Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 10, Num. 5, 2000, pp. 40-41

Australasian Biotechnology, Vol. 10 No. 5, 2000, pp. 40-41

INTELLECTUAL PROPERTY

INFRINGEMENT OF PROCESS PATENTS

Carolyn J. Harris, Watermark Patent & Trademark Attorneys

Code Number: au00057

Patents covering processes and methods are common in the chemical and biotechnological industries. They can cover a variety of processes such as preparing new chemical entities, preparing vectors, antibodies, proteins, methods for treating patients using known chemical entities, methods of diagnosis, methods for herbicidally treating crops and many others.

Infringement of a patent in Australia occurs by virtue of Section 13 of the Australian Patents Act 1990 which states that:

• “a patent gives the patentee the exclusive rights, during the term of the patent, to exploit the invention and to authorise another person to exploit the invention.”
• “Exploit” has been defined in the Patents Act 1990 in relation to processes as including

1. using the method or process; or
2. making, hiring selling or otherwise disposing of a product, offering to do so, using or importing it or keeping it for any of these purposes where the product is a result of the use of the method or process.

Thus, the patentee has the right to stop any other party using the method within Australia or disposing of the product resulting from the process if they do not have the patentee’s permission to do so.

  Direct Infringement

Assume a patentee has a patent covering a method of protecting plants from insect infestation which involves the use of two compounds, previously known as pesticides for plants, in a unique ratio which provides a synergistic effect. Patent protection has been granted on the basis that although the compounds used are known to treat plants, when the two compounds are combined, the effect is significantly more than the sum effect of the two compounds individually.

In this case, the patentee cannot control the sale of the compounds per se as they are known, but it is possible for the patentee to stop parties from using the patented method by virtue of his right to exclusively exploit the invention.

Take the example of a patentee having a patent for a method of producing an antibiotic from a bacterial vector. This new method is far more efficient and cheaper than existing methods. The patentee is able to prevent other parties from using the patented method, but cannot stop the sale of the antibiotic if it has been made by an existing method. The benefit of the patent to the patentee is that the antibiotic can be made more quickly and more cheaply than by other methods and therefore provides commercial advantage.

  Has Infringement Occurred?

It is somewhat more difficult to establish infringement of a process claim than to establish infringement of a product claim. Infringement of a product claim can be established relatively simply by comparing the allegedly infringing product with the product as defined in the claim.

However, if infringement of a process is being considered, it is necessary to establish that the process as defined in the patent is actually being used. Take the example mentioned above of the antibiotic produced by a bacterial vector. As the antibiotic can be produced by various methods (including the new patented method), analysis of the end product produced by any method will not necessarily indicate how the product was made. On this basis alone, it is not possible to establish whether infringement of the process patent has occurred.

However, the patentee can request an order from the Federal Court which may “for the purposes of enabling the proper determination of any matter in question in any proceeding” make orders for the inspection of property, the observation of property and the observation of any process. Whilst there are conditions applying to such an order, it can be obtained when the patentee can establish by way of evidence that there is more than just a suspicion that infringement is occurring.

The other order that may be required from the Federal Court by the patentee is one relating to the taking of samples of intermediate and final products of the alleged infringing process for examination and analysis. The analysis of these samples should assist in establishing whether or not infringement of the process has occurred.

  Infringement of Method of Treatment Claims

Consider the following claim:

“A method for administration of taxol to a patient suffering from cancer comprising infusing from 135 to 175mg/m2 of taxol over a duration not exceeding 6 hours.”

A claim such as this will be infringed if a person other than the patentee, or a person permitted by the patentee, administers to a patient taxol in the required amount in less than 6 hours. Thus, there will be no infringement if the administration takes place over 6 hours and 15 minutes.

  Contributory Infringement

Consider the claim above relating to the administration of taxol. Assume that a manufacturer of taxol sells the product with instructions or inducement to perform the claimed method. Is the manufacturer liable for infringement?

The manufacturer is not liable for infringement directly as the manufacturer is not administering the taxol to a patient. However, it is in the interests of the patentee to stop the sale of the taxol with instructions by the manufacturer, rather than taking action against the doctor who has administered the taxol (a potential customer of the patentee).

This type of problem was addressed by the inclusion of Section 117 of the Australian Patents Act 1990 which states that:

“If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.”

Until recently, interpretation of this clause meant that to infringe a method claim of a patent, use of a product infringes the invention only if the product is one which results from use of the claimed method or process.

As a consequence, it was not possible to successfully sue for contributory infringement of a method where the alleged infringer was supplying a product used in the method or process when:

1. the product was reasonably capable of use only in the method;
2. the supplier had reason to believe that the purchaser would put it to use in the method; or
3. the product was supplied with instructions or inducement by the supplier to use the method. This interpretation was a result of the awkward wording of section 117 and the definition of “exploit” found in the legislation.

However, in Bristol-Myers Squibb Co v F H Faulding & Co Ltd [2000] FCA 316 (March 2000), the court held that section 117 should be interpreted so as to have its intended meaning as recommended by the IP Advisory Committee prior to its drafting and enactment, and on this basis, the supply of a product to be used in a claimed method or process will constitute contributory infringement if the above conditions (a), (b) or (c) also apply. This significantly broadens the protection accorded to method and process claims in Australia and makes it possible for a patentee of a process to stop the supply of a product for the use in a patented process in certain circumstances.

  Conclusion

Infringement of process patents can occur directly and by way of contributory infringement, both of which can be stopped under the legislation of the Australian Patents Act 1990.

  Copyright 2000 - Australasian Biotechnology