As far as innovator companies are concerned, as well as the public, Australia’s process of approving generic agents and biosimilar is too secretive. There are no strict requirements that drug makers who want to bring a competing product to market need to notify the innovator company until it is too late in the process, once marketing approval has been given and the product will appear on the list of Australian medicines.
For innovator companies, this gives very little time, sometimes less than 2 months, to file legal action to stop commercialization, and if the company loses its patent defense, the company can be held liable for the loss of revenue suffered by generic or biosimilar companies. To the public, this late notification system prevents people from knowing whether a more affordable product comes to the market until it is too late.
However, there are signs that the Australian authorities are trying to fix the problem. That The Therapeutic Goods Administration is looking for feedback prescription medicines transparency measures which would make it difficult for pharmaceutical companies to defer notification of intent to launch a rival product.
Under current Australian law, after a competitor’s therapeutic product has received marketing approval and is placed on the Australian Therapeutic Goods List, short time intervals before commercialization may be owned by all innovator companies before the product is retailed and begins to erode the base price for the product. reference products.
There are rules for prior disclosure if competing products tend to violate innovator patents, but this is considered too weak. For example, a company is not required to disclose to innovators that it brings a competing product to market if it believes that its product will not violate 1 or more of the “legitimate” patent claims of the innovator. However, the opinions of competing companies may not be biased.
“In practice, this means that sponsors seeking marketing approval for generics or biosimilars in Australia generally do not notify their application innovators, and innovators only know generic or biosimilar products when approved,” according to an analysis current law and amendments filed by patent law attorneys at Shelston Intellectual Property of Sydney, Australia.
Patent lawyers offer FDA policy as an example of a far more effective model. “The current Australian regime for late and somewhat passive innovators is that approval of generic and biosimilar products is different from the rigid and transparent process of the US Food and Drug Administration,” they wrote.
In the United States, the FDA does not provide information about delayed drug applications unless it has been disclosed to the public. However, this information is generally available long before approval. Recent research of 249 Biological License Applications and New Drug Applications found that 89.2% were disclosed in ≥ 1 public media, and 78.7% of them were announced by press release.
Furthermore, under the US Biological Price Competition and Innovation Act, biosimilar applicants must provide notification to the reference product sponsor no later than 180 days before the date of the first commercial marketing of biological products. In practice, a review of potential patent infringement begins earlier than the beginning of that period.
Australian regulators put forward 2 possible solutions to the notification problems they have identified. Someone will require applicants to give advance notice to the innovator company whether or not they believe that violations can occur from marketing rival products, or at least make a statement to the authorities that they have a “reasonable belief” that there will be no patent attachment. . This still leaves a large force in the notification in the hands of the applicant.
The second option will require applicants to provide initial notification to all innovators for all generic and biosimilar applications whether they think patent infringement might occur. A copy of the notice must also be sent to the Australian regulator, in this case the Administration of Therapeutic Goods. This earlier notification will be required after the application for registration passes the initial assessment.
The authorities hope to provide more time for the patent dispute to be resolved before marketing authorization is granted. Competing companies are not the only ones that can hold companies accountable for lost revenue.
In that case it’s fair resolved, the Australian government is suing Sanofi and Bristol Myers Squibb (BMS), arguing that litigation surrounding patents for clopidogrel anti-clotting drugs (Plavix, Iscover) prevents generic rivals from coming to market. The availability of rival drugs in the Pharmaceutical Benefits Scheme in the country will trigger an immediate price reduction of 12.5%. The government requested assistance of $ 325 million, arguing that, except for patent litigation, generic products would be available in 2008 and result in substantial savings for the Australian health system.
However, Sanofi and BMS managed to ward off that, among other things, it was doubtful that competing companies would bring their medicines to the market on the date that the damage was expected to start increasing.
Although Sanofi and BMS defeated this lawsuit, their claim for patent infringement was settled out of court with a clopidogrel lawsuit against rival drug company Apotex Australia. Apotex has requested $ 138 million in compensation.
As a footnote to their analysis, lawyers from Shelston IP noted that there may be broader implications for the Australian notification system as it is now. “It is very open to debate whether Australia’s current arrangements are consistent with its obligations under the Australia-United States Free Trade Agreement,” they wrote.
Chahal HS, Szeto D, Chaudhry AH, Sigelman DW, Kim S, Lurie PG. Disclosure to the public about the submission of new drugs and therapeutic biologic applications with the US Food and Drug Administration [published online June 3, 2019]. JAMA Intern Med. doi: 10.1001 / jamainternmed.2019.1213.