Art Gardner, a Republican patent attorney seeking election to the U.S. Senate in Georgia, has recently proposed a reform to the nation’s patent laws to address the artificially high price of prescription medicines in the U.S.
Specifically, Gardner proposes to make it patent misuse to charge much more in the United States for the same drug than in the rest of the G7. According to Gardner, “it would be presumptive patent misuse to charge more than 125% of the average price in the other 6 countries in the G7 and it would be conclusive patent misuse to charge more than 150%.” This innovative change would be a simple change in the U.S. patent laws and would be very impactful. Said Gardner, “If the patent is being ‘misused’ in this way, the patent would be invalidated and/or unenforceable, opening up competition for generics. So the owner of a drug patent would have a strong interest in avoiding losing the protection of the patent and would hold down U.S. prices and/or drive up prices around the world. Either way, we (the U.S. consumers) would over time end up paying the real price of patented medicines, not the exaggerated price which includes a subsidy for foreigner consumers.”
Mylan Inc. (NASDAQ: MYL) recently prevailed in the United States District Court for the Northern District of West Virginia in a patent dispute involving Perforomist® (formoterol fumarate) Inhalation Solution, which has as the active ingredient a bronchodialating compound. The district court confirmed the validity of all patents asserted by Mylan. At issue were U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.
Mylan previously sued Teva alleging that Teva’s Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva’s defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva’s ANDA. The Court’s decision also prevents Teva’s ANDA, which has yet to receive a tentative approval from the U.S. Food and Drug Administration (FDA), from receiving final approval prior to expiration of the patents in suit.
As was predicted in Patent Office Litigation, much is going on in the world of contested proceedings at the United States Patent and Trademark Office. What no one could have predicted, however, was how broadly and rapidly the new challenges to the patentability of issued U.S. patents would become the standard defense tactic in U.S. patent litigation in all areas of technology. Indeed, 74% of the new contested proceedings are in the electronics/communications/method of doing business technology space, while 13% are in the mechanical space, and 13% are in the biotechnology, chemical, pharmaceutical space.
Brand name pharmaceutical giants are starting to realize that administrative patent trials at the Patent Trial and Appeal Board (PTAB) will present an unanticipated avenue for generic drug manufacturers to challenge blockbuster drugs. No commercially viable patent is safe it seems.
Approximately 80% of the claims challenged in petitions are instituted for trial on at least one proposed ground of unpatentability, but the dire statistics from the patent owner perspective do not stop there. As of the beginning of March, the Board had issued Final Written Decisions after the completion of the trial process in 19 proceedings – 11 IPRs and 8 CBMs. In all but three of these proceedings, the Board cancelled ALL claims for which trial was instituted! The Board cancelled 95.2% of all claims for which trial was instituted, and cancelled 82.9% of all claims that were initially challenged by the petitioner. These are draconian statistics for patent owners!
The intriguing software and hardware innovations of this technology giant makes Apple a fun corporation to profile for our Companies We Follow series. We’ve picked out the most interesting patent applications and issued patents published by the USPTO and assigned to this California-based corporation. These inventions run the gamut from digital media systems to hardware improvements for handheld mobile devices.
We begin our look at Apple today by taking an in-depth look at our featured patent application, which describes smarter methods of building playlists for digital content, like songs. This system can dynamically update playlists based on a user’s changing taste or if another user with a compatible device walks into the room. We also picked up on a few other patent applications featuring revolutionary technologies, including one microphone headset component that enables voice processing by sending data signals through an owner’s bones and body tissues.
Steel yourself, gentle reader. This month we go hunting the living dead: arguments that keep climbing out of the grave to bite and infect the unwary.
Four months after NIH rejected the latest attempt to misuse the Bayh-Dole Act to control drug prices zealots have risen from the crypt claiming the law should be used to haunt drug developers. March-in rights were designed to force universities to issue additional licenses if effective efforts are not being made to commercialize a federally funded invention; if the licensee cannot meet national health, safety or regulatory needs; or if the licensee fails to make the product in the U.S. despite a pledge to do so.
Critics claim there’s another trigger: if they don’t like the price of a drug. While the cost of new drugs is a concern, their solution sucks the life blood out of a system leading the world in protecting public health. It’s time to drive a stake through that spectre.
When the U.S. Supreme Court finishes hearing arguments in the upcoming case Alice Corporation v. CLS Bank International, it will be asked to judge whether or not software and computer-implemented inventions are eligible to receive patent protections through the U.S. Patent and Trademark Office. Should the Supreme Court uphold the original decision and declares that the Alice’s patents on computer-implemented systems for managing risk in financial transactions are patent ineligible, thousands upon thousands of software patents could become invalidated.
We discussed some of the issues in play with this major case in our previous look at amicus briefs filed with the U.S. Supreme Court for this case. We have also profiled the IBM amicus briefthat argued that the abstract idea doctrine was unworkable. These parties, though largely neutral, had a number of disdain for how the judiciary has handled the issue of software’s patent eligibility under Section 101 of Title 35 of the United States Code. Today, we’re taking a look at briefs filed for either side of this historic case to get a broader sense of the viewpoints involved in this issue. A number of major corporations, non-profit organizations in technological fields and renowned scholars have lent their ideas to these briefs, and readers may find their views on the patent eligibility of software programs to be enlightening.
A quick perusal of the amicus briefs published online by the American Bar Association shows that only a few of the briefs filed are supporting the petitioner, Alice Corporation, in this case. In fact, only three briefs in support of the petitioner are shown on the ABA’s official site listing amicus briefs for this case; there are a total of 40 amicus curiae briefs shown on that site, as of this writing.
On March 14, 2014, the United States Department of Commerce announced that it is asking the Internet Corporation for Assigned Names and Numbers (“ICANN”) to begin discussions on a transition proposal for replacing the Department with a non-governmental entity to serve as steward of the Internet’s Domain Name System (“DNS”). The Department’s announcement (the “Announcement”), and accompanying question-and-answer guidance, signals an effort to accelerate the transition to private-sector leadership of and supervision over the technical coordination of the DNS, which has proceeded sporadically since the late 1990s, when the Executive Branch set privatization as the eventual goal. The Department said it was acting “[t]o support and enhance the multistakeholder model of Internet policymaking and governance.” News reports have described speculation that the timing of the Announcement suggested a desire to pare back the U.S. Government’s role in Internet management in the aftermath of publicized disclosures of classified information involving foreign intelligence collection by the National Security Agency.
Also on March 14, ICANN announced that it was “inviting governments, the private sector, civil society, and other Internet organizations from the whole world” to participate in the development of the transition proposal. ICANN noted that the “responsibilities to be transitioned include the procedural role of administering changes to” the DNS and “to the authoritative root zone file–the database containing the lists of names and addresses of all top-level domains–as well as serving as the historic steward of the unique identifiers registries for Domain names, IP addresses, and protocol parameters.”
Making a startup into a successful small business venture requires more than an entrepreneurial heart and willpower. It takes a loyal base comprised of engaged, connected customers and clients to help a business go from start up to sustainable.
In other articles and discussions, IP WatchDog has touched on building and improving a solid company website and networking off line, but what about online networks? What have you done lately to engage potential clients that find your company page online? Are you putting a priority on these efforts as well? If not, now is the time to get serious.
How to Write a Patent Application is a must own for patent attorneys, patent agents and law students alike. A crucial hands-on resource that walks you through every aspect of preparing and filing a patent application, from working with an inventor to patent searches, preparing the patent application, drafting claims and more.
Without hesitation I recommend One Simple Idea and think it should be required reading for any motivated inventor. There is so much to like about the book and so much that I think author Stephen Key nails dead on accurate. The book is educational, information and inspirational. For the $14 cover price it is essential reading.
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