Amending overseas patents? Then consider amending in Australia: lessons from Neurim Pharmaceuticals v Generic Partners

Amending overseas patents? Then consider amending in Australia: lessons from Neurim Pharmaceuticals v Generic Partners

Amending overseas patents? Then consider amending in Australia: lessons from Neurim Pharmaceuticals v Generic Partners

You have invented a widget. Let’s assume your IP checklist looks like this:

  • Australian patent for widget granted? Check.
  • Overseas patents for widget granted? Check – although some claims needed amending to overcome objections raised by the overseas’ patent offices.
  • Someone starts to make and sell your patented widget product in Australia without your consent. You sue for patent infringement to stop them. Check.
  • As part of your infringement action, you want to amend the claims of your Australian patent so that they are more aligned with your overseas patents. Because you have commenced Court proceedings, you need to obtain the Court’s leave to amend[1]. Will the Court grant you leave? Or will it decline to do so on the grounds that you ought to have known of the need to amend the Australian patent (given the earlier amendments you made to the overseas patents), and your delay in making the amendments is unreasonable?


In the case of Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd (No 2)[2], Neurim (the patentee) was successful against Generic Partners and Apotex in obtaining the Court’s leave to amend in these circumstances. However, there will be other instances when the patentee is unsuccessful with such an application. If you find yourself amending overseas patents, what is vital to determine is whether you are doing so because the claims might otherwise be invalid. In these circumstances, consideration should be given as to whether the Australian claims should also be amended. Unless you have reasonable grounds to believe that the amendment in Australia need not be made, you should move to make the amendment and you should do so promptly.


Facts of Neurim case

In the Neurim case, the Australian patent was entitled “Method for Treating Primary Insomnia” and involved the use of melatonin. The (unamended) claims referred to melatonin being used to improve the restorative quality of sleep in the patient.

The amendments made to the claims of the overseas’ patents were similar in effect to those for which leave was being sought in Australia. The amendments overseas were as a result of objections raised by each of the overseas patent offices that the invention was not novel and did not involve an inventive step in light of certain prior art documents which disclosed that melatonin was used to treat primary insomnia. By the time the objections were raised overseas, the Australian patent had already been granted. (Accordingly, the amendments for which leave was sought to be made had not been necessary as part of the Australian examination process.)


Court’s discretion

In Australian Court proceedings, the Court has a discretion to determine whether leave should be granted to amend a patent specification. In exercising this discretion, it will disallow the patentee’s amendment in a number of circumstances including if the patentee had reasonable grounds to believe that the claim might well be invalid but the patentee delayed taking the necessary steps to amend it.


Neurim’s arguments for leave to amend

Neurim’s arguments included that:

  • The prior art documents disclosed that melatonin was used to treat lack of sleep quantity (that is, difficulty in initiating or maintaining sleep), but not to treat lack of sleep quality (being when the patient is asleep, but experiences a poor quality sleep).
  • Whilst the (unamended) claims disclosed that the treatment was for restorative sleep quality, it nevertheless amended the overseas claims to make this clearer so as to overcome the objections in those jurisdictions. It did not amend overseas because of a belief that the claims were otherwise invalid.
  • The rationale for seeking the amendments in Australia was to narrow the scope of the claims and reduce the scope of the issues in the Court proceeding.
  • The Australian patent was valid without the amendment. However, Neurim also acknowledged that if the Court disagreed with that proposition and was instead of the view that the unamended claims were invalid, the amendments could improve Neurim’s prospects of success in defending the challenge to the validity of the patent.


Apotex’s arguments against leave to amend

These included that:

  • On a broad interpretation of the relevant claims, they were invalid without the amendment.
  • The amendments would narrow the claims and would result in there being a better chance of the Australian patent being found valid.
  • The amendments that were sought to be made were the same or similar to the overseas amendments. Neurim had been on notice since the overseas amendments were made (a period of approximately 6 years) that the amendments were necessary, and it had therefore unjustifiably delayed in seeking to amend the Australian patent.


Court’s decision’s to give Neurim leave to amend

The Court decided that Neurim should have leave to amend the claims of the Australian patent. What was ultimately crucial was the inventor’s understanding of the relevant claims (which was that the claimed invention only covers one medical use, namely the treatment of lack of sleep quality in patients suffering from primary insomnia), that this view was supported by the specification, and that the prosecution histories of the overseas patents did not support that the patents would have been invalid without the amendments, making it clear that the treatment was for restorative sleep quality.


Take home points

From the comments of the Court in the Neurim decision, the take home points are:

1.    Even if your Australian patent has been granted, you may need to consider amending it in circumstances in which equivalent overseas patents have been amended.

2.    Amend as soon as possible. It is preferable to amend before any Court proceedings are issued because in those circumstances, you will not need to later obtain the leave of the Court.

3.    If the inventor construes the claim in a manner which means it would be valid, check whether that construction is consistent with other factors such as the body of the specification or the patent prosecutions overseas. If that construction does not seem reasonable in all the circumstances, consideration should be given to amending the claim and the patentee should move promptly to do so.


[1] S 105(1) Patents Act 1990 (Cth)

[2] [2019] FCA 154

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