Reexamined patent claims are assumed to be subset of original patent claims unless proven otherwise, for application of res judicata (claim preclusion).

Le-Nhung McLeland | April 24, 2014

Senju Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., and Allergan, Inc. v. Apotex Inc. and Apotex Corp.

March 31, 2014

Panel: Newman, Plager (author) and O’Malley (dissent).

Background: Appeal from U.S. District Court for the District of Delaware.

Senju Pharmaceutical Co., Ltd. and Kyorin Pharmaceutical Co., Ltd. (collectively referred to as “Senju”) jointly own U.S. Patent No. 6,333,045 for aqueous pharmaceutical formulations of the antibiotic Gatifloxacin. Allergan is the exclusive licensee under this patent for ophthalmic uses, and produces under license eye drops for treating the “pink eye” infection. The eye drop formulation contains disodium edetate (EDTA) which improves passage of the antibiotic through the cornea of the eye.

Apotex Inc. is a Canadian generic drug manufacturer which plans to formulate an ophthalmic solution containing the antibiotic, to be marketed by Apotex Corp. which is based in the U.S. Following the procedure enacted under the Hatch-Waxman Act, Apotex (referring collectively to Apotex, Inc. and Apotex, Corp.) filed with the FDA in July 2007 an Abbreviated New Drug Application (ANDA) for a generic version of the ophthalmic drug containing the antibiotic. Also under this procedure, Apotex filed a patent certification with the FDA and notified Senju about the certification. [This notice is required when the ANDA applicant certifies that a patent named in the New Drug Application (NDA) for the original drug is “invalid, unenforceable, or will not be infringed by the manufacture, use, or sale” of the generic drug. After receiving the notice, the NDA holder may sue the ANDA applicant for patent infringement under the provisions of 35 USC §271(e)(2)(A).] As would be expected, Senju filed suit against Apotex, alleging infringement of claims 1-3 and 6-9 of the patent.


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Reexamination Bites Another Patent Owner

Stephen G. Adrian | April 16, 2014

In Re Teles AG Informationstechnologien and Sigram Schindler Beteiligungsgesellschaft MBH

Decided April 4, 2014,

Before Dyk, Moore, and Wallach.  Opinion by Dyk

Summary:

This precedential decision illustrates a number of strategies that a patent owner may need to consider when an unfavorable decision is rendered by the Board of Patent Appeals and Interferences (now Patent Trial and Appeal Board) during a reexamination proceeding. Although an appeal to the Federal Circuit is most commonly pursued by a patent applicant, why would a patent owner consider an appeal to the U.S. District Court for the District of Columbia? In addition, this decision illustrates that while a broad claim construction may be desirable to ensnare infringers, a broad claim construction can also come back to bite the patent owner in a way to render claims invalid over the prior art.


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The Court Gives Roadmap to Patent Trolls on How to Obtain Lucrative Settlements from Customers without Declaratory Judgment Recourse from Manufacturers.

Stephen Parker | April 11, 2014

Microsoft v. DataTern, Inc. and SAP v. DataTern, Inc. (Precedential Opinion).

April 4, 2014

Before Chief Judge Rader, Prost and Moore.  Opinion by Moore.  Opinion dissenting-in-part by Rader.

Summary

DataTern, Inc., a company established to exploit IP opportunities (aka patent troll), sued hundreds of customers of Microsoft and SAP alleging infringement of its’ patents for a software product that facilitates interfacing of object-oriented applications with relational databases, seeking lucrative settlements from consumers disinterested in combating a full patent lawsuit without suing Microsoft and SAP.  Despite DataTern’s effort to avoid litigation with Microsoft and SAP, who as manufacturers of the products were well equipped and interested to seek legal recourse, Microsoft and SAP successfully filed declaratory judgment actions in New York district court and were awarded summary judgments for non-infringement.  DataTern appealed to the CAFC.   Although the CAFC affirmed the district court’s decision, as explained in the dissenting-in-part opinion of Chief Judge Rader, the CAFC’s opinion “creates a roadmap [for patent troll’s] to avoid declaratory judgment” actions by taking steps to ensure that their claim charts presented to allegedly infringing customers reference only customer activity and not activity of the product manufacturers.


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Nothing Lost but Nothing Gained: Generic Producer Evades Infringement but Fails to Invalidate Patent under §112.

Adele Critchley | April 3, 2014

Alcon Research Ltd., v. Barr Laboratories, Inc.

March 18, 2014.

Before Newman, Lourie and Bryson. Opinion by Lourie.

Summary:

The CAFC reversed the District Court’s judgment that Alcon’s patents lacked enabling disclosure and sufficient written description as Barr had failed to demonstrate that some experimentation was required, let alone undue experimentation.  Barr’s allegations that the claims were “too broad,” the specification was “too limited,” and the art was “too unpredictable,” was not sufficient without evidence to support that undue experimentation was required in order to practice the patented method.

The CAFC, however, affirmed the District Court’s judgment of non-infringement since Alcon had failed to prove that the polyethoxylated castor oil (“PECO)” in Barr’s product was present in a “chemically-stabilizing amount.”

The CAFC denied Barr’s judgment as a matter of law (“JMOL”) and Rule 59(e) (alter or amend a judgment) motions on non-infringement for the two patents that were omitted from the pretrial order and not litigated.


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