Snippets: Law Minister Moots ‘National Litigation Policy’

30 million/3 crore- This is the number of cases pending before Indian Courts, with a few cases languishing for close to a decade and a half. Is there a solution in sight? Probably (Probably roughly translates to “Sambhaavna” in Hindi, which is THE WORD that the Indian Railways and other Indian Govt. Departments swear by...)

The Union Law Minister, Mr.Veerappa Moily, has mooted the idea of a ‘comprehensive National Litigation Policy’ which envisages the restriction of the period of litigation to 3 years (Where are the Judges to dispose these cases? New ‘Benches’ have been constituted, but quite a few ‘Benches’ remain vacant or atleast sparsely occupied...)

One of the objectives of the policy is to reduce government litigation, which forms bulk of the pending cases. Also in the offing is the Right to Justice Bill (shouldn’t we first try and pass the Judicial Standards and Accountability Bill, 2010 and the Judges Assets Bill? Because if the faith in the Judiciary takes a beating, which citizen would want to exercise his right to justice?).

Lets be cautiously optimistic about the National Litigation Policy seeing the light of the day in the near future...

Food for thought: Should lawyers be optimistic at all about this policy?! ;-) 

(Image Source: www.cartoonstock.com)

Snippets: Kraft Foods Inc. Sues Britannia for Trademark and Copyright Infringement

In what promises to be a high-stakes dispute, US-based packaged  foods manufacturer, Kraft Foods Inc, has sued one of India’s most well-known packaged foods manufacturer, Britannia Industries, for copyright and trademark infringement.

According to the Economic Times, Kraft Foods has alleged that Britannia’s latest offering, 'Treat-O' biscuits, infringe Kraft’s trademark and copyright in its Oreo Cookies. Kraft has sought injunction to prevent Britannia from selling any product which incorporates “any distinctive element” of Oreo cookies.

ET reports that Kraft’s specific allegations are that Britannia’s Treat-O biscuits use the same trade dress as Oreo cookies. The trade dress here is the design etchings on Oreo biscuits, such as florets and inner rings. Also, apparently the ‘O’ in Treat-O is allegedly inspired from the ‘O’ in the Oreo.

Any further updates on the developments in the suit are welcome! We will keep our readers posted on the case.

I thank Rohan Coutinho for the scoop!

How Obvious is Obviousness?

I was asked by a very close friend of mine to point out (an impromptu viva voce of sorts) the primary difference between Section 25(1)(e) and Section 64(1)(f) of the Patents Act.

Section 25(1) of the Act relates to pre-grant opposition proceedings and Section 64 relates to revocation proceedings. The relevant portions of the provisions are reproduced thus:

Section 25. Opposition to the Patent:

(1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground-

(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what : was used in India before the priority date of the applicant's claim

Section 64. Revocation of the Patent:

(1)Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, 1[be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counterclaim in a suit for infringement of the patent by the High Court] on any of the following grounds, that is to say—

(f) that the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim;

Notice the difference between “is obvious AND CLEARLY does not involve any inventive step” in Section 25(1)(e), and “is obvious OR does not involve any inventive step” in Section 64(1)(f).

By using “logical operators” such as “and”/”or” between “obvious” and “inventive step”, is the Act saying that obviousness is not the same as lack of inventive step? Why not take a look at the definition of an “inventive step” under Section 2(ja) of the Act?

"inventive step" means 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

So inventive step = (feature involving technical advance over prior art OR economic significance OR both) PLUS non-obviousness

Stated otherwise, for a feature to qualify as an inventive step, it must constitute non-obvious technical advance OR non-obvious economic significance OR, non-obvious technical advance and economic significance.

If non-obviousness is so integral a condition for a feature to qualify as an “inventive step”, why do Sections 25(1)(e) and 64(1)(f) separate obviousness from lack of inventive step using “and”/”or”?

There are two ways of interpreting the definition of "inventive step", and consequently two ways of understanding its import on Sections 25(1)(e) and 64(1)(f):

First Interpretation

An inventive step could be a feature which constitutes a technical advancement over prior art, or has economic significance, regardless of it being non-obvious or otherwise. In a way, this means that even an obvious inventive step is an “inventive step” merely because it represents technical advancement or has economic significance.

Simply put, it appears to allude to novelty of the inventive step, regardless of its ingenuity.

The consequence of this is that lack of non-obviousness does not translate to lack of inventive step, it merely translates to lack of a non-obvious inventive step. If this interpretation of the definition of “inventive step” were to be accepted, the effect on construction of Sections 25(1)(e) and 64(1)(f) is as follows:

A. Under Section 25(1)(e), in order for the Controller to reject the patent application and accept the pre-grant opponent’s contention, the patent application must suffer from lack of an inventive step AND obviousness. In other words, the Controller must satisfy himself that the application is defective on both grounds.

B. Under Section 64(1)(f), the IPAB or the High Court may revoke the patent EITHER for lack of an inventive step OR for obviousness i.e. presence of one of these defects is sufficient reason to revoke the patent.

This line of argument appears to make sense. However, the hurdle to accepting this in toto is the absence of a comma separating “technical advance as compared to the existing knowledge or having economic significance or both” and “and that makes the invention not obvious to a person skilled in the art”.

 Let’s see if the second line of interpretation takes us to another possible logical conclusion.

Second Interpretation

In the absence of a comma separating “technical advance as compared to the existing knowledge or having economic significance or both” and “and that makes the invention not obvious to a person skilled in the art”, the construction that one could come to is, that non-obviousness is a condition precedent for an “inventive step” to be treated as one, mere novelty will not suffice.

Put simply, there is nothing inventive about a feature which is obvious. And since there is nothing inventive about an obvious feature, the invention too is no "invention" since it is obvious (reason? "invention" means a new product or process involving an inventive step...Section 2(j))

If this is how the definition of “inventive step” is to be construed, then the use of “AND”/ “OR” in Sections 25(1)(e) and 64(1)(f) do not materially differ. What this means is  “And” and “or” mean the same thing in Sections 25(1)(e) and 64(1)(f).

(Again) if this is the case, what is the purpose of using “CLEARLY does not involve any inventive step” in Section 25(1)(e)? The use of “clearly” could mean that even if the Controller finds the invention obvious, he has to be absolutely convinced of the absence of an inventive step before he rejects the patent application.

This practically translates to a “clearly reasoned order” by the Controller if he arrives at a finding which is adverse to the patent applicant.

Fine, this too makes some sense. But the irony is, under this interpretation, the standard of rigour to be followed by the Controller under Section 25(1)(e) would be higher and much more stringent than the standard to be followed by the Court or the IPAB in a revocation proceeding under Section 64(1)(f) (!!!)

Is this a conundrum worth thinking about, or is it mere futile semantic jugglery by a “blackcoat”?

(Image Source: www.cartoonstock.com) 

Announcements: New Feature on the Blog

Robert Oppenheimer, Albert Einstein and Werner Von Braun- What’s common to all of them, besides the fact that they were world-renowned scientists (and all of them had a German connection)? Their videos now form part of the blog’s new feature!

I realized that reading my posts can at times be a soporific exercise, so I decided to offer our readers something more interesting to look forward to, each time they visit the blog. Hence, the new feature on the blog- YouTube Videos on innovation, technology, management and the law (Please see on the top of the blog page, right below the title of the blog).

Readers can now watch the videos on the blog page itself. We’ll keep changing the videos from time to time; for now, we have provided videos of Robert Oppenheimer, Albert Einstein and Werner Von Braun (with Von Braun being one of my childhood idols after A.P.J. Abdul Kalam)

We hope our readers like this feature. Suggestions on videos are welcome!

Guest Post: Patenting ‘Life forms’ under the Patents Act, 1970- Patent Unconstitutionality? - II

This is a continuation from Aditya Arun Kutty's guest post.
Use of the term ‘Variety’

The use of the word ‘variety’ in s. 3(j) is further unreasonable and leads to discrimination between those who are breeders of plant variety and those breeders of animal variety. On one hand, breeders of plant variety are entitled to protection under ‘The Protection of Plant Varieties and Farmers’ Rights Act 2001 (PVRFR), and on the other, breeders of animal variety not only succumb to Section 3(j), they are left in the lurch since there is no separate legislation to protect their interests.

Furthermore, what constitutes ‘variety’ is also unclear as the dictionary meaning fails to identify what can be patented by virtue of its general nature and the Plant Varieties Act defines ‘variety’ only in the context of plant variety.

Also, the phrase ‘animal varieties’ was interpreted narrowly by the European Patent Office to limit the phrase to a variety and as not extending to animals per se. However 3(j) will not permit such an interpretation as it includes ‘animals in whole or any part thereof’.

Lack of a Clear definition

The EPO defines essentially biological process as consisting of entirely natural phenomena such as crossing or selection. Hence, EPO allows patenting of genetically modified plants or animals since genetic modification ensures that what is patented is not purely a natural phenomenon. 

Li Westerlund in his book on Biotech Patents,[i] states aspects of a biological process, which in practice, could lead to problems while deciphering its patentability quotient:

(i)                  Purely biological or essentially biological steps or a mixture of those steps, in a process.

(ii)                Purely biological/essentially biological steps but put together in a manner that levels the process at the higher technical standard.

(iii)               Biological/essentially biological steps plus a technical step in a process.[ii]

These steps clearly colour the fact that in the absence of a specific test to delineate patent-worthy inventions from the rest, the patent office to date remains ill-equipped to decide.

Article 14 strikes at arbitrariness because an action that is arbitrary must necessarily involve negation of equality. In this regard by not defining ‘seed’, ‘species’, ‘essentially biological process’ s. 3(j) leaves a tremendous scope for arbitrariness.

The only other legislative definition of a ‘seed’ would be that under the Plant Varieties Act, i.e. ‘a type of living embryo or propagule capable of regeneration and giving rise to a plant which is true to such type’. (s. 2(x))

In a case where seed is made by human interventions, (falling within this definition)its patentability would depend on the absolute discretion of the patent office.

Integration of words like patents, animals, essentially biologically process, without qualifying them with certain meaning, could well-nigh lead to denial of a patent (which inadvertently goes against the balancing objective of TRIPS under article 7) and this when provisions in foreign regimes such as the UK Patent Act specially accommodate for biotechnological inventions.

The situation in India as far as micro-organism patenting took a turn for the positive post the Dimminaco judgment of the Calcutta High Court (Process for preparation of alive vaccine for Bursitis). Subsequently, under the 2002 amendment to the Patents Act, only a micro-organism per se was unpatentable, qualifying the transgenic as patentable subject matter.

 Judicial Decisions/ Directives to seek Inspiration from

In the U.S. Animal Legal Defense Fund v. Quigg, the court held that an organism, “given a new form, quality, properties or combination not present in the original article existing in nature in accordance with the existing law”, could be patented.

Moreover, in the Harvard Oncomouse case, the first patent on a “non-naturally occurring non-human multicellular living organism”, patent was granted to a genetically engineered mouse.

In Ex Parte Allen, the patent examiner’s rejection of claims for a genetically engineered life-form was overruled. The board held that an oyster genetically engineered to be edible year round, constituted patentable subject matter. It was also opined that any multi-cellular organism may be patented by the inventor provided it:

A. it is created for the first time,

B. it is not a naturally occurring ,

C. is not a human being,

D. it is an item of manufacture or composition of matter, and

E. it meets all of the other conditions of patentability.

The EPC directive on legal protection of biological inventions 98/44/EC directly addresses patenting of life-forms. Under the directive, plants or animals may be patentable, if the technical feasibility of the invention is not technically confined to a single plant or animal variety. (This altered the EPC’s prior wording which explicitly excluded plant and animal varieties from patentability)

Article 6 of the Directive states that the human body, at the various stages of its formation (including the embryo and sequences or partial sequences of genes), is not patentable.

That said, it goes on to envisage that in case of an element of a human body, which has been removed through a technical process, can be patented even if the structure of the element is identical to that of a natural element.

In conclusion, I believe that the legislature needs to take a definitive stance prior to any litigation that may arise. Although common law will always factor equity into its analysis of legal issues, a statutory reference would serve to clarify the intention of the legislature. It would also give Courts the flexibility, precision and independence from subjective bias, to adjudicate an area of law in which the subject-matter is said to be ‘unforeseeable’.

Until and unless the law clarifies these terms, as was held in Sheo Nandan Parwan v State of Bihar- ‘the law will always frown on uncanalised and unfettered discretion conferred on any instrumentality of state.’

---

[i] Biotech Patents: Equivalency And Exclusions Under European And U. S. Patent Law, Kluwer Law International (August 2002)

[ii] Ibid.

Guest Post: Patenting "Life Forms" under Indian Patents Act, 1970- Patent Unconstitutionality?- I

We had promised to “generalize” IP by connecting it to traditional areas of the law such as Constitutional law. Keeping with that promise, we bring forth a guest post on (un)Constitutionality of Section 3(j) of the Patents Act, by Aditya Arun Kutty, a bright final year law student of Hidayatullah National Law University, Raipur.

Aditya is a self-confessed IP enthusiast, who has taken part in several IP moots and has also written on ISP liability and trademarks. In this post and the next, Aditya argues that Section 3(j) of the Patents Act may come under fire for being unconstitutional absent specific guidelines to reject applications which purportedly claim unpatentable subject-matter. Without further ado, here’s Aditya’s post:

The Restrictive Denotation of ‘Life form’ inventions under the Patents Act, 1970: Prospective Room for challenging the constitutionality of s. 3(j)?- Aditya Arun Kutty

It’s interesting to learn how biotechnology has empowered mankind to craft organisms. The introduction of new organisms into our environment has irrevocably changed the biological landscape. The patenting of living creatures has thus far proved to be a part of this conundrum; the debate has ranged from wholly disregarding such creatures as being patentable, to demarcating the line after grant, whereby it would be possible to limit such protective rights.

Patents, as affirmed, should be granted only to human inventions, not discoveries. As known, only inventions that meet the statutory requirements of being new, useful, and non-obvious, can be patented. Inventions or discoveries, such as naturally occurring organisms, laws of nature, natural or physical phenomena and abstract ideas, cannot be patented. 

The general prejudice against life-form patenting is that- existing living organisms - plants and animals as well as their genes - are no-one's invention and should therefore never be patented and put under private control.

Effectively the prohibition on patentability of plants and animals rests on three philosophical foundations[i]:

Firstly, patents on plants and animals would allow humans to hold exclusive rights on other living organisms, an arrangement that seemed (and continues to seem) immoral to many.[ii]

Secondly, it is argued that granting such patents would unjustly enrich those who were simply the first to apply for a patent on a naturally occurring organism.[iii]

Thirdly, some have invoke a Lockean philosophy of labor and just deserts in contending that live-organism patents were inappropriate because they did not require the patent holders to mix their labor with the naturally occurring item.[iv]

These reasons reflect what is known as the ‘product of nature’ theory, this was of-course explained in a more detailed manner in the Kalo case (Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) where the court’s application of this theory led it to determine that Kalo had failed to take an inventive step when it mixed bacteria to produce an improved fertilizer.

Gradually now, a showing of human intervention is required to file for a patent in the first part of the test. This basic requirement prevents the direct appropriation of naturally occurring organisms. The applicant's use will have some bearing on the quantifiable calculations; the evolutionary biology test does not assume that a biotechnologically altered organism is inherently man-made. It goes a step further to calculate and examine the probability of the organism's natural development as part of the first prong of the proposed test.

Let’s now take a look at section 3(j) of the Indian Patents Act:

Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. 

Although, according to article 27 of the TRIPS, a member state may exclude from patentability plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and micro-biological processes. Thus, with an ordre public exclusion having been carved out, the Indian legislation may very well be TRIPS compliant.

But the fact remains that if a law may be enacted by the parliament to give effect to an international treaty (Article 253), the same maybe struck down by the Supreme Court or High Courts of India as unconstitutional, if it violates any of the fundamental rights of the citizens.

Which brings us to the point that there a few plausible grounds whereby section 3(j) may not be justified or in litigation terms- may become prey to invoke the question on constitutionality.

Firstly, the usage of words ‘plants and animals in whole’, incorporates a blanket ban on the patentability of all living organisms, without even considering engineered animals.

Secondly, the silence of the Act on the patentability of the living forms coupled with the usage of wide terms such as ‘plant and animal’ leads to ambiguity as to the patentability of an organism which is a result of human intervention, leading to arbitrary powers in the hands of the Indian Patent Office to grant or deny a patent.

For instance, the Oxford dictionary meaning of the terms would suggest that the ordinary meaning of “plant” is a “living organism other than an animal, typically fixed to a substrate, able to subsist wholly on inorganic substances, and moving chiefly by growth” and “a living organism (such as a tree, grass or fern) that absorbs water and inorganic substances through its roots and makes nutrients in its leaves by photosynthesis.”

Finally, the term “animal” refers to a “living organism having sensation and voluntary motion, without rigid cell walls, and dependent on organic substances for food.” In addition, “a living organism which feeds on organic matter, has specialized sense organs and nervous system, and is able to move about and to respond rapidly to stimuli.”

It is clear from these definitions, that even if there is an organism which is a result of human intervention it can fall within the definition of ‘animals’, therefore disentitling it from patent protection. Thus, as of today, a product ‘X’ which is humanly engineered, would fall within the teeth of Section 3(j), no thanks to absence of specific guidelines and delineated definitions of terms such as ‘plants’ and ‘animals’.

[CONTINUED IN THE NEXT POST]

[i] M.T. Iwasaka Ryan, Chakrabarty to Chimeras: The growing need for evolutionary biology in Patent law 109 Yale L.J. 1505.

[ii] Tom Regan, The Case for Animal Rights, 1983; Peter Singer, Animal Liberation (2^nd edn, 1990)

[iii] O'Reilly, 56 U.S. (15 How.) 132-33

[iv] C.B. Macpherson (ed), Second Treatise of Government (Hackett Publ'g. Co. 1980) 8-30, ‘For John Locke's original discussion’

Snippets: Indian Patent Office Rejects Abbot Laboratories’ HIV Drug Patent Application

Today’s Economic Times carries a news report, according to which Abbot Laboratories’ application for a patent on its HIV combination drug, Lopinavir/Ritonavir, has been rejected by the Indian Patent Office.

Reportedly, Abbot’s patent application was opposed by Cipla, Matrix Laboratories and I-MAK (Initiative for Medicines, Access and Knowledge). The documents pertaining to the pre-grant opposition and an overview of the entire case, including the decision, are available here.

Extracts of I-MAK’s official press release are reproduced below:

“This weekend, India rejected an unmerited drug patent application, paving the way for access to lifesaving medication for HIV patients across the world. This groundbreaking victory for patients sets an important precedent to stop pharmaceutical companies from gaming the patent system, marking a new era of hope for millions of people living with HIV all over the world.

This drug combination, Lopinavir/Ritonavir, is considered to be the front line of defense for HIV positive patients who have failed to stay healthy with the first round of medicines available today. India, the world’s leading supplier of affordable medicines, can now supply this drug to patients across the globe who are desperately waiting for treatment.

The impact of the case is tremendous. There are over 33 million people living with HIV today and of these nearly 15 million require access to HIV drugs. Cost-savings generated over a three-year period by introducing generic Lopinavir/Ritonavir to 43 low and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment who currently lack access. That is 130,000 lives that could be saved from opening up the market for this drug alone.

Cheaper generic versions of this drug are ready to reach patients in India and across the world. Most recently, the Clinton Health Access Initiative has negotiated a price of $440 per patient, per year for generic versions of this drug from four suppliers. Enabling competition amongst Indian suppliers has been demonstrated to consistently drive down prices on HIV medicines, from $10,000 per patient per year in 2000, to as little as $79 today.

This affordable pricing by generic suppliers in India is in stark contrast to the unaffordable pricing by Abbott Laboratories on HIV drugs across the world over the last decade. “Abbott’s track record on pricing this drug unfairly for poorer countries motivated us to take on this case”, stated Tahir Amin, Director of the Initiative for Medicines, Access & Knowledge, the not-for-profit organization who brought the legal action. “They have gamed the patent system for nearly twenty years to extend the patent life on this drug. The time has come to say, ‘enough is enough’.”

I-MAK reports that Abbott Laboratories holds at least 75 patents on Lopinavir/Ritonavir alone. The rejection of this patent application in India was for a combination of existing drugs and techniques. The Indian Patent Office has put a halt to Abbott Laboratories patenting which, simply put, was not an invention.”

This decision is bound to ruffle a few feathers in the Pharma industry. We will shortly discuss the key aspects of the Patent Office’s decision. Insights into the proceedings before the Patent Office are welcome!