Americans cannot be expect to either personally or through their health insurance bear the burden associated with solely providing the return on investment required by investors to prompt pharmaceutical companies into the marketplace. Whether Americans pay through exorbitant prices out of pocket, or they pay through high priced health insurance premiums, there is no doubt that Americans subsidize individuals all around the world who pay far less than we pay in the United States. This is not a patent problem, but rather it is a government problem. Rather than seize control of the U.S. health care industry government should have tackled the underlying drivers of the cost, and a great place to start would have been in the staggeringly disparate cost of drugs between the U.S. and virtually every other country around the world.

GUEST CONTRIBUTION BY USPTO DIRECTOR DAVID KAPPOS… President Obama’s Global Development Policy — the first by a U.S. Administration — recognizes that raising the living standards of humanity is not just a moral imperative for the United States; it is vital for our economic and national security. Patents for Humanity advances this policy by leveraging the power of invention to improve lives. I invite all patent holders to consider how your inventions could further the aims of the President’s Global Development Policy. If you are actively addressing humanitarian needs with your patents, please apply to our Patents for Humanity prize competition by August 31st, 2012.

One week ago Mark Zuckerberg, the famed founder of Facebook.com, received U.S. Patent No. 8,225,376 titled “Dynamically generating a privacy summary.” Although this is not the first patent awarded to Zuckerberg, who now has 10 issued U.S. patents, this patent is noteworthy because it relates to the the first patent application filed by Zuckerberg. Despite this patent and recent patent acquisitions, for a tech company the size of Facebook this is a paltry number of patents. If Facebook is going to stay where it is they are going to have to continue to acquire patent assets and really change the internal culture to one that is innovative.

So maybe the Federal Circuit won’t find “preemption” to be useful in deciding this appeal; we’ll know soon enough. I, for one, can’t make sense of the DOJ’s fixation on “tying up.” In Flook, the Supreme Court made clear that a claim’s patent-eligibility does not turn on the range of uses that are preempted versus those that remain in the public domain. Even in Mayo, the Supreme Court discussed preemption explicitly only as an underlying policy concern, as a justification for an outcome that, to the Court, seemed right and just – not as a test that distinguishes a “law of nature” from a man-made process. By elevating “tying up” to the status of an actual analytical tool, DOJ proposes an unworkable test that fails to distinguish “products of nature” from man-made inventions and leads to absurd outcomes. It asks the Federal Circuit to rely on asserted facts and unstated claim constructions. It requires strained interpretations of leading precedent. It is evasive and avoids the hard work of construing the claims and applying them to the activities believed to be “tied up” – lawyer work that, if undertaken, may or may not show that the preemptive scope of these claims isn’t all it’s trumped up to be.

Of course, as is virtually inescapable at the USPTO, with every general rule there come exceptions. For example, according to 37 CFR 1.311(b), an authorization to charge the issue fee (37 CFR 1.18) to a deposit account may be filed in an individual application only after the mailing of the notice of allowance. 37 CFR 1.25(b) also makes clear that a general authorization made prior to the mailing of a notice of allowance does not apply to issue fees under 37 CFR 1.18. Thus, you must affirmatively do something after receiving a notice of allowance to accept the offer of a patent.

Although predictions on the outcome of an unusual case such as this are probably worthless, I think that it is most likely that this panel will rule in 2012 the same way that it ruled in 2011. It is probably safe to presume that the judges are fairly entrenched in their positions. In my view, no arguments were presented which show that Mayo was a game-changer with respect to the isolated DNA claims and the screening method claim. In particular, AMP’s main point about the relevance of Mayo—the preemption argument—was harshly criticized by Judge Moore. Among the three members of the panel, Judge Moore would appear to be the most likely to change sides, and I do not see this happening. Thus, I expect the same outcome as last year. However, the long-term outcome is much murkier, with an en banc hearing and/or a Supreme Court appeal almost certain.

Reasonable minds may disagree about how significant the gap is. Indeed, it could fairly be said that the investigation figure I report is 50% higher than the ITC’s (28% v. 19%), and that the sample size is too small to draw any statistical conclusions. Still, reporting the results together, the ITC and I agree that: (1) 43-47% of respondents at the ITC in the last 15-18 months are respondents named in NPE/PAE investigations; and (2) 19-28% of investigations at the ITC in the last 15-18 months are NPE/PAE-initiated investigations.

This deal will give GSK exclusive rights to BENLYSTA, which is a human monoclonal antibody that inhibits B-cell activating factor (BAFF) approved for treatment of systemic lupus erythematosus. It is believed that BENLYSTA has blockbuster potential. According to Human Genome Sciences, the principle patents covering BENLYSTA will generally expire between 2016 and 2023 in the United States and between 2016 and 2021 in the rest of the world. For 2011 sales of BENYLYSTA were approximately $52 million, but there is great optimism that the drug will become a blockbuster as it continues to gain market share and as it may ultimately be approved for treatment of other autoimmune diseases.

Earlier today, WIPO issued a press release, allegedly as the result of “recent media attention and requests for information” relating to what WIPO is and does, and exactly what happened regarding the computer deals that seem to quite clearly violate UN sanctions. Despite the belief of WIPO that the computer deals did not violate UN sanctions, the agency has implemented safe guards relative to their technical assistance program. There will be better coordination between UN organizations and committees to review deals that could potentially tread on UN sanctions.

Anyone who is even casually interested in patents and innovation has to know that over the past few years there have been massive patent battles surrounding the major innovators, copy-cats and manufacturers involved in the smart phone industry. According to the ITC, “Smartphone companies involved in Section 337 investigations during the first half of FY 2012 include: Apple (14), HTC (8), Motorola (4), Samsung (3), RIM (3), Nokia (3), and LG (1).” This has required the ITC to increase staff, and has been a burden on the Commission. But none of those companies are NPEs, are they? It seems the patent infringer lobby is using increases in ITC filings to support their preferred policy position despite the lack of a causal connection.

Licensing U.S. intellectual property strengthens the economy and improves our trade balance. Section 337, the statute that regulates unfair practices in import trade, is a key element of the nation’s trade laws and ensures that American innovators, including licensing companies, will not be harmed by the importation of goods that infringe valid and enforceable U.S. patents. Importers of foreign made products – both U.S. based and foreign companies – have appealed to Congress for several changes to Section 337 that would, in effect, limit access to the ITC and/or weaken the powers of the ITC to deal with cases of unfair trade practices. Weakening the ITC’s jurisdiction would benefit foreign economies, foreign competitors, and other foreign manufacturers to the detriment of the U.S. economy.

This new final rule eliminates 37 CFR 1.99, which provided for third-party submissions of patents, published patent applications, or printed publications in published patent applications, but did not permit an accompanying concise description of the relevance of each submitted document and limited the time period for such submissions to up to two months after the date of the patent application publication or the mailing of a notice of allowance, whichever is earlier.

Perhaps the infringer lobby needs a refresher course on the rights granted to a patent owner. 35 U.S.C. § 271(a) says: “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.” (emphasis added). So, as it turns out, importation of products covered by a patent during the term of the patent are an infringement of the patent rights granted. Let’s not forget that at the end of the day what these Silicon Valley elite are arguing is that it should be more difficult for a patent owner to stop infringement. The wrong-doers are NOT the patent owners who have the audacity to exercise rights granted by the federal government. The wrong-doers are those who infringe those rights and there is absolutely no reason to make it easier for them to engage in infringement.

Still, it seems a little reckless to me to select a trademark that incorporates “ARMOR” or “ARMOUR” when entering an industry that has a heavyweight such as Under Armour with a large trademark portfolio and the means to enforce that portfolio. Is the name BODYARMOR so critical to the success of the company and selling their drinks? I doubt it. So then why run the risk of incurring the wrath of a well funded and well known trademark owner? It just doesn’t make business sense if you ask me. That is why I always advise companies to consider doing a rather exhaustive trademark search and obtaining an opinion from an attorney prior to spending money on adverting and marketing campaigns.

One of the most complex issues in antitrust and patent law today involves agreements by which brand-name drug companies pay generics to delay entering the market. In the past decade, with the Supreme Court showing no interest in wading into the area, the Federal, Second, and Eleventh Circuits have upheld these agreements. And, with each court relying on its sister court, a momentum had developed that made it nearly impossible to discern a role for antitrust scrutiny. The Third Circuit just found that a reverse payment was “prima facie evidence of an unreasonable restraint of trade.”