This post has been guest authored by Sheenal Singh.
AstraZeneca is one of few pharmaceutical companies that make headlines on a regular basis. Here are the top four stories you need to know this month.
Crowdsourcing Cancer Treatments
In an unprecedented move, the Oncology Innovative Medicines Unit of AstraZeneca recently released preclinical data from more than 50 of its medicines to the public at large.
Leveraging the rise of crowdsourcing models in research, the company hopes to determine new drug combinations for cancer treatments. Specifically, the data released by AstraZeneca will be used in a competition created in partnership with the DREAM Challenge. Participants will attempt to develop computer models that identify the properties of drugs that make them powerful when combined. After the competition, the winners will be able to submit their research for publication in the journal Nature Biotechnology.
Discuss your Queries
New FDA requirements for Onglyza?
Earlier this year, in April 2015, the results of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)” trial for AstraZeneca’s relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) were discussed by an FDA Advisory Committee panel of medical experts. As a result of studies such as this one, the FDA may require new Onglyza drug label for warning about heart failure.
An Obvious Case
In July 2015, in the case of AstraZeneca LP v. Breath Ltd., the Federal Circuit Court of United States found that the District Court correctly determined that the asserted claims of US Patent 7,524,834 were invalid for obviousness, and affirmed. The ‘834 patent relates to drug product of Pulmicort Respules® (budesonide inhalation suspension).
Australian Court Invalidates Statin Patents
A notable development occurred in Australia earlier this month, where following four years of litigation, the High Court of Australia in AstraZeneca AB v Apotex Pty Ltd  HCA 30 has invalidated pharmaceutical giant AstraZeneca’s patents for rosuvastatin – a type of statin. AstraZeneca failed to show that its claimed method of administering low dosages of the drug involved an ‘inventive step’.
Marketed by AstraZeneca as Crestor, the decision paves a more certain future for manufacturers of generic versions of the drug which is widely prescribed to lower cholesterol among patients.
Under Australian law, a patent application must satisfy the tests of both novelty and inventive step. The Court dealt with the latter and clarified that the test to be applied is whether the invention discloses an inventive step in light of common general knowledge and the prior art base. While patent attorneys spend much of their time getting the specifications in an application right, this case shows that these descriptions will not be used to narrow or extend the Court’s field of view towards certain documents.
The Court considered that under the Patents Act 1990 (Cth), it was free to consider not only the common general knowledge, but also multiple prior art publications to determine which is relevant. To the skilled person armed with this pre-existing information about rosuvastatin (which included a European patent for the same compound), it would have been obvious to trial the drug in different dosages.
As AstraZeneca contemplates compensation likely payable to competitors it restrained from trading and the value of the company’s licensing arrangements for the drug in Australia, it remains to be seen how the decision affects a broad consumer base recently exposed to conflicting messages about the benefits and risks of using statins.
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