Supreme Court Finds Patent Rights Exhausted Overseas

In Impression Products, Inc. v. Lexmark International, Inc., the Supreme Court reversed the en banc decision of the Federal Circuit, and held U.S. patents rights exhausted by the patent owner’s sale of a patented article anywhere in the world. The Court recognized a patent owner’s ability to impose restrictions through licensing arrangements, but emphasized that patent laws cannot be used against subsequent purchasers. This decision is important for pharmaceutical and biotechnology companies with global operations, especially those who may price their products differently in different countries.

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Court Questions Applicability of Function Way Result Test In Chemical Cases

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit reviewed a preliminary injunction based in part on a finding of likelihood of success in establishing infringement under the doctrine of equivalents. Although the district court had applied the “function-way-result” test, the Federal Circuit suggested that the “insubstantial differences” test might be more appropriate for chemical cases. Does the court favor that test because it is more likely to lead to a finding of non-infringement?

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CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and remanded for entry of judgment in favor of Braintree. In reaching its decision, the court held Breckenridge to its previous stipulations, and found that proposed ANDA labeling for “colon cleansing” induced infringement of claims directed to “inducing purgation.” Continue reading this entry

USPTO Patent Term Adjustment Error Costs Patent Owners Time And Money

The USPTO appears to have dropped its plans to overhaul the Information Disclosure Statement (IDS) process, but that’s no excuse for its failure to process IDSs in accordance with its current rules. Most egregiously, the USPTO erroneously charges a Patent Term Adjustment (PTA) deduction for IDSs filed with a Rule 704(d) statement because its PTA calculation process fails to determine whether such a statement was included. While patent owners can file an application to be awarded that PTA, such an application requires a $200 fee–not to mention time to identify the error, prepare and file the petition, and ensure a Certificate of Correction is granted.

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Are Secret Sales Prior Art Under The AIA?

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC § 102(a)(1).  With this case, the court offered its first interpretation of the on-sale bar of the America Invents Act. Although the court did not address whether an entirely secret sale would qualify as prior art under the AIA, it decided that where the existence of the sale was made known to the public, the sale constitutes prior art even if the public disclosure did not reveal the invention. Continue reading this entry