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Biotechnology & Pharmaceutical Practice Group Newsletter
Winter 2004-2005
Canada Proposes Increased Data Exclusivity For Innovators, But Less Patent Roadblocks To Generic Market Entry
Pharmaceutical companies bringing new brand name drugs to market in Canada will receive 8 years of data exclusivity, up from the current 5 years. However, companies will also have less clout in using patents to block generic drugs before Canadian market entry. This is likely to create increased reliance on patent infringement lawsuits after generic entry.
These are among the proposed changes in regulations announced on December 11, 2004 that would revise the Canadian Patented Medicine (Notice of Compliance) Regulations (the Canadian version of the US Orange Book) and the Food and Drugs Act Regulations. There is a 75 day period for the public to submit comments.
Click here for full details.
Poster Presentation Kills US Patent Application
The US Federal Circuit recently affirmed a USPTO decision to reject a patent
application for methods of preparing soy fiber foods. The application was rejected because the methods had already been described in a printed publication more than one year before the application filing date. The "publication" consisted of a poster displayed at a meeting of chemists (2 days) and at a university (1 day). The poster provided an enabling disclosure of every claimed limitation of the invention. No copies of slides pasted on the poster were distributed. There was no prohibition on note-taking or copying. The presentation was not indexed for a library or database. The Court held that the poster constituted a printed publication citable against patentability because it had been made publicly accessible.
In Re Klopfenstein, 380 F.3d 1345.
US Willful Infringement Softens
In the US, patent infringement defendants who engage in reprehensible conduct may receive a court order to pay punitive damages. The US Federal Circuit has recently issued a decision helpful to defendants accused of willful infringement. The Court decided that an adverse inference of willful infringement cannot be drawn when a defendant does not obtain legal advice or refuses to produce an infringement opinion received from its lawyers. Furthermore, when an infringer merely fails to exercise a duty of care to determine whether or not it is infringing, this is not sufficiently reprehensible by itself to warrant punitive damages. The totality of the circumstances should be considered.
Knorr-Bremse v. Dana Corp., Fed. Cir., No. 01-1357.
USPTO Plays Grinch: Fee Hikes
Those planning to file a patent application this holiday season will have to dig a little deeper. Fees have increased as follows, effective Dec. 8, 2004:
| Item (utility patent application) |
Fee (US$); reduce by half for small entity |
| Provisional application filing fee |
$200 |
| Regular application fees due on filing |
$1000 (includes $300 filing fee, $200
examination fee and $500 search fee; may be partly refundable if application abandoned/withdrawn by applicant) |
| Excess claims fee |
$50 per claim over 20 |
| Independent claim fee |
$200 per claim over 3 |
| Multiple dependent claim fee |
$360 |
| Extensions of time (response within 1st/2nd/3rd month) |
$120/$450/$1020 |
| Excess pages fee (new fee category) |
$250 per each 50 sheets in excess of 100 (not including sequence listings) |
| Issue fee |
$1400 |
| Maintenance fees (1st-3rd) |
$900/$2300/$3800 |
A schedule of the new fees can be found on the USPTO website at http://www.uspto.gov/web/offices/ac/qs/ope/fee2004dec08.htm
Please contact Bereskin & Parr for additional information on fees.
Edited by Noel Courage. Please send feedback and suggestions to Noel at ncourage@bereskinparr.com.
The contents of this update are informational only, and do not constitute legal or professional advice
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