In Warner Chilcott v. Teva, the Federal Circuit used the appellant’s claim limitation, as defined in the specification, to uphold the district court’s finding that the claims of two patents were invalid as obvious. The claims at issue covered the osteoporosis drug Atelvia®. Warner Chilcott, the holder of the patents, filed suit in November 2011 following Teva’s ANDA application to make and sell a generic version of the drug.

Continue Reading Federal Circuit Affirms Holding of Obviousness of Claims Covering Warner Chilcott’s Osteoporosis Drug, Altevia®

A patent has a term of twenty years from the patent application’s effective filing date. To compensate inventors for any undue delays in patent examination caused by the U.S. Patent and Trademark Office (“USPTO”), Congress established a system to adjust patent term. In Pfizer v. Lee, the Federal Circuit examined whether certain errors caused by the USPTO give rise to Patent Term Adjustment (“PTA”).
Continue Reading Federal Circuit Determines that Certain PTO Delays May Not Necessitate Patent Term Adjustment

For the first time, the Federal Circuit addressed the requirement of “actual notice” of a published patent application in order for a patent holder to obtain damages before issuance of a patent. The case arose from the appeal of a district court’s grant of summary judgement that Adobe Systems was not liable for patent pre-issuance damages under 35 U.S.C. § 154(d), because it had no knowledge of the published U.S. Patent Application that matured into the asserted U.S. Patent No. 8,578,820.
Continue Reading Practice Tips for Biotech Regarding Provisional Patent Rights After Rosebud v. Adobe

Another layer of complexity has been added to patent prosecution under the District Court of Michigan’s expanded interpretation of the obviousness type double patenting (“ODP”) doctrine. The district court held that a continuation application can, in certain circumstances, invalidate its earlier filed and earlier issued parent under ODP. If upheld, patent prosecutors must carefully consider the scope of the claims in a continuation application especially when the parent application/patent receives patent term adjustment (“PTA”) extending its expiration date.
Continue Reading Parent Patent Invalidated by Later Filed and Later Issued Continuation Application Under Obviousness Type Double Patenting

The Federal Circuit recently denied Dow Chemical’s request for rehearing and rehearing en banc of Dow Chem. Co. v. Nova Chems. Corp. decided on August 28, 2015. The panel decision found that when multiple methods of measurement for a claimed parameter exist, a patentee must designate which method is being used. For a review of the court’s decision in the Dow Chem case, see our previous article here
Continue Reading No Review for Dow Chemical

Momenta brought suit against Teva and Amphastar asserting that (i) Teva’s importation into the U.S. of an enoxaparin product would infringe Momenta’s ‘886 patent under 35 U.S.C. § 271(g), (ii) Amphastar’s manufacture in the U.S. of enoxaparin infringes the ’886 patent under 35 U.S.C. § 271(a), and this infringement does not fall within the safe harbor of 35 U.S.C. § 271(e)(1), and (iii) Amphastar’s sale of enoxaparin in the U.S. infringes the ‘886 patent under 35 U.S.C. § 271(g).
Continue Reading Momenta v. Teva – Effective Claiming of Methods of Testing Drug Products

The patent eligibility of diagnostic testing methods remains uncertain after the Federal Circuit refused to rehear Ariosa v. Sequenom. In Ariosa, the Federal Circuit panel found that Sequenom’s patent on fetal DNA testing was patent ineligible, despite noting the high commercial value of the technology. The panel concluded that the claims failed Mayo’s two step analysis for patent eligibility. The claims recited a method for detecting fetal DNA (cffDNA), which can be used for non-invasive genetic testing of the fetus in a variety of applications.
Continue Reading Patent Eligibility of Diagnostic Methods Still Uncertain in Wake of Federal Circuit’s Denial of En Banc Review of Ariosa v. Sequenom

In an effort to enhance the quality of patents prosecution in the United States, the PTO launched the Enhanced Patent Quality Initiative (EPQI) in February 2015 with a notice and request for comments in the Federal Register. The comment period closed in May 2015. According to PTO Director Michelle K. Lee, “[p]atents of the highest quality can help to stimulate and promote efficient licensing, research and development, and future innovation without resorting to needless high-cost court proceedings. Through correctness and clarity, such patents better enable potential users of patented technologies to make informed decisions on how to avoid infringement, whether to seek a license, and/or when to settle or litigate a patent dispute.”
Continue Reading PTO Director Highlights Two Programs under the Enhanced Patent Quality Initiative

Here in Washington, D.C., the Trans-Pacific Partnership (TPP) is the latest talk of the town. The TPP is a proposed trade agreement among twelve Asia-Pacific countries concerning a variety of economic policy matters, including intellectual property. TPP’s membership includes several of the U.S.’s largest trading partners, e.g., Canada, Japan, and Mexico. The membership countries reached agreement in early October after years of negotiation. Congress is expected to vote on the agreement in 2016. The full text released on November 15, 2015; the whole of Chapter 18 relates to intellectual property. Overall, it appears that the patent-related provisions in the TPP reflect well-established U.S. patent practice. If ratified, the TPP would likely benefit U.S. companies as it would simplify worldwide patent procurement.
Continue Reading Trans-Pacific Partnership: What does it say about patents?