What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of September 2013.
Mark Lemley’s firm files DJ Action against Myriad
On September 20, 2013, Counsyl, Inc. filed a declaratory judgment complaint in the United States District Court for the Northern District of California against Myriad Genetics, Inc. Counsyl seeks a declaration that claims from 8 Myriad patents are invalid and not infringed. Further, Counsyl seeks their attorneys fees because they assert that this is an exceptional case given that Myriad is pursuing enforcing its patent portfolio despite losing on “certain claims” in the patents at issue at the Supreme Court in Association for Molecular Pathology v. Myriad Genetics.
The problem with the Counsyl declaratory judgment action is that there does not seem to be any contact with Myriad, so they claim that “[t]here is a definite, concrete, real and substantial controversy between Counsyl and Myriad of sufficient immediacy to warrant the issuance of a declaratory judgment…” However, there are no facts in the filing that show anything other than suspicion that Myriad may at some time sue Counsyl because Myriad has stated that they aggressively intend on asserting rights to the patents they own. Of course, Myriad has a right to seek to enforce their patents and this type of nebulous, generalized fear has never been sufficient to support declaratory judgment jurisdiction.
Counsyl is represented by Daralyn Durie and Mark Lemley of Durie Tangri. Lemley is also a Professor of Law at Stanford University.
Promise not to infringe insufficient in ANDA Litigation
On September 26, 2013, the United States Court of Appeals for the Federal Circuit issued a panel decision in Sunovion Pharmaceuticals v. Teva Pharmaceuticals USA et al. The dispute started when Reddy submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, which included a so-called paragraph IV certification with respect to the ’673 patent under the Hatch-Waxman Act.
The United States District Court for the District of New Jersey granting summary judgment in favor of Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively “Reddy”), finding they did not infringe claims 1, 2, and 8 of Sunovion’s U.S. Patent 6,444,673 (the “’673 patent”). The ’673 patent is listed as referenced to LUNESTA® in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the “Orange Book”). During the second quarter of 2013 LUNESTA® had sales of nearly $200 million. The primary issue in the case was whether Dr. Reddy’s promise not to infringe was enough to avoid a finding of infringement.
The Federal Circuit explained: “if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue.” Accordingly, the Federal Circuit reversed the district court and held that “any so-called certification pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law. Simply saying ‘But I won’t do it’ is not enough to avoid infringement.”
Licensing deals stall in Pharmaceutical Sector in first half of 2013
Despite a positive a positive first half of 2013 in terms of IPOs and venture capital interest in the pharmaceutical industry, a recently release report by EvaluatePharma suggests that licensing deals have stalled. Key findings of the report include:
- IPO activity continues to increase as 20 companies floated in the first half of the year raising $1.28 billion between them. Only 16 companies completed IPO’s during the whole of 2012.
- The industry raised $2 billion in venture finance during the first half of the year with two thirds of the total coming in the second quarter.
- A total of 416 licensing deals were closed, with $1.59 million changing hands in the first half of 2013. Given these weak numbers, the industry may struggle to match the total of 2012, which was the slowest in at least five years.
- The pharma industry saw $29 billion worth of M&A transactions in the first six months, putting 2013 on track to be the best year since 2010 (excluding mega-mergers).
- US product approvals have nearly matched the encouraging pace of 2012, with 17 approved by June 30. Should the remaining 29 small-molecule therapies and nine biological agents make it to the market this year, projected five-year US sales will reach $16.3 billion, above the $15.9 billion projected from 2012.
Mylan settles with FTC over Agila Acquisition from Strides
On September 27, 2013, the Federal Trade Commission announced that it will require Mylan, Inc., and Agila Specialties Global Pte. Ltd and Agila Specialties Pvt. Ltd. (collectively, Agila) to divest 11 generic injectable drugs as a condition of allowing Mylan’s proposed acquisition of Agila from Strides Arcolab Ltd. (Strides). Mylan proposed to acquire Agila for approximately $1.85 billion, under an agreement dated February 27, 2013.
According to the complaint filed by the FTC, Mylan and Agila are two of only a limited number of current or likely future competitors. In addition, the injectable generic products of concern are highly susceptible to supply disruptions caused by the inherent difficulties of producing sterile liquid drugs.
The proposed consent order is designed to remedy the alleged anticompetitive effects that the proposed acquisition. It requires Mylan to divest either Mylan or Agila/Strides products as follows: 1) Mylan’s fluorouracil injection and methotrexate sodium preservative-free injection to Intas Pharmaceuticals Ltd.; 2) Mylan’s etomidate injection, ganciclovir injection, meropenem injection, and mycophenolate mofetil injection, as well as Agila/Strides’amiodarone hydrochloride injection and fomepizole injection to JHP Pharmaceuticals, LLC; and 3) Agila/Strides’ acetylcysteine injection and mesna injection to Sagent Pharmaceuticals. The proposed order also requires Mylan to release all of its rights relating to labetalol hydrochloride injection to Gland Pharma Ltd. Finally, the proposed consent order contains supply and technology provisions to ensure the acquirers can immediately and effectively compete in the marketplace.
Amgen and ShanghaiTech University announce China R&D Center
On September 24, 2013, Amgen (NASDAQ: AMGN) and ShanghaiTech University announced the two organizations have entered into a memorandum of understanding (MOU) to form a strategic partnership for the advancement of biopharmaceutical discovery and translational research in China. This agreement includes plans for Amgen to open a China research and development (R&D) center at ShanghaiTech University.
“Amgen and ShanghaiTech University share mutual goals of scientific excellence and rigor and will benefit from each other’s strength and expertise in advancing biopharmaceutical discovery in China,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Expansion into China is a business priority for Amgen and opening this R&D center is another clear and important step forward in Amgen’s commitment to the China market.”
Under the terms of the MOU, Amgen will co-locate its China R&D center with ShanghaiTech University’s two life science institutes: the Shanghai Institute for Advanced Immunochemical Studies (SIAIS) and the iHuman Institute.
Forest Laboratories sues over SAVELLA® generics
Forest Laboratories, Inc. (NYSE:FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced the filing of patent infringement lawsuits in the U.S. District Court for the District of Delaware against Apotex Corp., Hetero USA Inc., Lupin Ltd., Mylan Pharmaceuticals, Inc., Par Pharmaceuticals, Inc., Ranbaxy Laboratories Ltd., and related companies and subsidiaries. The complaint alleges the aforementioned companies are infringing U.S. Patent No. 6,602,911 (“the ‘911 patent”), U.S. Patent No. 7,888,342 (“the ‘342 patent”), and U.S. Patent No. 7,994,220 (“the ‘220 patent”), which relate to Forest’s SAVELLA® product. Forest licenses the ‘911 patent, the ‘342 patent, and the ‘220 patent from Royalty Pharma.
Teva Pharmaceutical scores patent victory over Mylan on AZILECT®
On September 23, 2013, Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced the U.S. District Court for the District of New Jersey has issued a favorable ruling in the Company’s patent infringement lawsuit against Mylan regarding an AZILECT® (rasagiline tablets) patent which covers methods of treating Parkinson’s disease (PD). The Court has upheld the validity of Teva’s patent. Teva anticipates the Court will enter Judgment that prevents Mylan from launching its generic version of Azilect® until Teva’s patent expires in 2017.
Teva filed a lawsuit suit against Mylan in October 2010. Similar lawsuits were filed against Watson and Orchid in October 2010, Apotex in May 2011 and Sandoz in April 2012. Teva reached settlement agreements with Watson, Apotex and Orchid earlier this year. Sandoz has agreed to be bound by a final judgment in the case against Mylan.
Last month, Ambry Genetics and Gene By Gene responded to Myriad’s motion for preliminary injunction in a 109 page brief that sets out its invalidity case as well as the basis for its antitrust counterclaims. Supported by declarations from numerous luminaries and illuminaries in the gene patenting debate (including several of the individual plaintiffs in the Myriad case, and anti-gene patenting economist and Nobel Prize winner Joseph Stiglitz), the brief makes its points good and bad in an exhaustive fashion. Not surprisingly, the brief focuses on the Supreme Court’s decision in the AMP v. Myriad Genetics case, categorical exclusion being the easiest and most direct for the defendants to prevail. The brief also alleges invalidity for anticipation or obviousness and non-infringement, as well as challenging Myriad’s claims of irreparable harm, the balance of the hardships and the public interest, the latter based on the generic testing being “critical to patient care” (indeed, as in AMP, the intuitively persuasive argument is that patients will benefit, regardless of the evidence for or against that proposition).
Patent awarded on new Hepatitis C treatment
On September 17, 2013, BioLineRx Ltd. (NASDAQ: BLRX), announced today that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for BL-8020, an orally available, interferon-free treatment for hepatitis C. The patent covers the use of BL-8020 for treating HCV-infected patients non-responsive to an anti-HCV therapy (patients who failed to achieve a sustained virologic response following treatment).
BioLineRx is currently conducting a Phase 1/2, open-label study at two sites in France to evaluate the efficacy, safety and tolerability of BL-8020 in patients infected with HCV. The study will include up to 32 HCV-infected patients of any genotype who have previously failed or relapsed following treatment with the standard-of-care. The primary endpoint of the study is to evaluate the effect of a 16-week combination therapy with Ribavirin and HCQ. The study is specifically designed to allow intra-subject analysis, in order to determine the extent to which HCQ enhances Ribavirin’s antiviral activity.
Orphan drug designation for treatment of Acute Radiation Syndrome
Soligenix, Inc. (OTCQB: SNGX), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures, announced on Monday, September 16, 2013, that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient SGX94 for the treatment of acute radiation syndrome (ARS). SGX94 is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.
The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application, and certain tax credits.
Avanir settles ANDA litigation with Actavis over NUEDEXTA
On September 3, 2013, Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that it has entered into a settlement agreement with Actavis South Atlantic LLC and Actavis, Inc. (collectively, “Actavis”) to resolve pending patent litigation (Case: 1:12-cv-01122-UNA) in response to Actavis’ abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir’s NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.
The settlement agreement grants Actavis the right to begin selling a generic version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances. The parties have also agreed to file a stipulation and order of dismissal with the United States District Court for the District of Delaware which will conclude this litigation with respect to Actavis. The settlement does not end Avanir’s ongoing litigation against the other three ANDA filers.
In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the Department of Justice where it is subject to review.
For an additional rundown of recently filed biotech and pharma cases please see the Patent Docs Court Report.