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Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under the 35 U.S.C. § 271(e)(1) Safe Harbor?
The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA…more
Earlier this year, a judge of the U.S. District Court for the District of Columbia reaffirmed the facial constitutionality of the 8(a) Program in response to a challenge by a small business owner, and he also rejected an argument that…more
California’s prohibition on non-competition agreements is less than absolute. For example, non-compete agreements may be enforced against partners or sellers of businesses. Additionally, in SingerLewak LLP v. Andrew Gantman (2015)…more
I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment…more
Russell Reitz, a Camarillo pharmacist, with a modest prescription-filling service, R&O Pharmacy, sold his business to Philidor Rx Services, a mail-order pharmacy, for $350,000. Reitz stayed on as manager, only to see an avalanche of…more
Historically, financial sponsors approached financial services investments with caution. Since the financial crisis, however, things have changed, creating valuable opportunities for financial sponsors to invest in a sector that…more
Cybersecurity has become, as it should, an extremely important topic on company boards’ agendas. The main question on everyone’s mind is: “How can we eliminate this problem?” The answer, unfortunately, is that you can’t. Hackers are…more
Economic Freedom, “Hong Kong Style”: Respecting Privacy And Ensuring Companies Can Resolve Disputes Efficiently
Hong Kong has always been known for its economic freedom. However, that economic freedom needs rules and protections to operate on a day-to-day basis. Recently, Hong Kong has taken bold steps forward with new rules and guidelines…more
The Texas Supreme Court recently added another opinion to its ever-growing body of law interpreting arbitration agreements. The opinion falls in line with prior decisions on two key issues: 1. what amounts to waiver of the right to…more
One of the hurdles business must deal with in moving forward with a merger agreement is the merger review process. We have previously spoken about this process and some of the difficulties businesses can face in complying with the…more
A New York City attorney is suing the U.S. State Department over a proposed change to the International Traffic in Arms Regulations (ITAR). The change pertains to how the regulations define “public domain,” and, if implemented, could…more
The FCC continues to dispose of pending petitions or requests for waiver of its TCPA rules. One slightly unusual request was the petition filed last February by National Grid USA, Inc. (“National Grid”) requesting a limited waiver of…more