Contents
- FDA To Speed Up Inspection And Warning Process
- U.S. Patients Receive Greater Access to Unapproved Medications
- Recent Cases
FDA To Speed Up Inspection And Warning Process
By: Isabel Raasch
On August 6, 2009, the USFDA's top official Margaret Hamburg vowed to speed up the reporting of warnings related to problems found during inspections and to act more aggressively in serious cases that could harm consumers and patients. The announcement follows criticism of the delays caused by the agency's previous requirement that all warning letters be reviewed by the agency's top lawyer before being sent to manufacturers. This procedure will now only be used for certain legally complex cases. Under the new policy, the agency will strive to send warning letters promptly, whereupon companies will have up to 15 working days to respond before the agency takes further action. Ms. Hamburg also stated that the agency will move quickly to close cases after problems found during inspections have been resolved and that it would make such information public.
For more information, please see:
http://www.reuters.com/article/rbssHealthcareNews/idUSN0642179520090806?sp=true
U.S. Patients Receive Greater Access to Unapproved
Medications
By: John Norman
Seriously ill patients will have greater and easier access to unapproved medicines due to new USFDA regulations. The new rules establish who is eligible for these new experimental drugs and when manufacturers can charge for them. The FDA predicts a 50% increase in individual applications, and a 25-50% increase in applications from groups of patients. It is also hoped these new rules will encourage companies to provide experimental medicines outside of clinical trials.
For more information, please see:
http://www.alertnet.org/thenews/newsdesk/N12141146.htm
Recent Cases
By: Beverley Moore
Purdue v. Pharmascience; merits of a 55.2 proceeding; 2009 FC 726; oxycodone; July 16, 2009
The Court granted an order of prohibition to Purdue in the face of Pharmascience's allegations that the patent was invalid.
Regarding the anticipation allegation, the Court found that none of the alleged documents met the disclosure requirement. In considering obviousness, the Court applied the Supreme Court's test in Sanofi and looked at testimony from the inventors as well as the experts. The Court then went on to hold that a considerable amount of work had been required in order to achieve the invention. Furthermore, the trials of the inventors were not routine and it was not self-evident that what was being tried ought to work. Thus, the work was inventive. The Court also found in favour of Purdue regarding the allegations of inutility and overbreadth.
The full text of the decision can be found at:
http://www.gowlings.com/resources/enewsletters/pharmacapsules/pdfs/V8N10_20090820a.pdf
Apotex v. Lilly; interlocutory motion in a section 8 proceeding; 2009 FC 693; raloxifene; July 3, 2009
Apotex brought an actionpursuant to section 8 of the NOC Regulations and as part of its relief, Apotex claimed that it should be compensated by a disgorgement of Lilly's revenues through an application of the principles of unjust enrichment. Lilly brought a motion to strike that part of the claim. The Court granted the motion to strike.
The Court held that as there has been a judicial determination of the available remedies under section 8 in the context of a full trial, it can now make preliminary determinations on motions to strike. The Court held that it was bound by the Court of Appeal in Merck which held that the only remedies included in section 8 are those that would compensate the generic company for the losses it had suffered. An accounting of profits has the same remedial aim as unjust enrichment, in that it would return to the plaintiff what rightly belongs to it, namely the revenues earned by infringing use of its intellectual property. As the generic company is not a patentee, it cannot claim these remedies. The Court further found that a private cause of action entirely based on unjust enrichment is outside the jurisdiction of the Federal Court.
By motion, Lilly had also requested a stay of the section 8 proceeding pending its motion for leave to appeal the underlying Court of Appeal decision to the Supreme Court. The stay was declined.
The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc693/2009fc693.html
Abbott v. Sandoz; merits of a 55.2 proceeding; 2009 FC 648; clarithromycin; July 7, 2009
The application involved two patents. The Court granted prohibition on the basis of one of the patents, but not the other. Both patents related to extended release formulations.
The Court addressed obviousness allegations against both patents but found that neither allegation was justified. The Court also found in favour of Abbott on the inutility claims of one of the patents.
However, the allegations of double patenting were found justified in part. In particular, double patenting was asserted in respect of two patents. In respect of the first, the Court did not find double patenting on the basis that it was a forced divisional. However, in respect of a second patent, the Court held there was double patenting and refused to consider the dedication to the public, because the dedication occurred after the NOA. The Court held that a patent's claims should be construed as of the date of the NOA. Thus, no effect could be given to a dedication that occurred after the NOA. The Court found that this patent in the proceeding was not patentably distinct over the dedicated patent.
The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc648/2009fc648.html
ratiopharm v. Pfizer; impeachment decision; amlodipine; July 8, 2009
The Court found the patent invalid on all five grounds alleged in final argument, namely obviousness, improper selection, utility, sufficiency and section 53 of the Patent Act.
During the course of the trial, the court considered a single claim which was specific to the besylate salt of amlodipine. Once construed, it was found to be unrestricted as to any particular use or form of the compound. The Court considered a number of factual witnesses detailing the background of the invention and the drafting of the patent. The Court also considered the number of expert witnesses from both sides.
In addressing the obviousness allegations, the Court found that the besylate salt was found through routine salt screening tests. Furthermore, the Court held that it was not clearly superior to the other salts screened and that it was chosen as a reasonable compromise. Thus, the patent was found invalid for obviousness. The Court then addressed the selection patents, indicating that this should really be a question of obviousness. Considering the language used in the patent, the Court held that superlatives in the patent cannot create a selection patent where none in fact exists. As, on the face of the evidence, the Court found that there was nothing unique or outstanding about the besylate salt, the patent was invalid as a selection patent.
The Court then found that the promise of the patent was that the besylate salt would be unique and outstanding. When the evidence was considered, the Court held that this was not the case. Thus, the promise was not fulfilled and the patent was invalid for inutility. Furthermore, the Court found that there were a number of serious errors, omissions and insertions in the patent as well as general departures in comparison to what the inventors had contemplated. Thus, the patent was invalid for insufficiency.
Finally, the Court considered section 53 of the Patent Act and due to those same errors and omissions, the Court found that there were misstatements in the patent, they were misleading and there was sufficient intent to make those misleading statements. Thus, the patent was invalid under section 53 of the Patent Act.
This decision has been appealed.
The full text of the decision can be found at:
Canada Research-Based Pharmaceutical Companies (Rx&D) et al. v. Canada; Judicial Review of PMPRB decision; July 10, 2009
In this decision, the innovators were successful in overturning the PMPRB's requirement for reporting of third party payments. A full summary of this decision can be found in Gowlings' recent Drug Pricing and Reimbursement newsletter here.
The Full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc719/2009fc719.html
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