Post-Grant Insights: The Need for Seamless Coordination of District Court & PTAB Litigation
IP|Trend: Inter Partes Review: Is it Litigation or Something Else?
Post-Grant Insights: The Preparation and Pace of the PTAB
2014 IP Record Shows Continued Growth for Design Patent Filings
Controlling the Cost of Patent Litigation
Post-Grant Insights: The Impact of PTAB Appeals on the Federal Circuit
.bit: Why Brands Need to Pay Attention
Post-Grant Insights: Key Considerations in PTAB Oral Hearings
Post-Grant Insights: What claims to include in your PTAB petition
Polsinelli Podcasts - Removing Caps on Punitive Damages: What is the Impact on Business?
IP|Trend: Dust up After the Breach
Thinking Compliance When Protecting Your Ideas Internationally
What are the Implications of Alice v. CLS?
Protecting Trade Secrets During Business Collaboration
IP|Trend: Inter Partes Review: Is It Still Right For You?
IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
Bill Beutler on Editing Wikipedia
Inter Partes Review Appeals: What You Need to Know
The AIA Has Moved the Cheese
Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more
In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more
The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more
Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...more
Seven organizations of health care professionals argue in an amici brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") that Myriad's isolated DNA and cDNA claims, as well as claim...more
When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the...more
The increasing importance of genetic markers and diagnostic tests in the drug approval process and the delivery of health care requires consideration of who will underwrite the necessary research and development, Michael...more
You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more
In This Issue:
- Measures to Supervise Overseas Investments of Central Enterprises
- Provisions Governing Overseas Manufacturers of Imported Food
- China to Amend Measures for Foreign Invested Medical...more
Sometimes solutions to thorny issues are within our grasp if only we looked in the right place. The Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. raises the specter of the...more
The U.S. Patent and Trademark Office held the first of two planned hearings aimed at fulfilling one of the reporting provisions of the Leahy-Smith America Invents Act (see "USPTO to Hold Hearing on Genetic Diagnostic...more
Traditional pharmaceuticals (small molecule drugs) have long been subject to widespread generic competition under the generic competition provisions of the Drug Price Competition and Patent Term Restoration Act, aka...more
On July 6, 2011 the European Commission (Commission) published the
results of its second monitoring exercise of patent settlements in
the pharmaceutical sector (Second Monitoring Report). The Commission notes “with...more
Case law in pharmaceuticals: trademarks, patents and regulatory issue...more
Back in the 1960s, counting sheep gave way to a lilting commercial ditty as a means for solving the age-old problem of falling asleep: “Take Sominex tonight and sleep, safe and restful sleep, sleep, sleep.” If you took two...more
Clearing U.S. pharmaceutical trademarks for use and registration is more complicated and unpredictable than clearing marks in other industries. Unlike trademarks in other fields, pharmaceutical marks must be approved by the...more
The U.S. Court of Appeals for the Federal Circuit recently affirmed two separate district court decisions finding that patents on newly approved pharmaceutical active ingredients are eligible for patent term extension under...more
On 30 November 2010, European Commission officials carried out unannounced inspections at the premises of a number of pharmaceutical companies in several Member States. Reason was the Commission's suspicion that they may have...more
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