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Central Valley Regional Water Board investigating Manure Pond Depth to Groundwater for Certain Dairies
This blog is re-posted from the Milk Producers Council Newsletter. If you have any questions please contact Kevin Abernathy at the Milk Producers Council or Lee N. Smith or Craig Tristao of our office.. The Central Valley Regional Water Quality Control Board (Regional Board) officials confirmed Thursday that they are in the process of contacting about 70 dairies to investigate whether their manure retention ponds are in direct contact with groundwater. Some dairies have already reported receiving the letters, which order them to submit technical reports to help determine whether their ponds intersect the water table. Regional Board officials said the effort is focused in an area of the northern San Joaquin Valley known for historically shallow water tables, near communities like Hilmar, Turlock and Merced. The targeted area appears to include parts of Stanislaus, Merced and San Joaquin Counties. Initial reports indicate that the Regional Board is giving dairies until July 31 to respond to their request for information determining whether the dairy’s pond intersects. The letters require affected dairies to have a licensed civil engineer or land surveyor prepare a “Groundwater Separation Study,” which would include the elevation of the land surface near the lagoon, the lowest part of the top embankment, depth of groundwater below ground surface, “highest anticipated groundwater,” and a comparison of the elevation of the bottom of the lagoon to highest anticipated groundwater. If the ponds intersect groundwater or highest anticipated groundwater, the Regional Board is asking dairies to respond by October 31 with a “remedial workplan” including a time schedule for “elimination of the threats to groundwater associated with this condition.” The October 31 deadline appears to be for submitting the plan, and the letters to not state a specific deadline for when affected dairies would have to fully implement the remedial workplan. However, they would have to propose a time schedule for doing so. Milk Producers Council has requested additional information and is closely monitoring the situation; and will provide updates as developments warrant.view the article
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If A Patent Is expired, Can It Be Used Freely By Everybody?
It is important to remember that a patent does not give anybody the right to do what the patent covers. For example, if I had a patent on a more effective delivery system for MDMA or LSD, having a patent doesn’t change the fact that those drugs are considered Schedule 1 and illegal under almost every circumstance — meaning that my delivery system couldn’t be used even though I had a patent on it. While a patent doesn’t give the patentee the right to practice the invention, it does give them the right to sue people to stop them from using the invention (or to recover financial damages). The expiration of a patent simply means that the owner of that patent can no longer sue anybody for using the inventions claimed in the patent. Those things together mean that the impact of expiration of a patent on the ability to freely copy what was patented is limited. Taking the game “monopoly” as an example, the game was initially covered by a patent, by copyright, and by trademark law (though it does seem likely that recent Supreme Court decisions may have rendered that game not patentable today). When the patent expired, the copyright and trademark in the game remained in place. So while a company could sell a game with the same game-play mechanics that were claimed in the patent without fear of being sued for infringing the patent, that company could still be sued if they violate the copyright to the game or call it “Monopoly”. The bottom line is that the expiration of a patent simply means that the patent is no longer in play (sometimes subject to revival for unintentional or unavoidable delay in paying maintenance fees). However, there are other intellectual property rights (copyright, trade secret, trademark, trade dress, state-level trademarks, rights of publicity, etc.) that can give rise to significant liability. The expiration of the patent will not impact those other rights. The mere expiration of a patent does not mean that anybody can freely practice everything in the patent until they are satisfied (preferably by a lawyer’s opinion letter) that what they intend to do is (a) legal, and (b) does not violate any other IP rights. The other thing about patents is that it is common for a single patent application to result in numerous patents. There is even a thing called a “terminal disclaimer” that is used when a second patent claims something not significantly different than the first patent. Because patent maintenance fees are expensive, infrequently a patent owner will allow one patent to go expired for non-payment of fees, counting on other patents in the family to cover the same material. You’ll want to go to https://portal.uspto.gov/pair/PublicPair and look up the expired patent. First, make sure it is really expired. Second, check the “continuity” tab and see if there are other patents still in force (or pending applications) in that patent family. Perhaps most importantly, you need to seek proper legal advice. A good IP lawyer should be able to walk you through it. It is tough to provide a firm answer in the abstract, and the facts specific to what you want to do will be critical in having a lawyer give you the right answer.view the article
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U.S. Supreme Court Holds That A Copyright Claimant May Not File Infringement Suit Until The Copyright Office Registers A Copyright
Although an author automatically gains copyright protection for her work immediately upon the work’s creation, an author may not file an infringement action in court until “registration of the copyright has been made” in accordance with the Copyright Act. The Supreme Court was recently called upon to resolve a split amongst the circuit courts regarding when registration of a copyright is deemed made. Some circuits held that a registration of a copyright is made as soon as the claimant delivers the required application, copies of the work, and fee to the Copyright Office; other circuits held that registration is made only after the Copyright Office reviews and registers the copyright. The Supreme Court in Fourth Estate v. Wall-Street.com,LLCresolved the split by holding that registration occurs, and a copyright claimant may commence an infringement suit, when the Copyright Office registers a copyright. The Court further held that, upon registration of the copyright, however, a copyright owner can recover for infringement that occurred both before and after registration. Fourth Estate Public Benefit Corporation is an online news producer that licensed articles to Wall-Street.com, LLC, a news website. The license agreement required Wall-Street to remove from its website all content produced by Fourth Estate before canceling the agreement. Wall-Street canceled, but continued to display articles produced by Fourth Estate. Fourth Estate sued Wall-Street and its owner for copyright infringement. Because the Copyright Office had not yet acted on Fourth Estate’s registration applications, the District Court, on Wall-Street’s motion, dismissed the complaint. The Eleventh Circuit affirmed the dismissal. The Supreme Court’s ruling of course has no effect on the statutory scheme that allows for preregistration infringement suits to be filed in limited circumstances. Claimants are still allowed to bring suits under those statutes, provided that they eventually make registration as required to maintain their suits. The Court’s ruling in Fourth Street means that many copyright suits currently in progress are not ripe for adjudication and can likely be dismissed on motion. It is also important to note that, while the Court’s ruling allows claimants to sue for infringement occurring prior to registration, nothing provides for the tolling of the statute of limitations while the Copyright Office processes registration. With a three-year statute of limitations for copyright infringement, and an average application processing time of seven months, parties should not delay in getting their applications on file.view the article
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SCOTUS Finds An Inventor’s Sale of Product to Third Party can Qualify as Prior Art 35 U.S.C. § 102(a)
In Helsinn Healthcare v. Teva Pharmaceuticals USA, the Court affirmed a Federal Circuit decision invalidating the patent for Helsinn=s nausea drug Aloxi, based on patent law=s Aon sale@ bar. In short, the Court found that the sale of an invention to a third party who is obligated to keep the invention confidential by agreement may place the invention “on sale” for purposes of the Leahy‑Smith America Invents Act (AAIA@), which bars a person from obtaining a patent on an invention that was Ain public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.@ An exception to the on sale bar is made if a sale or offer to sell is made 1 year or less before the effective filing date of a claimed invention, and certain other conditions are met. The facts of the case are as follows. While Helsinn was in development of a drug, which uses the active ingredient palonosetron to treat chemotherapy‑induced nausea and vomiting, it entered into two agreements with a third party, MGI Pharma, Inc., a license and supply and purchase agreement. These agreements gave MGI the right to distribute, promote, market and sell two specific dosages of the palonosetron in the United States. In exchange, MGI made up-front payments to Helsinn and agreed to future royalties on distribution. Most importantly, the agreements required MGI to keep confidential any proprietary information regarding palonosetron. The agreements were disclosed to the public in a joint press release and related filings with the SEC, but the specific dosage formulations covered by the agreements were not included in the disclosure. On January 30, 2003, nearly two years later, Helsinn filed a patent application covering the two doses of palonosetron. Over the next 10 years, it filed additional patent applications, all claiming priority to the January 30, 2003 date. Years later, Teva Pharmaceuticals sought FDA approval to market a generic palonosetron at one of Helsinn=s dosages. Helsinn brought suit claiming the product infringed its patent. Teva argued that the fourth patent was invalid because the specific dose was Aon sale@ more than one year before Helsinn filed its initial patent application in 2003. The District Court held that the “on sale” provision did not apply because the public disclosure of the agreements did not disclose the specific dosages. The Federal Circuit court, however, reversed, and concluded that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the terms of the agreements. In a unanimous ruling, SCOTUS found that an inventor=s commercial sale of an invention to a third party invalidates the patent, even if the third party is obligated to keep the invention confidential due to the “on sale” bar. The Court recognized that the pre-AIA statute included the “on sale” bar and noted the precedent that secret sales could invalidate a parent. It then applied the presumption that Congress intended the same with the AIA, which includes the same “on sale” language. Further, the Court found that the addition of the catchall phrase “or otherwise available to the public” is not enough of a change from the pre-AIA statute to conclude that Congress intended to alter the meaning of “on sale.” The practical application and effect of this ruling is interesting to note. On the one hand, a modest inventor can argue that upholding the Federal Circuit=s decision would discourage innovation in the biotech sector, particularly among small or start-up companies who lack resources to have their drugs developed and distributed in-house, as they frequently rely on third party investment and partnerships which can help with costs of further research and development. Third party investments and partnerships, however, subjects them to the “on sale” bar and can discourage them from engaging in time-consuming and costly research, because it causes them to lose the ability to receive patent protection. Also, being forced to file costly patent applications for the sole purpose of avoiding future patentability issues will further discourage small businesses from entering the industry, especially when their invention has not been tested to be commercially viable. On the other side, competitors can argue that the Aon sale@ bar is triggered only when the invention is at a stage when it is ready for patenting and sale, or when the inventor is ready to start making profits before patenting it, and thus, the Aon sale@ restriction is appropriate. Further, a one-year grace period provided in the AIA is sufficient in which to assess commercial viability. In any event, all inventors should be aware of the fact that this decision has vast implications for patent-holders in the United States as well as for investors intending to sell their invention pre-patent application.view the article
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8 Mistakes Inventors Make With Patent Attorneys
Coleman & Horowitt is a proud sponsor of Valley Innovators, a company dedicated to the advancement of knowledge, mentorship and development of capital for startups. As part of our sponsorship, attorneys from Coleman & Horowitt participate in podcasts, to provide useful information to entrepreneurs and start-up companies. Gary Shuster, an inventor and Coleman & Horowitt attorney who offers consulting services to entrepreneurs and start-up companies, was recently featured on a Valley Innovators Podcast where he discussed common mistakes inventors make with their patent attorneys. The podcast may be found at: https://soundcloud.com/valleyinnovators/8-mistakes-inventors-make-with-patent-attorneys-podcast-episode-4listen to the podcast