Greenblum & Bernstein, P.L.C.
REEXAMINATION AND POST-GRANT
PRACTICE GROUP NEWSLETTER
keePingTABs No. 26
In This Issue
· Taking Stock of IPR, CBM and PGR Petitions
· Latest Versions of G&B Spreadsheets
· Recent Developments In The Law
Jill M. Browning
Taking Stock of IPR, CBM and PGR Petitions
Through September 30, 2016, there have been 5143 petitions for inter partes review (“IPR petitions”) filed, as well as 476 petitions directed to covered business methods (“CBM petitions”) and 37 Post-Grant Review (PGR) petitions. It will be interesting to see if the number of IPR petitions will top FY 15’s total of 1,737 petitions. AS of now, with one month to go, the total is 1,565. The number of Bio/Pharma petitions has increased from about 9% in FY15 to about 13% thus far in FY 16, while the number of electrical/computer petitions has decreased from 63% in FY 15 to about 55% thus far in FY 16.
Patent Owner’s continued to file preliminary responses in FY16 in the vast majority of cases, with only 239 instances reported so far not filing such a response.
Patents from the electrical/computer arts continue to constitute the largest percentage, although it has declined from about 64% to about 51%, with bio/pharma petitions growing from about 9% to about 16%.
Latest Versions of G&B Spreadsheets
Please click here for the latest G&B spreadsheet reflecting all PGR filings through October 31, 2016.
Recent Developments In The Law
Shire’s LIALDA patent withstands Kyle Bass Attach at Board
Coalition For Affordable Drugs II LLC. v. Cosmo Technologies LTD.
On October 5 2016, the PTAB upheld Shire’s US Pat. No. 6,773,720 B1, directed to an oral pharmaceutical composition directed to an active pharmaceutical ingredient that treats colitis and Crohn’s disease (sold under the name LIALDA).
The Coalition For Affordable Drugs II LLC (CFAD), whose hedge fund manager is Kyle Bass, argued this patent was obvious in the view of the prior art. The PTAB disagreed, based on a claim construction argument directed to the meaning of “wax”, one of the ingredients in LIALDA. The PTAB concluded that CFAD defined the claim term wax in an “unreasonably broad” manner that was not consistent with the patent’s disclosure. The PTAB further concluded that the asserted prior art did not disclose the claimed invention or that “a person of ordinary skill in the art ‘would have been motivated to combine the formulations’” [disclosed in the two prior art prior art patents] and that “combination (…) would result in the compositions [the patent].
Kyle Bass criticized this decision, stating it “enables Shire to improperly maintain a government-granted monopoly and to exploit the U.S. health-care system, doubling the price of LIALDA since 2007, much like EpiPen”.
PTAB’s decisions about inter partes review are final and non-appealable.
MEDTRONIC, INC v. ROBERT BOSCH HEALTHCARE SYSTEMS, INC.
On October, 20, 2016, the United States Court of Appeals for the Federal Circuit continued to affirm its earlier rulings that decisions concerning inter partes review are final and nonappealable. Here, the CAFC held that a request for reconsideration of a decision to institute proceedings is not reviewable on appeal. The CAFC reasoned that the decision to institute and a reconsideration of that very decision are “closely related” and it would be nonsensical to hold that a decision to institute an IPR would not be reviewable but a reconsideration of that decision would be reviewable. Therefore, the Court concluded that “[n]othing in Cuozzo [Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016)] casts doubt on that interpretation of the statute, especially in light of the fact that the Supreme Court held that the particularity requirement, which is contained in section 312, is nonappealable.”
The Court reasoned that the Board has inherent authority to reconsider its decisions and further that the “statutory language” is “not limited to an initialdetermination to the exclusion of a determination on reconsideration.”
PTAB holds Patents covering Gattex® unpatentable in challenge by Kyle Bass
COALITION FOR AFFORDABLE DRUGS II LLC, v. NPS PHARMACEUTICALS, INC.
On October, 21, 2016, the PTAB found U.S. Patent No. 7,056,886, which covers Gattex,® unpatentable in two final written decisions. This challenge was brought by Kyle Bass’s Coalition for Affordable Drugs (CFAD).
Gattex® is a Shire drug directed to increasing the uptake of nutrients in the intestines so perhaps avoid intravenous feeding.
Both decisions held all the challenged claims are unpatentable as obvious in view of the prior art. The first decision concluded that claims were obvious in view of a combination of six patents, while the second decision relied on a combination of fiver patents.
Shire’s reliance on evidence of secondary considerations, including unexpected results and commercial success, were not sufficient to overcome the rejections in the PTAB’s view.