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.
Oil States Energy Services LLC v. Greene’s Energy Group, LLC, now scheduled for oral argument before the Supreme Court on November 27, is clearly receiving all the attention this fall. The possibility of finding Patent Trial and Appeal Board (PTAB) post grant proceedings unconstitutional cannot be understated. But oral arguments will also be heard on that same day in the less-noticed SAS Institute v. Matal… Should any form of IPRs survive Oil States, the following SAS Institute decision should be watched with equal anticipation. A reversal in SAS Institute will no doubt have you rethinking your PTAB strategy.
Owens Corning v. Fast Felt (Fed. Cir. 2017) illustrates an example of how the broadest reasonable interpretation (BRI) standard increases the chances that an obviousness argument could successfully invalidate a patent claim during a post grant patent review proceeding; and make it more difficult to overcome an obviousness rejection during patent prosecution. It also illustrates how broadening a claimed invention’s field of use could be detrimental to the claim’s validity and make it harder to overcome an obviousness rejection.
What is a bad patent? Congress has established the requirements for obtaining a patent. The patent office grants a patent to applicants when they meet those requirements. It is simple. No trolls involved. If there are bad patents, then either the law is bad, or the patent office is not following the law when they grant the patents. Is the patent office issuing patents that do not meet the requirements set forth by Congress in the Patent Act? Or is the Patent Act too generous in setting forth the conditions for granting a patent?
Sleep Styler creator Tara Brown, an ophthalmologist by trade, turned to Knobbe Martens for help securing IP protection as soon as she had her final prototype – a no-heat hair roller – in hand. Attorneys helped her file for patent protection and obtain trademark registration. Brown then raised over $40,000 in an August 2016 Kickstarter campaign, and in March 2017, her Shark Tank episode aired, where she agreed to take $75,000 in funding in exchange for 25 percent equity. The very next week, sales soared from $70,000 in revenue to $3 million, and within three months hit the $50 million mark.
Corporate Counsel Should Carefully Consider the Company’s Trade Secret Position and Form a Game Plan to Protect the Company
Among the most disastrous mistakes with trade secrets is believing you own them when you do not. A number of highly-contentious trade secrets disputes have arisen when joint ventures and similar business partnerships were dissolved. Even companies with forward-thinking legal departments who carefully document such deals may find that they inherit new issues with acquisitions of companies where the prior legal department wasn’t as careful or complete. Compounding these issues is the fact that documentation varies globally – and over time. Even in a well-documented deal, upon dissolution of the relationship, it can turn out that the ownership of trade secrets the company thought belonged to it is unclear, or is joint. In a poorly-documented deal, it may be unclear who owns contributed or even jointly-developed trade secrets – or it may never have been considered in the first place. Even where the documentation is clear, the facts may not be, because over time the history of “contributions” can be lost or muddied by time, additional facts, or complexity.
One of the most valuable benefits of Open Prosecution is when a patentee is forced to enforce a patent. If the patentee filed for a Continuation, it could file for an additional patent with new Claims but the same Priority Date as the original patent, and add it to the lawsuit. And, of course, before that second patent is issued, the patentee files for yet another Continuation. The plaintiff in a patent infringement lawsuit can use an Open Prosecution model to continue to introduce new patents as a counter-strategy to the IPRs filed by the defendant. More than a few patent infringement lawsuits ended in favorable settlements once the defendant realized it had a formidable opponents with additional patents up its prosecution sleeve.
The reality created by eBay in light of the AIPA is simple: If you scrape an invention off the USPTO website and massively commercialize it, you get to keep it. Ubiquity has become a defense. How odd that ubiquity caused by your own initial theft becomes an impenetrable shield in patent infringement litigation… Of course, not all infringers should be liable for willful patent infringement. Some infringers are not the experts in the field. Some are users of technology produced by the experts. If you are a small coffee shop and you purchase a router, you are not an expert and you are not willfully infringing. You just bought a product that some infringer sold you and you reasonably believed could be lawfully purchased and used. But if you are the company producing that router, it must be assumed that you are willfully infringing.
Patenting and secrecy are the two major methods of protecting technology that supports competitive advantage. Trade secrets protect a wide range of confidential information, ranging from customer lists to strategic plans and business methods. While this has been true for decades, the legal landscape in which businesses must choose between them has changed dramatically in recent years, mainly as a result of two forces. The first of these was a series of court rulings that collectively have narrowed the scope of patentable subject matter and have made patents more difficult to enforce. The second was the America Invents Act of 2011 (the “AIA”), which effectively eliminated or reduced certain risks of choosing secrecy, while providing new ways to challenge patents in administrative proceedings. Considered together, these forces require innovators to reconsider their cost/benefit models for evaluating protection mechanisms. This paper discusses risk factors counsel should weigh when advising clients on these issues. I do not advocate one method over the other, but instead suggest that decisions should be guided by clients’ business needs and priorities rather than by patent eligibility alone.
We’ve learned from experience that just because a theory’s off base doesn’t mean it won’t take root, particularly when it involves patents and medicine. “No Vaccines Before the Next Zika Outbreak?: A Case for IP Preparedness” by Professor Ana Santos Rutshman, a faculty fellow in Health Law and Intellectual Property at DePaul University, Co-Director of the Global Healthcare Innovation Alliances at Duke University, and consultant to the World Health Organization, previews her upcoming UCLA law review article. It could be titled “Developing Treatments Without Patents: Let’s Give it a Try.” The article blames exclusive licensing for the lack of a Zika vaccine citing the failed deal between the Department of the Army and Sanofi. The remedy: banning exclusive licensing for federally supported inventions related to specific diseases while imposing price controls on other life science discoveries. Before this bandwagon rolls, let’s look at the quality of its construction.
Patent monetization has become nearly impossible for middle-market technology companies without engaging in some level of legal action. Management teams have consequently shied away from pursuing licensing opportunities, even when the revenue potential of a company’s intellectual property is compelling. While traditional debt and equity investors have an aversion to patent monetization stories, there are specialized investors willing to underwrite capital raises aimed at financing licensing revenue initiatives. By structuring these financings in a way that isolates monetization risk to the patent investor, companies can pursue licensing initiatives that have the potential to generate significant residual value for all stakeholders in the capital stack. In addition to capital, patent investors bring monetization expertise that can play a critical role in the success of a licensing revenue strategy… In many contexts, licensing revenues will only persist so long as the underlying patents remain valid. Increasingly, however, licensees and strategic third parties seek to invalidate patents in Inter Partes Review, rather than continue to pay or renew patent licenses. The uncertainty of future revenue streams further justifies financing structures that ameliorate such risk.
The TC Heartland decision follows the trend of eroding patent holder rights due to the potential for infringers to more easily move the lawsuit to a more favorable forum and in some cases have the issues of infringement and discovery for same stayed for a year or more. As patents and mechanisms to enforce patents become weaker, the high-tech economy of Northern California will begin to diminish as foreign companies encounter fewer obstacles in their way to compete against companies with weaker IP rights… Because so much hinges on a stay motion in modern patent litigation cases, this predominant statistic influences where plaintiffs should consider filing their patent complaint.
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.
Only Article III courts can provide a fair, neutral and unbiased forum for assessment of patent validity. For over two hundred years, patent validity, patent infringement and patent damages have been consolidated to be heard in federal district courts. Federal courts supply impartial judges that are immune from influence by the executive or legislative branches. Furthermore, federal courts supply jury trials that enable a fair application of due process rights in the hearing of a patent dispute. Patent validity review is only a single component of patent infringement cases and it is efficient to have this component of the matter reviewed in a single matter.
Many district courts have interpreted Alice as authorizing invalidation of issued patents as “abstract” based solely on the pleadings. They have done so even where the invalidation rests on resolution of a disputed issue of fact or of claim construction or scope. In short, since Alice, the Federal Circuit has done nothing to clear up the district courts’ confusion, but instead has affirmed pleading invalidations more than 90 percent of the time. Nothing in Alice, or Mayo for that matter, authorized these “pleadings invalidations.” Whether you agree with the decisions or not, both Alice and Mayo, were decided on summary judgment.