The legal concepts of obviousness versus unexpected results, particularly in chemistry and pharmaceuticals, are shaping the patenting strategies of certain chemical and pharmaceutical innovation trends. In the Indian context, the unexpected results are key to the grant of many chemical compositions, drug compositions or minor modification patents. Lately, pharmaceutical companies have been seeking patent protection for many innovative drug compositions purely based on unexpected results. But what constitutes an ‘unexpected result’ for the purpose of an appropriate patent is not an easy question to answer. This also brings to the forefront the need for clinical trial elements that gain importance in thoughtful evaluation of the nonobviousness of patents when confronted by the argument of unexpected results.
For instance, Canadian CA2130577C and US5721244A patent for drug compositions like angiotensin-converting enzyme inhibitors and diuretics in hypertension, US9066957B2 patent for Dry powder inhaler containing long-acting beta-agonists and inhaled corticosteroids in chronic obstructive pulmonary disease, and US9066957B2 for combinations of antiretrovirals and protease inhibitors in HIV are successfully patented drug-drug compositions with unexpected/surprising effects.
Patent eligibility of such compositions is guided by the argument of unexpected results. We know that the terms additivity, synergism and antagonism are frequently used to obtain approval of patents for drug-drug compositions demonstrating an interaction. When we talk about drug-drug interaction, we find there is no clear answer due to the absence of any agreement on the agreed definition of drug-drug interaction (DDI). However, for the purpose of determining inventive steps, technical secondary considerations such as surprising /unexpected results may be presented as evidence of nonobviousness.
One such often-used technical secondary consideration may be the finding of unexpected results. This argument finds acceptance by the patent examiner in India and other jurisdictions, particularly in the chemical and pharmaceutical fields. In any case, the applicants must show that the properties of the claimed invention and the cited art differ to such an extent that the difference is unexpected. This means that the patent office may allow technical secondary considerations to be presented as evidence of nonobviousness. This particularly happened in the chemical compositions patent applications where one such pertinent consideration was the discovery of surprising or unexpected results attributed to the claimed combination of various components.
This technical secondary consideration was not limited to the claims of the synergetic effects only. It works fine for all the patent applicants as the factor of unexpected results is increasingly becoming a routine factor used to prove the lack of motivation to combine. At times, the patent applicant seeks to claim synergistic effect as an argument to obtain a patent. One must know that synergy by itself is no guarantee to overcome an examiner’s prima facie case for obviousness. In any case, claimed synergy must be unexpected or surprising, and the applicant should prove that it could not have been predicted based on prior art references.
Synergism vs Unexpected Results Distinguished
When the unexpected result is greater than the addition of the known result of the claimed components, it is called a synergistic effect. The argument that the unexpected result is greater than expected results is good enough to contest Section 3(e), which puts a bar on patenting of “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance “ However, presence of synergetic effected can tip the scale to patentability as in such a situation the mere admixture bar to patentability will not apply. In patent applications, demonstrating synergistic effects can be powerful evidence of unexpected results. It is not necessary that every unexpected effect would result in synergism.
Unexpected vs Different Results
While patent professionals often confidently assert that their claims yield results exceeding expectations, it is common that only a naked assertion is provided. This naked assertion can lead to a common misstep, where patent professionals seem to open the door to the office rebutting their case by finding that there is an unintentional conflation between “unexpected” and “different.” It may be noted that differentiation in outcomes does not necessarily translate to achieving truly unexpected results. Additional evidence and reasoning would be necessary to move from merely different results to unexpected results. For instance, in appeal 2022-003331 (Application 16/166204.)
The US Patent Trial and Appeal Board (PTAB) clearly underscores the pivotal divergence between unexpected and different results. In this case, the Claim for ceramic electronic components was rejected based on a combination of references. The applicant’s response to rejection was limited to the optimisation of ranges in the prior art. The patent office insisted that there was no evidence of criticality or unexpected results. The applicant argued that certain unexpected results were achieved, as supported by a table with performance data in the specification. The applicant gave evidence by pointing to the table in the specification showing improved results as compared to the prior art. The PTAB was not impressed and noted that:
“it is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference.” Here, other than naked use of the word “unexpected” in the Appeal Brief, the Appellant provides no explanation of why the relied-upon results would have been considered “unexpected” as opposed to “superior.” In view of that deficiency, the Appellant’s argument fails to carry the Appellant’s burden of showing that unexpected results support a conclusion of nonobviousness.” [Emphasis added]
The PTAB ruling, in this case, reinforces the importance of clarity in demonstrating the authentic unexpectedness of a claimed invention’s outcomes, not merely some difference or even superiority.
Obviousness and Unexpected Results: Position in the US
In Graham v. John Deere Co., 383 US 1 (1966), we have seen that the court considered for the first time the argument of the applicant relating to unexpected results that may have tipped the scales towards a conclusion of nonobviousness. In this landmark case, the Supreme Court clarified the nonobviousness requirement under US patent Law. The patent in dispute was for a combination of old mechanical elements designed to absorb shock from plow shanks in rocky soil to prevent damage to the plow. The Supreme Court, in this case, stepped in to resolve two contradicting decisions, with the Fifth Circuit holding the patent valid, ruling that a combination is patentable when it produces an “old result in a cheaper and otherwise more advantageous way.”
The Eighth Circuit held that since there was no new result in the combination, the patent was invalid. The court, in this case, found that the differences between Scoggin invention and the pertinent prior art would have been obvious to a person reasonably skilled in that art. This landmark case laid down four criteria to be considered in determining obviousness viz
- the scope and content of the prior art;
- the level of ordinary skill in the prior art;
- the differences between the claimed invention and the prior art; and
- objective evidence of nonobviousness, we are more concerned with the need for objective evidence where the applicant claims unexpected results to prove nonobviousness.
Position of Inventive Step Determination in India
The introduction of the test of obviousness in Patents Acts,1970 was made in 2002 when the term ‘inventive step’ was made a prerequisite condition that defined the term “invention” in addition to novelty and industrial application. Section 2(1)(j) defines an “invention” as “a new product or process involving an inventive step and capable of industrial application.” The term ‘inventive step’ was also defined under Section 2 (1)(ja), which reads “inventive step” as “a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.”
These changes in the law now made it mandatory for the examiner to conduct the obviousness analysis during the prosecution of the application before the grant. The first Supreme Court case which discussed the doctrine of nonobviousness was Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, where the court equated inventive step and obviousness and observed that “obvious” was an equivalent word for “inventive step” used in Section 26(1)(a) of the 1911 Act and that obviousness must be strictly and objectively judged. The court placed reliance on the opinion of Salmond L. J. in Rado v. John Tye & Son Ltd. – “Whether the alleged discovery lies so much out of the Track of what was known before as not naturally to suggest itself to a person thinking on the subject, it must not be the obvious or natural suggestion of what was previously known.”
Again, the Madras High Court in Bajaj v TVS (MANU/TN/0174/2008) placed inventive step at higher pedestal when the court observed that “an ‘inventive step’ which is a necessary ingredient of invention in order to make an applicant eligible for grant of patent under the Act must be relating to an invention involving technical advance or having economic significance or both along with a necessary factor that such invention should make it “not obvious to a person skilled in the art.” Like the Supreme Court, the Madras High Court observed that “Even though the term ‘obvious’ has not been defined under the Patents Act, it can be safely stated to be a circumstance where a person of skill in the field, on-going through the specification, would complete the product.”
IPAB on Unexpected Results
In Green Cross Holdings vs Deputy Controller Of Patent And Designs appeal case Intellectual Property Appellate Board ruled that “Even though applicant’s modification results in some degree of improvement and utility over the prior art, it may still not be patentable if the substitution of stabilizer was within the capabilities of one skilled in the art unless the claimed mixture produces a new, unexpected result which is different in kind and not merely in degree from the results of the prior art….”[IPAB 78 of 2014]. In this case, the patent for the invention relating to ‘Pharmaceutical preparation of recombinant factor VIII lyophilized without Albumin as a stabilizer’ was refused by the patent office, and IPAB affirmed the decision of the patent office. However, in both rulings, the court fell short of introducing secondary consideration in the obviousness analysis. To some extent, the Supreme Court ruling “that obviousness must be strictly and objectively judged” matches the fourth ingredient of the doctrine of obviousness as established by the US Supreme Court in Graham v. John Deere Co. discussed above.
Patent Eligibility of Combination of Prior Art
When we speak about a combination of the prior art, we mean that if a combination of the prior art would have been obvious to try, the patent is more likely to be held as obvious. It is this aspect of the combination where the patent practitioners seek to justify the grant of a patent based on the discovery of unexpected results. This means any prior art combination which appears to be obvious to try at the time of the invention will be held as non-patentable. This normally misses out on the important aspect that when the application for a patent is filed, all the aspects of the inventions are not researched by the inventor. While the obvious-to-try analysis takes place at the time of invention, technical secondary considerations of nonobviousness based on the discovery of unexpected may be relevant to defend the patentability issue during the prosecution stage.
This view finds favour with the applicant in Knoll Pharm. Co. v. Teva Pharms. USA, 367 F.3d 1381, 1385 (Fed. Cir. 2004), where the federal circuit observed that “Evidence developed after the patent grant is not excluded from consideration, for the understanding of the full range of an invention is not always achieved at the time of filing the patent application.” The federal circuit held that “[t]here is no requirement that an invention’s properties and advantages were fully known before the patent application was filed, or that the patent application contains all of the work done in studying the invention, in order for that work to be introduced into evidence in response to litigation attack.”
This patent invalidation litigation was for the US 4,587,252, claiming the methods and compositions for treating pain by administering a combination of hydrocodone and ibuprofen in specified amounts. When Knoll sued for infringement of the ‘252 patent, Teva moved a motion for summary judgment; the district court ruled that the patent was invalid on the ground of obviousness. On Appeal, the Federal Circuit reversed the district court ruling. The district court held that the subject matter of all the claims was obvious in view of the prior art and granted summary judgment of invalidity. The court stated:
“The prior art expressly teaches one of ordinary skill in the art to combine an opioid with an NSAID. Furthermore, based on the prior art, a person of ordinary skill in the art of pain management would have had a reasonable expectation of success in combining hydrocodone, a narcotic analgesic, with ibuprofen, an NSAID.”
The district court refused to consider evidence that Knoll presented to show unexpected results using the combination of hydrocodone and ibuprofen because the “unexpected benefits or results” were discovered after the ‘252 patent had been issued.
This ruling opens the doors for the patent applicants to conduct additional experiments and provide later-obtained data in support of patent eligibility. In terms of patent prosecution, it is called secondary evidence in support of the patent eligibility when the question of obviousness is debated during the prosecution of the application. Does it mean that the applicant is allowed to discover /invent unexpected results to support the grant of a patent?
The question before the court here was not when the evidence was discovered, but the question before the court was whether, and to what extent, technical secondary considerations that arise after the date of invention outweigh the obviousness of trying predictable, known solutions at the time of invention. This leaves enough room in patent prosecution, where the battle over obviousness is fought by the patent professionals to find themselves utilising unexpected results as part of their argument. No doubt, the later found unexpected results can be used as technical secondary considerations, and the patent professional assertion that a claimed invention achieves an unforeseen outcome can sway the balance in favour of patentability even at the examination stage in the patent office.
Position in India
The admissibility of technical (secondary or later) evidence to prove enhanced efficacy under section 3(d) is invariably questioned by the patent Office. In an appeal (OA/33/2015/PT/KOL) against the refusal of a patent application for “Topical Co-enzyme Q10 Formulations and Methods of Use Thereof”, for the reason that “evidence for enhancement of activity (as proposed by further documents) are beyond the scope of ‘invention’ as described in the complete specification as on record.” IPAB looked into this aspect and overruled the Controller’s order. IPAB allowed the filing of post-published documents and ruled that
“The claims are novel and also inventive in view of the cited documents and completely supported by the specification as originally filed. Filing of additional documents, data, and evidence in support of the invention to overcome the objection raised and attack a specific objection is something that is allowed under the Patent Law of not only India but also other foreign jurisdictions.” [Emphasis added]
In this case, the relevance of post-filing data to prove unexpected results to determine an ‘inventive step’ was not discussed and adjudicated as IPAB found the invention otherwise novel and inventive. However, in the Indian context, if the applicant brings up the post-published data to cross the therapeutic efficacy objections raised by IPO under section 3(d) or in the pre-grant opposition proceedings, he will be permitted to do so after this ruling.
Caution and Precaution
Whenever an applicant seeks to use unexpected results to counter obviousness investigation by the examiner/court, he must bear in mind that a bald statement of exitance of unexpected results is insufficient to get favourable results from the patent office or courts. Like evidence of synergy to overcome the examiner objection of mere admixture under section 3(e), the exitance of claimed unexpected results to counter obviousness is also difficult to establish. A detailed specification supported by comparative data and well-reasoned arguments, including the post-filing research results in support of the claims of unexpected, can improve the chances of a successful grant or defending invalidations.
It is important to keep in mind that showing unexpected results must be based on evidence, not merely argument or speculation. The unexpected result evidence produced at a later date must have some basis in the specification to tilt the obviousness scale in favour of the grant. Expert advice to deal with patent applications claiming unexpected results as the basis of the grant of the patent will be helpful in countering the objections raised by the patent office during the prosecution of the application or during the opposition proceeding before or after the grant of the patent.
