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Patents

Chapter Five

Syllabus topic 1, "Introduction to Intellectual Property Rights (IPRs)"

Pages 17 to 20 of 842

In one line

A patent is a twenty year right to stop others working an invention, given in exchange for telling the world how the invention works.

In exam wording: a patent is a statutory grant conferring on the patentee, for a term of twenty years from the date of filing, the exclusive right to prevent third parties from making, using, offering for sale, selling or importing the patented product or the product obtained directly by the patented process, in consideration of a full and particular disclosure of the invention in a specification open to public inspection.

Why the law has this at all

An invention is expensive to make and cheap to copy. A pharmaceutical company may spend a decade and enormous sums finding a molecule that works. A competitor with the molecule in hand can manufacture it in months.

Without a patent the rational course is secrecy. Keep the process behind a locked door and hope nobody works it out. Secrecy protects the inventor but teaches nobody, and the art does not advance.

A patent is a bargain that buys disclosure. The inventor files a specification describing the invention so fully that a person skilled in the art could perform it, the specification is published, and in exchange the inventor gets twenty years of exclusivity. When the term ends, the disclosure is already in the public domain and anybody may use it.

That is the whole theory, and it is worth stating in the exam, because every argument in Module IV about access to medicines is an argument about whether the bargain is a fair one.

The three requirements

Novelty. The invention must be new, meaning not anticipated by publication or by use anywhere in the world before the priority date. Section 2(1)(l) of the Patents Act 1970 defines "new invention" and section 13 governs the examiner's search.

Inventive step. Section 2(1)(ja) defines it as a feature of an invention that involves technical advance as compared to existing knowledge, or has economic significance, or both, and that makes the invention not obvious to a person skilled in the art. The words "technical advance" and "economic significance" are India's own; TRIPS Article 27.1 says only "non-obvious".

Industrial application. Section 2(1)(ac): capable of being made or used in an industry. TRIPS Article 27.1 offers "capable of industrial application" with a footnote permitting a member to read it as synonymous with "useful".

What cannot be patented in India

Section 3 lists the exclusions, and four of them matter for this paper.

Section 3(d) excludes the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance. This is the provision construed in the Novartis case, worked in [Section 3(d) and the Novartis Case].

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Section 3(j) excludes plants and animals in whole or any part thereof other than microorganisms, and essentially biological processes for the production or propagation of plants and animals. This is India's use of TRIPS Article 27.3(b).

Section 3(k) excludes a mathematical or business method, a computer programme per se, and algorithms. The words "per se" are what the Delhi High Court had to construe in the Ferid Allani case.

Section 3(p) excludes an invention which in effect is traditional knowledge, or an aggregation or duplication of known properties of traditionally known components. This is worked in [Biopiracy: Turmeric, Neem, Basmati, and the Digital Library].

What a patentee actually gets

Section 48 gives the right to prevent third parties, who do not have the patentee's consent, from making, using, offering for sale, selling or importing for those purposes the patented product, or the product obtained directly by a patented process.

Note what is absent. There is no right to work the invention. A patented drug still needs a marketing approval. A patented device may still infringe somebody else's patent.

Section 53 fixes the term at twenty years from the date of filing, which matters because examination can take years and every year of delay is a year of the term gone. That is why TRIPS Article 62.2 requires grant within a reasonable period of time.

A worked example

Dr Meera Pillai, in a laboratory in Hyderabad, finds a new catalyst that halves the energy needed to make a common fertiliser.

Day 1. She files a provisional specification at the Indian Patent Office describing what she has. That date is her priority date, and everything published anywhere in the world after it is irrelevant to novelty.

Month 12. She files a complete specification with claims defining the monopoly she asks for. Under section 11A the application is published after eighteen months from priority.

She has twelve months from the priority date to file abroad under Article 4 of the Paris Convention, or thirty months if she uses the Patent Cooperation Treaty, which is why [The Patent Cooperation Treaty 1970: What an International Application Is] exists.

Examination. She requests examination; the examiner searches the prior art and objects. She amends the claims. This takes three years.

Grant, in year four. She now has sixteen years of the twenty left.

A competitor copies the catalyst. Meera sues under section 48. If the competitor pleads that her invention is obvious, the burden of proving obviousness lies on the competitor, but if her patent is for a process and the competitor makes an identical product, section 104A reverses the burden and the competitor has to prove it used a different process. TRIPS Article 34 is the reason that provision exists.

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What it does NOT mean

A patent is not a right to sell. Regulatory approval is a separate question entirely.

A patent is not granted for an idea. It is granted for a claimed invention, and the claims define the monopoly. Everything outside the claims is free.

A granted patent is not a valid patent. Section 64 allows revocation on a dozen grounds, and Indian patents are frequently revoked. The Monsanto case turned on how a revocation counter-claim must be tried.

A patent does not last twenty years from grant. It runs from filing, and in India there is no extension for regulatory delay.

Quick revision

  • Patent: a statutory right to exclude, for twenty years from filing (section 53 of the Patents Act 1970), in exchange for a full disclosure.
  • Three requirements: novelty (section 2(1)(l)); inventive step (section 2(1)(ja), which requires technical advance or economic significance and non-obviousness); industrial application (section 2(1)(ac)).
  • Section 48 confers a right to prevent making, using, offering for sale, selling and importing. It confers no right to work the invention.
  • Key Indian exclusions: section 3(d) new forms without enhanced efficacy; 3(j) plants and animals; 3(k) computer programme per se; 3(p) traditional knowledge.
  • Section 104A reverses the burden of proof for process patents, which is TRIPS Article 34.
  • The term runs from filing, so examination delay eats it; TRIPS Article 62.2 requires grant within a reasonable period.

Test yourself

1. What is the bargain a patent represents, and why does it matter to this paper? The bargain is disclosure for exclusivity. An inventor who has found something new could keep it secret, and secrecy would protect the invention for as long as nobody worked it out, but it would teach nobody and the art would not advance. The patent system offers an alternative: describe the invention in a specification so fully and particularly that a person skilled in the art can perform it, allow that specification to be published, and receive in exchange the exclusive right to prevent others working the invention for twenty years from the filing date. At the end of the term the disclosure is already public and anybody may use it freely. The bargain matters to this paper for two reasons. It is the justification the whole international patent system rests on, so a student who cannot state it cannot explain why the Paris Convention or the Patent Cooperation Treaty exist. And it is the thing Module IV puts in question, because every argument about access to medicines is an argument about whether twenty years of exclusivity is too high a price for the disclosure obtained.

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2. State the requirements of patentability and the principal Indian exclusions. Three requirements. Novelty, meaning that the invention was not anticipated by publication or public use anywhere in the world before the priority date, defined in section 2(1)(l) of the Patents Act 1970. Inventive step, defined in section 2(1)(ja) as a feature involving technical advance compared with existing knowledge, or having economic significance, or both, and making the invention not obvious to a person skilled in the art, a formulation that goes beyond the bare non-obviousness required by TRIPS Article 27.1. And industrial applicability, defined in section 2(1)(ac) as being capable of being made or used in an industry. Section 3 then lists what is not an invention, and four exclusions matter here: section 3(d), which excludes the mere discovery of a new form of a known substance that does not enhance the known efficacy of that substance; section 3(j), which excludes plants and animals in whole or in part other than microorganisms and essentially biological processes, and is India's use of the flexibility in TRIPS Article 27.3(b); section 3(k), which excludes mathematical and business methods, computer programmes per se and algorithms; and section 3(p), which excludes an invention that is in effect traditional knowledge or an aggregation or duplication of the known properties of traditionally known components.

3. What does a patentee get, and what does a patentee not get? Section 48 confers the right to prevent third parties who do not have the patentee's consent from making, using, offering for sale, selling or importing for those purposes the patented product, or the product obtained directly by a patented process. That is a purely negative right and it is the whole of what the grant confers. The patentee does not get a right to work the invention: a patented medicine still requires marketing approval from the drug regulator, a patented device may itself infringe an earlier patent held by somebody else, and a patented process may be prohibited by other law altogether. The patentee does not get a monopoly over the field, only over what the claims define, so a competitor who works outside the claims infringes nothing. The patentee does not get a right that is safe from challenge, because section 64 permits revocation on numerous grounds and revocation is common. And the patentee does not get twenty years of enforceable exclusivity, because the term runs from the date of filing under section 53 and every year spent in examination is a year of the term consumed, which is why TRIPS Article 62.2 obliges members to grant within a reasonable period of time so as to avoid unwarranted curtailment of the period of protection.

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The rest of this subject

These notes are cut from the University's printed syllabus. Open the syllabus itself, or the past papers, for the same subject.

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