In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.
On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the ’707 patent’s claimed protein purification process.
Last week the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals clarified the scope of the on-sale bar rule under the America Invents Act (AIA). The on-sale bar in general means that a sale or an offer to sale of an invention more than one year prior to the effective filing date of a patent qualifies as prior art. The Federal Circuit held that 35 U.S.C. § 102 as revised in the AIA does not change the long-settled rule that a sale can invalidate an invention even if the sale does not disclose the details of the invention.
Yesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010. The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product. The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
To read our full alert on the oral argument, please click here.
On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit. See The Medicines Company v. Mylan, Inc., 2015-1113 (Fed. Cir. 2017). The patents-in-suit were U.S. Patent Nos. 7,582,727 (“the ’727 Patent) and 7,598,343 (“the ’343 Patent”). MedCo initiated a suit against Mylan, Inc. (“Mylan”) in response to Mylan submitting an Abbreviated New Drug Application (“ANDA”). Through submitting an ANDA request, Mylan wished to obtain approval from the Food and Drug Administration (“FDA”) for a generic drug that would directly compete against MedCo’s ANGIOMAX® product. To counter Mylan’s ANDA request, and keep their product exclusive, MedCo filed suit alleging that Mylan’s ANDA drug infringed claims in both the ’727 and ’343 Patents.
The district court held on summary judgment that Mylan’s drug did not satisfy the “efficient mixing” limitation of the ’343 Patent; however, following a 6-day bench trial found that Mylan’s drug did infringe the ’727 Patent because the asserted claims did not include an “efficient mixing” limitation. Mylan argued on appeal that the district court erred by not including the “efficient mixing” limitation as part of the “batches” limitation in the ’727 Patent.
U.S. patent law elevates the importance of “the inventor” to an extent unseen in the rest of the world. Unlike many other countries, ownership of patent applications in the United States initially vests in the inventors listed on the application. This is true even where a contractual obligation for inventors to assign their ownership rights to others exists, such as the case in many employment or academic settings. This post summarizes two cases where an incorrect determination of inventorship on a patent application resulted in negative consequences for patent owners and/or licensees of an issued patent.
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price Competition and Innovation Act (“BPCIA”) “patent dance” information exchange process may expose the biosimilar maker to eventual infringement damages in the form of lost profits, and preclude limiting damages to a reasonable royalty. Janssen Biotech, Inc. et al v. Celltrion Healthcare Co., Ltd. et al, 1:15-cv-10698 (D. Mass, 2017).
Janssen sued Celltrion for patent infringement under the BPCIA following the FDA’s acceptance of Celltrion’s abbreviated Biologics License Application (“aBLA”) for a biosimilar version of Janssen’s Remicade (infliximab). In the course of litigation, Celltrion moved to dismiss the complaint for lack of standing based on Janssen’s alleged failure to add a necessary party. To guide the parties’ settlement negotiations, the court sought to clarify whether, in the event the action was dismissed and Janssen was forced to refile the complaint with the proper plaintiffs, Janssen would be prevented from seeking lost profits damages under the BPCIA.
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.
Since Kyle Bass founded Coalition for Affordable Drugs X LLC (CFAD) to challenge pharmaceutical patents, CFAD has filed numerous petitions with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (Office) seeking to institute inter partes review (IPR) proceedings to invalidate a number of pharmaceutical patents, including three patents owned by Anacor Pharmaceuticals, Inc., as previously discussed at Global IP Matters. On October 21, 2016, the PTAB issued written decisions on the two IPRs filed by CFAD invalidating claims of U.S. Patent No. 7,056,886 (the ‘886 Patent) that covers Shire PLC’s drug Gattex®.
Gattex® is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). The medicine helps the remaining intestine (bowel) absorb more and reduces the need for parenteral support.
Gattex® received FDA approval in 2012 and had sales of $67.9 million in 2014 and sales of $141.7 million in 2015.
In almost every U.S. patent suit, the patentee’s counsel considers how the case could have been facilitated had the patent at issue been drafted and prosecuted differently. These considerations demonstrate that patents should be drafted and prosecuted with an eye toward the possibility of litigation. There have been several landmark decisions in patent cases that directly impact patent prosecution. This article analyzes some of those decisions in chronological order to provide suggestions for a patent prosecutor in drafting or prosecuting a patent application.
- The term “invention” should be cautiously used in the description section of the specification and during prosecution.
The implementation protected by a patent is set forth in the claims. Prosecutors have traditionally used the term “invention” in the specification and during prosecution to highlight aspects of the claimed implementation. In 2007, the Federal Circuit, however, noted in Verizon v. Vonage that “[w]hen a patent … describes the features of the present invention as a whole, this description limits the scope of the invention.”
As the scope of the patent is well understood to be defined by the claims, this Federal Circuit ruling indicates that the use of the term “invention,” even when used in the specification or during prosecution, can narrow the scope of the claims. To avoid the issue of whether each disclosed “invention” limits the claims during a possible infringement suit, prosecutors should typically avoid use of the tem “invention” throughout drafting and prosecution.