Category Archives: Patents

In another precedential opinion, the Federal Circuit Court of Appeals continued its focus on defining claim term meanings in light of the specification and prosecution history.[i] At issue was Auerbach, et al. (U.S. Pat. 8,822,438), which involves the use of a CYP17 enzyme inhibitor with an anticancer or steroid to treat prostate or breast cancer.[ii] Notably, the patent provides using the anti-androgen abitraterone acetate, seen below, and prednisone.[iii]

Abitraterone acetate is an oral anti-androgen used in prostate cancer treatment, designed to inhibit enzymes involved in androgen steroid synthesis.[iv] The patent was asserted against Amneal Pharmaceuticals LLC, Dr. Reddy’s Labs, Inc., Wockhardt Bio AG, Mylan Pharmaceuticals Inc., and more.[v] Pat. ‘438 was challenged, via Inter Partes Review and through litigation, as obvious. Read More →

The Federal Circuit has been active in clarifying what constitutes patentable subject matter in the medicinal and biotechnology fields, issuing a precedential and nonprecedential opinions over the last few weeks. The cases highlight the importance of including manipulation steps in patent claims, i.e. where a human provides an active step in the claimed subject matter that is not readily known.

In a precedential opinion, the Federal Circuit found modifying a person for his or her natural state is sufficient to overcome the subject matter requirement of the patent laws under 35 U.S.C. §101. [i]  At issue was a composition and method of using dietary supplements to enhance athletic performance.  The language in the claims provides for adding amino acids that “increases beta-alanyl-histidine dipeptide synthesis”[ii] The lower court found the claims were directed to consuming beta-alanine, which is a natural substance, making the claims patent ineligible.[iii] The Federal Circuit noted that the application defined “dietary supplement” as a non-natural or conventional food of the human diet.[iv]  Further, the claims provide for adding beta-alanine to overcome a subject’s natural homeostasis and produce greater levels of creatine.[v] Noting that while using a natural law, modifies the subject to an unnatural state.[vi] Further, the Court noted that the dietary supplement is not a natural or conventional food, but an addition to the diet, 13 much greater than that of a standard diet.[vii] The Federal Circuit also looked at compositions of glycine and beta-alanine, finding that some evidence appears to indicate the two components interact, which would make the compositions patent eligible.[viii] Read More →

The Federal Circuit Refines Patentability Requirements in pharmaceutical and Chemical Technologies

A decision from the Federal Circuit Court of Appeals has refined what is required to show obviousness and anticipation in a pharmaceutical patent.  The patent involved lacosamide, an amino acid-like drug used in epilepsy treatment, shown below:

Accord, a generic drug manufacturer, submitted an abbreviated new drug application (ANDA) to the FDA seeking to manufacture and distribute a generic version of lacosamide, prompting the owner of the patent, UCB, to file a patent infringement suit.[i]  Accord challenged the validity of the lacosamide patent, arguing the UCB patent fails to meet the nonobviousness and novelty patenting requirements and that other UCB patents protect a patentably indistinguishable compound, known as nonstatutory double patenting. Read More →

The U.S. Patent and Trademark Office recently issued new guidelines to determine patent eligibility.  For years after Alice,[i] Mayo,[ii] and Myriad,[iii] software and biotechnology patent applicants have had difficulty patenting many inventions, particularly in the trending “personalized medicine” field where patient genetics and proteomics are considered when selecting treatment regimens. Read More →

The Federal Circuit recently issued a much needed development in patentability case law, in Vanda Pharma. Inc. v. West-Ward Pharma. Int’l Ltd.[i]  Beginning in 2012, the U.S. Supreme Court upended years of patent law regarding patentable subject matter in biotechnology, relying on earlier case law stating natural laws and natural phenomena were not patent eligible subject matter.[ii]  These decisions included a commentary about elements of the patented work that was, in the Court’s opinion, well-understood, routine, conventional activity previously engaged in by researchers in the field, thereby adding an element of obviousness and anticipation analysis to the patent-eligibility inquiry.[iii]  A test issued by the Supreme Court, and further clarified by the Federal Circuit, provide that where a claim recites a natural law, the elements of the claim must be considered to determine if the claim as a whole is directed to an application of the recited law.  However, since these decisions, significant questions still plague patent examiners, attorneys, and courts regarding the requirements to meet patent eligibility. Most notably, to what constitutes sufficient material to distinguish a claim directed to a natural law versus an application of that law.  Since 2014, the U.S. Patent and Trademark Office released at least one new guideline each year to the patent examining corps providing amended instruction on determining patent eligibility.[iv] Read More →