Clash of the Pharmaceutical Titans
Learn about the High Court's ruling in the Astrazeneca AB & Anor v. Apotex Pty Ltd case and what the decisions' significance is.
11 September 2015
Do you remember the feeling of excitement and anticipation at 11:55pm on the eve of your birthday when you were a kid? And the thrill you felt when you got to rip open your presents when the clock struck 12?
That’s what intellectual property lawyers around Australia felt this week, eagerly awaiting a huge pharmaceutical judgement.
Cholesterol levels in the limelight, but not for health reasons.
Apotex, the largest Canadian-owned pharmaceutical company, took AstraZeneca, one of largest pharmaceutical companies in the world, to court in a claim against the patent for rosuvastatin. The High Court decided in favour of Apotex this week.
AstraZeneca claimed a patent in Australia over their single, orally-administered 5-10 mg of rosuvastatin, a drug used to lower blood cholesterol levels. Apotex challenged the validity of the patent on three main grounds:
- a lack of novelty, which means there was public disclosure before the filing of the patent application;
- lack of inventive step; and
- not a “manner of manufacture” (see NRDC case).
The High Court unanimously affirmed the previous decisions. They found that the “invention” would be obvious to a skilled person in that field, with access to common general knowledge and public information relevant to that “invention”.
This decision is important for two reasons.
1. There is large sums of money involved.
AstraZeneca managed get a court order to keep the generic rosuvastatin products off the shelves for a period of time while the case was in the courts. The companies affected are expected to claim compensation for losses incurred.
2. The High Court was definitive with its approach towards “obviousness”.
Obviousness is a critical point in most patent disputes, and the court affirmed that as the legislation uses plain and ordinary language, assessing patents using a “skilled person” tool should not be unnecessarily complicated.
Here is the full judgement by the High Court.
Pfizer in pain over pain-treatment drug.
Another huge pharmaceutical patent case was decided this week on the other side of the world.
The UK High Court ruled against pharmaceutical juggernaut Pfizer’s attempt to protect their ‘blockbuster’ $5 billion a year drug, Lyrica. Lyrica was originally used to treat general anxiety and epilepsy, and the patent for those uses is expired.
Pfizer obtained a secondary patent after realising that Lyrica could also be used to treat pain, protecting that use until 2017. When generic versions of Lyrica started appearing on shelves, Pfizer sought remedy against a breach of their intellectual property rights.
The UK High Court ruled that the secondary patent was invalid, except for some specific types of pain. As a result, generic versions of Lyrica did not infringe on Pfizer’s patent.
Pfizer has indicated that they are going to appeal the decision, so stay tuned.
To maximise the protection of your invention, start your Patent Application now.
For more information, call a LawPath Consultant on 1800 LAWPATH.
Dominic is the CEO of Lawpath, dedicating his days to making legal easier, faster and more accessible to businesses. Dominic is a recognised thought-leader in Australian legal disruption, and was recognised as a winner of the 2015 Australian Legal Innovation Index.