Category: IP
Photocopiers – A Recurring Data Security Risk
In a case that illustrates the data privacy risks associated with modern copiers, the United States Department of Health and Human Resources (HHS) has announced a $1,215,780 settlement with Affinity Health Plan, Inc. (Affinity), arising from an investigation of potential violations of the HIPAA Privacy and Security Rules.
This matter started when Affinity was advised by CBS Evening News that CBS had purchased a photocopier previously leased by Affinity. CBS explained that the copier’s hard drive contained confidential medical information relating to Affinity patients. As a result, on August 15, 2010, Affinity self-reported a breach with the HHS’ Office for Civil Rights (OCR). Affinity estimated that the medical records of approximately 344,000 persons may have been affected by this breach. Moreover, Affinity apparently had returned multiple photocopiers to office equipment vendors in the past without erasing the data contained upon the … Read More »
Navigating the Isolated DNA Patent Eligibility Jungle
Introduction
For over 150 years the Supreme Court has provided three categories of exceptions to patent eligibility under 35 U.S.C §101: abstract ideas, laws of nature, and physical phenomena, since these are the basic tools of scientific and technological work.[1] The Roberts Court has revised the standard for review of “abstract ideas” and “laws of nature” in Bilski v. Kappos and Mayo v. Prometheus, respectively. The Court’s much awaited decision in AMP v. Myriad addressed the “physical phenomena” exception with respect to patents claiming isolated DNA.[2]
The recent decision in Myriad will have an impact reaching far beyond the patentability of isolated DNA. Patent eligibility for isolated DNA is crucial for the continued growth of the biotechnology and diagnostics industries. The decision, disallowing patenting of isolated DNA, will have a chilling effect on these industries. Furthermore, the decision casts a cloud on … Read More »
What Goes Up…Must Come Down: Viagra patent invalidated by Canadian Supreme Court
Pfizer and Teva have been fighting a legal battle over Pfizer’s patent for Viagra in Canada. The first shot was fired when Novopharm Limited, now Teva Pharmaceutical Industries, applied for a notice of compliance in order to produce a generic version of Viagra in Canada. Teva alleged that Pfizer’s Canadian Patent 2,163,446 was invalid for obviousness, lack of utility and insufficient disclosure. The lower Federal Court held that the patent was valid because the invention was not obvious. The lower court also concluded that the invention was useful, and that the patent did not fail to adequately disclose it. The lower court prohibited the issuance of the notice of compliance.
Teva dropped its allegations of obviousness, and appealed to the Supreme Court of Canada. In a decision published on November 8, 2012, the Supreme Court held 7-0 that the patent was … Read More »
The Perils and Promise of 3D Printing: Are DIY Life Sciences in Your Future?
With news that 3D printing (without question one of the coolest technologies to come down the road in quite some time) can be used to produce guns, we must now ask ourselves what other things might be built using a 3D printer. What about, say, a medical device? Or human tissue? Or body parts?
Some folks are batting around billion dollar numbers, imagining that the official market for these breakthroughs will be the big story in the years to come. And, to be sure, that “official” marketplace will be an important element in the new world of bio-mechanical printing. But as an IP lawyer, my first thought was this is going to be crazy.
So what is 3D printing, and why is it such a big deal? 3D printing is, as you might imagine from the name, a technology that permits three-dimensional … Read More »
Can Human Genes Be Patented?
On Monday, April 15, 2013, the United States Supreme Court will hear a challenge to Myriad’s patents on two isolated genes, BRCA 1 and BRCA 2. The two patented genes, when mutated, can put women at higher risk for breast and ovarian cancer. With the granted patents, Myriad has secured its position as the only place to go for testing of these genes, with a high price tag. Scientists, researchers and patients who believe the patents are blocking further research and limiting the availability of testing, are leading the challenge against Myriad’s patents.
Below is an in-depth look at patent eligibility and the challenge against Myriad, from Mercedes Meyer (may take a few moments to load):
Download (PPT, Unknown)
Five Tips for Dealing with “First Inventor to File”
It’s here.
Thanks to the America Invents Act (AIA), as of March 16, 2013, the U.S. patent system became a “first inventor to file” system. That is, the inventor who files first will get a patent, even if the inventor who first conceived the idea files at a later date. This is very different from the old system, which was a “first to invent” system that awarded patents to the first inventor, even if that inventor was not the first to file.
The new system obviously puts a premium on timely action. The days of lengthy product testing to flesh out and perfect an invention may be gone forever. The system no longer accommodates those who linger. It rewards those who can move quickly.
Here are some suggestions for being ready to move quickly and exploit “FITF.”
File early. By all means, don’t rush … Read More »
Patent War Between St. Jude Medical and Volcano Has Mixed Results
St. Jude Medical and Volcano have been embroiled in a legal battle over patents held by both companies, related to pressure wire technology that is used for heart patients. The battle began over two years ago when St. Jude Medical sued Volcano, in Delaware district court, for infringement of 5 of its patents for pressure guide wire products. The patents in suit were U. S. Patent No. 5,938,624, U.S. Patent No. 6,196,980, U.S. Patent No. 6,112,598, U.S. Patent No. 6,167,763 and U.S. Patent No. 6,248,083. St. Jude requested an injunction and damages for infringement of the five asserted patents.
Volcano replied by counterclaiming, alleging that St. Jude Medical had infringed four of its own patents, but later dropped one of those patents from the suit. The three remaining patents asserted by Volcano against St. Jude were U.S. Patent No. 6,976,965, U.S. … Read More »
The Federal Circuit’s Recent “Safe Harbor” Ruling Could Impact Biosimilars Drug Development
A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry. In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.
As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886. The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides. Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale. (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.) The district court granted Momenta a preliminary injunction, concluding that Amphastar’s testing … Read More »
Life Sciences – Just Another Way to Say “Intellectual Property”?
There is no corner of the American economy more deeply dependent on intellectual property rights than the life sciences. Of course, we all know that patents have long been central to the success of pharmaceutical and medical device manufacturers, and the unanimous decision in the Prometheus case this past month has brought additional scrutiny to a market segment often misunderstood in the popular press. That said, for players in the life sciences space, patents are only one of many ways that intellectual property shapes their business. In fact, the trademark, unfair competition and copyright laws can be just as critical, and a strategic understanding of their value can provide companies with real ownable distinction in the market.
What is a product with “ownable distinction?” It is the opposite of a generic commodity, and it is the holy grail in the life sciences. It … Read More »
The FTC Finally Issues its Report on Consumer Privacy
Interactive marketing is everywhere, and the Federal Trade Commission has struggled mightily over the past several years to deal with complex privacy issues that grow out of sophisticated, data-intensive marketing practices. On March 26, the FTC released its long-promised final report on consumer privacy. Critically, we now have a sense of the FTC staff position on future legislation, best practices and the secondary market in customer data.
The FTC was clear that it wants additional legislation to address general privacy concerns, data security and breach notifications. This is a change from the staff’s prior position that self-regulation would be sufficient, and lends weight to current efforts before congress to do exactly that (although the fact that we are currently in a highly partisan election year does diminish the likelihood of immediate action).
The rest of the report flowed logically from the principles … Read More »