Posts Tagged: "pharmaceuticals"

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the use of a claimed invention in connection with carrying out clinical trials will constitute an invalidating public use. Patent applications are typically filed early on in the process of developing and commercializing a pharmaceutical drug product. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar. The circumstances under which clinical trials involving administration of a drug product that occur prior to the critical date may constitute an invalidating public use is a murky area of the law and courts’ decisions in this area are highly dependent on the facts of the case before them.

Protecting innovation through patents is the lifeblood of the global pharmaceutical industry. Without patents the world and its expanding population would be deprived of new and, ultimately, affordable life-saving medicines. Nevertheless, the high profitability of pharma companies has prompted an increasingly widespread (and often ill-informed) political debate on patents. This is not just because of mounting health costs but also the lack of access to life-saving medicines in developing countries. But this argument on the alleged high costs caused by patents falls short because most patents for essential medicines on the World Health Organization (WHO) list are expired and are available at generic medicine prices. Even so, patients in countries where they are most needed do not have access to generics. And the reasons for this are multiple, not least inadequate, poorly-funded healthcare systems.

Most assaults on public/private sector R&D partnerships are launched by those who believe patents are inherently bad and that through some undefined magic publicly funded inventions will be developed if they were only made freely available.  However, every couple of years attacks come from another, more threatening direction — claims by well placed, but inexperienced “experts” that if their pet theories were adopted technology transfer from the public sector would sky rocket. One idea being promoted is that universities should double or triple the number of their inventions to justify continued federal funding, thus triggering a spike in commercialization rates. In reality the only  spike would be in patenting dubious inventions to pad the numbers, leading to depressed licensing rates as portfolios were filled with junk.

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from their efforts. However, in the pharmaceutical industry, the practical duration of protection is often substantially shorter since obtaining a patent is just one piece—albeit a critical one–of bringing a drug to market.

Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what was expected by a person of ordinary skill. The court pointed out “’the mere fact that a certain thing may result from a given set of circumstances is not sufficient’ to render the results inherent.” Millennium Pharmaceuticals, 2017 WL 3013204, at *6 (citations omitted by author). The court also held that it is never appropriate to consider “what the inventor intended when the experiment was performed,” even though Millennium “conceded as a matter of law that the ester is a ‘natural result’ of freeze-drying bortezomib with mannitol.” Id. Thus, hindsight reasoning should never be applied and, obviousness is “measured objectively in light of the prior art, as viewed by a person of ordinary skill in the invention.”

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners, to put it mildly, the PTAB has not been inhospitable to pharma patent owners according to a report issued in mid-June by BiologicsHQ, a searchable database of drugs, patents, and companies involved in PTAB inter partes review (IPR) proceedings developed by attorneys at Fitzpatrick, Cella, Harper & Scinto. The BiologicsHQ report shows a much different story in terms of drug patents facing IPR challenges at the PTAB. The report looks at a combination of data sources, including the Orange Book, Center for Drug Evaluation and Research (CDER) listed biologics and statistics on America Invents Act (AIA) trials published by the PTAB. The BiologicsHQ report draws the conclusion that, despite widespread concerns about the PTAB operating as a patent death squad in IPRs, “such concern is not justified for drug patents.”

IP-skeptics charge that these inventions are little more than a way for pharmaceutical companies to cynically prolong patent life and maximize profits, without providing any meaningful innovation. This rather simplistic view misunderstands how the patent system works, and the role of patents in incentivizing drug discovery and development. In reality, many of today’s most significant medicines owe their existence to the ability of medical innovators to secure patents for novel new forms and new uses of existing treatments.

The Supreme Court of Canada issued a ruling in AstraZeneca Canada Inc. v. Apotex Inc., which gives patent owners a far greater ability to protect their intellectual property in the face of Canada’s Promise Doctrine, a part of Canadian patent law that requires an invention to be “useful” in order to be patent-eligible subject matter. The ruling is being heralded by patent owners, especially those in the pharmaceutical space, and it provides an interesting juxtaposition in contrast to recent United States policy, which has been tipping the scales in the favor of generic drugmakers over branded pharmaceuticals.

The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the Middle East… If we are to have a fighting chance against superbugs and pandemics, we must invest in innovation and safeguard the property rights that incentivize these discoveries. Short-sighted efforts to enervate existing intellectual property rights laws and policies will not only damage incentives to innovate, they may hand a victory to the superbugs.

Generic drug manufacturers can pose major financial threats to those companies that invent and develop the copied drugs both domestically and internationally… Before TRIPS, most of the world’s developing countries had very weak patent protections, especially for pharmaceuticals. These weaknesses included — but were not limited to — shorter patent terms ranging from 4 to 7 years, narrowly defined patents which allowed for imitations, and greatly reduced monopoly rights of the patent owner by the permissive use of compulsory licenses. This divergence demonstrates a disconnect between the above mentioned weaknesses and the strong protections of industrial countries with their 20-year patent terms and almost unlimited monopoly rights… For pharmaceutical patent owners, these TRIPS amendments try to harmonize the worldwide rights afforded to them by balancing the interests of the rights holder and those of consumers.

Drug manufactures spend billions of dollars in R&D and it takes years to get FDA approvals and patent protection. It is vital that these companies keep a vibrant and thriving product pipeline to offset costs of failed drugs, which do not work as intended or do not get FDA approval. Yet, all the money spent can yield tremendous dividends when a drug reaches “blockbuster” status. To attain this label, a drug must be so popular that it generates at least $1 billion in annual sales. Often treating the most common chronic and long-term ailments such as diabetes, high cholesterol and blood pressure, for example… In 2015, Pfizer spent $7.7 billion on R&D costs and Eli Lilly spent $4.5 billion. The forecast for Pfizer and Lilly in 2022 is expected to grow to $7.8 billion and $5 billion respectively. This is on trend with the worldwide pharmaceutical numbers at an expected growth of 2.8% to $182 billion in 2022. Both companies are targeting the largest therapy areas with sales which include oncology leading the group followed by anti-diabetics and anti-rheumatics.

The Federal Circuit affirmed a Patent Trial and Appeal Board (“Board”) decision finding a patent owned by Novartis AG and Mitsubishi Tanabe Pharma Corp. (collectively “Novartis”) to be unpatentable as obvious… Refusal by the Board to institute an IPR based on a particular reference does not necessarily preclude the Board from relying on that reference as additional support for a motivation to combine other references. Separate patentability arguments for dependent claims must be clearly argued lest they stand or fall with parent claims. A nexus for non-obviousness due to commercial success must clearly flow from the patented invention and not from subject matter known in the prior art.

Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their erectile dysfunction (ED), but they may not be the only ones facing dysfunctionalities. As the patents on these lucrative lifestyle drugs come to an end, price tags and bottom lines are expected to plummet… The lifestyle drug market is extremely lucrative. These medications can be used by all age groups worldwide and increased individual awareness of health and beauty has created a demand for physical fitness and improved performance of all our body parts. People are living longer, have higher disposable income, and the demand only grows more when a drug touts the high quality and safety of their formulations after it passes the stringent requirements for FDA approval… The real question, however, is whether U.S. patent law and policy will continue to give pharmaceutical companies the incentives necessary to innovate lifesaving medicines, or whether we will continue to see more and more blockbuster lifestyle drugs moving into the future.

Although Dupixent hasn’t been granted FDA approval as of yet, the drug has made it further than Amgen’s AMG-317, the code name for Amgen’s own IL-4 inhibitor developed during the 2000s, which failed in phase 2 clinical trials… The major impetus behind this suit was Sanofi-Aventis and Regeneron’s discovery that Amgen hired litigation counsel to assert the ‘487 patent and is also working on retaining experts. The plaintiffs believe that the only likely target for any potential Amgen infringement suit asserting the ‘487 patent would target Dupixent, “the only IL-4 inhibitor expected to come to market in the near future.”

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and “exclusivity” separately. “Exclusivity” refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition. Some differences are that patents can be issued or expire at any time – before, during or after FDA approval– while exclusivity attaches upon approval of a drug product. Further, some drugs have both patent and exclusivity protection while others have just one or neither… Make no mistake, it would be tremendously unwise to proceed sans patents. No patent means the generic can enter the market as soon as the FDA exclusivity period expires, and having a patent can extend the exclusivity period to the end of the patent term, often years later.