In early 2017,
the IP High Court established new criteria by which the scope of a patent right
may be extended and redefined the manner in which subtle differences between
the invention, the components comprising the invention, the production method
of the invention, and other aspects of the invention could be judged relative
to a competitor’s product which may or may not infringe upon the invention.
This was in
response to a case brought by Debiopharm International SA against Towa
Pharmaceuticals KK., for allegedly infringing the Debiopharm patent protecting
a pharmaceutically stable preparation of an oxaliplatin solution (Japanese
Patent No. 3547755B). Towa manufactured and sold generic forms of oxaliplatinum
and also included an equivalent amount of glycerin relative to oxaliplatinum,
whereas Debiopharm’s oxaliplatin solution was composed of only oxaliplatinum
and water and was free of other additives. The IP High Court deemed that Towa’s
product was not in itself and/or obtained based on a superficial difference
relative to Debiopharm’s oxaliplatin and its method of preparation. Therefore,
Towa’s product cannot be judged to be substantially identical to that of
Debiopharm.
Patent Term
Extension: Background
Owing to the
necessity of verifying the safety and efficacy of medicinal and agrochemicals
prior to making them commercially available for use by consumers or on farms
producing food for consumers, the approval and testing regimens tend to
continue for a greater period of time compared to, for example, the approval
and testing regimens for a mechanical or an electronic apparatus, and thus,
could substantially limit the time that the approved medicinal or agrochemical
could be protected by the eventually granted patent.
The Patent Term
Extension System was designed in order to extend the scope of a patent for up
to five (5) years beyond the time that the patent would have expired so as to
compensate for the lengthy approval and testing regimens often required in the fields
of medicine and agrochemicals.
At the same time,
a generic medication or drug having the same active ingredients, bioequivalence,
intended effect, dosage, mode(s) of administration, etc., may be approved
approximately eight (8) years after the innovator medication or drug was approved.
This system is seen as being beneficial for both a) the biotech - pharmatech
industry as they are able to obtain an adequate return on their R&D, and b)
consumers who can eventually purchase cheaper medications having the same
quality as the innovator medication.
The Supreme Court
had previously ruled (Genentech Inc. v. the Commissioner of Japan Patent
Office, decision by the Supreme Court of Japan, November 17, 2015, Hei 26
(gyo-hi) 356) that an application for a patent term extension would be rejected
if the medicine or drug (in this case, the anti-VEGF antibody Avastin) to be
covered by the patent term extension included a new feature(s) (i.e., dosage, indications,
mode(s) of administration, effect, etc) which may be different from and were
not covered in the original patent. This would constitute a new drug. As the
previously patented drugs do not provide coverage for the newly-approved drugs
which are different due to the dosage, indication, etc., time-consuming
regulatory approval for the new invention, i.e., the “newer version” of the
patented medicine or drug would be required.
Returning to the
Debiopharm International SA vs. Towa Pharmaceuticals KK case (IP High Court
Decision H28 (ne) No. 10046, January 20, 2017); unlike Debiopharm’s patented
invention for oxaliplatin, Towa included glycerin in their formulation. The metrics used to define “substantially
the same” in order to judge whether a generic medication or drug is
substantially the same as an innovator medication or drug would be clarified by
this case.
Debiopharm argued
that since Towa’s oxaliplatinum contained the same amount of oxaliplatin,
carried the same indication, and used Debiopharm’s clinical trial data in order
to attain regulatory approval, there were no substantial differences between
the two medications. Towa argued that the inclusion of glycerin in their oxaliplatinum
resulted in a medication having greater stability, and thus, constituted a
feature having a substantial difference.
The IP High Court
ruled that “substantially the same” should be determined by comparing the
patented drug and the potentially infringing drug in terms of the ingredients,
dosage, mode(s) of administration, indications, effect, etc. These comparisons
must also be viewed in light of the common knowledge of a person skilled in the
art at the time. In short, any difference between the patented medicine and the
potentially infringing drug must be minor (i.e., does not provide a novel
effect) in order for the two drugs to be considered “substantially the same”.
The addition of
glycerin was viewed as being an inventive step exceeding a slight variation or
difference relative to the features of Debiopharm’s patented drug. Thus, the
High Court concluded that Towa’s oxaliplatinum did not infringe the Debiopharm
patent.
Note: The Doctrine of
Equivalents (DOE) may not be applied in order to determine the scope of “substantially
the same”. If the allegedly
infringing product contains an ingredient or step, etc., which was
intentionally excluded from the scope of the patented invention, a special
circumstance exists by which it can be judged that the allegedly infringing
product is not “substantially the same”, and accordingly, there has been no
infringement.
Given that the Japanese
government has expressed the intention of raising the proportion of the market
that generic non-patent-protected pharmaceuticals occupy to 80% by 2020, and
has begun a large-scale advertising campaign to educate the public as to the
safety and low cost associated with generics, it appears that the issue of
determining the scope of “substantially the same” will surely be revisited in
the future.