As I mentioned in a previous posting, anecdotally, the Orphan Drug Act has been quite successful in providing incentives to pursue drug research in areas that may have otherwise been overlooked. Here are several links that provide further information and analysis:
The Orphan Drug Act
Drug trial cost estimates
A criticism of the Orphan Drug Act
Background on the law
Eldon John Strandine, 94, recently died. He held 17 patents for various aspects of the poultry industry and food safety. (Chicago Tribune)
From Judy Newman at the Wisconsin State Journal:
The United States could have a backlog of 1 million patent applications awaiting approval within five years if Congress doesn’t pass a bill that would boost funds for the nation’s patent office, deputy director Jon Dudas said Monday in Madison.
According to Dudas, USPTO has 470,000 patent applications waiting for action with an average processing time of 27 months. The funding bill has passed the House, but is awaiting action in the Senate. S. 1760 (PDF).
The Federal Circuit Bar Association has announced its sixth annual “bench & bar” conference beginning June 26 in beautiful Colorado Springs. Program (pdf).
The Intellectual Property Law Association of Chicago (IPLAC) is hosting a federal judicial panel on April 29 (pdf). Judges Cudahy, Duff, Holderman, Moran, Ashman and Brown are all scheduled to attend.
This is a second installment the SKB v. Apotex case brief
Experimental use was a major issue in the case. According to the court, experimental use may only be used to negate a 102(b) public use if the purpose of the experimental use was to assist in designing or testing of a claimed feature. Thus, in SKB, the “clinical trials tested only the safety and efficacy of PHC hemihydrate as an antidepressant” and were not an experimental use of the chemical compound as claimed in claim 1.
One striking idea from the case is that experimental use is now analyzed on a claim-by-claim basis. Thus, the court found that the clinical trials “may serve to negate a public use bar with regard to the inventions claimed in the more specific claims of the ’723 patent.”
Rather than determining whether the invention was undergoing experimental use, courts must now determine whether an alleged experimental use negates a 102(b) public use for each claim individually.
The AIPLA has issued a response (pdf) to the FTC’s October 2003 patent law report (pdf). Here are some highlights of the report:
The AIPLA
1) Agrees that a post-grant review process may help enhance patent quality;
2) Opposes reducing the presumption of validity associated with an issued patent;
3) Sees no need for any legislative change regarding the suggestion for combining prior art references;
4) Supports additional USPTO funding;
5) Strongly opposes increased use of PTO Rule 105 information requests;
6) Skip for now;
7) Agrees with an 18-month publication rule for all pending patent applications;
8) Supports prior user rights in use before the effective filing date.
9) Strongly supports requiring written notice of infringement or deliberate copying of the patentee’s invention, knowing it to be patented, as a predicate for liability for willful infringement; and
10) Questions whether economic analysis should be applied in patent law decisionmaking.
(Thanks for Dennis Gregory for the update.)
Berkeley’s IPblog has been covering patent reform issues. The NRC is also urging patent reform.
Smithkline Beecham Corp. (SKB) v. Apotex Corp. (Fed. Cir. 2004)
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(Figure shows IR spectrum for Paxil) |
Always controversial Judge Richard A. Posner of the 7th Circuit sat as the district judge in this case. His outcome was preserved on appeal, but only after two of his holdings were reversed. This is a very well written, interesting opinion by Judge Rader. If you only read one every three-months, this should be it.
Simplification: The case involved PHC anhydrates (without water) and PHC hemihydrates (some water). In the 70’s PHC anhydrates were invented in the UK. In 1984, SKB invented PHC hemihydrates and eventually patented a PHC hemihydrate compound. (U.S. Patent No. 4,721,723) In 1998, Apotex filed an ANDA to market a prior art PHC anhydrate.
The holding is simple: 1) SKB’s clinical trials that occurred more than one year prior to filing are a public use under §102(b). The clinical trials were not a form of experimental use because the trials were experiments of the medical usefulness of the claimed compound (a PHC hemihydrate) and did not reflect upon the structure or ability to enable the claimed compound. 2) There is no room for a policy-driven inquiry during claim construction. Posner erred in adding a “commercially significant” limitation into the compound claim.
The most interesting aspect of Posner’s opinion was left for another day as moot. In his opinion, Posner created a new equitable defense to infringement that would bar enforcement of a patent when the patentee’s own conduct significantly inhibits non-infringing practice of the prior art. In this case, Apotex’s ANDA request involved making a prior-art PHC anhydrate. SKB argued that after 1984, the environment became seeded with hemihydrate crystals, and that it was no longer possible for Apotex to make PHC anhydrate that would be free of infringing hemihydrate. Under Posner’s new defense SKB would be estopped from enforcing its patent because its conduct (manufacturing hemihydrates and seeding the environment) had effectively eliminated Apotex’s ability to practice the prior art.
There is much more to this opinion including a thought provoking concurrence by Judge Gajarsa.
Read Part II, Part III, and part IV.
Here is a link to Judge Posner’s Opinion. (Thanks Howard Bashman)
Scanner Technologies Corp. v. ICOS Vision Systems Corp. (Fed. Cir. 2004)
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(Figure shows lens, mirrors, camera, ect.) |
In a standard claim construction case, the Federal Circuit vacated a grant of summary judgment in an infringement case involving technology for inspecting electronic components. (U.S. Patent No. 6,064,756 and 57). The lower court found that “comprising . . . an illuminating apparatus” was limited to a single apparatus, while the appellate court held that the phrase would include one or more.
Update: April 29, 2004. Although ICOS Vision Systems lost the appeal, their press release indicates that they may still have a good case.
Anton DeProft, president and chief executive officer of ICOS Vision Systems, commented, “We are disappointed with this decision, but note that the ruling was on a very narrow issue of claim construction, and involved a relatively limited number of systems we sold. We continue to believe that we do not infringe any valid patents of Scanner Technologies and intend to continue to vigorously defend our rights.”
Congressional bills and floor proceedings are captured in the Library of Congress – Thomas service (“in the spirit of Thomas Jefferson”). Click here to search for recent legislation involving patents.
From Leland Meitzler at the Genealogy Blog:
The U.S. Patent and Trademark Office has begun shredding about 35 million patent documents — some dating back to the agency’s creation on July 30, 1790 — as it moves toward full electronic processing.
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But Brigid Quinn, spokeswoman for USPTO, countered: “Nothing valuable is being disposed of. There is nothing original. These are paper copies of copies of copies. Nothing is historical or archaeological, and we’ve been doing this for years.”
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As for what happens to historical patents, Ms. Quinn said, “The original patent goes to the patent holder, and original copies are kept in our warehouse for 10 years. Then they go to the Federal Records Center, where they are kept for 40 years. They are then examined by the National Archives,” which decides if they should be preserved or destroyed.
GTE Mobilnet v. Cellexis International (D. Mass, April 20, 2004)
In a 1996 settlement agreement, plaintiff had agreed not to sue GTE or its subsidiaries, joint ventures or affiliates over disputed patent rights. In March 2000, plaintiff sued Bell Atlantic Mobile for infringement. At the time of the suit, Bell Atlantic Mobile was not an affiliate of GTE. However, four months later, through a series of transactions and transformations, Bell Atlantic Mobile became “Cellco” and an affiliate of GTE. After a trial, the Jury decided that Bell Atlantic Mobile (now Cellco) was an affiliate under the settlement agreement. Thus, the plaintiffs case was dismissed.
Commentary: This case simply involved contract interpretation. Drafting the settlement agreement with more clarity up-front could have avoided this litigation and its associated costs.
Guidant is in the news, having turned a profit this quarter. Guidant’s IP portfolio includes many medical device patents including a device that allows the heart to beat while surgeons perform coronary bypass surgery. (U.S. Patent 6,019,722). The website xq23 has more info about innovations in cardiac surgery.
Jon Dudas recently testified about IP piracy. Here is an exerpt from his prepared speech:
During a House International Relations Committee hearing in 2003, the Secretary General of Interpol identified a disturbing potential trend when he testified that IP crime “is becoming the preferred method of funding for a number of terrorist groups.” A customs expert with the European Commission recently stated that al-Qaeda and Hezbollah are among organizations believed to be using counterfeit goods to launder money and fund their activities. Mr. James Moody, former chief of the Federal Bureau of Investigation’s Organized Crime/Drug Operations Division, has stated that counterfeiting is likely to become “the crime of the 21st Century.”
Dudas reports that the IP crime and enforcement have become a top priority at the department of commerce. The people at GNU have their own philosophy on piracy:
Publishers often refer to prohibited copying as “piracy.” In this way, they imply that illegal copying is ethically equivalent to attacking ships on the high seas, kidnaping and murdering the people on them. If you don’t believe that illegal copying is just like kidnaping and murder, you might prefer not to use the word “piracy” to describe it. Neutral terms such as “prohibited copying” or “unauthorized copying” are available for use instead. Some of us might even prefer to use a positive term such as “sharing information with your neighbor.”
Many patent attorneys probably believed that, in their practice, they could avoid the moral dilemmas faced by criminal defense attorneys. As patent infringement becomes demonized as a crime, those dilemmas may become more frequent. Read the book.
MIT has released its 2004 “Technology Scorecard” (Excel) ranking U.S. patent portfolios of 150 technology companies in eight sectors. Ranks are based on the number of patents, patent citations, scientific paper citations, and technology cycle time. Pfizer and Delphi topped their respective sectors.
Adam Jaffe has done quite a bit of work in this area and has promoted the use of patent citation data as a proxy for patent quality and knowledge transfer.
Intellectual property traditionally takes the form of either patent, copyright, trademark, or trade-secret protection. Often, a business may protect a single technology with multiple IP types. For example, a new electronic gadget may have patents on its core technology and implementations, copyrights on particular computer code used in the gadget, trademarks on the look and feel of the gadget, trade-secrets on the manufacturing process and other implementation particulars that may not be patentable, and integrated circuit topography protection for the IC layout.
Karl Lenz introduced some of these ideas in his arguments that patents on software should be banned. However, this protection overlay is a reality that inventors and businesses can use to their advantage.
Fieldturf Int’l., Inc. v. Triexe Mgmt. Grp., Inc. (N.D. Ill. 2004)
An interesting case is brewing in the Northern District of Illinois between Fieldturf International and Triexe Management Group (Sportexe) over synthetic turf technology. (e.g., U.S. Patent 6,338,885). Fieldturf alleges that Triexe infringed its patents, intentionally interfered with its prospective economic advantage and committed common law conversion by selling or offering to sell synthetic turf to the U Wisc, UC Berkeley, the Baltimore Ravens, and a fourth project in Ireland. Triexe has denied the material allegations and has asserted counterclaims.
Prior litigation between the parties has involved domain name disputes stemming from Triexe’s registration of the domain name fieldturf.net. In his decision, the ICANN arbitrator found that Triexe’s registration was confusing and done in bad faith. In addition, Fieldturf recently lost an appeal in another patent infringement case for lack of standing. (Stephen Nipper).
Litigants in appellate courts may soon be citing unpublished opinions if the Federal Rules of Appellate Procedure are amended to conform to a recent advisory committee recommendation. (article). Federal Circuit Chief Judge Robert Mayer has a problem with citing unpublished opinions because they are generally “not written with the extra care and concern for language” evident in published opinions. Federal Circuit Judge William Bryson also indicated that he would write opinions differently if he knew they could be cited. The Federal Circuit Judges have unanimously voiced their opposition (pdf) to the proposed changes.
In the view of the judges of the Federal Circuit, the adoption of Rule 32.1, which will override our local rule, may adversely affect the administration of justice by skewing the allocation of judicial resources, delaying issuance of precedential opinions, increasing the issuance of judgments without an accompanying opinion, and harming litigants.
J. Craig Williams’ opinion is that “citing an unpublished opinion is something like citing part of the law. It just doesn’t work.”
Golden Blount, Inc. v. Robert H. Peterson Co. (Fed. Cir. 2004).
In an infringement action over a patented fireplace burner assembly, the district court, after a bench trial, found for the plaintiff patent holder. (U.S. Patent 5,988,159). A Federal Circuit panel vacated the infringement holding:
Because the district court’s sparse opinion provides this court with only bald conclusions for review, we conclude that the district court’s judgment as to literal infringement, contributory infringement, induced infringement, and infringement under the doctrine of equivalents is insufficient under Rule 52(a).
Additionally, the appellate court upheld a finding of validity. (Apparently, bald conclusions of validity satisfy Rule 52(a) because of the accompanied presumption of validity). Finally, the court refused to hear an inequitable conduct charge that had not been raised below.
From the Malta Independent Daily: Generic pharmaceutical companies are exploiting gaps in international patent rights to develop and stockpile drugs. For example, Malta and Iceland appear to be serving as safe-havens.
Asked by this newspaper why Pharmaco chose to locate its production base here, managing director Stenthor Palsson said that Malta, like Iceland, fell outside the patent jurisdiction of a number of pharmaceutical products.
(Thanks to PHOSITA for the link).
Update (April 20, 2004) As a followup on its story, the Independent is now reporting that “Malta to join the European Patent Office.”
eWeek’s op-ed page is calling for patent reform. Ironically, the editorial points to the settlement between Sun and Microsoft as another example of the problems of the patent system.
Like Cold War superpowers agreeing to reduce nuclear stockpiles, Sun and Microsoft have stepped back from their own form of mutual assured destruction.
Perhaps eWeek is a bit too cynical. Another point-of-view would see the settlement as an indication that patenting does not lead to a technology stalemate. Sun and Microsoft were able to work through their differences and arrive at a solution that will be beneficial for both parties. Collaboration may also be aided by potential amendments to §102(f)/103