Patent Eligibility Of Immunization
Methods
The Federal
Circuit has addressed patent-eligible subject matter (under 35 U.S.C. §101)
in the context of patent claims directed to infant immunization
schedules. The CAFC determined that
two of the three patents at issue included patentable subject matter in view of the Supreme Court’s decision in Bilski v. Kappos, because the claims
included the step of immunization. The
patent claims directed only to comparing certain data sets did not meet the
patent eligibility test under Section 101.
In Bilski, the Supreme Court determined
that the exclusion of subject matter from patent-eligibility should be
considered on a case-by-case basis and the exclusion should be applied
narrowly. Here, Classen
Immunotherapies owns three related patents which state that the schedule of
infant immunization for infectious diseases can affect the later occurrence
of chronic immune-mediated disorders including, for example, asthma, hay
fever, cancer and diabetes. Generally,
the claims of two of the patents are directed to a method whereby the
immunization schedules and occurrence of chronic disease is screened and
compared and the lower risk schedule is identified and the vaccine is
administered on that schedule. The
claims of the third patent, however, are generally to a method of determining
whether an immunization schedule affects the incidence or severity of a
chronic immune-mediated disorder, but the comparison or determination is not
subsequently applied to any particular immunization schedule.
The lower court
found all claims invalid under 35 U.S.C. §101 because, in the court’s
opinion, the claims were directed to an “abstract idea.” Before Bilski,
the CAFC agreed, finding that the claimed methods are not associated with a
machine and do not transform matter. Classen appealed to the Supreme Court, which remanded the case back to
the CAFC to reconsider its ruling in view of the Supreme Court’s Bilski decision, which found that the
“machine-or-transformation test” is not the sole standard of patent
eligibility and further cautioned to apply Section 101 narrowly.
The CAFC has now determined that, even
where mental steps are involved, the case law does not support a universal or
rigid rule to eliminate subject matter from patent-eligibility. Rather, the CAFC concluded that the claims
that included the physical step of immunizing a child in accordance with the
determined schedule were directed “to a specific, tangible application” and,
thus, encompasses patent eligible subject matter. However, the claims that were directed only
to the method of “determining whether an immunization schedule affects the
incidence or severity of a chronic immune-mediated disorder” (and did not
include the subsequent step of immunization on an optimum schedule), were
simply directed to “the idea of comparing known immunization results that
are, according to the patent, found in the scientific literature, but does
not require using this information for immunization purposes.”
AMERICA
INVENTS ACT
The
Leahy-Smith America Invents Act (“AIA”) was signed into law on September 16,
2011, making sweeping changes to the U.S. patent practice. The most significant aspects of the AIA
include:
First-to-File System: The U.S. patent system will
change from a first-to-invent system to a first-to-file system for patent
applications with an earliest claimed priority date of March 16, 2013. Current interferences will eventually
be replaced with derivation proceedings, which
are only available in limited circumstances.
Post-Grant Review Proceedings: A third party will be able to
challenge a patent (that claims an earliest priority date of March 16, 2013)
based on a broader range of issues, as long as the challenge occurs within
nine (9) months of issuance of the patent (or broadening
reissue).
Inter Partes Review: Inter partes reexamination will
be replaced with inter partes review proceedings, available as of September
16, 2012. This proceeding may be instituted nine (9) months following
issuance of a patent or after termination of a post-grant review, and can be
based on prior art patents or printed publications.
Preissuance Submission by Third
Parties:
Third parties may submit patents, published applications and other printed
publications to the USPTO. The submission must include a description of
the relevance of each document, and the submission must be made within
prescribed time periods.
Supplemental Examination: If a patent owner can show a substantial new
question of patentability, supplemental examination may be requested to
consider, reconsider or correct information believed to be relevant to the
patent. This procedure will allow, in certain circumstances, patent
owners to cure a patent of inequitable conduct.
Best Mode Requirement: Disclosure of best mode remains a
requirement of a disclosure, but failure to comply with the best mode
requirement will no longer be a basis for invalidating a patent.
USPTO Patent Fees: Most fees were raised by 15% and the USPTO will be able to establish
new fees in the future.
Over the
next several years, many aspects of the AIA will be clarified as case law
develops implementing the new act. |
