The Patent Trial and Appeal Board (the “Board”) issued a final written decision determining that the Coalition for Affordable Drugs (ADROCA), LLC (“Petitioner”) failed to prove unpatentable claims 1-52 of U.S. Patent No. 8,440,703 (the “’703 Patent”) owned by Acorda Therapeutics, Inc. (“Acorda”). The ’703 Patent covers using a composition with the compound fampridine to treat certain neurological disorders. The Board had instituted inter partes review(IPR) on three obviousness grounds, each including the reference known as “S-1.” S‑1 is an Acorda Securities and Exchange Commission filing that describes clinical trials testing fampridine’s effect on certain neurological disorders. At trial before the Board, Acorda argued that the ’703 Patent was entitled to the filing date of its provisional application, eliminating S-1 as 102(b) art, and that S-1 reported the inventors’ own work, eliminating S-1 as 102(a) art.
The Patent Trial and Appeal Board (PTAB) has issued a final written decision determining that the Coalition for Affordable Drugs VIII, LLC (“Coalition” or “Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (the “’135 Patent”) were obvious.
In a consolidated Hatch-Waxman patent infringement action, a district court judge in Delaware recently found claims directed to a treatment for multiple sclerosis invalid as obvious.
On January 13, 2017, the Supreme Court granted certiorari to two related petitions brought by Amgen, Inc. and Sandoz, Inc. to resolve disputes regarding the interpretation of the Biologics Price Competition and Innovation Act (BPCIA). In 2009, Congress passed the BPCIA to create an abbreviated regulatory pathway through which the Food and Drug Administration (FDA) can approve a biological pharmaceutical product as a “biosimilar.” 42 U.S.C. § 262(a), (k). A biosimilar is a drug product that is highly similar to an approved biological product or “reference product.” 42 U.S.C. § 262(i)(2).
The Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision affirming an examiner’s rejection of claims directed to oral inhalation of the drug zanamivir to treat influenza. The examiner rejected the applicant’s claims on the basis that they were obvious over two prior art references. The first reference taught treating influenza by the nasal inhalation of zanamivir, and the second reference taught treating influenza by the inhalation of a compound similar to zanamivir. The second reference did not explicitly teach oral inhalation, but the court found that teaching “inhalation” generally includes both oral inhalation and nasal inhalation. The court found that treating influenza by oral inhalation would be obvious because influenza affects the lungs, and oral inhalation delivers more drugs to the lungs than nasal inhalation. The applicant further argued that one of skill in the art would not use an oral inhalation method of zanamivir to treat influenza because oral inhalation delivers more drugs to the lower respiratory tract, and it was thought at the time of the invention that it was more effective to deliver anti-influenza drugs to the upper respiratory tract. The court rejected this argument because some strains of influenza also attack the lower respiratory tract and young children are more susceptible to lower respiratory tract infections.
The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On May 23, 2014, AstraZeneca filed a patent infringement action in the District of Delaware against Wockhardt. AztraZeneca alleged that Wockhardt’s submission of an Abbreviated New Drug Application (ANDA) to the FDA with a Paragraph IV certification infringed several of AstraZeneca’s patents pursuant to 35 U.S.C § 271(e)(2). Prior to the initiation of the litigation, Wockhardt submitted an ANDA seeking the FDA’s approval to market a generic version of AstraZeneca’s ONGLYZA drug product. Wockhardt’s ANDA was submitted with a Paragraph IV certification, which means that Wockhardt asserted that AstraZeneca’s patents covering ONGLYZA were invalid or unenforceable or not infringed by Wockhardt’s ANDA product. Wockhardt sent a Notice Letter to AstraZeneca stating that Wockhardt had submitted an ANDA with a Paragraph IV certification and that it intended to engage in the commercial manufacture, use and sale of a generic version of the ONGLYZA product before the expiration of AstraZeneca’s patents. Pursuant to the Hatch-Waxman Act, AstraZeneca filed suit within 45 days of receipt of Wockhardt’s Notice Letter.
In a decision issued on August 25, 2016, Judge Sleet weighed in on the ongoing debate about whether a claim directed to a method of treatment is patent eligible subject matter under 35 U.S.C. § 101.
After a rehearing en banc, the Federal Circuit ruled that a product must be the subject of a commercial sale or offer for sale to trigger the “on-sale” bar under § 102(b). Particularly, the court ruled that merely receiving a commercial benefit without commercially marketing a patented product is not enough to trigger the on-sale bar. Thus, the court found that the transaction between a patentee and its contract manufacturer was merely a pre-commercial activity that did not trigger the on-sale bar.