PTAB ADOPTS IDENDEX IN FINDING MARKUSH GROUP NOT ENABLED

Attorney: Richard D. Kelly
September 7, 2021

     In Post Grant Reviews (PGR) the Patent Trial and Appeal Board (PTAB) may consider all statutory challenges to patent claims including those under 35 U.S.C. § 112. One such challenge was brought in Syngenta Crop Protection v. FMC Corp in PGR2020-00028 (Syngenta), decided August 31, 2021, against U.S.P. 10,294,202 (‘202 patent). The PTAB found all challenged claims, 1-3, 9-13, and 21-30, unpatentable as lacking an enabling disclosure commensurate in scope with the claims and a subset, claims 9 – 13, as lacking written description, 35 U.S.C. § 112(a).<... Read more

Claims to a Spread-Spectrum Method For Sending Data Over a Communications Channel Are Patent Ineligible under Section 101

Attorney: Marina I. Miller, Ph.D.
August 23, 2021

Plaintiff Zyrcuits IP LLC has sued Defendants Acuity Brands, Inc. and Universal Electronics Inc. for infringement of claim 4 of U.S. Patent No. 6,671,307 (the ‘307 patent). Defendants argued that Zyrcuits's complaints should be dismissed because the ‘307 patent is invalid under 35 U.S.C. § 101 for failing to claim patentable subject matter. Applying the two-step framework from Alice, the court found that the ‘307 patent was invalid under § 101, as the claims of the ‘307 patent are directed to the abstract idea of grouping data together with a single code and do not contain any inventive concept.... Read more

The Week That Was In Skinny Labels

Attorney: Richard D. Kelly
August 9, 2021

This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin’s lawsuit claiming Hikma induced infringement of Amarin’s patents on the use of its heart drug Vascepa® . The patents in suit are U.S. Patent Nos. 9,700,537 (the ’537 patent), 8,642,077 (the ’077 patent), and 10,568,861 (the ’861 patent) under 35 U.S.C. § 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.<... Read more

AlphaFold 2, Open Source AI for Protein Structure Prediction

Attorney: Yuki Onoe
August 2, 2021

7月15日に興味深いNature論文が発表された。タイトルは “Highly accurate protein structure prediction with AlphaFold”[1] (AlphaFoldによる高精度タンパク質構造予測)で、Google傘下のDeepMind社によって開発されたニューラルネットワークに関する詳細が記載されている。同技術によれば、あるタンパク質について“with atomic accuracy even where no similar structure is known”[2](同様の構造が未知の場合でも原子レベルで)精度良くその構造を予測することができるとされている。DeepMind社は同時に AlphaFold 2のソースコードを開放しており、さらに高精度のタンパク質構造予測を目指してより一層活発な研究開発が期待される。<... Read more

The Federal Circuit Rejects PacBio's Argument that Oxford Used the Then-Emerging Global COVID-19 Crisis to Win on Invalidity for Lack of Enablement

Attorney: Grace Kim
July 15, 2021

In the recent decision PacificBiosciences of California, Inc. v. Oxford Nanopore Techs., Inc., No. 20-2155 issued on May 11, 2021, the Federal Circuit affirmed the district court’s holdings on two important issues, which are particularly of present-day relevance: (1) the influence of the global COVID-19 crisis on the public or jury’s view of the enforcement of intellectual property; and (2) the question of enablement.<... Read more

Prophetic "Examples" Past, Present and Future

Attorney: Richard D. Kelly
July 14, 2021

 On July1 the USPTO issued a notice regarding prophetic examples reminding practitioners of the need to distinguish between examples actually performed and theoretical or paper examples. Generally, this admonishment is considered to apply to the chemical and biologic arts where cookbook-type examples are found presenting data. MPEP 608 and Janet Freilich, Prophetic Patents UC Davis L. Rev. (2019). The MPEP was silent on prophetic examples prior to the 1981 edition.<... Read more

A Digital Camera (A Mechanical/Electronic Device) is Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
July 6, 2021

Yu sued Apple for infringement of the claims of U.S. Patent 6,611,289. The district court granted Defendants’ motion to dismiss on the basis that the asserted claims were invalid under 35 U.S.C. § 101. Yu appealed. The Federal Circuit (“the Court”) found no error and affirmed.<... Read more

New Legislation Supports Biosimilar Drugs, Clarifies Qualifications for Obtaining FDA Exclusivity

Attorney: Elissa Sanford
May 20, 2021

Recent litigation, including the Federal Circuit decision in Amgen v. Sanofi, has created concern among biologics manufacturers with regard to whether their existing intellectual property will remain protected, and whether they will be able to secure patents for future drugs. The uncertainty surrounding the patentability of biologics has led the industry to search for potential alternatives to patent protection. One such alternative could lead to pharmaceutical companies leaning on the exclusivity granted by the U.S. Food and Drug Administration ("FDA") as a way to avoid the patent route entirely. Where patents are a property right granted by the United States any time during the development of a drug, FDA exclusivity attaches upon approval of the drug and grants certain delays and prohibitions on the approval of competitor drugs. Biologics are covered by a considerably longer exclusivity period than other drug types, usually with 12 years total of market protection, as delineated by the Biologics Price Competition and Innovation Act ("BPCIA").... Read more

Reliance on a Single Non-Enabling Reference to Establish Obviousness

Attorney: Marina I. Miller, Ph.D.
May 10, 2021

Raytheon appealed a final inter partes review decision of the Patent Trial and Appeal Board (Board) finding claims 3 and 16 of US 9,695,751 unpatentable as being obvious in view of the Knip reference. The Board found that Knip discloses the claimed power density limitation for a geared gas turbine engine. During the proceeding, Raytheon submitted evidence establishing that Knip’s disclosure of highly aggressive performance parameters for a futuristic turbine engine was based on the use of nonexistent composite materials. In response, the petitioner, General Electric Company (GE), never provided any evidence suggesting a skilled artisan could have made a turbine engine with the claimed power density. “Because the relied-upon prior art fails to enable a skilled artisan to make and use the claimed invention,” the Federal Circuit (the Court) reversed.<... Read more

NCE Status Now Limited Active Moieties

Attorney: Richard D. Kelly
May 4, 2021

On April 23 President Biden signed into law changes narrowing the scope of eligibility for the non-patent “new chemical entity” (NCE) 5-year exclusivity provisions of 21 U.S.C. §301 et seq. The 5-year exclusivity comprises a 4-year data exclusivity provision during which time a generic applicant cannot rely on the drug application to establish either safety or efficacy which is followed by a 1-year marketing exclusivity. The exclusivity provision found in 21 U.S.C. § 355 (c)(3)(E)(ii) prior to the amendment described the NCE as applying to a drug where “no active ingredient” has been previously approved under § 355. Active ingredient is defined in 21 § 314.3(b) as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease ….” Some drugs become active only after being metabolized to what is called the active moiety. Prodrugs are an example of this phenomenon. Under the prior definition both a prodrug which metabolized into the active drug and the metabolite might each be capable of receiving separate NCE status.<... Read more