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“Obviousness – A Vague Phantom”

Obviousness is one of the most important tests a patent applicant has to satisfy in order to be entitled to the grant of a patent. While in a large number of countries the test of obviousness has been crystallized, India is on its way to formalizing such a test.

A patent is granted for an invention which is something new, not obvious and useful. Useful simply means 'capable of industrial application' that is to say, utility. In so far as utility of a patent is concerned, the first question that arises is what is the quantum of utility? As was held by the Bombay High Court in the Unichem Laboratories case the amount of utility to support a patent is very small and it is not necessary that the invention as described should be commercially useful.

If something is known and lacks novelty, no further question arises and it is clearly not an invention. If however the invention is new, the second question that arises namely, "Are the changes made obvious?" Once it is clear that the invention is new since it has not been anticipated by prior art, the next enquiry is to determine the magnitude of "novelty" or somehow measure it to check and see whether the steps taken by the Patentee are routine and obvious or are they inventive so as to deserve a patent.

Obviousness by its very definition is something plain, straight forward and once realizable. It's like stating the 'obvious.' For example, visualizing from a distance that a short child will not be able to open the door latch, to block the mouth of a jar whose lid has been lost with a cloth or folded paper, to prevent a table from rocking due to its uneven legs by putting a little piece of paper underneath one leg, to balance an object with some support, irrespective of the nature of the support or to connect two objects with a fastener – be it a nut, bolt a wire passing through or adhesive.

From whose eyes is obviousness assessed?: The hypothetical person of ordinary skill in the art

The edifice of the law of obviousness is founded on the hypothetical construct of a "person of ordinary skill in the art". It is from the eyes of such a person of ordinary skill that the obviousness of an invention is judged. There are several important elements of the person of ordinary skill in the art:

i. The person of ordinary skill in the art must belong to the relevant field. In other words, for assessing the inventive step of an invention pertaining to drugs, the person of ordinary may be from the field of medicinal chemistry.

ii. The person of ordinary skills must look at the prior art from a position of his personality including the fact that he may or may not be risk taking and is subject to normal biases and prejudices. The characteristics of a person of ordinary skill in the art are eloquently explained in the Genentech case as follows:

"The skilled person in this field is well aware of the fact that even a small structural change in a product (e.g. a vector, a protein, a DNA sequence) or in a procedure (e.g. a purification process) can produce dramatic functional changes. Therefore, the said expert would constantly be conditioned by the prior art and, before taking action, would carefully ponder any possible modification, change or adjustment against the background of the existing knowledge. Under these circumstances, in the Board's view, the skilled person would adopt a conservative attitude. However, this must not be seen in the sense of being reluctant or opposed to modify or adjust a known product or process, but rather in the sense of being cautious. For example, the skilled person in question would neither go against an established prejudice nor try to enter into "sacrosanct" or unpredictable areas nor take incalculable risks….."

iii. That the person of ordinary skills in the art must not be supplied with the solution to the problem. He must be given the problem and asked whether he can solve it. This is referred to as the 'Hindsight Element'. Obviousness is not established by drawing a line

from the solution to the problem or finding the explanation for how the inventor did it. It is not permissible to look at the invention and try and figure out the logic behind it and then look for prior art documents which support disclosures throwing light on such logic. This concept of hindsight is explained in detail at a later section in this article.

Thus, the third element is that the obviousness has to be determined as on the priority date and ex-post facto analysis is not permitted.

Approaches to obviousness

The Indian approach thus far

It was not until the year 2005 that India for the first time defined as to what constitutes an "inventive step" by incorporating a new provision in the definition section of the Patents Act. Section 2(1)(ja) of the Act defines "inventive step" to mean "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."

Since the year 1972, when the Patents Act, 1970 was brought into being, there have been a handful of cases in India that have dealt with the obviousness issue extensively. In the Bishwanath Prasad Radhey Shyam case, the Supreme Court held that obviousness has to be strictly and objectively judged. The Supreme Court further recognized that obviousness is something that is a natural suggestion of what was previously known.

Another test of whether a document is a publication which would negate the existence of inventive step, as suggested by the Supreme Court in the Bishwanath Prasad case is as under:

"Had the document been placed in the hands of a competent craftsman (or engineer as distinguished from a mere artisan), endowed with the common general knowledge at the 'priority date', who was faced with the problem solved by a patentee but without knowledge of the patented invention, would he have said, "this gives me what I want?" (Encyclopedia Britannica. To put it in another form: "was it for practical purposes obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention the subject of the claim concerned?" [Halsbury, 3rd Edn. Vol. 29, p 42 referred to by Vimadalal J. of Bombay High Court in F.H & B. Corporation v. Unichem Laboratories AIR 1969 BOM 255."

This test of obviousness was reinforced by the Single Judge of the Delhi High Court in Roche v. Cipla. In contrast, in the Enercon decisions the Intellectual Property Appellate Board invalidated certain patents and gave contradictory approaches to what ought to be the obviousness tests. In parts, the IPAB stated that the test of 'obviousness' in India is a different one from that in USA and UK. At another place, the IPAB applied the Windsurfing/Pozzoli tests of the UK courts (discussed below). The standard of obviousness in India is being currently litigated before various forums in India, including the Patent Office, the Intellectual Property Appellate Board, the various High Courts as well as the Supreme Court. In fact, the Supreme Court in the Novartis case devoted several days of hearing on the interpretation of Section 2(1)(ja) and it is anticipated that the judgment will shed light on the standard of obviousness to be adopted in India.

The United Kingdom approach

In the case of Windsurfing International Corporation v. Tabur Marine Ltd. in the UK, a four step test for inventive step was given. As the Pozzoli case came along, four-step test was split into five as follows:-

(1) (a) Identify the notional "Person skilled in the art"; (b) Identify the relevant common general knowledge of that person;

(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;

(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of art" and the inventive concept of the claim or the claim as construed.

(4) Viewed without any knowledge of the alleged invention as claimed do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention.

What emerges from the above analysis is that when conducting an "obviousness" enquiry to determine whether an alleged invention is patentable or not, Courts in various jurisdictions including India, have recommended a five point test, based on the existence of statutory terms in their domestic legislations (for example, the Windsurfing test in UK often referred to as the Windsurfing / Pozzoli Test).

The "Long Jumper" Test

The obviousness test can best be illustrated by the "Long Jumper" test that visualizes an athlete, a long jumper. A cartoon illustrating him in figure-1 (following page) shows that he is expected to jump from a baseline to a hypothetical line drawn a few yards ahead. There is an audience that watching him and will try him predict whether he can leap from the baseline to the forward line. One person in the audience thinks that he will not jump as he knows the athlete and knows that he has recently recovered from a lumbar injury, while another viewer thinks that he is familiar with the determination of the athlete and offers an opinion that the athlete will make it. A third person may be the final judge and may take into account all factors to give a final opinion.

Transposing this situation into the obviousness context, the elements, therefore, are:

(a) Take an athlete and this element is akin to a person of ordinary skills in the art;

(b) The athlete has certain physical and mental strength and this is akin to common general knowledge of the other person of ordinary skills in the art;

(c) The baseline from where the athlete is to start is the prior art or even the closest prior art;

(d) The line to which he has to jump is like the inventive concept; and

(e) The question to be asked is whether he will make it.

The audience is the Plaintiff's legal experts (saying that he will not make it) and the Defendant's legal experts (saying that he will certainly make it). The decision maker is the Judge.

Figure 1: Cartoon showing the test of obviousness

 

The subjectivity of the obviousness test

It is well recognized that while obvious standards around the world involve objectivizing as-much-as can be done, but at the end of the day, the obviousness test is a highly subjective one. In order to reduce the subjectivity in obviousness determinations, Courts have often prescribed the objective indicia or the secondary considerations for determining obviousness. The subjectivity of the obviousness standards has been the explained by Chisum in his treatise on the Law of Patents in the following words:

""The legal conclusion as to whether a given product or process was obvious at the time of invention to one of ordinary skill in the pertinent art who had knowledge of all relevant prior art is a path fraught with pitfalls, including especially the inherent difficulty of making such a hypothetical judgment and the tendency to use (even subconsciously) "hindsight" and the inventor's own work to determine obviousness. The adversary system fails to guide adequately the decision maker along the path; in infringement trials, the opposing sides tend to offer conflicting expert testimony. Consequently, the courts look to objective guideposts – what Judge Learned Hand in his many incisive opinions on the subject called the "history of the art" for aid and assistance"

Since the obviousness test is subjective and is largely a question of personal judgment, Courts have placed the burden of proving invalidity on the opponent or the defendant and require the said burden to be discharged with clear and cogent evidence. Thus, if it appears according to one opinion that a person of ordinary skills would take a left turn, while according to another opinion that he would take a right turn, it is not clear as to how he would react and respond and thus the patent cannot be invalidated.

It is also important to note that the test of obviousness is field – specific. In the mechanical world, it is easy to visualize the obvious. However, in the world of chemistry and pharmaceuticals in particular, it is difficult to visualize what a small change to the structure of a compound may result in. Even though fluorine, chlorine and bromine are all halogens, changing one to the other of a compound may result in completely different properties. Thus, in Eli Lilly vs. Zenith Goldline, changing the fluorine to hydrogen created olanzapine which was a far superior product to the previous compound. Similarly, changing the Ethyl group to a Methyl group resulted in far superior biological and therapeutic properties.

It is well-known that small changes in chemistry may result in major and dramatic results. This unpredictability in chemistry has led the Nobel Prize Committee to state how difficult it was to grant Nobel Prize in chemistry as against physics. They said:

"One must sympathize with the chemists and the Nobel Chemist jury of the time who were faced with all this. How can Chemists keep track of this flying circus of acrobatics energy shifts, bondings and reactions? Certainly no single existing approach sufficed."

The millions of dollars that are spent by the pharmaceutical industry each year is primarily because different compounds are picked out from combinatorial libraries and then tested for certain properties in-vitro or in the lab. Those that are promising candidates are then worked with all sorts of modifications to see the effect of those modifications and one in several thousand compounds may turn out to have exceptional chemical, physical or biological properties. The development from the initial stage to the manufacture of a viable drug takes 10 to 15 years, may be even longer, as a lot of time is lost in checking whether the drug would do well in human beings (in-vivo). The drug is also tested for solubility, bio-availability, thermodynamic stability, etc. A critical factor is safety and toxicity as a drug must not lead to unwanted side effects.Where drugs target specific receptacles, they need to be selective and selectivity might require alterations of a structure.

The Hindsight Bias: Do not look from the eye of the inventor

A well recognized concept in psychological research, hindsight bias is the inclination to see events that have already occurred as being more predictable than they were before they took place. The recognition is particularly relevant for obviousness determinations in patent law, since once a product and process have been invented, in hindsight it appears to be obvious. Courts in the United States have repeatedly cautioned against the hindsight. For instance, in the Ortho – McNeil case, the Court said that it is impermissible to simply retrace the path of the inventor with hindsight and discount the number and complexity of the alternatives that are faced by the person skilled in the art should he attempt to reach the invention from the prior art.

For demonstrating the hindsight bias, the author conducted the following experiments:

(a) The "Maze hindsight bias" experiment

12 participants participated in the maze experiment which was divided into two parts. In the first part, an ordinary maze with its three corners covered with "Post-its" was given to a group of participants and they were asked to find the way out to the exit point of the maze. Every time a participant reached a covered corner, the path was shown by unflagging the Post-its. The process was repeated on reaching a dead end until the participants could solve the maze and the time taken by each participant was noted.

In the second part, an ordinary maze was given to the participants without any covered corners and they were asked to solve it for its exit point. Time taken by each participant to complete the maze was recorded by the conductor of the experiment.

The objective of the experiment was obvious and known to the participants beforehand and each maze was approximately to be completed within 30 seconds. The time difference between the two parts could be used to calculate the quantitative value of "Hindsight Bias".

It was observed that all the participants took a longer time to complete the maze in part 1 of the experiment which had covered corners. On the other hand, the participants could solve the second maze in lesser time and with greater efficiency.

It could be concluded that when an individual is oblivious of the result, it takes them longer time to reach the object and the efficiency levels are low. On the other hand, when the object is known to the individual, it takes them less time to reach the object with higher efficiency. The hindsight bias experiment demonstrated that when you know where you have to go, it is far quicker than when you get lost.

Patent law faces a critical quandary. It is important for an invention to be non obvious at the time of its invention for it to be granted a patent. Once the object to be achieved is obvious and pre-mediated, the path to reach the object is effortless. Determining whether an invention was non obvious in the past raises daunting specter of hindsight.

Figure 2: The Maze Hindsight Experiment

 

Figure 3: The ‘Cake on the Table’ Test

 

The Pink Stick Experiment:

The experiment concerns two lists as follows:-

List-I (receptacles), which can be:

(a) A jar
(b) A bottle
(c) A box; AND

List-II (consisting of objects to be placed in a receptacle), namely:

(a) A flower
(b) A stick
(c) A small fruit

If I were to pick one object from each of the lists and combine them with colours which are normally 8 to 10 usual candidates (for example, blue, red, etc.) I could get a unique combination which would in most cases be very difficult to visualize for someone. A third experiment was based on this and referred to as the Pink Stick Experiment – as a pink color stick was placed in a brown coloured box.

A group of participants were chosen. The conductor of the experiment had a combination of a 'pink stick in a brown box' written down in a piece of paper which was hidden from the participants. The participants were asked to choose an object from List II and attach it to a colour from the list of colours mentioned. Then they were asked to choose a receptacle from list I with a colour to place the previous object into. It was observed that none of the participants could match the conductor's combination. Every participant identified their own unique combination.

If you take the number of colours for both the receptacles group and the object group, then the possibilities are large. This experiment demonstrated that even to visualize a pink stick in brown box was so difficult, although we often hear persons attacking inventions say that if you take one object from this list and another object from that list and combine the two, then you get the invention.

Their attack is based on the fact that the lists are known. Thus, it is easy to say that sticks are known, boxes are known and the colours pink and brown are known and so there is nothing so great about visualizing a pink stick in a brown box.

However, if the pink stick were a solution to a complex problem, you would need much more than routine and obvious visualization by an ordinary person in the trade to arrive at it.

One learning from the above experiment is that to render the complex solution obvious, there must be some reason, motivation, teaching or suggestion which should prompt the person to pick an object from each of the lists. Without such a reason, motivation, teaching or suggestion, it would be impossible for a person of ordinary skill to simply pick the correct objects from both lists and reach the complex solution.

The above can also be demonstrated by means of another experiment, the 'Cake on the Table' experiment:

A survey was conducted with 20 people. They were asked to look at a picture A comprising of a prominent white cake placed on a table for 15 seconds. The picture was taken away and they were asked to list three things they remembered to have seen in the picture. Again, they were shown a picture B for 15 seconds where there were a lot of other things including a cake on a table which was merged in between other objects. Based on their observation, they were again asked to list three things they remembered to have seen in the picture.

It was found that 85 % of the people could observe the cake in picture A while only 30 % of the people surveyed could observe the cake in Picture B. It was clear that the likelihood of identifying an object was high when it was prominent and distinctly visible but the likelihood of its identification substantially decreased when the same object was merged with other objects and wasn't prominent like the one in the previous picture. Had the cake in the second picture been a prominent white cake like the one in the first picture, it would be easily identifiable. But, in the presence of other miscellaneous objects, it tends to get lost in the picture. Hence, there is a tendency of an ordinary prudent person to get blind to what is obvious.

Thus, the following emerges from the above experiments:

(a) Patent law faces a critical quandary. It is important for an invention to be non obvious at the time of its invention for it to be granted a patent. Once the object to be achieved is obvious and pre-mediated, the path to reach the object is effortless. Determining whether an invention was non - obvious in the past raises daunting specter of hindsight.

(b) The above experiment showed that in a thick patent specification, if a particular compound or disclosure appears, it may be missed by the person of ordinary skills in the art. The question to ask is whether he would find it, not whether he could find it. It is this "likelihood" and "potentiality" which has to be seen. Sometimes, a person gets blind to the obvious.

Therefore, the maze experiment, the cake on the experiment and the pink stick experiment will lead one to the conclusion that obviousness, in patent law, denotes a subjective analysis of facts and law. India, as an epicenter of patent battles, has recently witnessed a deluge of enquiries into obviousness. The cited cases and the ensuing experimentation clearly denotes that the enquiry of obviousness call for a radical shift in approach. That being said, this article has endeavored to highlight the obscure.