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The Panel also considers that it is appropriate that the Government continue to seek damages from i got oxycontin the owners of VIAGRA - Online Drug Store invalid patents that have resulted in significant costs to the PBS by is tramadol tracked delaying the entry of generic versions. The Government, through the PBS, is the party most affected by the actions taken by patentees com new phentermine cheapest online pharmacy phentermine to prevent generic entry. Given this, it is appropriate that the Government seek compensation for the higher price it has been forced to pay because of delay in the automatic price reduction. Although some submissions argue that the risk of paying damages to the Government could result in delay in the timely introduction of new products to the Australian market, little evidence has been provided to support these arguments. However, the Panel considers that the recovery of damages in isolation is insufficient.

The PBS is the party that 'internalises' most of the benefits of a successful challenge to a patent through reduced subsidies. Therefore the Government should take a more active role where another party is challenging the validity of questionable patents that incur significant costs to the PBS. For example, the Government could put in place mechanisms for assessing the validity and significance of particular patents to the PBS budget. Possible mechanisms include: • making it a mandatory condition of being granted an injunction for pharmaceutical cases that the patentee undertakes to repay any damages to the com new phentermine cheapest online pharmacy phentermine Government; • providing the challenger of com new phentermine cheapest online pharmacy phentermine a patent with a portion of the damages obtained by the Government from an undertaking by the patentee; • providing a challenger with a combination of guaranteed and conditional subsidies or negotiating some other arrangement; •requiring the patentee to repay to the Government an amount based on the lost reduction in PBS subsidy due to the delayed entry to the market of generics; or • requiring the patentee to pay a portion of its profits for the product during the injunction period to a successful challenger. Draft recommendation 8.1: As the party that 'internalises' the most benefits of a successful challenge to a patent for a product on the PBS, the Government should take a more active role in managing the cost of the PBS where a patent relating to a PBS-listed pharmaceutical is successfully challenged in the courts. This could involve ensuring that the Government recoups more of the cost to the PBS arising from delayed generic entry. It should also include implementing measures to reduce disincentives for generic manufacturers to challenge patents by providing negotiated incentives for a party who successfully challenges a patent. Patent certificates Section 26B of the Therapeutic Goods Act 1989 (Cth) provides that a generic manufacturer seeking to rely on data provided by an originator company for registration of the generic's goods on the ARTG must provide a certificate to the TGA in relation to any patents that may exist for the goods.277 An originator company who commences proceedings in response com new phentermine cheapest online pharmacy phentermine to a patent certificate must then comply with the requirements set out in s.26C and s.26D of the Therapeutic Goods Act. 8.5.1.Section 26B certificates 8.5.1.1.Current Law A pharmaceutical company that is successful in obtaining regulatory approval for a new drug is entitled to a period of five years data protection for the clinical efficacy and safety data provided to the TGA.278 This means that for five years no other entity can rely on the data to gain approval to market a bioequivalent, or biosimilar, generic drug.



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