Weldon Amendment Welded Onto The Patent Act

In 2004, the Consolidated Appropriations Act (Public Law Number 108-199, Section 199) was passed with the "Weldon Amendment" (named for its sponsor, former Republican Congressman Dr. Dave Weldon), a rider stipulating that "[n]one of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism."  On September 16, 2011, when President Barack Obama signed into the law the America Invents Act, the Weldon Amendment became an integral part of the Patent Act.  Effective immediately, here is what this new patent law requires:

SEC. 33.  LIMITATIONS ON ISSUANCE OF PATENTS
(a) LIMITATION.-Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(b) EFFECTIVE DATE.-
(1) IN GENERAL.-Subsection (a) shall apply to any application for patent that is pending on, or filed on or after, the date of the enactment of this Act.
(2) PRIOR APPLICATIONS.-Subsection (a) shall not affect the validity of any patent issued on an application to which paragraph (1) does not apply.

No one yet knows what "directed to or encompassing a human organism" means.  The United States Patent and Trademark Office will have the first opportunity to apply this restriction as the initial arbiter of patent applications.  Inevitably, the federal courts will weigh in to provide more authoritative interpretations.  Eventually, Congress may have to amend this provision to clarify it.  Meanwhile, the inclusion of this restriction on patenting "a human organism" directly within the patent statute strongly signals that at least some biotechnological advances have unsettled both Congress and the President.

A Clockwork Orange - 2011

London's burning!  London's burning!  All across the town, all across the night.  Alex The Large and his droogs would be in their element.  As Alex might say,

What we were after now was the old surprise visit. That was a real kick and good for laughs and lashings of the old ultraviolence.

Mirabile dictu, Egypt's bloggers and tweeters are now covering protests, mass violence, and looting in England.  While there will always be an England, it will never quite be the same England it was before even the injured were considered fair game for mugging.

Rue Britannia:  Britannia ruined by knaves.

Myriad Genes To Patent

The United States Supreme Court must be despairing of how many patent appeals are coming its way.  After all, patent law is few people's cup of tea.  As one old, though obscure, joke puts it:

Question:  What's the difference between a patent attorney and a tax attorney?
Answer:  Patent attorneys are like tax attorneys, but without the scintillating personalities!

Watch out, Supremes, because the Court of Appeals for the Federal Circuit may have just teed you up to grant yet another writ of certiorari in a patent case.

Like Prometheus v. Mayo, a dispute focused on the patentability of methods of medical diagnosis and treatment, Association for Molecular Patholody v. Myriad raises fundamental questions of patentable subject matter and the interpretation of 35 U.S.C. 101.  On July 29, 2011, the Court of Appeals for the Federal Circuit largely overturned a decision on summary judgment by Judge Sweet of the Southern District of New York that rendered unpatentable claims to isolated DNA molecules per se and methods of diagnosis relying on comparisons of mutated DNA molecules with corresponding patient DNA samples.
 
It would be natural for the Supreme Court to combine the appeals of Prometheus v. Mayo and Association for Molecular Pathology v. Myriad because they both probe similar and related issues of patentable subject matter.  Such a combined appeal would have the potential to settle fundamental issues of patent eligibility surrounding many biotechnology inventions for a generation.

The eyes of biologists, the biotechnology industry, and patient advocacy groups are now firmly fixed upon the Supremes.

When Patents Attack

This American Life, a quirky and wonderful weekly radio program on National Public Radio, has featured stories on comedians, how to speak to kids, psychopaths, unconditional love, and mind games.  On July 22, 2011, TAL investigated a special breed of trolls:  patent trolls.  Here is how TAL describes the program:

Why would a company rent an office in a tiny town in East Texas, put a nameplate on the door, and leave it completely empty for a year? The answer involves a controversial billionaire physicist in Seattle, a 40 pound cookbook, and a war waging right now, all across the software and tech industries.  We take you inside this war, and tell the fascinating story of how an idea enshrined in the US constitution to promote progress and innovation, is now being used to do the opposite.

This patent who dunnit is fascinating and entertaining.  Moreover, it transforms a field of law often viewed - even by other, non-patent, attorneys - as dry, technical, and inaccessible, into something that, like Lord Byron, seems mad, bad, and dangerous to know.  Listen to the program here.


Hear it before you go infringing. You'll never go in the patent pool again! 

Toxodebtosis

Toxoplasmosis is a fascinatingly tragic condition.  A mouse infected by the protoctistan, Toxoplasma gondii, behaves strangely.  Instead of scampering away at the first whiff of feline scent, as an uninfected murine certainly would, the mouse is dangerously attracted to eau de chat.  As its predator steadily approaches, the unfortunate mouse simply awaits, even welcomes, its catastrophic end.

Humans may also be infected by T. gondii.  Those with toxoplasmosis often exhibit an unreasonable penchant for obviously risky behavior.  Neurally transfixed by the parasite, an infected person may not only stare danger in the eyes, but willingly step within its opened jaws.

Though many metaphors, some more purple and florid than others, have been offered to describe the debt ceiling crisis currently threatening the United States, toxoplasmosis may be as good as any.  Like a parasitized mouse, the American economy and polity seem to be marching steadily and willingly towards a possible August 2, 2011, default.  Unlike the mouse, however, if the United States is consumed by default, it will likely take the rest of the world with it.  The weird serenity currently infecting the political classes in the District of Columbia, some of whom appear not simply to have accepted default, but positively to welcome it, suggests a debilitating political disease capable of leading to much economic pain.

While it remains unlikely that the United States will actually default next week, equity, bond, gold, and even food markets, as well as credit rating agencies, have already begun to price in significant economic damage.

Can a treatment be found in time?  If so, will it merely control the symptoms, or cure the disease?  Whatever the result, the current debt ceiling crisis amounts to the largest and most dangerous game of cat and mouse ever played.

When Two Tribes Go To War

A war is raging in the United States between two great parties.  These two have radically different belief systems, seem unable to agree on fundamental issues, and are increasingly competing on every level for the support of the people.  Their hotly contested battlegrounds include budgets, culture, technology, foreign policy, and social policy.  Each party has a long and glorious tradition, and constantly yearns to wrest influence from the other.  One party currently controls the White House and leads the United States Supreme Court, while the other has a stranglehold over Silicon Valley.  Never the twain shall meet;  ever the twain shall battle for supremacy.

Democrats and Republicans?  No, far more important:  Harvard and Stanford.

Technology provides a vivid illustration of this clash of titans.  Over the past two decades, Harvard has seen its once seemingly-unassailable champion - Microsoft - challenged, and toppled, by Stanford's relentless battler - Google.  However, Stanford is now threatened anew by a Cantabridgian contestant - Facebook - whose spectacular rise may end Google's hegemony.  Where Google accommodated itself (for a time, at least) to the requirements of the Chinese government, brash Facebook has helped sweep aside dictatorial regimes in Tunisia and Egypt, with the mere flick of its newsfeed.  Perhaps more importantly, Facebook now commands more attention (in traffic and stickiness) than Google.

The battle is far from over.  Not only is Stanford's current champion fighting back with new initiatives, such as Google+ - a social media service aimed at the heart of Facebook, and currently exploding in popularity -  it continues to attract, educate, and graduate new generations of entrepreneurial talent unmatched anywhere in the world.  Unmatched anywhere, that is, except at Harvard.

When the two great tribes go to war, far more is at stake than scoring a point.

Prometheus Rebound To The Supreme Court

On its second opportunity, the United States Supreme Court has granted a writ of certiorari to hear an appeal of Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester ("Prometheus v. Mayo"), a decision by the Court of Appeals for the Federal Circuit ("Federal Circuit") that ratified - for the second time - the patentability of methods to determine optimal drug dosage levels in therapeutic treatments.  This bodes ill for the patentability of inventions involving methods of medical diagnosis and therapy.
As discussed previously on LEXVIVO, on December 17, 2010, Prometheus, Inc., a San Diego-based biotechnology company, prevailed in appealing a district court's grant of summary judgment that had found claims in Prometheus' exclusively licensed patents (U.S. Pat. Nos. 6,355,623 and 6,680,302) invalid as drawn to non-statutory subject matter under 35 U.S.C. §101.  In Prometheus v. Mayo, a unanimous panel of the Federal Circuit "again [held] that Prometheus' method claims recite patentable subject matter under §101."  The court's previous finding that Prometheus' claims constituted statutory subject matter was successfully appealed by defendants-appellees Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Mayo") to the Supreme Court, which vacated and remanded the Federal Circuit's decision on April 29, 2010, "for further consideration in light of Bilski v. Kappos," a business method patent case the Supreme Court had decided the day before.  It would appear that the Supreme Court has now called two strikes on the Federal Circuit on this issue.

The claims at issue cover methods for determining the optimal dosage of thiopurine drugs, such as 6-mercaptopurine and azathiopurine, used to treat inflammatory bowel diseases that include Crohn's disease and ulcerative colitis.  For example, claim 1 of the '623 patent involves (1) administering a drug capable of producing 6-thioguanine inside a patient suffering from a gastrointestinal disorder, (2) determining the concentration of 6-thioguanine in the patient's blood, and (3) indicating the need to increase or decrease the drug's dosage depending on whether the drug's blood concentration is outside of the therapeutically desired range of 230-400 pmol per 80,000,000 red blood cells.

Now, the Supreme Court will have an opportunity to clarify the patentability of inventions directed to methods of diagnosing medical conditions, as well as those that combine such diagnostic methods with methods of treatment.  Any optimism the biotechnology industry might have derived from the Federal Circuit's December 17, 2010, decision in Prometheus v. Mayo may now be tempered by the specter of the Supreme Court adopting the argument that Justice Stephen Breyer (joined by now-retired Justices John Paul Stephens and David Souter) made in his vigorous dissent to the dismissal of the writ of certiorari of a kindred case, Laboratory Corporation v. Metabolite Laboratories, Inc..  In his dissent, Breyer described the medical diagnostic method contested in that case as follows:
A similar conclusion in Prometheus v. Mayo by a majority of the Supreme Court could redraw the boundaries of patentable biological subject matter in United States patent law.

law at issue in the abstract patent language of a "process." But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.

At most, respondents have simply described the natural

Big Dilemma Over Smallpox

Smallpox virus (Variola vera) has been one of the most horrific diseases to afflict humanity.  Fortunately, worldwide vaccination programs appear to have eradicated it among humans.  However, both the United States and Russia maintain carefully-guarded stocks of the virus for research purposes.  Over the years, international pressure to destroy these last laboratory stocks of smallpox virus has been building.  Many assumed that the World Health Assembly, the decision making body of the United Nations World Health Organization, which held its 64th conference from May 16th to 24th, 2011, would vote to do just that, thus consigning Variola vera to the dustbin of disease history.  Instead, the Assembly granted the virus a stay of execution until at least 2014: 

Reaffirmed that the remaining stock of smallpox virus should be destroyed 

The Health Assembly strongly reaffirmed the decision of previous Assemblies that the remaining stock of smallpox (variola) virus should be destroyed when crucial research based on the virus has been completed. The state of variola virus research will be reviewed at the 67th World Health Assembly in 2014 and in light of that, determining a date for destruction of the remaining virus stocks will be discussed.

Bioethicists disagree about whether or not to destroy the virus.  As long as it survives, the risk of its release - either accidental or deliberate - will persist.  If it is destroyed, the best opportunity to derive future insights into its, and other disease organisms', biology may be forgone forever.  In the meantime, the virus that has taken about half a billion lives in recent history will continue to hang, like the Sword of Damocles, over the future health of humanity.  

Osama Bin Laden - Pioneer Of Bioterrorism

It appears that Osama bin Laden was killed on May 1, 2011.  Among his nefarious "accomplishments", bin Laden was the first internationally prominent proponent of bioterrorism. Worries about the deliberate misuse of biological agents have prompted the United States Federal government to set up new anti-bioterrorism facilities, such as the Center for Excellence for Emerging and Zoonotic Animal Disease, to be located in Kansas.  Despite the demise of bin Laden, the threat of bioterrorism is likely to remain firmly fixed both in the public consciousness and in the wishlists of terrorists.

On Fast Track, Patent Office Run Over By Budget Deal

As LEXVIVO previously reported, the United States Patent and Trademark Office ("USPTO") entered 2011 by proposing several significant reforms designed to improve the efficiency and quality of the patent application process.  Included in these proposed changes were a new fast-track patent pathway and new satellite Patent Offices.  The Federal budget compromise recently agreed between Congress and President Obama, the Full-Year Continuing Appropriations Act, 2011 (Pub. Law 112-10), brings this brief patent office perestroika to a halt.  Here is an email USPTO Director David Kappos sent to his employees last week:

As you may know, the FY 2011 budget was signed by the president on April 15, 2011 and contains the USPTO’s appropriation through the end of this fiscal year, September 30, 2011. With the enactment of the Full-Year Continuing Appropriations Act, 2011 (Pub. Law 112-10), USPTO spending authority for FY 2011 has been limited to $2.09 billion. In view of the funding cuts reflected in the final budget and affecting the U.S. government as a whole, we will be unable to expend the additional $85-100 million in fees that we will be collecting during this fiscal year—funds that we had anticipated being able to use to fund operations this year.

In short, the Continuing Appropriations Act for FY 2011 does not allow us to maintain spending at the levels planned for this year. Further, I am mindful of the fact that we may very well be operating at the FY 2011 level for the foreseeable future. As a result, we have had to make some difficult decisions in order to ensure the responsible stewardship of the agency. It is against that backdrop that I must reluctantly announce, effective immediately, that:

• All overtime is suspended until further notice;

• Hiring—both for new positions and for backfills—is frozen for the rest of the year unless an exemption is given by the Office of the Under Secretary;

• Funding for employee training will be limited to mandatory training for the remainder of the year;

• Funding for contracting of Patent Cooperation Treaty (PCT) search is significantly reduced;

• The opening of the planned Nationwide Workforce satellite office in Detroit and any consideration of other satellite locations are postponed until further notice;

• Only limited funding will be available for mission-critical IT capital investments;

• The Track One expedited patent examination program, scheduled to go into effect on May 4, 2011, is postponed until further notice.

In addition, all business units will be required to reduce all other non-compensation-related expenses, including travel, conferences and contracts.

Trademark activities are unaffected and will maintain normal operations.

I want each of you to know that we have not come by these decisions easily. I recognize that these measures will place additional burdens on your offices, your staff, and your ability to carry out the agency’s mission. However, I believe that they are absolutely necessary to ensuring that the agency can continue to operate through the remainder of this fiscal year and into FY 2012.

I thank you for continuing cooperation and patience, and I appreciate your dedication and service during this challenging time.

David Kappos

Under Secretary of Commerce for Intellectual Property and Director of the USPTO

Ironically, the USPTO does not contribute materially to the Federal deficit.  Instead, it is financially self-supporting, covering its operations through the collection of fees from patent and trademark applicants.  However, Congress has traditionally appropriated these fees for other governmental purposes, leaving the USPTO continually short of money to pay for improvements, such as skilled new patent examiners to help alleviate the huge backlog of patent applications.  In an age of austerity, the USPTO might be celebrated as a governmental exemplar of financial self-sufficiency.  Instead, it continues to act as a piggy bank continually filled by inventors, only to be raided by Congress.  It is difficult to see how this strategy benefits technological innovation.