supra) the invention was a pharmaceutical nasal spray with two drugs that had to be compared one used benzalkonium chloride (BZK) which functions as a preservative, absorption and enhancer while the other drug used was 20 mM of citric acid. The Court held that the ordinary skilled persons reading the prior arts would consider citric acid undesirable in a liquid nasal formulation containing salmon calcitonin, so the obviousness objection was rejected.
31. InBishwanath Prasad Radhey Shyam Vs. Hindustan Metal Industries â the difficulty in deciding patentability has been underlined, it was they held that the patent was nothing more than a workshop improvement and it did not lie outside the track what was known before.
32. In Technograph Printed Circuits Limited Vs. Mills and Rockley (cited supra) the invention was electric circuit networks, where the respondent expert had given evidence and the Court held that it was unlikely that the unimaginative technicians would have been led to the present invention by the state of the prior art. This was stressed by the learned counsel for the appellant to prove the point that when the inventor has given evidence and there is no contra evidence, the patent must be granted.
33. In Dr. Thomas Thomas N (cited supra) because there was no time, the appellant did not appear for the hearing. This cannot apply to the present case where not only at the appellant filed written submissions on 27th November but had also argued the matter in detail.
34. Finally, we come to the Windsurfing Internation Inc. Vs. Tabur Marine (cited supra) for deciding obviousness and where it was held that Answering the question on obviousness required four steps to be taken, those steps have already been referred to:
35. In Unigene Labs Vs. Apotex (cited supra) there is a reference to KSR case {KSR vs. Teleflex [550 US 398 (2006)]} where the US Supreme Court said that when there are a finite number of identified, predictable solutions, a person of ordinary skill will reasonably pursue all of the options and if it leads to anticipated success, it is not be innovation but ordinary common sense.
36. In this case, we find from the prior arts that the bioactive agent CCFA was being administered with a degree of success in achieving sustained release; the vehicle in which the drug was administered parentarally, orally or otherwise was by mixing it with non aqueous liquid carrier heating it and subjecting it to irradiation. While D1 claimed the composition comprising a bioactive agent with modified liquid carrier, one of the embodiments it actually dealt with a composition of the drug with non modified liquid carrier. Therefore the whole spectrum which is before the person with ordinary skill looking at D1 was a vehicle which contained modified oil or non modified oil or a composition or mixture of the two in differing ratios. Therefore it should not be a matter of surprise if the person of ordinary skill by trying the various combinations arrives at this specific ratio to find that this has predictable degree of sustained release. And in KSR it was held that the person of ordinary skill is a person of ordinary creativity not an automation. We have referred to this person of ordinary skill in para 42 of IPAB Order No.250/2012 - OA/8/2009/PT/CH â Sankalp Rehabilitation Trust Vs. F. Hoffmann-La-Roche AG and Ors. by order dated 2.11.2012.
Para42. The non-obviousness and novelty factors are sometimes sitting there cheekâby-jowl, âThe Law of Patentsâ by Nard second Edition says that Novelty âseeks to assure the public domain remains undisturbedâ while nonâobviousness âdemands that the claimed invention be sufficiently removed from the prior artâ. This text also says that non-obvious enquiry is âa more aggressive sentryâ and âa richer policy tool that allows for the combination of prior art references and demands more complex rules.â In KSR, the US Supreme Court held that the analysis of obviousness must be made explicit, and the reasoning to support the conclusion of obviousness must be articulated with rational underpinnings, the Court may have to look at the inter-related teachings of the multiple patents, the effect of demands known to the design community and the background knowledge possessed by a person having ordinary skill in the art. So the determination on obviousness is a legal one. The Court has to see a) what is the prior art b) the differences between the prior art and the invention and c) the skill of the imaginary ordinary man. This man has skill but until KSR came along he had no inventive or creative capacity. Such a person is hard to find, but we had to conjure this man in our mind as we do the man on the Clapham omnibus. By way of diversion, it seems he is referred by the acronym Mr.PHOSITA or just PHOSITA, the preferred acronym could be POSIT it sounds better or POSITA if you please. Getting back to the track, as KSR says this man is âA person of ordinary skill is also a person of ordinary creativity not an automaton.â So an automaton- like unimaginative but skilled man has now been allowed to have a modicum of creativity and imagination by the grace of the U.S.Supreme Court! We must remember that this ordinary man has skill in this art. He is not ignorant of its basics, nor is he ignorant of the activities in the particular field. He is also not ignorant of the demand on this art. âHe is just an average man........ Well... just an ordinary man.â But he is no dullard . He has read the prior art and knows how to proceed in the normal course of research with what he knows of the state of the art. He does not need to by guided along step by step. He can work his way through. He reads the prior arts as a whole and allows himself to be taught by what is contained therein. He is neither picking out theâ teaching towards passagesâ like the challenger, nor is he seeking out the âteaching away passagesâ like the defender. In this case he is a person familiar with or engaged in pEG chemistry. He knew that it was a time of intense activity in this field of chemistry. The person defending the patent will undoubtedly inform the Court that there was nothing in the prior art to encourage the person skilled in the art to work toward the invention. KSR says âThe question is not whether the combination was obvious to the patentee but whether the combination was obvious to the person skilled in the art. Under the correct analysis, any need or problem known in the field of endeavour at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.â And one of the easy ways by which âa patents subject matter can be proved obvious is by noting that there was an obvious solution encompassed by the patents claims.â KSR also says that if pursuit of known options within the technical grasp of the person skilled art leads to the anticipated success â it is likely the product not of innovation but of ordinary skill and common senseâ.
37. If we apply the Windsurfing tests, the obviousness is clear:
1. The underlying concept was the composition with a low proportion of the modified liquid carrier to result in sustained release. Admittedly D1 achieved it.
2. The common general knowledge on that date is what was obtained in D1, so in this case, the necessity of any other evidence for proving obviousness does not arise.
3. The difference is in the ratio. We have already seen the whole spectrum from a CCFA composition with only modified liquid carrier to a CCFA composition with only a non modified liquid carrier was there and the mixture of varying proportions in between. So a composition with a very low proportion of one or the other is what one might say âno big dealâ.
4. The difference is not, in the words of Gurley âbeyond what was known in the artâ.
38. The citations D1 and D2 disclose the same composition comprising one (preferred ceftiofur crystalline free acid) or three bioactive agents and a vehicle comprising a modified liquid carrier and an unmodified liquid carrier wherein the ratio by volume of modified liquid carrier to the unmodified liquid carrier is between 0.01:99.99 to about 90:10 (v/v), the total amount of each being 100 percent with particular 10:90 to about 20:80 (v/v) so the ratio of 0.00001:99.9999 to less than 0.01:99.99 as recited in claim 1 of the present application that provide the composition with predictable sustained release properties is quite obvious. We hold it is obvious not because it is simple or with the benefit of hindsight, but for all the reasons above. It is obvious.
39. The learned counsel referred to the words in the impugned order which state that therefore âit can be obviousâ to the person skilled in the art and posed the question whether this means that there is a doubt in the mind of the Controller. We do not think so. Reading the order as a whole it is clear that he only meant that âthe person skilled in the art would find it obviousâ.
40. Considering the fact that by a grant of patent, the applicant gets an exclusive monopoly in his invention, a full and fair disclosure of what is known to him is perhaps only to be expected. The patent applicant cannot leave it to the Controller and to the streaming download of knowledge from the computer at the Controllers finger tip. The applicant ought to have referred to the prior art D1 in the specifications since the common specification for D1 and the invention are almost identical. We are sure in the near future, there will be better drafting standards.
41. The Controller was therefore right in holding that D1 describes the production of a modified carrier in the same way as the invention and the differences is only in ratios. Accordingly the appeal is dismissed. No order as to costs.