Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.
Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer… Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years. While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.
The first bit of good news for Bass came with respect to his IPR petition against Celgene Corporation. Celgene Corporation filed a motion for sanctions against the Coalition for Affordable Drugs on July 28, 2015. On September 25, 2015, the PTAB, in a decision authored by Administrative Patent Judge Michael Tierney, explained that the purpose of the America Invents Act (AIA) was to “encourage the filing of meritorious patentability challenges, by any person who is not the patent owner, in an effort to improve patent quality.” Given that Bass and the Coalition for Affordable Drugs did not own the patent in question the law allows these types of challenges. The PTAB also shot down the argument that financial motivation is at all relevant, explaining on some level financial motivation is what drives all IPR challenges.
In order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement knocks that term down to 5 years. Sources have confirmed to me that a TPP deal that so substantially reduced biologic data exclusivity will face an uphill battle in Congress.
While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.
The panel decision in this case reads recent Supreme Court precedent to create an existential threat to patent protection for an array of meritorious inventions. It avowedly holds that “groundbreaking” new diagnostic methods that make a significant contribution to the medical field” are ineligible for a patent whenever they (1) incorporate the discovery of a natural phenomenon, and (2) the techniques involved in putting that discovery to its first practical use were individually known beforehand. In other words, the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel. As the example of this case vividly shows, that cannot be correct.
Fuels derived from biomass are not the only option being pursued to solve the problem of switching away from petroleum-based fossil fuels, or at least getting more mileage from those fuels. U.S. Patent Application No. 20140339367, titled Efficient Low Carbon Emission Airplane Integrating Jet Fuel and Cryogenic Fuel Systems, would protect a hybrid fuel airplane having at least one cryogenic fuel tank conforming to the airplane body’s outer mold line as well as a jet fuel tank located in the airplane’s wing. This configuration, developed by the Boeing Company (NYSE:BA) of Chicago, IL, would introduce the use of cryogenic fuels, which are fuels that require storage at extremely low temperatures in order to remain in a liquid state. Cryogenic fuels could be attractive for the airline industry because they create low emission levels and possess a high energy density per mass unit of fuel. One challenge, however, is that cryogenic fuels require large volume tanks because they have a low volumetric energy density per liter. It is because of these benefits and challenges that Boeing is pursuing alternative airplane designs to accommodate for the use of cryogenic fuels.
The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. One of the most significant sticking points in the negotiations is the issue of intellectual property protection for pharmaceuticals, specifically data exclusivity. Data exclusivity is a means of correcting a free-riding market failure, providing the innovative firms with a limited period of time in which data from clinical trials and other required testing cannot be used by competing firms to secure market access.
Greenwood and Castellani will have two major problems as they seek relief. First, the IPR provisions do not include a standing requirement, which means that anyone can bring an IPR for any reason. The second problem is potentially more challenging. An IPR fix would create a so-called scoring problem with the Congressional Budget Office (CBO). What this means is that if this relief were provided for the biotech and pharmaceutical industries, as desired by Goodlatte and Castellani, it will cost the federal government money and increase the deficit unless it is offset.
Ex parte Khvorova is the first PTAB decision on patent eligibility in the life sciences. Until now, the PTAB has been remarkably silent on eligibility in life sciences in the midst of significant judicial activity. The invention relates to synthetically designed and produced small interfering RNA (“siRNA”) molecules, which were discovered in nature for their ability to suppress gene expression. Claim 85 recites a method of rationally designing siRNA molecules with optimal suppression efficacy.
Nanotechnologies are proving to have a major impact on oil spill cleanup innovation in recent years. Researchers at Ohio State University have pioneered a type of mesh coated with a fluorosurfactant, a material which attracts water but repels oil. The mesh has many nanoparticle bumps sandwiched between layers of polymer, which increase the mesh’s surface area and its ability to repel oil. The idea is to pump contaminated water through the mesh to more easily separate oil from the water. Microorganisms have also shown effectiveness in consuming large amounts of oil and oil-eating bacteria like Thalassolituus oleivorans and members of the genus Oleispira have been thriving in the Gulf.
The USPTO continues to issue patents related to biotechnology and organic chemistry inventions despite the Supreme Court rulings and USPTO guidelines implementing the ruling related to the scope of patentable subject matter. Although the sky has not fallen, applicants must expect more rejections under 35 U.S.C. § 101 and must budget for more office actions before receiving an allowance from TC 1600. Furthermore, applicants can expect these challenges in several art unit groups, particularly in art unit group 1630. As a matter of strategy, if a rapid allowance is sought, applicants should carefully draft applications and claims to comply with the Interim Guidelines and utilize options to speed prosecution. Because of the uncertainty in the relevant case law and its rapidly evolving nature, applicants should consider whether to appeal intractable rejections under § 101. Further analysis is necessary to determine whether appeals of rejections under § 101 by TC 1600 are successful.
There have been reports of technological advances which could make bionic vision a reality. One company, Occumetrics Technology Corp. of British Columbia, Canada, has been making a stir with claims of a bionic lens which could help recipients to see three times better than a human’s normal visual acuity, which we commonly refer to as “20/20 vision.” The lens can purportedly be painlessly implanted into a person’s eye in a procedure similar to cataract surgery. The company claims that the replacement operation could be performed as an outpatient procedure that takes less than 10 minutes to complete.
This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during drug approval. However, because of the differences between these two types of drugs, stemming from the increased complexity in manufacturing and patent protection, unique provisions were included in the BPCIA. Unfortunately, as Judge Lourie of the Federal Circuit put it, the BPCIA could win a “Pulitzer prize for complexity or uncertainty.” And, it is these new provisions that could prove the downfall of the BPCIA, at least as it currently exists.
Although the consequences posed by climate change could be dire, there’s no reason to believe that human ingenuity and innovation cannot provide a path forward to answer these challenges… Methods of developing fuel from biological sources on the earth is often a less energy-intensive process than mining for oil or natural gas deep below the earth’s crust, further reducing the production energy required and, subsequently, the amount of carbon released into the atmosphere. Private sector investment in biofuels has been increasing. In 2012, bio-based chemicals and biofuels were responsible for $96 billion in U.S. business-to-business economic activity, according to the National Research Council. Near the end of March, Colorado-based Red Rock Biofuels recently announced a $200 million biofuels refinery that it would be operating in Lakeview, Oregon; the facility will refine pine needles and sawdust into a jet fuel that will be used by Southwest Airlines.