The 8th Annual World Intellectual Property Day is April 26, 2008, and focuses on celebrating innovation and promoting respect for intellectual property. Dr. Kamil Idris, Director General of the World Intellectual Property Organization (WIPO), highlighted the intrinsic link between creativity, innovation and IP.
Let us know what you think is the best way to celebrate World IP Day. Out-Law.com is running a photography competition for pupils at two London schools as an event to mark the date. No word yet if the Public Patent Foundation (PUBPAT) will be having any festivities. You can see a whole round-up of activities here.
Think this is all much ado about nothing? Consider this:
- Economists estimate that two-thirds of the value of large businesses in the US is due to intangible or intellectual property assets.
- The World Bank estimates that, on average, 40% of company valuations are from intellectual property.
- PriceWatershouseCoopers estimated that as much as 90% of the value of the world’s top 2000 enterprises would consist of intellectual property.
And so, on World Intellectual Property Day, here’s to you o’ inventors and artists, great and small, who enrich our existence with the fruits of their innovative thoughts and creative vision. Cheer!
See more on World IP Day here. You can even download and print your own Innovation postcards.
Posted April 26th, 2008 by Stephen Albainy-Jenei in
Current Affairs
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2 Comments »
It seems that — on the spur of the moment — ProBlogger has declared today Blogger Appreciation Day and has asked readers to email another blogger to let them know that you appreciate something about them. He also suggested writing a post with your words of appreciation.
I have a lot to be appreciative for and, frankly, I don’t always stop and take the time to let people know that I really do appreciate their efforts. I especially appreciate all the great bloggers I’ve had the privilege of interacting with over the years.
I started making a list of all the great blogs but it became a little overwhelming in size. Then, while mulling over my laundry list of people to recognize, I realized that one group of bloggers I really need to thank are those that (without prompting) link to Patent Baristas in the course of discussion on their own blogs.
So, in commemoration of the Semi-Official First Annual Blogger Appreciation Day, here are some of the blogs that have linked to Patent Baristas over the last month or so. I hope that you will take a look at these great sites and maybe find a new gem to add to your list of favorites.
I’m certain that there are more out there that I’ve not seen. Please feel free to leave your thoughts and links in the comments section below.
Posted April 14th, 2008 by Stephen Albainy-Jenei in
Blawg Reviews,
Current Affairs
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5 Comments »
The big buzz around the IP world is that Rick Frenkel, the anonymous blogger of the Troll Tracker blog who just revealed his identity, along with his employer Cisco, have been sued for defamation by two attorneys from Texas, Eric Albritton and T. John Ward, Jr.
The lawsuit may be due to a posting over who filed what when in a lawsuit against Cisco for patent infringement. For Cisco, their response is apparently:
“The parties have mutually agreed to make no comment on the lawsuit in question at this time. That said, we would like to underscore that the comments made in the employee’s personal blog represented his own opinions and several of his comments are not consistent with Cisco’s views. We continue to have high regard for the judiciary of the Eastern District of Texas and confidence in the integrity of its judges.”
This story of mystery and intrigue can be followed at the Prior Art, by IP Law & Business writer Joe Mullin.
Earlier posts:
Also see:
Posted March 12th, 2008 by Stephen Albainy-Jenei in
Current Affairs
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1 Comment »
patent troll (PAT.unt trohl) n. A company that purchases a patent, often from a bankrupt firm, and then sues another company by claiming that one of its products infringes on the purchased patent.. —adj.
In a follow-up to our previous story about lawyer Raymond Niro, from the plaintiffs’ IP firm Niro, Scavone, Haller & Niro, and his offer of $5,000 “to anyone that can provide information that leads me to the identity of Troll Tracker,” Niro has responded with what he felt were some misconceptions in the story.
Niro, described as the Original Patent Troll, is interested in learning the identity of the anonymous author of the blog Patent Troll Tracker, a blog written for the stated purpose “to bring to light the extreme problems our US patent system is having with patent trolls: corporations that make no products, but do nothing but acquire patents to sue and make revenue.”
Troll Tracker insists that he (or she) is “Just a lawyer, interested in patent cases, but not interested in publicity.”
A patent troll is the term coined in 2001 by Intel Corporation assistant general counsel Peter Detkin to characterize Niro and his client TechSearch LLC when Intel was defending a patent suit against them. Ironically, Detkin is now considered by some to have become a troll himself.
Niro responds:
Please let me correct a couple of misconceptions in your blog.
1. I do not want to find out the name of the Troll Tracker in order to sue for patent infringement; rather, I want to know his name to expose him, so that he can’t hide behind anonymity and may ultimately be held accountable for what he says.
2. Acacia does not own the patent in question. It is owned by Global Patent Holdings who has no connection to Acacia.
3. Anyone that operates a website runs the risk of infringing Global’s patent if (as we believe) that patent covers the manner in which JPEG images are displayed on a website. Troll Tracker is no exception.
4. As for silencing critics, I doubt that is possible. But anyone should be held responsible for what they say and have the courage to express their views by putting their names on whatever it is they publish.
In addition, Niro mentioned that he has raised the reward to $10,000 for information leading to the identity of the Troll Tracker. “It seems to me if you really have anything truthful to say, you are not afraid of identifying yourself,” Niro stated.
While Niro frames this as a reward, not a bounty, the meat of the issue is that patent infringement is a high-stakes game. Global Patent Holdings has now filed three patent lawsuits against 16 companies for infringment of claim 17 of the ‘341 patent by downloading responsive data, including audio/visual and graphical presentations, such as JPEG images and/or other compressed data, on their web sites.
According to IP Law 360, Global Patent Holdings has proposed, for companies that sell products through their websites, a fully paid-up royalty of up to $250,000 for companies with annual revenue of between 0 and $50 million (are they asking for 0.5% of the company’s present annual revenue?). For companies of (annual?) revenue more than $51.2 billion, the proposed royalty is $15 million (closer to 0.03%).
For companies that do not sell products through their websites but have compressed images on those sites, Global Patent Holdings is seeking half the amount - $125,000 and $7.5 million.
Many people consider a patent troll to be anyone that doesn’t produce a product or service themselves but instead makes money from licensing the rights to companies already making products. Under that definition, I suppose Thomas Edison would be a troll.
See the earlier story here.
Posted December 12th, 2007 by Stephen Albainy-Jenei in
Patent Reform,
Current Affairs
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13 Comments »
A new website popped up recently that is an attempt to serve as a global resource for dialogue on intellectual property rights and its role in advancing research and innovation.
The site, called Essential Innovation, is an online forum that will feature commentary and analysis on the importance of continued innovation, and the potential consequences a decline in intellectual property rights will have on global public health. This forum demonstrates cooperation to protect innovation from groups spread around the world, joining academic thought leaders, as well as scientists, researchers, doctors and inventors who create important advances in products and services.
The group believes that there has been an increase in attacks on intellectual property (IP) by nongovernmental organizations (NGOs) and governments. In a number of countries, notably Thailand and Brazil, recognized IP protections for life-saving medicines are being disregarded under the guise of promoting greater access. In addition, the World Health Organization (WHO) in November will also consider policy guidelines that significantly weaken IP protections on pharmaceuticals.
According to the group:
Patients around the world are in desperate need of new therapies to treat a variety of conditions. We need strong IP protection to encourage Brazil’s creative class, and the creative classes in countries around the world, to go for it and develop the next line of life-saving medicine.
This is an all-volunteer effort to provide a resource for anyone –media, NGOs, government officials, academics –looking for information from the scientists, researchers and inventors who are actually developing new medicine around the world. The Internet is littered with biased opinions about innovation from a small group of activists who have never done anything to advance science to save lives. This is most apparent in the claims from MSF, Oxfam and others that the patent system does not produce innovation. Nothing could be more patently absurd.
These issues are never as black and white as they seem — especially not as simple as the poll on the site puts it when it asks “Should one steal a medicine to extend a life?” and provides only a yes or no answer. This issue, like all of life, is complicated and often can only be answered with an “It depends.”
Read more here.
Posted November 7th, 2007 by Stephen Albainy-Jenei in
Biotech News,
Current Affairs
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2 Comments »
The Michigan Law Review’s companion journal First Impressions published an online symposium on the Supreme Court, the Federal Circuit, and Patent Law. The symposium is in light of recent Supreme Court decisions KSR v. Teleflex, Microsoft v. AT&T, and eBay v. MercExchange.
A diverse group of authors explores whether these cases, considered together, represent a recent upheaval in patent law and redefine the relationship between the Federal Circuit and the Supreme Court or if such predictions are overblown.
Posted November 7th, 2007 by Stephen Albainy-Jenei in
Blawg Reviews,
Current Affairs
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In the matter of Triantafyllos Tafas v. Jon W. Dudas, et al. consolidated with Smithkline Beecham Corporation, et al. v. Jon W. Dudas, et al. (1:07cv1008), the district court held that it was willing to grant GSK’s Motion for a Preliminary Injunction to enjoin enactment of the USPTO’s new rules, “Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications,” (Final Rules).
It is interesting to note that the USPTO fought against the injunction claiming that the public interest is most benefitted by the Final Rules going into effect immediately. The PTO claimed that the rules promote efficiency and timeliness and are needed immediately to alleviate the harm entrepreneurs suffer because of the current system’s uncertainty.
In addition, they argued that patent applicants who are preparing to comply with the Final Rules would face uncertainty as to how to proceed with patent prosecution and as to which rules would govern their application during the period of an injunction. [Note: If you’ve faced this great uncertainty, email me and I’ll send you a reassuring note back to soothe your fears.]
GSK countered that preserving the status quo while the litigation proceeds is important for maintaining stability for patent holders. Innovation is encouraged when patent holders and applicants have certainty about how their patents will be treated. The fact that three amicus briefs were filed by organizations representing a wide array of industries, all urging the Court to grant the preliminary injunction because their interests will otherwise be harmed, further demonstrated the possibility of potential immediate harm to the public if the rules were allowed to go into effect on November 1.
Fortunately, the court agreed with GSK noting:
Allowing the implementation of rules that may or may not remain in effect is likely to cause much greater uncertainty and squelching of innovation than a preliminary injunction giving the Court time to consider the validity of the Final Rules before they go into affect. Accordingly, the Court will find that the public interest is most served by continuing the status quo and granting the TRO.
Therefore, after considering the likelihood of GSK’s success on the merits, the possibility of irreparable harm to GSK if the injunction is not granted, the balance of hardships between the parties, and the public interest, the Court finds that GSK’s Motion should be granted.
GSK Preliminary Injunction Order (pdf)
Posted November 1st, 2007 by Stephen Albainy-Jenei in
Patent Reform,
USPTO,
Current Affairs
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5 Comments »
Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO) gave a briefing to biotech & pharma bloggers on key issues related to follow-on biologics, patent reform and PDUFA pending legislation.
In the conference call, Greenwood provided an overview of the biggest issues for BIO and then fielded questions from the participants. Greenwood acknowledged that the Biotech industry is facing a perfect storm of troubles as it comes up against a myriad of legislation proposals aimed at the drug industry and patents.
On PDUFA:
While disappointed that about $250 million in fees, Greenwood felt that BIO has done well in getting sensible changes to the Prescription Drug User Fee Act (PDUFA) reauthorization bill. Particularly in that it has moved away from a one size fits all plan for risk management to a more rational approach on a case-by-case basis.
Mr. Greenwood said that the greatest concern right now is the timing of the renewal of the previous bill, which expires Sept. 30. He expressed concerns that moral at the FDA is not good because of layoff notices and indicated that there could be a temporary extension, which could futher lower moral.
PDUFA increases funding for the Food and Drug Administration through fees paid by the drug companies, which increase the speed of drug approval at the FDA. The user fees have gone from being 7 percent of the FDA’s budget to 59 percent.
On Follow-On Biologics:
In July, the Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which lays out a pathway for approving the development of follow-on biologics. Greenwood said that they want to see a follow-on biologics law passed but that “a good law that parallels the framework laid out in the Hatch Waxman Act.
The Hatch-Waxman Act allows generic manufacturers to file an ANDA demonstrating bioequivalence to an innovator drug, rather than an NDA, which is far costlier as it requires data establishing safety and efficacy.
The legislation includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company. The Act amends section 351 of the Public Health Service Act to provide for an approval pathway for safe biosimilar and interchangeable biological products (relying in part on the previous approval of a brand product):
- A biosimilar applicant is required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. A demonstration of biosimilarity includes analytical data, animal testing and one or more clinical studies, unless such a requirement is determined by the FDA to be unnecessary.
- The Act provides incentives for the development of both new life-saving biological products and interchangeable biosimilar products: 12 years of data exclusivity for the brand company during which a biosimilar product may not be approved, and 1 year of exclusivity for the first interchangeable biological product.
- The biosimilar applicant must provide its application and information about its manufacturing process to the brand company. A series of informational exchanges then occur in which the biosimilar applicant and the brand company identify patents in question and explain their views as to their validity or infringement.
Unlike small molecule drugs, which are approved under the FDCA, most biologics are approved under the Public Health Service Act (PHSA). The FDCA provides a framework for approving generic copies of small molecule drugs, but no commensurate legal framework is currently in place for approving follow-on biologics either under the FDCA or under the PHSA. The complexity of biologics makes it impossible to analyze them in a laboratory to the degree possible with chemical drugs, and to show without clinical trials that one biologic has the same safety and effectiveness profile as another.
To be approved as a generic, a drug must have the same active ingredient, strength, dosage form, and route of administration as the reference drug, and it must also be bioequivalent. The bioequivalence of the generic drug is demonstrated through relatively simple analyses such as blood level testing, without the need for human clinical trials.
Currently, the full Senate has not considered the bill passed by the Senate committee, and the House has taken no action thus far on two different bills addressing regulation of biosimilars. Aaron Barkoff of the Orange Book Blog said that he wondered if generic companies would try to get the legislation delayed until the next administration. Greenwood acknowledged that it is a possibility and gave a nod to the many interests involved.
Mr. Greenwood stated that any legislation should include 14 years of data exclusivity in order to protect the investment needed in the drugs from the biotechnology industry. The current protection for small molecule drugs is, on average, 13.5 years prior to generic entry. Therefore, the length of time for data exclusivity would put the biotech industry on par with the pharmaceutical companies.
Earlier, BIO released a set of principles to guide the development of a pathway for the approval of follow-on biologics. BIO also developed a detailed rationale supporting the need for substantial data exclusivity. Meanwhile, generic manufacturers expressed concern that a 12 year exclusivity for the brand company is too long.
On Patent Reform:
Greenwood noted that patent reform is being inspired by the high-tech industry, which feels threatened by so-called patent trolls. While acknowledging that the high-tech industry needs to defend itself, he expressed concern that the proposed changes are not good for the biotech business model.
Donald Zuhn of Patent Docs asked what is the most significant issue in the current patent reform bills. Greenwood indicated that the proposed rules for apportionment of damages would be most harmful to the biotech industry. Unlike a computer, which may be made up of many (often insignificant) parts, a drug company may rely on just one or two patents and need to spend a dozen years developing a drug. Apportioning damages would never take into account the true value of the invention.
The Patent Reform Acts of 2007 (both House and Senate) propose changes to damage calculations that would require specific economic analysis to ensure that any reasonable royalty damage award captures “only [the] economic value properly attributable to the patent’s specific contribution over the prior art.” These calculations would apparently apply to calculations of both past and future damages.
Such a provision on apportioning damages could require courts to adjudicate the economic value of the entire prior art, the asserted patent claims, and also all other features of the accused product or process whether or not patented. A massive undertaking. Greenwood said that he did not see any convincing evidence of the need for such a provision over the current system.
Read the draft legislation here: Biologics Price Competition and Innovation Act of 2007 (S. 1695).
About Follow-on Biologics here.
About Patent Reform Act of 2007 here.
Posted September 18th, 2007 by Stephen Albainy-Jenei in
Patent Reform,
Biotech,
Current Affairs
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