Federal Circuit holds that claims directed to diagnosing neurotransmission or developmental disorders are invalid for failing to recite patent eligible subject matter

In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC,[1] the Federal Circuit affirmed the district court’s ruling that claims covering methods for diagnosing neurological disorders by detecting autoantibodies are directed to a natural law together with conventional steps, and are therefore invalid under 35 U.S.C. § 101. Although the claims at issue were said to be directed to patent ineligible subject matter, the court offered further guidance for applicants in the diagnostic space. Continue Reading

Supreme Court Unshrouds the ‘On Sale’ Bar as Applied to Secret Sales

This week, the Supreme Court issued a decision holding that a secret sale qualifies as prior art. At issue was whether the America Invents Act (AIA) changed the “on sale” bar to patentability to exempt secret sales as prior art.[1] The case, Helsinn Healthcare v. Teva Pharmaceuticals USA, arose out of agreements entered into by Helsinn and MGI Pharma, to which Helsinn granted the right to sell a treatment used to reduce nausea caused by chemotherapy. The agreements included a provision requiring MGI Pharma to keep confidential any proprietary information received under the agreements. Approximately two years after execution of the agreement, Helsinn filed four provisional patent applications covering the treatment.

Helsinn asserted its patents against Teva, which sought to market a generic version of the treatment. Teva raised a defense contending that Helsinn’s patents were invalid under the “on sale” provision of the AIA. The District Court sided with Helsinn and held that the “on sale” provision did not apply because the public disclosure of the agreements did not disclose the specific dose of the treatment. On appeal, the Federal Circuit reversed and held that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements.

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The ‘Integrated Into a Practical Application’ Test of the 2019 Revised Patent Subject Matter Eligibility Guidance

On Jan. 4, 2019, the USPTO announced revised guidance relevant to Section 101 rejections (“2019 Revised Patent Subject Matter Eligibility Guidance”). The 2019 Revised Patent Subject Matter Eligibility Guidance explains that a claim that recites a judicial exception is not “directed to” the judicial exception if the judicial exception is “integrated into a practical application” of the judicial exception. The procedure, referred to as “revised Step 2A,” changes how examiners should apply Step 2A of the Alice/Mayo test, which asks whether the claim in question is “directed to” a judicial exception. This article considers the effect of the new integrated into a practical application test and offers practical tips for applicants.

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The Federal Circuit Weighs In on Evidentiary Considerations for Famous Marks and Analyzes Third-Party Usage

The Court of Appeals for the Federal Circuit recently held that the Trademark Trial and Appeal Board (TTAB) erred in concluding that there is no likelihood of confusion between Omaha Steaks International’s registered trademarks and Greater Omaha Packing Company’s (Greater Omaha) GREATER OMAHA PROVIDING THE HIGHEST QUALITY BEEF trademark. Most significantly, the Federal Circuit held that the TTAB erred in analyzing the fame of the registered trademarks and third-party usage, in connection with the likelihood of confusion factors enumerated in In re E.I. DuPont DeNemours & Co., 476 F.2d 1357, 1361 (CCPA 1973) (the DuPont Factors). The TTAB’s prior ruling was vacated in Omaha Steaks International, Inc. v. Greater Omaha Packing Co., Inc., 908 F.3d 1315 (Fed Cir. 2018), and the case was remanded for further proceedings.

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PTAB Denies Institution Despite Petitioner Demonstrating Reasonable Likelihood of Prevailing With Respect to at Least One Claim

In SAS Institute v. Iancu, 138 S. Ct. 1348, 1351 (2018), the Supreme Court held that when the Patent Trial and Appeal Board (the Board) institutes an inter partes review, it must decide the patentability of all the claims the petitioner challenged.  The Court found that 35 U.S.C. §314(a)’s requirement that the Board find “a reasonable likelihood” that the petitioner will prevail on “at least 1 of the claims challenged in the petition” suggests a regime where “a reasonable prospect of success on a single claim justifies review of them all.”  Id.  The  policy argument that partial institution is efficient because it permits the Board to focus on the most promising challenges and avoid spending time and resources on others was said to be a question for Congress, “not this Court.”  Id. at 1352.

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Beware of Fraudulent Requests to USPTO to Change Official Trademark Registration Records

We have been alerted by the United States Patent and Trademark Office (USPTO) of unauthorized attempts by unknown parties to amend our clients’ trademark registration records.  Filing Correspondents and Attorneys of Record must remain vigilant for notices from the USPTO and respond to them swiftly to verify whether the requested change was authorized.  We have been in contact with the USPTO and it assures us this situation is getting its highest attention.

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Trademark Office Takes Tougher Stance on Registering Rights to Colors on Packaging

Trademark law recognizes that a color can be used to identify the source of products and therefore, enjoys protection under trademark law. Let’s test your color brand awareness:

• What can Brown do for you? – shipping services
• The little Purple pill – gastrointestinal medicine

If these colors brought UPS and Nexium to mind, then these companies have done their job in using these colors to identify them as the source of their services and products. This association is often built up over time in a process that trademark attorneys refer to as acquiring distinctiveness.

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USPTO Memo Addresses Eligibility of Method-of-Treatment Claims in View of Federal Circuit Decision

In a memorandum dated June 7, 2018 (Memo), the U.S. Patent and Trademark Office (USPTO) set out new guidance concerning method-of-treatment claims, which should be welcome news for patentees. The memo addressed the decision by the U.S. Court of Appeals for the Federal Circuit in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018). In particular, the guidance suggests that claims directed to methods of treating a disease will typically meet patent eligibility standards under step one of the U.S. Supreme Court’s Mayo test.[1]

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Additional Discovery of Clinical Trial Data in Inter Partes Review

In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase III clinical trial protocol from patent owner Novartis.

The patent at issue in the IPR, U.S. 9,187,405, claims a method for treating relapses in relapsing-remitting multiple sclerosis by orally administering fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” In its petition for IPR, Apotex alleged that the prior art taught that 0.5 mg of fingolimod was known to be an effective maintenance dose for treating multiple sclerosis. Novartis responded that to the extent that the prior art taught the use of 0.5 mg of fingolimod, it was only in the context of a treatment wherein the maintenance dose is preceded by a loading dose, something that is explicitly absent from the claimed methods. See paper 8 at 25.

After the Patent Trial and Appeal Board (PTAB) instituted the IPR, Novartis elaborated on its position in its response (paper 27), stating that the effectiveness of 0.5 mg as a maintenance dose in the absence of a loading dose, as required by the claims, was a surprising discovery. Although its briefing is heavily redacted, it appears that Novartis asserted that its Phase III clinical trial was aimed at showing the effectiveness of a 1.25 mg per-day dose, and that the study included a 0.5 mg dosing only at the suggestion of the U.S. Food and Drug Administration (FDA). Novartis supported this assertion with an expert declaration authored by a member of the advisory board that helped Novartis design the Phase III clinical trial. After deposing Novartis’s expert, Apotex moved for additional discovery, seeking several documents, including Novartis’s Phase III clinical trial protocol.

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Core Wireless: Moving Beyond Eligibility as the Exception to the Exception?

January was an exciting month for patent professionals still attempting to make sense of the fallout from the Supreme Court’s 2014 Alice Corp. v. CLS Bank International decision. Hot on the heels of its Jan. 10 decision in Finjan, Inc. v. Blue Coat Systems, Inc., the Court of Appeals for the Federal Circuit decided Core Wireless Licensing v. LG Elecs., Inc. on Jan. 25, affirming denial of LG’s summary judgment motion seeking to invalidate Core Wireless’ display interface patent claims for being directed to an exception to statutory subject matter under 35 U.S.C. § 101. In combination with Finjan and earlier decisions, this potentially establishes a trend that courts are increasingly comfortable differentiating between patent claims done on a computer and the maligned “do it on a computer” claims that are the target of much eligibility exception concern.

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