The U.S. Patent and Trademark Office (USPTO) sent out a gentle reminder in the Federal Register to all patent applicants and registered patent practitioners that the export of subject matter (transfer of information) abroad under a foreign filing license is limited to purposes related to the filing of foreign patent applications.

The Notice states:

Applicants who are considering exporting subject matter abroad for the preparation of patent applications to be filed in the United States should contact the Bureau of Industry and Security (BIS) at the Department of Commerce for the appropriate clearances.

Why?

If an invention was made in the United States, technical data in the form of a patent application, or in any form, can only be exported for purposes related to the preparation, filing or possible filing and prosecution of a foreign patent application, after compliance with the EAR or following the appropriate USPTO foreign filing license procedure. See 37 CFR 5.11(c). A foreign filing license from the USPTO does not authorize the exporting of subject matter abroad for the preparation of patent applications to be filed in the United States.

Exports of technology related to commercial and  dual-use items are generally subject to the Export Administration Regulations (EAR)  administered by the U.S. Department of Commerce’s Bureau of Industry and Security (BIS); exports of technology related to defense articles are subject to the International Traffic in Arms Regulations (ITAR), administered by the U.S. Department of State’s Directorate of Defense Trade Controls (DDTC). However, jurisdiction is granted to the USPTO under both the EAR and ITAR for technical data that is exported for limited the purpose of filing or possible filing and prosecution of a foreign patent application.  The scope of a foreign filing license granted by the USPTO is set forth in 37 CFR 5.15.

It is noteworthy that foreign filing licenses (for the filing of a patent application in a foreign country) do not cover all information related to the invention — only that which is truly necessary for the preparation of the application.  They also do not authorize the export of any technology that is not specifically submitted to the USPTO as part of a U.S. patent application or a petition for a foreign filing license. The USPTO explains:

For example, the USPTO has received short abstracts, PowerPoint® slides and even titles of inventions as the disclosure for which a foreign filing license is requested. Although the USPTO will usually process such requests, any foreign filing license granted under 37 CFR 5.15(a) or 5.15(b) on such short description may not authorize filing abroad the ultimate resulting patent applications and may not authorize any additional material added after the initial foreign filing license request. Such additional material that was not submitted to the USPTO for its review may be deemed to have altered ‘‘the general nature of the invention in a manner which would require such application to be made available for inspection under such section 181.’’

Furthermore, a foreign filing license does not permit transfers of technology that occur between employees of a company located in the U.S. and employees of an affiliated company overseas. A license must be obtained from the U.S. Department of Commerce or U.S. Department of State (depending on the technology) in order to  report on new inventions to a foreign parent company.  A foreign filing license also does not authorize the transfer of controlled technology to foreign nationals located in the U.S. as this is also classified as an export.

The USPTO has established a Licensing and Review web page that includes frequently asked questions regarding foreign filing licenses and related matters.   Information regarding the EAR may be obtained from the BIS Web site here.

This notice does not change existing law or regulations so it doesn’t mean exports without a license before the Notice were OK.  Now’s a good time to rethink outsourcing.

See: Outsourcing Legal Work (to the Midwest)

Posted July 31st, 2008 by Stephen Albainy-Jenei in Technology Transfer, USPTO, Current Affairs
| | 2 Comments »

Well, it looks like Margaret Peterlin, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office (USPTO), has announced that she will be leaving the USPTO in August with plans to pursue employment opportunities in the private sector.  It was probably going to happen some time after January 20th of next year anyway.

Commerce Secretary Carlos Gutierrez appointed Margaret J.A. Peterlin, formerly a national security House aide, to serve as Deputy Under Secretary.  Before joining the USPTO, Ms. Peterlin was Counsel for Legal Policy and National Security Adviser for the Speaker of the U.S. House of Representatives, J. Dennis Hastert.

Earlier, patent antagonist Greg Aharonian complained that the appointment of Ms. Peterlin to her position was unlawful because she does not have “a professional background and experience in patent or trademark law” as is apparently required under 35 U.S.C. § 3(b).

After a short run in the courts, U.S. District Court for the District of Columbia dismissed a lawsuit against the Secretary of Commerce for hiring an allegedly incompetent person to office. See Gregory Aharonian, et al. v. Carlos Gutierrez, Secretary of Commerce (07-1224) .  See the complaint at: http://www.bustpatents.com/peterlin.pdf.

The U.S. District Judge held:

A claim alleging violation of the standard in 35 U.S.C. § 3(b) is unreviewable under the [Administrative Procedure Act], however, because 35 U.S.C. § 3(b) lacks standards that a court could meaningfully use in evaluating this type of high-level personnel decision. Because the only statutory standard is vague and highly subjective, the decision whom to appoint Deputy Director must be considered “committed to agency discretion by law.”

This kind of case makes you wonder why we have a rule that can’t be enforced because it’s too vague.  I’m sure we’ll see more political appointees leaving their posts as January nears.

See more:

Can You Sue to Remove a Political Appointee Who Doesn’t Meet the Job Description?
When is a Patent Office Appointee Qualified? Judge Says Always.

Posted July 30th, 2008 by Stephen Albainy-Jenei in USPTO, Current Affairs
| | 4 Comments »

Just a final reminder of that we ended up having some iPod Shuffles left over from the BIO2008 International Convention.  In the new Patent Baristas iBarista contest, everyone has two new chances to pick up one of the iBarista iPods.

Chance 1.

For everyone to have an equal chance, I will randomly select a winner of an Apple iPod shuffle 1 GB from everyone who submits a new  comment on the PatentBaristas.com website in the month of July ‘08.  One entry per person — multiple comments will not increase your chances.  Comment spammers will be disqualified.

Chance 2.

For a chance to win another Apple iPod shuffle 1 GB, all you need to do is post a new link to the PatentBaristas.com website on your website.  I will randomly select a winner from everyone who posts a new link to the PatentBaristas.com website in the month of July ‘08.  One entry per person — multiple links will not increase your chances.  Link spammers will be disqualified.

Don’t forget to review the provisos here.  Otherwise, all of the previous iBarista iPod Giveaway Terms and Conditions still apply.

Given the response so far, this could be an easy win.

Posted July 28th, 2008 by Stephen Albainy-Jenei in Light Roast, Current Affairs
| | 9 Comments »

AstraZeneca filed an application for a patent term extension (PTE) of the patent term of U.S. Patent No. 5,674,860 under 35 U.S.C. § 156 in the United States Patent and Trademark Office.  They tried to get the extension based the time for FDA review under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) of Symbicort®, having the active ingredients, formoterol fumarate dihydrate and budesonide.

The Patent Office determined that the ‘860 patent was ineligible for patent term extension based upon the regulatory review period because (1) Symbicort does not constitute the first permitted commercial marketing or use of the product Symbicort (formoterol fumarate dihydrate and budesonide) under the provision of law under which such regulatory review period occurred, and (2) the PTE Application was not timely filed.

To qualify for a patent term extension under section 156, there are several requirements that must be satisfied. Section 156(a)(5)(A) provides:

(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b) if— (5)(A) except as provided in subparagraph (B) or (C), the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred;

Based on this statutory language, one of the eligibility requirements for a patent term extension is that the permission for the commercial marketing or use of the product be the first permitted commercial marketing or use of the product.  The term “product” is defined as a single entity or in combination with another active ingredient.

In this case, the PTE Application indicated that Symbicort contains two active ingredients: formoterol fumarate dihydrate and budesonide. The FDA official records indicate that formoterol fumarate dihydrate and budesonide were each approved for commercial marketing or use before the approval of Symbicort:

Because both active ingredients in Symbicort have been previously approved for commercial marketing or use before the approval of Symbicort, Applicant’s approval of Symbicort does not qualify as the first permitted commercial marketing or use of either active ingredient, as required by section 156(a)(5).  Therefore, the ‘860 patent is ineligible for patent term extension based on the regulatory review period of Symbicort.

AstraZeneca argued that since the product Symbicort is a synergistic combination of formoterol fumarate dihydrate and budesonide, it should be considered as a single active ingredient for patent term extension purposes. The Manual of Patent Examining Procedure (”MPEP”) which states: “Furthermore, an approved product having two active ingredients, which are not shown to have a synergistic effect or have pharmacological interaction, will not be considered to have a single active ingredient made of the two active ingredients.” MPEP § 2751.

The Patent Office begged to differ:

Applicant’s argument is incorrect. The synergistic effect of the active ingredients formoterol fumarate dihydrate and budesonide has no relevance in determining “first permitted commercial marketing or use of the product” as required by 35 U.S.C. § 156(a)(5)(A). The term “product” as used in 35 U.S.C. § 156 includes any new drug or antibiotic drug, “as a single entity or in combination with another active ingredient.” 35 U.S.C. § 156 (f)(2). Section 156(f)(2) says nothing about whether a combination is synergistic. See Arnold Partnership v. Dudas, 362 F.3d 1338, 1343 (Fed. Cir. 2004) (”Moreover, this court doubts that synergistic effects are an appropriate distinction for term extension policies, particularly where the statutory language does not distinguish at all between synergistic and nonsynergistic combinations.”).

AstraZeneca could appeal.

See the entire decision here.

Posted July 28th, 2008 by Stephen Albainy-Jenei in Pharmaceutical, USPTO
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Better Living Through Chemistry

The World Anti-Doping Agency claims that Italian rider Riccardo Ricco tested positive at the Tour de France after a secret molecule was planted in the blood booster EPO (erythropoietin) during its manufacture. Apparently, Roche included a molecule in the third generation of EPO, called Continuous Erythropoiesis Receptor Activator (CERA), that acted as a flag in drug tests showing when an athlete was using the substance.  Unlike single injections of rEPO, CERA interacts with erythropoietin receptors and has a longer-lasting effect. CERA is linked to polyethylene glycol (PEG), which allows it to last (and be detected)  longer in the body. (via Pharmalot)

Better Living Through Chemistry II

The Alcohol and Tobacco Tax and Trade Bureau issued a ruling to clarify that certain brewed products that are classified as “beer” under the Internal Revenue Code of 1986 do not meet the definition of a “malt beverage” under the Federal Alcohol Administration Act. Why does it matter, you ask?  Well, the definition of a “beer” under the IRC differs from the definition of a “malt beverage” under the FAA Act in several significant respects.  First, the IRC does not require beer to be fermented from malted barley; instead, a beer may be brewed or produced from malt or “from any substitute therefor.”  Second, the IRC does not require the use of hops in the production of beer.  Third, the definition of “beer” in the IRC provides that the product must contain one-half of one percent or more of alcohol by volume, whereas there is no minimum alcohol content for a “malt beverage” under the FAA Act.  So, a fermented beverage that is brewed from a substitute for malt (such as rice or corn) but without any malted barley may constitute a “beer” under the IRC but does not fall within the definition of a ” malt beverage” under the FAA Act.  Similarly, a fermented beverage that is not brewed with hops may fall within the IRC definition of “beer” but also falls outside of the definition of a “malt beverage” under the FAA Act.  Got that?  (via FDA Law blog)

Roche Wants Genentech for $43.7 billion

Swiss drug giant Roche is proposing to take complete control of San Francisco-based Genentech for nearly $44 billion.  Roche already owns 56 percent of Genentech, the world’s biggest biotech company in terms of stock value and second biggest in revenue to Amgen. Under the offer, Roche offered to buy all of Genentech’s remaining stock for $89 a share, or about $43.7 billion.  If the deal goes through, the final price will likely be much higher.

Is “Y” for whiners in Gen Y?

Scott Greenfield of Simple Justice has it out for Generation Y in a response to writings by Bad Court Thingy.

BCT writes:

So why isn’t Generation Y convinced that partnership is next to godliness, why isn’t there any loyalty to the firms that gave these young attorneys a job? Because we’ve watched what has happened to our parents generation.

Greenfield responds:

We thought you would watch us and understand that there’s a lot of life that sucks.  It always has, and success is understanding that it will be a struggle, that there will be accomplishments and setbacks, but that you still have to keep pushing through.  Ten percent inspiration and 90% perspiration.

In the end, BCT notes “But Boomers, be nice to us. We’ll be picking out your nursing homes.”  (via What About Clients)

Lord of the Links

It seems that Rudy Giuliani’s son, Andrew, has been kicked off the Duke University golf team and is suing to get back on. The 22-year-old aspiring pro golfer claims in a federal suit that Duke’s new golf coach trumped up a series of allegations to force him out and turn his classmates against him.  They claim the coach suspended him for a series of minor or fabricated infractions. Then the coach allegedly told Giuliani the suspension would be lifted only if all 12 of his teammates lobbied for him. Nice.  (via WSJ Law Blog)

The Virtual Attorney

Wired GC has an audio interview with Craig Johnson of Virtual Law Partners.  According the their web site, VLP is a distributed, web-based law firm that goes beyond the constraints of “brick and mortar” law firms to provide excellent legal service at rates lower than those of conventional law firms.  Also known as outsourcing.

Posted July 25th, 2008 by Stephen Albainy-Jenei in Friday Round-Up
| | 1 Comment »

The United States Court of Appeals for the Federal Circuit found in favor of Eisai in Aciphex patent infringement suit against Teva Pharmaceuticals and Dr. Reddy’s Laboratories .  Eisai v. Dr. Reddy’s and Teva (07-1397/98)

After Eisai filed infringement actions contesting Teva Pharmaceuticals and Dr. Reddy’s Laboratories’ submission of abbreviated new drug applications (ANDAs) to the Food and Drug Administration for Aciphex (rabeprazole), the district court found that Dr. Reddy’s and Teva failed to prove the remaining allegations of inequitable conduct and that Eisai had established that Dr. Reddy’s and Teva infringed Eisai’s patent (US 5,045,552).

The ’552 patent claims rabeprazole and its salts.  Rabeprazole is part of a class of drugs known as proton pump inhibitors, which suppress gastric acid production by inhibiting action of the enzyme H+K+ATPase.  Rabeprazole’s sodium salt is the active ingredient in Aciphex, a pharmaceutical approved for the treatment of duodenal ulcers, heartburn, and associated disorders.  Aciphex has over $1 billion in worldwide yearly sales.

Dr. Reddy’s and Teva each filed Abbreviated New Drug Applications (ANDAs) under the Hatch-Waxman Act looking to manufacture a generic version of Aciphex before the expiration of the ’552 patent.

The factual determinations of obviousness include 1) the scope and content of the prior art, 2) the level of ordinary skill in the art, 3) the differences between the claimed invention and the prior art, and 4) evidence of secondary factors, also known as objective indicia of non-obviousness.  Where the patent at issue claims a chemical compound, the analysis of the third Graham factor (the differences between the claimed invention and the prior art) often turns on the structural similarities and differences between the claimed compound and the prior art compounds.

The court stated:

Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound.  See Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007).   In keeping with the flexible nature of the obviousness inquiry, KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007), the requisite motivation can come from any number of sources and need not necessarily be explicit in the art.  See Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007).  Rather “it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship . . . to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old.”  Id. (quoting Dillon, 919 F.2d at 692).

Teva tried to argue that a combination of three prior art references made the ’552 patent obvious: 1) European Patent No. 174,726, claiming lansoprazole (EP ’726); 2) United States Patent No. 4,255,431, claiming omeprazole (’431 patent); and 3) an article by Brändström, et al., entitled “Structure Activity Relationships of Substituted Benzimidazoles” (Brändström).

The court noted that omeprazole is structurally farther afield from rabeprazole than is lansoprazole and that rabeprazole, lansoprazole, and omeprazole are all Brändström core structure compounds.

In the end, the court found that potential solutions are less likely to be genuinely predictable in the chemical arts:

Under these assumptions, one of skill in this art may have considered [rabeprazole] a candidate for a lead compound in the search for anti-ulcer compounds.  To the contrary, the district court emphasized the differences between anti-ulcer action and gastric acid inhibition.  The trial court specifically noted that Teva’s expert testified with respect to the EP ’726 data that “[t]he level of acid secretion . . . from these [anti-ulcer] data . . . cannot be determined.”  SJ Validity Order at 13.  In this context, this court consults the counsel of KSR that “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.”  127 S. Ct. at 1742.  Thus lansoprazole’s candidacy as a starting point to develop new anti-ulcer compounds versus new gastric acid inhibitors does not resolve the lead compound analysis, at least not in the absence of any contrary indications.  Cf. Takeda, 492 F.3d at 1359 (negative side effects could dissuade one of skill from using a particular compound as a starting point).

In KSR, the Supreme Court noted that an invention may have been obvious “[w]hen there [was] . . . a design need or market pressure to solve a problem and there [were] . . . a finite number of identified, predictable solutions.” 127 S. Ct. at 1742 (tense changes supplied to clarify, as the Court stated and as per 35 U.S.C. § 103, that the obviousness inquiry must rely on evidence available “at the time” of the invention, see Takeda, 492 F.3d at 1356 n.2).  The Supreme Court’s analysis in KSR thus relies on several assumptions about the prior art landscape.  First, KSR assumes a starting reference point or points in the art, prior to the time of invention, from which a skilled artisan might identify a problem and pursue potential solutions.  Second, KSR presupposes that the record up to the time of invention would give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound.  See Takeda, 492 F.3d at 1357  (“Thus, in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.”).  Third, the Supreme Court’s analysis in KSR presumes that the record before the time of invention would supply some reasons for narrowing the prior art universe to a “finite number of identified, predictable solutions,” 127 S. Ct. at 1742.  In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained that this “easily traversed, small and finite number of alternatives . . . might support an inference of obviousness.”  To the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these “identified, predictable solutions” may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.

In other words, post-KSR, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound.  Teva cannot create a genuine issue of material fact on obviousness through the unsupported assertion that compounds other than lansoprazole might have served as lead compounds.  Further, the record contains no reasons a skilled artisan would have considered modification of lansoprazole by removing the lipophilicity-conferring fluorinated substituent as an identifiable, predictable solution.  In sum, the district court properly concluded that the record did not support a case of obviousness of the ’552 patent as a matter of law.

Posted July 24th, 2008 by Stephen Albainy-Jenei in Pharmaceutical, IP Litigation
| | 1 Comment »

The business method patent industry is in a state of flux now, due to recent and upcoming Federal Circuit cases, most notably Bilski, and potential federal legislation that could have a profound impact in this area.  Thus, in-house and private practice attorneys who are involved with business method patents are very interested in the effects these potential reforms will have on BMPs going forward.

These topics are of primary concern to in-house counsel and executives at financial institutions and insurance companies and they will be covered in an up-coming conference on Business Method Patents. The speakers will be top IP counsel from the leading banking and insurance firms.

American Conference Institute’s Business Methods Patents will be held Wednesday, November 19, 2008 to Thursday, November 20, 2008 in New York, NY.

With all that’s at stake, you cannot afford to miss this conference.

Get all of the details here.

Posted July 14th, 2008 by Stephen Albainy-Jenei in Conferences
| | 2 Comments »

Jon Gowshall and Ross Walker, patent attorneys with the UK law firm Forresters, announced that they have successfully defended European patent (UK) number 0706376 (to Angiotech Pharmaceuticals Inc and the University of British Columbia), claiming a stent which eluted paclitaxel to prevent restenosis

In the case, the House of Lords overturned the first and second instances finding of obviousness. The result is moving the principles for assessing inventive step in the UK closer to those applied by the European Patent Office.

The patent teaches that restenosis can be prevented by preventing the growth of local blood vessels (angiogenesis). The inventors had discovered, in experiments, that paclitaxel, a recently discovered cancer drug, had remarkable anti-angiogenic properties. They concluded from this that it could prevent restenosis when delivered from a stent. The claimed stent is sold as the Taxus stent. It is a great commercial success.

The European patent was challenged in the UK Patents Court by Conor Medsystems Inc. The only ground of alleged invalidity was that the claimed stent was obvious.

Conor argued that the patent did not teach that the stent actually worked in preventing restenosis. They argued that, because of this, the test for obviousness was not whether the worker in the field would find it obvious that taxol on a stent would treat restenosis, but whether that worker would find it obvious to test the combination, without any expectation of success.

The Patents Court accepted Conor’s argument. The Judge agreed that, because the application did not actually show that paclitaxel would prevent restenosis, there was no need to decide if one might expect it to succeed.

The Court of Appeal agreed with the judge in the Patents Court and upheld his decision and Angiotech appealed to the House of Lords. The House of Lords is the highest court in the UK, and so the supreme court of appeal. It decides on points of law rather than the facts of an individual case and its decisions are binding on all courts below it.

The House of Lords upheld Angiotech’s appeal, and found that the claimed stent was inventive, using the proper test for obviousness. A number of important findings on the law of obviousness come from the decision. The overall tenor of the decision moves the UK law closer to the practice of the European Patent Office in assessing obviousness.

The Lords confirmed that inventive step must be decided on the claimed invention and the disclosure in the application has nothing to do with this assessment. In other words, the court must decide whether the subject matter of the claims is obvious, and the content, or otherwise, should not affect this decision.

However, the Lords also followed recent practice of the European Patent Office, as exemplified by T 1329/04. They confirmed that, before considering inventive step, the patent must pass a “threshold test” of plausibility. In that test, the court reviews the whole specification and decides whether, on the basis of the specification alone, it is plausible that the invention will work. The Lords found it plausible that the claimed invention would work to treat restenosis, based on the data and teaching in the specification.

Finally, the Lords confirmed that the court must assess the obviousness of the claimed invention in the light of the purpose for which is intended. The court should also take into account the expectation of success that the skilled person would have of achieving that purpose with the invention. Both of these principles are followed by the European Patent Office. The Netherlands court also applied them in parallel proceedings, which was noted with approval by the Lords.

Lord Hoffman described the idea of assessing whether something is obvious to try without an expectation of success (the test applied in the Patents Court) as an “oxymoronic concept”, with no precedent in patent law.

The Lords held that the claimed stent was inventive, in that a skilled person would not have tried it with any reasonable expectation that it would be effective to treat restenosis. In doing so, they have moved the UK approach to obviousness significantly closer to that taken by the European Patent Office.

You can read the text of the full decision here.

Posted July 10th, 2008 by Stephen Albainy-Jenei in International, IP Litigation
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