A passing moment of social awkwardness between a couple on a
dance floor is nothing compared to the situation when
the sidestepping is between two companies to avoid a
'patent dance' and there are billions of dollars
of biologic drug profits at stake. Resolution of patent issues
between drug companies can be the last hurdle to biosimilar market
entry in some cases.
The patent dances in the US and Canada are outlined
If the biosimilar manufacturer can resolve patent issues
quickly, or avoid the 'patent dance' entirely, then it can
hit the market sooner. For the original maker of the drug, if the
patent dance is avoided before biosimilar drug approval,
then it has to chase the biosimilar manufacturer for patent
infringement after market approval, while the biosimilar
manufacturer is already eating away at market share.
In the US 'dance', the Biologics Price Competition
and Innovation Act1 (BPCIA)
provides a complex information exchange process in which reference
product sponsors and biosimilar applicants may engage before
commencing any patent infringement litigation.2 In the
statute as written, it appeared that the biosimilar applicant was
required to provide a copy of its full drug submission to
the reference product owner, which contains very detailed
information about the biosimilar drug and its
manufacturing. However, a Court recently decided that it was
optional to provide this drug submission. In Amgen Inc. v.
Sandoz Inc.3, Sandoz offered to provide limited
portions of its submission, called an abbreviated
biologics license application (aBLA), for its drug
Zarxio (filgrastim) to the reference product manufacturer, Amgen.
Amgen demanded the entire aLBA. Amgen and Sandoz could not agree on
the extent of disclosure of required by the BPCIA. The Court
decided that not only was disclosure of the aBLA not required, but
the biosimilar could be approved for market entry without going
through the BPCIA's elaborate information exchange and patent
review process – sidestepping the 'dance'
The same result would not occur in Canada, where there is also a
specialized litigation option available to protect certain patented
biologic drugs on the market. This unique Canadian system is
informally called the "NOC Regulations."4 The
process may block a second-entry drug that is referencing a patent
owner's clinical trial data. It is not optional to address
patents listed on the Health Canada Patent Register.
It remains to be seen the extent to which companies can avoid
the US patent dance in the future. In Canada, companies can expect
to always have to address patent issues when there are patents for
the drug of interest listed with Health Canada.
1 H.R. 3590, 111th Congress (2010).
2 42 U.S.C. § 262(l) (2103).
3 No. 3:14-cv-04741-EDL (ND Cal, 10.24.14).
4 Patented Medicines (Notice of Compliance) Regulations,
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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