September 21, 2006 DePaul University, Chicago, IL APLF- DePaul University College of Law 2006...

September 21, 2006DePaul University, Chicago, IL

APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

Alicia Alvarez Berkenwald, Chem. Eng. Patent Attorney

Protection of Biochemical Inventions in Argentina.

Overview of Patentable Subject Matter

• Argentina: agricultural country

• Agriculture: competitive advantage

• Factors: - Direct sowing- Agribiotech

APLF- DePaul University College of Law 2006 Symposium on Intellectual Property

Law

Country Features

• Agribiotech: main protection systems

- Plant Breeders’ Rights - Patent Law


Law

The Legal Frame


Law

Patent Law

• 1995: New Patent Law

- Specific provisions on living matter

• 1996: Regulatory Decree

- More restrictive than PL


Law

Patent Law

• 2002: Permanent working team

- Secretary of Agriculture / Patent Office

• 2003: Guidelines for patentability

- Restrictive interpretation of PL and regulatory

decree

• An invention is everything created by man which allows the transformation of matter or energy for exploitation by man


Law

Invention

• Not considered inventions:

- Discoveries

- Any kind of living matter and substances …

… pre-existing in nature or identical to a natural element -- Even purified and isolated


Law

Patentability Criteria


- Animals, parts or components that lead to a whole individual


Law



- Plants, propagation materials, parts or components that lead to a whole individual


Law


• Not patentable:

- Microorganisms pre-existing in nature -- even isolated and purified

• Patentable:

- Modified microorganisms


Law


• Not patentable:

- Cells that may lead to a plant or animal

• However, any cell component is considered a substance


Law


• Patentable:

- Modified substances

- Synthetic substances different from natural ones

- DNA, plasmids, proteins, sequences, etc.,which are not

identical to a natural element


Law


• Not patentable:

- Essentially biological processes - “Series of steps that result in the obtention of plants

or animals and that are accomplished to a great extent

by action of phenomena existing in nature e.g. Selection

and Cross-Breeding”


Law


• Patentable

- Microbiological processes - “Industrial processes that use, apply or result in a microorganism”


Law


The Sunflower Seed Ruling


Law

• First decision concerning biochemical inventions

• Dealt with for the first time: - Clarity of claims - Enablement requirement



Law

• CIC applied for a patent claiming a sunflower seed comprising an oil with a greater content of stearic acid, obtainable by treating parent seeds with a mutagenic agent, germinating seeds, culturing plants, collecting and selecting seeds, optionally repeating stages



Law

• First office action: seeds cannot constitute patentable subject matter

• Seeds and plant varieties can be protected by

Plant Breeders’ Rights

• UPOV 78: no double protection allowed



Law

• New Claims:

- Product Claim: a sunflower oil characterized for having a

content of stearic acid 12% greater that the content of stearic acid in the oil obtained from wild seeds



Law

• New Claims:

- Method Claim: method for preparing a sunflower oil by

treating parent seeds with a mutagenic agent, germinating

seeds, culturing plants, collecting and selecting seeds,

optionally repeating stages



Law

• After 3 office actions, the application was rejected • The applicant judicially requested the reversal of the PTO decision

• The Lower Court and the Federal Court of Appeals

confirmed the PTO decision on the following basis...



Law

• The applicant defined the product (oil) by the content of

stearic acid in relation to the content of stearic acid of the

oil obtained from wild seeds • The applicant failed to define the stearic acid content of

the oil obtained from wild seeds

• Claim is indefinite



Law

• Method Claims: the proposed method leads to obtain

a sunflower seed or plant (plant variety)

• Seeds and plants are protected by Plant Breeders’ Rights

• Double protection is not allowed

• A method to obtain the oil was not disclosed



Law

• The result of the method is fortuitous since it depends on

selecting the appropriate seeds • Reproducibility is not guaranteed

• The applicant failed to provide enough explanatory

information



Law

• Understanding what went wrong:

-The sunflower seed should have been protected through

Plant Breeders’ Rights.

-The oil could have been protected by a Patent if the claim

had been properly drafted.


Conclusions

• Plant Breeders’ Rights:

- Plants or seeds, even genetically modified

- Propagation materials


Law

Conclusion

• Patents:

- Plants and animals: No

- Plant or animal parts: No, if a variety is hidden

- Plant or animal cells: No, if a variety is hidden

- MO, DNA, genes, vectors, proteins, sequences: Yes,

if not identical to a natural element


Law

Conclusion

• Patents:

- Process for the production of plants or animals: No, if

essentially biological

- Process for the production of a plant or animal: Yes, if

it includes a technical step

- Process for treating plants or seeds: Yes, if new features

are non-inheritableAPLF- DePaul University College of Law

2006 Symposium on Intellectual Property Law

Conclusion

• IP system in AR is still developing

• Litigation is increasing and decisions are favoring IP

• Plant Breeders’ Rights can be supplemented by

Patent Rights


Law

Conclusion

Thank you.

E-mail: [email protected]: www.goberal.com.ar

September 21, 2006 DePaul University, Chicago, IL APLF- DePaul University College of Law 2006...

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