Author Archives: David Rucando

Recent Doctrine of Equivalence Case: “Insubstantial Differences” Test May Be More Suitable than a “Function-Way-Result” Test for Chemical Arts.

The Doctrine of Equivalence is alive and well.  For the chemical arts, the CAFC recently suggested that the “Insubstantial Differences” test may be more suitable than a “Function-Way-Result” Test.

See Christopher E. Loh’s post for Fitzpatrick, Cella, Harper & Scinto

 

When is and “and?” When is and “or?”

May 12, 2017  –  [Looking back to 2008 case]

“And” Connotes Alternatives in Topiramate Litigation

When is and “and?” When is and “or?” That sounds silly. But reading Chisum on Patents in the law library reminded me of one of the holdings in the topiramate litigation of Ortho-McNeil v. Mylan, 520 F.3d 1358 (Fed. Cir. 2008), in which the meaning of and was taken seriously. While most dictionary definitions of “and” are additive, dictionary definitions also show use of “and” to “connote alternatives.”

In the Ortho-McNeil v. Mylan case, the Court of Appeals of the Federal Circuit (CAFC) held that the term “and,” in Ortho-McNeil’s claim [US Pat. No. 4,513,006 “Anticonvulsant Sulfamate Derivatives”] was used to connote alternatives rather than in the additive sense.

Ortho-McNeil’s US Pat. No. 4,513,006 claimed a genus of sulfamates covering Topiramate. The disputed clause stated: “R2, R3, R4, and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 together may be a group of formula (II).” (Emphasis added) [A full copy of claim 1 appears below.]

The CAFC said that the two subsets did not need to simultaneously exist. The claim was not limited to compounds that were in both subsets because, construed in context, the claim to compounds that were of a first subset “and” a second subset covered compounds that were either in the first group “or” the second subset.

Here “and” meant to “join alternatives” because, in this case, the claim did not use the word “and” in isolation. Rather, the claim used “and” in a larger context with clarifying adverbs “independently” and “together.”

More on the word “AND”

Chef America v. lamb-Weston, 358 F.3d 1371 (Fed. Cir. 2004)

  • A court may not re-write a patent claim even to avoid a nonsensical result.
  • Here, however, giving “and” its most common dictionary meaning would fail to cover the patent owners own drug product and render dependent claims meaningless

The CAFC distinguished Chef America:

To the contrary, this court and the district court must interpret the term to give proper meaning to the claim in light of the language and intrinsic evidence. Giving and its most common dictionary meaning would produce in this case the nonsensical result of not covering topiramate and rendering several other dependent claims meaningless. In Chef America, the only possible interpretation of the claim led to a nonsensical result. This situation is distinguishable because claim 1 can and should be interpreted as the patentees intended, with the meaning of and connoting alternatives.

https://en.wikipedia.org/wiki/Topiramate

Topiramate claim 1-1

4-Aminopyridine: Acorda Win & Loss

May 3, 2017

Acorda won at the PTAB but lost in the US District Court.

Acorda Therapeutics, Inc. is fighting is to extend the life of their 4-aminopyridine formulations and methods.

Acorda will retain market exclusivity to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg at least through July 2018.

The US District Court in Delaware ruled that Acorda’s four patents set to expire between 2025 and 2027 are invalid.  A few weeks earlier, the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld the four patents challenged via the inter partes review (IPR) process [U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent)]. These patents, if valid and enforceable, are calculated to expire in 2025, 2025, 2026 and 2027, respectively.

ACORDA THERAPEUTICS, INC., et al. v. ROXANE LABORATORIES, INC., et al.

Case #: 14-882
Judge: Chief Judge Leonard P. Stark

Next?: Acorda will appeal. Meanwhile Acorda announced restructuring and layoffs

http://www.4-traders.com/ACORDA-THERAPEUTICS-INC-8238/news/Acorda-Therapeutics-Implements-Corporate-Restructuring-to-Align-Cost-Structure-with-Focus-on-Promi-24209186/

http://cen.acs.org/articles/95/i15/Troubled-biotechs-cut-jobs.html

Fierce Pharma

http://www.fiercepharma.com/pharma/court-nixes-4-acorda-patents-teeing-up-amprya-generics-for-2018

Acorda press releases

03/31/2017: http://ir.acorda.com/investors/investor-news/investor-news-details/2017/US-District-Court-Issues-Decision-to-Invalidate-Four-AMPYRA-Patents-Company-Will-Appeal-Ruling/default.aspx

03/09/2017: http://ir.acorda.com/investors/investor-news/investor-news-details/2017/Patent-Trials-and-Appeal-Board-PTAB-Upholds-Four-AMPYRA-Patents/default.aspx

Nucleophilic Covalent Drugs

May 1, 2017

Prof. Kate Carroll of Scripps Research Institute extended covalent drug discovery to cysteine-oxidized proteins by developing a library of nucleophilic drug candidates. For example, Prof. Carroll provided pyrolidinedione nucleophiles that react with protein tyrosine phosphatases.

See J.AmChem.Soc. 2017, DOI:10.1021/jacs.7b01791

http://pubs.acs.org/doi/10.1021/cen-09517-notw7

US 2016/0195532 “Targeted Covalent Probes and Inhibitors of Proteins Containing Redox-Sensitive Cysteines”

 

 

Patent-Related Notes from C&EN

April – 2017

Syngenta Patents Infringed:

Syngenta says a U.S. district court has found that the agrochemical maker Willowood infringed two Syngenta patents relating to the fungicide azoxystrobin. Damages for the infringement will be assessed at a trial later this year.

Solvay won a patent infringement lawsuit in China:

Solvay has won a patent infringement lawsuit in China against the Yantai-based firm Sunshow Specialty Chemical. The suit involved an ultraviolet stabilizer for thermoplastic olefins produced by Solvay’s Cytec Industries subsidiary.

10% of NIH Grants Directly Lead to Patents

According to Science (2017, DOI: 10.1126/science.aal0010), 10% of NIH Grants Directly Lead to Patents. Meanwhile, 30% of NIH grants are cited in patent applictions.   (See “By the numbers” – C&EN, 2017, 95 (14), pp 21–21April 3, 2017.)

<link rel=”stylesheet” href=”/sites/all/themes/shared/science_jcore/library/css/style-jcore.css”>

The applied value of public investments in biomedical research

Abstract

Scientists and policy-makers have long argued that public investments in science have practical applications. Using data on patents linked to U.S. National Institutes of Health (NIH) grants over a 27-year period, we provide a large-scale accounting of linkages between public research investments and subsequent patenting. We find that about 10% of NIH grants generate a patent directly but 30% generate articles that are subsequently cited by patents. Although policy-makers often focus on direct patenting by academic scientists, the bulk of the effect of NIH research on patenting appears to be indirect. We also find no systematic relationship between the “basic” versus “applied” research focus of a grant and its propensity to be cited by a patent.

Steadymed wins IPR Challenge of United Therapeutics’s Remodulin® Product-by-Process Patent Claims

Final Decision – March 31, 2017

IPR2016-00006

STEADYMED LTD., (Petitioner)  v. UNITED THERAPEUTICS CORPORATION, (Patent Owner)

U.S. Patent No. 8,497,393 B2 “Process to Prepare Treprostinil, the Active Ingredient in Remodulin®”

Link to PDF: https://ptabdata.uspto.gov/ptab-api/documents/663936/native

Exit mobile version