Tag: Patent prosecution

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Don’t B Late; Federal Circuit Interprets the B Delay Calculation
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Producers of generic medicines and biosimilars even more supported by EU
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Significant changes ahead for Australian patents

Don’t B Late; Federal Circuit Interprets the B Delay Calculation

Mayo Foundation v. Iancu reads more like an arithmetic problem than a Federal Circuit decision. The reason is the case involves the Patent Term Adjustment Act (PTA) (see 35 U.S.C. § 154(b)). PTA determinations require calculating how many days of delay, from the effective filing date to the Notice of Allowance, are attributable to the applicant and how many to the PTO. Under one PTA scenario, the applicant is entitled to an adjusted term, recovering every day the application is pending beyond three years past the effective filing date for the balance of delay attributable to the PTO. This is called a “B Delay” (§154(b)1)(B)). However, the B Delay is subject to several exclusions. The disputed exclusion in Mayo concerned a Request for Continued Examination (RCE) of the application, which Mayo filed before the PTO declared an interference. 

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Producers of generic medicines and biosimilars even more supported by EU

Effective 1 July 2019, the EU adopted a regulation by introducing a supplementary protection certificate (SPC) manufacturing and stockpiling waiver. This waiver also applies for biosimilar versions of SPC-protected medicine during the term of the SPC.

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Significant changes ahead for Australian patents

The Australian Government has proposed significant changes to Australian patent law following an inquiry into the IP system recently completed by its advisory body, the Productivity Commission.  These include:

  • Amending the inventive step threshold to reflect that of the European Patent Office
  • Phasing out innovation patents
  • Requiring applicants to identify an invention’s technical features in their claims, and
  • Adding an objects clause to the Patents Act.

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