It is that time of the year again where I am preparing my materials for my yearly ethics presentation, which will take place during the 8th Annual PLI Patent Law Institute. This year the Patent Law Institute will take place in New York City on February 3-4, 2013, and in San Francisco on March 17-18, 2013. The webcast will be from the New York location on February 3-4.
One of the primary segments of my ethics presentations is always a rundown of the activities of the Office of Enrollment and Discipline over the last year or so. As I started to review the cases one case jumped out at me that deserved stand alone attention. The case is In re Hunaid Basrai, which was decided on June 18, 2013.
According to §11.15 “Any practitioner who is suspended or excluded under this Part shall not be entitled to practice before the Office in patent, trademark, or other non-patent matters while suspended or excluded.” However, reinstatement to practice after is possible. In order to be reinstated, however, the disciplined practitioner must serve the sentence and then petition the Office for reinstatement.
It is not common to see a petition for reinstatement, much less an actual reinstatement. That is, however, what happened with respect to Mr. Basrai, who was suspended nunc pro tunc from October 26, 2009, for a period of 60 months, but with the last 24 months stayed. Basrai’s petition for reinstatement was successful, and he is once again a patent agent registered to practice at the USPTO.
Siemens AG, a multinational conglomerate of engineering and electronics developers, is a major source of innovations in a wide array of fields, including medical technologies, communications, power generation and industrial automation. Recently, subsidiary Siemens Water Technologies announced a partnership with Texas A&M to develop more efficient systems of removing heavy metals from industrial wastewater. The next few weeks will be interesting ones for Siemens as they chart a course under a brand new CEO who has only been serving since August.
We’re taking a look once again at Siemens here in IPWatchdog’s Companies We Follow series to get an idea of how the corporation is applying its research and development to medical technologies and other industries. As always, we’ve pulled up a number of patent applications and issued patents assigned to Siemens by the U.S. Patent and Trademark Office that should interest our readers.
Our featured patent application today discusses improvements to methods of ultrasound therapy in medical settings. Ablation therapies in this system would have better safeguards that keep a patient’s skin from becoming uncomfortably warm during the procedure. Another medical technology innovation is discussed in a patent application focused on imaging a patient’s tongue for speech therapy. Other applications include more secure telecommunications systems and protocols and a system of detecting short circuits in the charging systems of electric vehicles.
Protecting the intellectual property of biologics is complicated, difficult, and essential to the future of medicine. Not surprisingly, the proposed 12-years of data exclusivity for biologics is one of the remaining sticking points in the Trans-Pacific Partnership trade negotiations. Data exclusivity is essential to the future of biologic medicines, but the nuances of their production greatly complicate the logistics of protecting their intellectual property.
What makes biologics different
The chemical structures of traditional “small molecule” pharmaceuticals are generally well defined. Accordingly, laboratory analysis can determine all of the components and replication (generic production) is fairly straightforward. In contrast, due to their complexity, biologics are very difficult and sometimes impossible to characterize scientifically. In many cases, some of the components of a finished biologic may be unknown. Consequently, the U.S. Food and Drug Administration (FDA) has struggled to establish “interchangeability” for complex proteins. Unlike conventional “small molecule” drugs for which a generic drug can be shown to be the same as an innovator drug, a biosimilar [follow-on biologic (FOB), subsequent entry biologic (SEB)] is a product that is similar but not identical to the pioneer biologic.
As any viewer of “Shark Tank” can attest, the variety of financial arrangements which are negotiated between inventor entrepreneurs and investors is broad. A final agreement is always the result of negotiation between the two parties. Unfortunately, many inventors go into the gunfight with a knife, so to speak, over-matched and under-prepared.
Unless you are a veteran of previous negotiation and thoroughly understand the potential value of your invention, you would be wise to engage the services of an attorney and/or a firm who has previously negotiated financial transactions for similar inventions. You don’t want to leave money on the table, nor do you want to have an unrealistic view of your work. Expert assistance can help you avoid either outcome.
The following descriptions are by no means exhaustive, but represent a sample of the strategies you might employ in order to monetize your work:
This paper proposes amending 35 U.S.C. 271 Infringement of Patent with elements drawn from § 2-403 of UCC Article 2, Sale of Goods, and with elements of the Patent Exhaustion Doctrine. This amendment, if enacted, would prevent patent trolls from proceeding against Bona Fide Purchasers for Value with respect to certain specific infringements, in order to strengthen consumer confidence in the marketplace, by ensuring that vendors can deliver the products that they sell, free of threats of patent infringement litigation against such innocent buyers.
Ten years ago if you said that patent eligibility would become one of the most important, hotly debated issues in the patent field most in the industry probably would have thought you simply didn’t know what you were talking about. Five years ago some saw the issues percolating, but still many in the trenches with their day-to-day practice life would likely still have raise a cautious eyebrow and questioned why you thought even the Supreme Court might turn its back on a solid generation of well established patent law. The tone was perhaps cautious, but most couldn’t imagine that the Supreme Court and the Federal Circuit would cease their expansive view of patent eligibility.
Oh how times change!
Today, after several years of substantial turmoil, patent eligibility in a variety of economically significant technologies is extremely uncertain, including software, natural products, medical diagnostics and personalized medicine. It is with great irony that one of the few things we know with any degree of certainty is that business methods are patent eligible. We likewise know that at least some cDNA is patent eligible, except that man-made cDNA that happens to be identical to what occurs in nature. Of course, that raises more questions than it answers.
Tech sector giants have been crying and moaning about how the patent system has run amok and needs to be scaled back, and continually beg for patent reform that would gut the patent system and weaken patent rights. Immediately after successfully lobbying for the America Invents Act (AIA), they are back at it again supporting new legislation aimed at making it more difficult to enforce patent rights pending in Congress. If they prevail with the passage of the Innovation Act, they will be back at it again no doubt. The longer term goal is to strip the International Trade Commission of its patent jurisdiction, which would make it impossible to stop the importation of infringing goods prior to entering the country. See Will the ITC Lose Its Patent Jurisdiction and Are Some Patent Holders More Equal Than Others?
The grumbling of the tech giants is increasingly being picked up by patent abolitionists who say “see, even Microsoft thinks there should be no patents,” which only adds to the hysteria. Of course, Microsoft is one of the top patenting companies year after year and they aggressively pursue software patens themselves. So while some of Microsoft’s public statements suggest that they do not like software patents, they aggressively seek them and then aggressively pursue licensing strategies. So it seems that Microsoft may talk a good game about software patents being undesirable and a real scourge, but when push comes to shove they will get as many patents as they can. Quite curious if you ask me!
So why do the tech giants want to make it hard for small businesses and individuals to get patents? Do you remember when “Wang” was synonymous with “computer,” or at least “word processor”? Perhaps not, but once upon a time it was indeed. The story of Wang is the story of technology companies generally speaking. What has always been true is that technology companies that reach the top are only passing through on their way down; to be replaced by smaller, leaner companies that pursue appropriate strategies and have solid and expandable innovations in demand.
Even mighty Microsoft couldn’t maintain their monopoly, and only the foolish would anticipate Google, Facebook and other tech giants to be on top indefinitely. That isn’t how the tech sector works, or is intended to work. But if a vibrant, robust and strong patent system is not there for start-ups today they will never become the giant, innovation shifting, growth companies of the future. That would be terrible for the economy, lead to stagnant innovation and guarantee that slothful, giant companies that have lost the ability to innovate would remain dominant rather than going the way of the dinosaur.
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