By Donald Zuhn --
Yesterday, we counted down the first third of the top fifteen stories that were covered on Patent Docs in 2007 (see "Top Stories of 2007: #15 to #11"). Today, we count down stories #10 to #6, and tomorrow, we will count down the top five stories. In case you missed the articles the first time around or wish to go back and review them at your convenience, we have also provided links to our coverage of these stories (as well as a few links to articles on related topics). As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our ranking, please let us know.
#10 - Drug Pricing and Compulsory Drug Licensing in the Developing World
Developing countries have begun to deal with the high price of patented drugs by using -- or threatening to use -- tools provided by international agreements such as GATT, TRIPS, and the Doha Declaration (e.g., compulsory licensing and parallel importing). However, in 2007, the developing world started to apply these tools to more than just patented anti-AIDS drugs, drawing criticism from and raising the concern of Western drug companies. For information regarding this and other related topics, please see:
- "Neocolonialism in the Current Global Drug Pricing Regime?" August 19, 2007
- "More on the Global Drug Patenting Crisis," August 14, 2007
- "EU Trade Commissioner Sends Warning Letter to Thailand," August 13, 2007
- "Trying to Find a Solution to the Global Drug Pricing Crisis," July 16, 2007
- "Pharma Sanity Lacks Global Reach," July 13, 2007
- "Brasil Prevails in Dispute with Abbott over AIDS Drug Pricing," July 9, 2007
- "Africa (Still) Depending on the Kindness of Strangers in Anti-AIDS Drug Pricing," May 29, 2007
- "U.S. Trade Policy Becoming Less Pharma-Friendly," May 18, 2007
- "The "Unfairness" of World Intellectual Property Protection According to The New Yorker," May 17, 2007
- "Worldwide Drug Pricing Regime in Chaos," May 9, 2007
- "Not Getting It about Patented Drug Prices at The Wall Street Journal," May 6, 2007
- "A Modest Proposal Regarding Drug Pricing in Developing Countries," May 2, 2007
- "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries," May 1, 2007
- "Abbott Agrees to Offer AIDS Drug at Reduced Price," April 12, 2007
- "No New Abbott Medicines for Thailand," March 14, 2007
- "More Compulsory Licensing in Thailand," February 1, 2007
#9 - Regulation of Foreign Drugs Found to be Lacking
The past year saw reports of the appearance of contaminated excipients obtained from overseas manufacturers in a variety of pharmaceutical products. In addition, the FDA's role in this story -- through its less than adequate inspection of overseas generic drug manufacturers -- came to light. For information regarding this topic, please see:
- "The Effect of Foreign Generics on the U.S. Drug Supply - Part III," July 17, 2007
- "The Effect of Foreign Generics on the U.S. Drug Supply - Part II," June 20, 2007
- "The Effect of Foreign Generics on the U.S. Drug Supply - Part I," June 19, 2007
#8 - Senate Passes Biologics Bill
In July, the U.S. Senate Committee on Health, Education, Labor & Pensions passed the Biologics Price Competition and Innovation Act, which would provide an FDA approval pathway for biosimilars (interchangeable biological products) that relies in part on the prior approval of the corresponding brand product. Congress is expected to take up biologics legislation again in 2008. For information regarding this and other related topics, please see:
- "Biologics Legislation Faces Unresolved Issues," December 28, 2007
- "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
- "Biotechs Facing New Challenges," August 13, 2007
- "Three New Biosimilars Pass EMEA Test," July 26, 2007
- "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
- "Senate Committee Passes Biologics Legislation," July 5, 2007
#7 - OMB Approves New IDS Rules Despite Criticism
In July 2006, the USPTO published new Information Disclosure Statement (IDS) rules for comment. Last July, the Patent Office submitted the new IDS rules to the OMB for approval. Not wanting to see a repeat of what happened with the new continuation and claims rules, two groups sent letters to the OMB taking the Office to task for its "analysis" regarding the effects of the new IDS rules on applicants. Earlier this month, the OMB announced -- despite harsh criticism and evidence to the contrary -- that there would be no significant economic impact from the new IDS rules. While the Patent Office has indicated that the new IDS rules will take effect in early 2008, the Office has not indicated to what extent the new IDS rules have changed since they were first published (even the new continuation and claims rules were modified between initial publication and promulgation). Considering the comprehensive analysis provided in the two letters sent to the OMB, the Patent Office could soon be facing another court challenge of a new rules package. For information regarding this topic, please see:
- "The OMB Isn't Listening, Either", December 11, 2007
- "More on Second Letter to OMB Criticizing the IDS Rule," October 24, 2007
- "OMB Receives Second Letter Criticizing Proposed IDS Rule," October 23, 2007
- "Cantor Fitzgerald VP Criticizes IDS Rule in Letter to OMB," October 18, 2007
#6 - Congress Working on Patent Reform
In September, the House of Representatives passed its own version of patent reform legislation. Senator Patrick Leahy, the Chairman of the Senate Judiciary Committee, recently indicated that the Senate's own patent reform bill would continue to be refined and that the Senate would act on the bill "as early as the floor schedule permits" in 2008. Thus, patent reform will continue to be a major story in the coming year. For information regarding this and other related topics, please see:
- "Patent Reform Discussed on Senate Floor," December 21, 2007
- "Enjoined New Rules and Patent Reform Finally Appearing on Biotech Industry's Radar," December 20, 2007
- "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning," December 17, 2007
- "IPO President Seeks Deletion of Patent Reform Provision," December 12, 2007
- "Senate May Act on Patent 'Reform' Bill in the New Year," December 2, 2007
- "The Wall Street Journal Gets It Half Right," November 5, 2007
- "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
- "Patent 'Reform' Bill Passes House of Representatives," September 9, 2007
- "Reversal in Microsoft Case Weakens Patent Reform Argument," August 7, 2007
- "San Francisco Chronicle Opines on Patent Reform," August 6, 2007
- "Patent Reform Bill to Be Delayed?" June 12, 2007
- "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007
- "Could Creating a U.S. 'Utility Model' Patent Fulfill the 'Need' for Patent Law Reform?" May 21, 2007
It is natural at this time of year to reflect upon the events of the past twelve months in the hope that such a review might provide some indication of what to expect in the coming year. In order to help focus on possible developments in biotech and pharma patent law in 2008, over the next three days, we will count down the top fifteen stories that we covered at Patent Docs in 2007. In addition, we will provide links to our coverage of these stories (as well as a few links to articles on related topics) in case you missed the articles the first time around or wish to go back and have another look during the New Year's holiday. Today, we count down stories #15 to #11. Tomorrow, we will count down stories #10 to #6, and on New Year's Day, we will count down the top five stories. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our ranking, please let us know.
As beneficial as the bill seems for biogeneric companies, the generic industry cites critical issues that undercut the cost benefit to consumers. For instance, 
ActivBiotics 
In the December 26, 2007 Federal Register, the USPTO
In a December 21, 2007 
The PPH gives an applicant the option of requesting a fast
track examination of a JP or US application upon receiving a
ruling from the JPO or the USPTO that at least one claim in the corresponding US or JP application is patentable. The
prosecution in the second office is based on the patentable results from the
first office, and thus, applicants can expect to obtain patents in both offices
faster. Updated requirements for
participation in the USPTO-JPO PPH will be published 
Ophthalmologists and Genentech have forged a compromise over the availability of Genentech's anticancer drug, Avastin
The controversy arose when 
The decision outraged the ophthalmological community and their patients, who mounted a broad-based campaign against it. These efforts were led by the American Association of Ophthalmologists (AAO) and the American Society of Retinal Specialists (
This is good news for AMD patients. It is also good news for Genentech, which has further distanced itself from any negative consequences of off-label use. Since the company is not itself selling Avastin
Also missing from the announcement is whether Genentech will participate in, support or even provide Avastin
The authors and contributors of Patent Docs wish their readers a Happy Holidays. Publication of Patent Docs will resume on December 26th.
On Tuesday, Senators 
Acknowledging that he was one of the Committee members seeking further improvements, Senator Hatch (at left) singled out the bill's treatment of inequitable conduct as one of the areas in which the Senate bill required work. Noting that Senator Leahy had done a good job "initiating" the process of develop an effective solution to "the problem of the inequitable conduct defense" during Judiciary Committee deliberations in July, Senator Hatch argued that "more must be done to change the use of this defense as an unfair litigation tactic." The Senator contended that with further refinements to the bill's inequitable conduct provision (as well as to the bill's provisions on damages, post-grant review, and venue), the Senate bill would "garner even greater support." Reflecting on his work on the Drug Price Competition and Patent Restoration Act (the Hatch-Waxman Act), Senator Hatch argued that the final Senate bill must "promote and protect a structure that fosters a strong and vibrant environment for innovators," or suffer the consequences of "fewer and fewer drugs."
Senator Leahy (at right) concluded his remarks by stating that he intended "to seek and hear the views of any and all parties and to include all interested staff and Senators," while asserting that "[t]his will continue to be an open and deliberative process, with the goal of favorable Senate action as early as the floor schedule permits." Senator Hatch closed the discussion by noting that while "some would like to play political football with this bill to pursue other agenda items," the Senate bill was "far too important and should not fall prey to such partisan tactics from either side."
Although the article does a good job of introducing the new rules and patent reform issues to a non-legal audience, perhaps not surprisingly, it takes a few missteps along the way. For example, in discussing the limit on continuations resulting from the benefit claims limits of new Rule 1.78(d) (see 
In addition, by contending that the new rules, if implemented, will limit total claims to 25, independent claims to five, and the total number of continuations per application family to two, the article glosses over the U.S. Patent and Trademark's strongest argument against a permanent injunction: namely, that there are no hard and fast limits on claims or continuations. By so describing the impact of the new rules, the article may provide those in the biotech and pharma industry with too rosy a picture of the final outcome in the consolidated cases of SmithKline Beecham Corp. v. Dudas and Tafas v. Dudas. (While experienced patent prosecutors understand that the mechanisms provided by the new rules for securing additional claims and continuations - ESDs and petitions with a showing - are illusory, these mechanisms nevertheless allow the Patent Office to argue with a straight face that the new rules do not limit the number of claims an applicant can present or the number of continuations that an applicant can file.)
The power of our fear of terrorism to drive out (or at least suppress) rational decision-making has arisen again, this time concerning recent advances in synthetic biology. An article in The Washington Post yesterday (see "
These efforts are opposed by groups, like the Canadian Environment, Technology and Concentration, and up until now the argument has been over proprietary rights to synthetic biology technology. These concerns are voiced by Dr. Tom Knight and Dr. Drew Eady of MIT, who believe that efforts by Dr. Venter's group and others are an improper attempt to monopolize the field. (While eminent scientists, it is important to note that these arguments are not, at present, supported by any legal principle or precedent.) Jim Thomas and the ETC group are the first to play the terrorism card with regard to synthetic biology. According to a recent report from the group, "[u]ltimately synthetic biology means cheaper and widely accessible tools to build bioweapons, virulent pathogens and artificial organisms that could pose grave threats to people and the planet." According to the ETC report, "[t]he danger is not just bio-terror but bio-error," nicely combining the traditional Frankenstein (or, more recently, Franken-food) fears of technology outstripping human capacity to restrain it with the terror of terrorism. ETC disdains the efforts made by all synthetic biologists to engineer these bacteria against errant introduction into the environment, asserting that "we've heard that before" when confronted with the enfeebled nature of these synthetic organisms. After all, according to Jim Thomas, ETC's program manager, genes engineered into crops have been found in other plants. Ignored by this analogy is that recombinant organisms, by definition, are merely the native plant or animal that has been genetically-engineered to contain an additional gene encoding a desired gene product, and that under these circumstances the likelihood that they may "escape" into the environment is difficult to reduce to zero. The synthetic organisms, in contrast, can be (and according to Dr. Venter, have been), so genetically crippled that they have multiple metabolic deficiencies that should prevent growth outside the laboratory environment.
as the Bush administration's ban on federal funding of stem cell research) have been disastrous. Any similar ban for synthetic organisms is just as likely to be unavailing and to merely hurt innovation. "The cat is out of the bag," according to 
In a December 17, 2007 
oncology drugs in the United States, including drugs for treatment of severe pain related to cancer (phase II), oral mucositis, and leukemia (each in phase I). This transaction is expected to close in the first quarter of 2008.
Judge James C. Cacheris of the U.S. District Court for the Eastern
District of Virginia today extended until December 27th the deadline
for the parties to file summary judgment motions regarding the merits
of plaintiffs' complaint seeking a permanent injunction against
implementation of the misguided "new rules" relating to continuation
and claims limitation practices. The deadline for amicus filings (for the amici who have already had their motions for leave to file an amicus brief granted) was also extended until the 27th. No reason was given for the extension,
which the court issued sua sponte, although it may be due to the on-going dispute over discovery in the case.
To date, motions for leave to file an amicus brief have been filed by
the following entities, where the filing date and any limitation in the
scope of the motion is indicated in parentheses: Pharmaceutical
Research and Manufacturers of America (October 26); the Biotechnology
Industry Organization (October 29): Elan Pharmceuticals, Inc. (October
29 and December 6); Monsanto Co. (November 26); Intellectual Property
Institute of William Mitchell College of Law (November 27); and the
American Intellectual Property Lawyers Association (relating to the
retroactive application of the new rules to pending applications;
December 11). Additional parties wishing to file amicus briefs should contact SMoore@KellyDrye.com, JDesmarais@Kirkland.com, and Lauren.Wetzler@usdoj.com and ask consent to file the brief and seek extension of time to December 27, and then file a motion for leave to file as amicus and for extension of time with the Court.
products and technology acquired by Affymetrix will enable it to accelerate development of new genetic analysis products, and add value to its available product portfolio.
According to the Beijing Intellectual Property Institute (BIPI) 
In a second e-mail, Patent Warrior alerted us to a letter that U.S. Representatives Michael Michaud (at right) and Donald Manzullo (at left) sent on Friday to other Members of Congress. Representatives Michaud and Manzullo noted in their letter that during debate on the House bill, several Representatives argued that "the bill would weaken U.S. patent protections and thereby encourage developing nations to do likewise." The Representatives now point 
to the China Intellectual Property News article as providing support for this position. Representatives Michaud and Manzullo conclude their letter by noting that the Senate bill could be voted on in early 2008, and urging other Members of the House "to carefully consider [the bill's] implications for international patent rights and impact on U.S. competitiveness" if a conference report on patent reform returns to the House for consideration.
been able to delete 101 of those genes. Once the set of minimal genes has been identified, they can be introduced into a bacterial "shell," and this would result for the first time in a synthetic organism that does not exist in nature.
Of course, Dr. Venter (at right) and his group has applied for patents on this organism; examples of such patent applications are published International Application Publication No. 
Mr. Thomas thinks otherwise. In a 
Harvard geneticist (and "godfather" of the synthetic biology field) 
The WIRED article also quotes MIT biological engineer 
About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.
January 4-8, 2008 - 
The '220 patent is directed to methods of transplanting DNA into a eukaryotic genome to yield hematopoietic cell lines. These cell lines are generally useful for simulating an in vivo micro-environment in vitro. Thus, they are useful for drug discovery and toxicology screening.
Later in 1999, GA filed for a reissue of the patent on which it had sued Invitrogen. The reissue patent was not issued until 2006. At that point, GA again filed suit against Invitrogen - this time in the Eastern District of Texas' "Rocket Docket."
for the Convention can be obtained 
