1) Dimminaco A.G filed a patent application for a process to prepare a bursitis vaccine containing a living virus. The patent application was rejected on grounds that it did not constitute an "invention" under the Patent Act. 2) The key issues before the Court were whether a process producing an end product with a living organism can be patentable, and if the claimed process would constitute a "manner of manufacture". 3) The Court held that there is no bar to patenting such processes. Since the claimed process was a novel method of vaccine preparation involving defined chemical steps, it was a patentable "manner of manufacture" under the Act.

1. DimminacoA.G.v.ControllerofPatentsDesigns(2002)I.P.L.R.255(Cal)
Facts
§ The Appellant, Dimminaco A.G, filed for a patent application for an invention relating
to a process for preparation of the bursitis vaccine. The vaccine was useful for
protecting the poultry against the contagious bursitis infection. However, the process to
prepare the vaccine contained a living virus in the end product.
§ The patent application filed by Dimminaco A.G. was examined by the Patent Officer
Examiner under Section 12 of the Patent Act, 1970. On such examination, the Examiner
gave a finding that the said Patent Application did not constitute an
invention under Section 2 (j) (i) of the Patent Act, 1970.
§ Dimminaco A.G. further appealed against this rejection to the Controller of Patents &
Designs.
§ Acting under delegated authority by the Controller, the Assistant Controller of Patents
and Designs too refused to accept the Patent Application and upheld theobjection.
§ Hence, the appellants approached the Calcutta High Court with this appeal.

2. Issues:
1) Is there a statutory bar to accept a manner of manufacture as
patentable if the end product contains a living organism?
2) Will a process of preparing a vaccine that contains a live virus be
considered to be ‘methods or process of manufacture’ under the Patent
Act, 1970? If yes, will it be construed to be an invention as under
Section 2 (j)(i) of the Patent Act, 1970?

3. Law
• Section 2 (j)(i) of the Patent Act, 1970 stated – “(j) ‘Invention’
would mean any new and useful –
i. Art, process, method or manner of manufacture;
ii. Machine, apparatus or other articles;
iii. Substance produced by manufacture and includes any new
and useful improvement of any of them and an alleged
invention;”
Section 5 of the Patent Act, 1970 stated – “Inventions where
only methods or process of manufacture patentable –
• 1) In the case of inventions –
• a) Claiming substances intended for use, or capable of being
used, as food or as medicine or drug, or

4. Cont….
• b) relating to substances prepared or produced by chemical
process (including alloys, optical glass, semi-conductors and
intermetallic compounds),
• No patent shall be granted in respect of claims for substances
themselves, but claims for the methods or processes of
manufacture shall be patentable.
• 2) Notwithstanding anything contained in sub-section (1), a
claim for patent of an invention for a substance itself intended
for use, or capable of being used, as a medicine or drug may
be made and shall be dealt, without prejudice to the other
provisions of this Act, in the manner provided in Chapter IV-
A.”

5. Analysis:
§ The Court held that there is no statutory bar to accept a manner of manufacture to be
patentable if the end product contains a living organism. In this case, the processclaimed
in the patent application was a new and novel process for the preparation of vaccine that
involved chemical steps under specific scientific conditions. Therefore, the Court held
that it was a new process and was patentable under Section 5 of the Patent Act. In other
words, since the end product was a new article, the processleading to its manufacture was
held to an invention, and thus patentable.
§ To decide whether in a particular case, the process of manufacture that is involved in
the invention ought to be patented or not, the vendibility test can be used.
§ A vendible product is one that can be passed on from one man to another upon the
transactions of purchase and sale. Therefore, the vendibility test is satisfied if:
* the invention results in the production of some vendible product; or
* if it improves/restores former conditions of a vendible product; or
* if its effect is the preservation and prevention from deterioration of some
vendibleproduct.

6. Cont…
• § Since ‘manner of manufacture’ is not defined in the statute,
the dictionary meaning of the word has to be used. The Court
held that the dictionary meaning of the word ‘manufacture’
includes the process of preparing a vendible commodity which
contains a living organism.
• § The Court also rejected the Patent Office’s understanding of
the lyophilizing. It held that the as a result of the process of
lyophilizing, nothing is killed or destroyed – the biological
activity of the material is retained and not wasted. Therefore,
as a matter of practice, patents had been granted by various
Patent Offices, to processes that involved living organisms.

7. Conclusion
• § There is no statutory bar to accept a manner of manufacture
as patentable if the end product contains a living organism.
• § Since the claim process for patent, that is, the bursitis
vaccine, led to a vendible product, it was certainly a substance
after going through the process of manufacture. Therefore,
the process was an invention, and thus patentable.